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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Painful Joint Prostheses Patients selected for entry into this study will be men or women of any ethnic background who are scheduled to undergo clinical and diagnostic evaluation by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania Health System or by the collaborating physicians at the Rothman Institute or the VA Philadelphia Medical Center. Study I: FDG-PET imaging in painful partial or total joint prostheses Each patient who is a candidate will be evaluated by one of the collaborators mentioned above for a painful partial or total joint prosthesis. The patient will undergo an appropriate routine evaluation including history, physical examination, radiographic, scintigraphic, and necessary laboratory evaluation. An initial diagnosis must be made for each patient. The diagnosis of loosening will be established based on clinical examination and/or radiographic evaluation demonstrating clear evidence of this complication. Other etiologies for the joint pain, except for infection and aseptic loosening, need to be excluded. Surgical intervention (prosthesis revision) may or may not be planned for the patient who is a candidate for this study. Study II: FDG-PET imaging following uncomplicated partial or total joint arthroplasty All patients fulfilling the below will be considered potential candidates for this study. Each patient must have a diagnosis of degenerative joint disease caused by osteoarthritis (no previous hip surgery) and have undergone primary partial or total joint arthroplasty by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania or referring hospitals. Other causes of degenerative joint disease will be excluded by physical, radiographic and laboratory evaluation as clinically indicated. Osteoarthritis is the most common cause of degenerative joint disease, and in order to avoid any confounding factors in experimental results that may be caused by other types of disorders, only this group of patients will be studied. A patient will be eliminated from this group at anytime if the post-operative course is complicated by any process that is thought to influence the outcome. Variations from an uncomplicated postoperative course will be determined by the operating surgeon and clinical signs or other evidence to suggest infection, early loosening, or any other process directly involving the prosthesis Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into the study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Snoring Sleep Apnea Syndromes yrs. of age or greater generally good health Intact dentition / upper and lower wisdom teeth ( by extraction or lack of development ) Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by polysomnogram) Subject must have a concerned observer to assess of sleep and snoring behavior during trial period Presence of Wisdom teeth (third molars) active oral disease acute illness BMI (body mass index) > 30
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Clinical diagnosis of acromegaly The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry Life expectancy of at least 2 years Adenectomy within past 6 months, or likely during study period Radiotherapy for acromegalic disease within 1 year, or likely during study period Unstable concomitant dopamine agonist therapy
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Migraine Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up Failure to consent Pregnancy Allergy to study medication Findings inconsistent with migraine Patients requiring hospital admission for further investigation and treatment Patients with active peptic ulcer disease Patients with Type 1 diabetes Patients taking corticosteroids for another condition within 7 days Active systemic fungal infection Patients previously enrolled in the study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Hypogonadism Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Newly diagnosed or previously untreated acromegalic patients Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT) IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI) Symptomatic cholelithiasis Other protocol-defined
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Male or female patients aged 18 years Newly diagnosed or previously treated acromegalic patients Lack of suppression of GH nadir to <1.0 microg/L, after oral administration of 75 g of glucose (OGTT) IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI) Symptomatic cholelithiasis Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x > upper limit of normal, or total bilirubin 1.5 x > upper limit of normal Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Medically acceptable methods oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended History of immunocompromise, including a positive HIV test result (ELISA and Western blot). Other protocol-defined inclusion/
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Permanent Atrial Fibrillation Patient has signed informed consent form Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month New York Heart Association (NYHA) Class I, II, III Patient is able to comply with follow-up times and will comply with the protocol > 18 years of age Paroxysmal atrial fibrillation NYHA Class IV Left ventricular ejection fraction (LVEF) < 35 Patients with unstable angina Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment Patient candidate for cardiac surgery, or coronary angioplasty (PTCA) Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability Life expectancy < 12 months due to other medical conditions Pregnancy The patient is enrolled in any concurrent (drug and/or device) study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-99.0, Congenital Adrenal Hyperplasia (CAH) Familial Male-Limited Precocious Puberty (FMPP) Males, ages 0 with known or suspected FMPP or 2. Patients (males and females, ages 0 with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type. 3. Patients with excess androgen of unknown etiology or 4. Relatives of patients in this protocol Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no longer be followed on this protocol. 2. Patients with significant non-endocrine medical conditions. 3. Females who are pregnant at the time of initial enrollment
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-21.0, Congenital Disorders Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January June, 2004 Those who did not meet criteria
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-45.0, Acne Vulgaris Patients with mild to moderate facial papulopustular acne Contraindication against use of hormonal contraceptives
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-65.0, Acquired Brain Injury (Including Stroke) Age between eighteen and sixty-five years old At minimum, one year post-injury Glasgow Coma Score (GCS) of 12 or less, or stroke with hemi-paresis signifying a moderate to severe acquired brain injury A TBI that resulted in either a closed or open head injury or a stroke that resulted in severe disability Perform at least one standard deviation below the norm on the DANVA2-Adult Faces test, a standardized assessment of facial affect recognition Verbally able to express a basic understanding of emotional descriptors (e.g. Happy, sad, angry, fearful) Demonstrate basic comprehension for short paragraphs presented in 2 ways: 1)auditorily and 2)silent reading. This measure is part of the Discourse Comprehension Test Diagnosed mental illness Uncorrected visual acuity Uncorrected hearing impairment Perceptual impairment (visual neglect and/or visual discrimination) Impaired verbal expression/ aphasia Alcohol or substance abuse
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 40.0-65.0, Quality of Life Menopausal Syndrome Libido Disorder Women who: 1. are 40 to 65 years of age, at least 12 months postmenopausal (no spontaneous menses in the last 12 months, or be over the age of 55 years, or hysterectomy with one or both ovaries in situ and follicle-stimulating hormone [FSH] > 20 IU/L. (An FSH > 20 IU/L will also be used to confirm menopausal status in non-hysterectomised women < 55 years, where menopausal status is unclear.) 2. are sexually active -defined as being involved in any form of sexual activity at least once a month. Women do not require a partner. 3. have a body mass index (BMI) 18-34 kg/m2. 4. answer affirmatively to the following questions In previous years did you find sexual activity satisfying? Do you feel that you have experienced a significant decrease in your desire or interest? Would you like an improvement in your desire or interest for sexual activity? Would you like to be treated for this? 5. Have a clinically acceptable screening bilateral mammogram 6. Have ≤ 4 mm endometrial double thickness and no other abnormal findings on TVU if not hysterectomised. 7. Have a clinically acceptable Pap smear if the cervix is present, 8. Be able and willing to participate in the study as evidenced by providing written informed consent. 9. have a baseline DHEAS level of < 2.1 umol/L Have a BMI < 18 or > 34 kg/m2 2. Dyspareunia not alleviated by use of lubricants. 3. Severe depression (Beck Depression Inventory Score-II [BDI] > 20). 4. Have partnership problems. This will be established by interview by asking the following questions if a woman is in a specific relationship: 1. Are you satisfied with your partner as a friend? 2. Do you have concerns about your relationship? 5. Have used recent androgen therapy (testosterone implant within the last 28 weeks, transdermal testosterone cream within the last 8 weeks, tibolone within the last 12 weeks, oral testosterone within the last 4 weeks and injected testosterone within the last 6 weeks). 6. Have used treatment for depression (antidepressants, antipsychotics, antiepileptics) within 2 months ). 7. Have known severe psychiatric illness. 8. Have used estrogen, including vaginal conjugated equine estrogen, vaginal ring delivering up to 7.5 µg/day, or estrogen-progestin combinations in the last 2 months. (Use of Ovestin or Vagifem pessaries or cream will be allowed.) 9. Used phytoestrogens within 1 week prior to Week -4 (Visit 1). (Women will be allowed to participate in this trial, provided they cease using phytoestrogens for at least 1 week before visit 1.) 10. Have renal disease, liver disease, epilepsy, or diabetes mellitus or any other major illness that has occurred within the last 6 months. 11. Therapies known to induce liver enzyme metabolism or alter the metabolism of DHEA e.g. antiepileptics, dexamethasone, or antituberculous drugs. 12. Undiagnosed genital bleeding. 13. Have moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, or have androgenic alopecia. 14. Active malignancy or treatment for malignancy in the preceding 5 years (excluding non-melanotic skin cancer). 15. Report alcohol consumption > 3 standard drinks per day. 16. Have a history of cerebrovascular disease, thromboembolic disorders, myocardial infarction or angina at anytime before study entry or thrombophlebitis within the last 5 years. 16. An abnormal thyroid-stimulating hormone (TSH) value at screening (however, participants with an abnormal TSH, but normal free T4 and free T3 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study). 17. Have abnormal liver function (LFTs) which is significant and/or an ALT or AST > 3 times the upper limit of normal or bilirubin > 2 times the upper limit of normal
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Psoriasis Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents Be aged 18 years or older Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis Be a candidate for systemic therapy in the opinion of the investigator Be naive to efalizumab treatment Weigh no more than 125 kg For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab Have a history of hypersensitivity to efalizumab or any of its components Are using any excluded therapy Have a history of or ongoing alcohol or illegal drug abuse Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded Have any history of opportunistic infections (e.g., systemic fungal infections, parasites) Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Patients will undergo testing during screening, and any patients who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal or squamous cell skin cancer may be enrolled Are pregnant or lactating women Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 65.0-999.0, Dementia Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy Subjects under age 65 will not be recruited, in order to enhance the clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging Overt dementia, as discussed above Cognitive dysfunction has impaired subject's ability to perform activities of daily living Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.) Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing Cholinesterase inhibition therapy already initiated
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Male and female patients (> 18 years) with prior surgery of micro or macroadenoma of the pituitary At least 6 months chronic treatment with 30mg octreotide (long acting release) Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used Lack of suppression of GH nadir to < 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient Patient's written informed consent Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass Radiotherapy planned or radiotherapy for acromegaly within the last 2 years Symptomatic cholelithiasis that is clinically relevant Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis. Other protocol-defined inclusion/
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome PCO ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 50.0-75.0, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndrome Essential Thrombocythemia Myeloproliferative Neoplasm Paroxysmal Nocturnal Hemoglobinuria Polycythemia Vera Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase Primary Myelofibrosis Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Ring Sideroblasts Refractory Cytopenia With Multilineage Dysplasia Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts Patients aged >= 50 and < 75 years (yrs) with CMML, or previously untreated MDS or MPD Patients aged < 50 yrs at high risk for regimen related toxicity using standard high dose regimens; factors considered high risk pre-existing conditions such as a chronic disease affecting kidneys, liver, lungs, or heart or previous failed HCT An human leukocyte antigen (HLA)-identical related or an HLA-matched unrelated donor (Fred Hutchinson Cancer Research Center [FHCRC] matching allowed will be Grade 1.0 to 2.1) is available Recovery from the effects of previous chemotherapy, with a minimum of 21 days from initiation of last therapy; hydroxyurea or anagrelide may be used to manage elevated cell counts in patients up to the time they begin therapy under this protocol Patients < 12 yrs of age must be discussed on a case by case basis with the primary investigator (PI) of the protocol prior to registration A signed informed consent form or minor assent form MDS: MDS classifiable by the World Health Organization (WHO) system as RA, RARS, refractory cytopenia with multilineage dysplasia (RCMD), RCMD and ringed sideroblasts (RCMD-RS) or RAEB MDS: No previous myelosuppressive therapy; for the purpose of this protocol myelosuppressive chemotherapy will be defined as chemotherapy given with the intent of inducing a complete remission (e.g., standard 7+3, high dose intermittent ARA-C [HIDAC], or Mylotarg) MDS: Patients must have < 10% marrow blasts; fewer than 10% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning CMML: Patients with CMML1 who have not received myelosuppressive therapy must have < 10% marrow blasts; fewer than 10% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning; OR patients with CMML who have progressed beyond CMML1 and have received myelosuppressive chemotherapy must have < 5% marrow blasts; fewer than 5% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning Organ dysfunction as defined by the following Symptomatic coronary artery disease or cardiac ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%); if shortening fraction is < 26% a cardiology consult is required with the principal investigator (PI) having final approval of eligibility; ejection fraction is required if age > 50 years or there is a history of anthracycline exposure or history of cardiac disease Diffusing capacity of the lung for carbon monoxide (DLCO) < 35%, TLC < 35%, forced expiratory volume (FEV)1 < 35% and/or receiving supplementary continuous oxygen; the FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules Liver function abnormalities: Patient with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; the patient will be excluded if he/she is found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, or symptomatic biliary disease Bone marrow documenting blast count >= 10% or >= 5% in CMML patients who have progressed beyond CMML1 and received myelosuppressive chemotherapy Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this does not apply to patients with non-hematologic malignancies that do not require therapy Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence Presence of >= 5% circulating leukemic blasts (in the peripheral blood) detected by standard pathology Active central nervous system (CNS) involvement of disease Karnofsky performance score < 70% or Lansky-Play Performance score < 70 for pediatric patients
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Estrogen Receptor-positive Breast Cancer HER2-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment) + nodes OR if 1-3 + nodes, either ER OR HER-2/neu+ OR have high-risk node negative disease that is HER-2/neu positive OR >= 2.0 cm tumor size HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration WBC >= 4,000 ANC >= 1,500 Platelet count >= 100,000 Serum creatinine =< 1.5 x IULN Except for the following, no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situcervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible; this includes Angina pectoris that requires the use of antianginal medication Cardiac arrhythmia requiring medication Severe conduction abnormality Clinically significant valvular disease Cardiomegaly on chest x-ray Ventricular hypertrophy on EKG Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg) Current use of digitalis or beta blockers for CHF
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Migraine Headache Aura Male and female patients between the ages of 18 to 70 years, inclusive. 2. Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months. 3. Patients who have a history of migraine and have had at least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks per month). Current and past migraine medication history must be recorded. 4. Patients who agree to: not use the study drug within 72 hr of a prior migraine attack, and to use the investigational medication when they have a pain rating of Moderate or Severe (on a None, Mild, Moderate or Severe Scale) prior to dosing. 5. Patients who speak, read, and understand English sufficiently well and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures. 6. Patients who are willing and able comply with the study schedule and study requirements, and agree to return to the clinic within 5 working days of use of the investigational treatment. 7. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator. 8. Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. Prohibited methods the rhythm method, withdrawal, condoms alone, or diaphragm alone Patients who are currently taking tricyclic antidepressants, valproate, divalproex, barbitals, thiazolidinediones, phenothiazines, benzodiazepines, lithium or any hepatic toxic drugs must be excluded. 2. Patients who are currently taking medications that prolong the QT/QTc interval (see Appendix 4) must be excluded. 3. Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded. 4. Patients with a history of allergy or intolerance to phenothiazines and related drugs (prochlorperazine, chlorpromazine, promethazine, mesoridazine, thioridazine, fluphenazine, perphenazine) must be excluded. 5. Patients with a history of extra-pyramidal disorders, movement disorders, neuroleptic malignant syndrome, or major affective disorder must be excluded. 6. Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded. 7. Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded. 8. Patients who have a history of pheochromocytoma, seizure disorder or Parkinson's disease must be excluded. 9. Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 mos), congestive heart failure, or transient ischemic attack must be excluded. 10. Patients who have a history of a major neurological disorder other than migraine (subarachnoidal bleeding, stroke, brain tumor) must be excluded. 11. Patients who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, Bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion, would present undue risk to the patient or may confound the interpretation of study results must be excluded. 12. Patients who have a history of asthma or chronic obstructive lung disease should be excluded. 13. Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded. 14. Patients who have a history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) must be excluded. 15. Patients who have a marked prolongation of QT/QTc interval (e.g., demonstration of a QT interval >450 ms on screening ECG) must be excluded. 16. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 10.0-999.0, Cystic Fibrosis have confirmed diagnosis of cystic fibrosis have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height be able to reproducibly perform spirometry maneuvers be clinically stable for at least 4 weeks prior to screening have abnormal renal or liver function have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease have had a lung transplant
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-38.0, Polycystic Ovary Syndrome All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS are according to modified Rotterdam (7); i.e., oligoovulation defined as < 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey >8) or laboratorial (total Testosterone >=0.81 ng/dL) or polycystic ovary > 10cm3. Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol Age >18 years old and <= 38 years old No endometriosis on laparoscopy Not willing to participate in the study use of IUD or contraceptive pill within 2 months before the study Hyperprolactinemia (>20ng/mL) Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL) High 17-OH progesterone (>=4.9ng/mL) Endometriosis Known allergy to clomiphene or raloxifene
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 50.0-999.0, Hypogonadism Androgens Subjects were at least 50 years of age A body mass index (BMI) between 18 and 34 kg/m^2 Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire) Calculated free testosterone measurement of <0.26 nmol/L in the morning History or current diagnosis of breast or prostate cancer any clinically significant abnormal finding on physical examination including the prostate Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14) Prostate specific antigen (PSA) level > 4 ng/mL at screening Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism Hyperprolactinaemia or treatment with prolactin-lowering drugs History of known chronic polycythemia and/or hematocrit >50% at screening History or presence of severe sleep apnea Unstable or untreated endocrine disorders History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-999.0, Low Back Pain Age > 21 Chronic axial low back pain without radicular pain for > six months, not responding to at least three months of non-surgical management under the direction of a physician One or two discs at L5/S1, L4/L5 or L3/L4 with abnormal findings by MRI, including any of the following: loss of disc hydration, loss of disc height, high intensity zone (HIZ), Modic changes at adjacent vertebral endplates, or herniation without nerve root compression Subject states that he/she is willing to undergo lumbar spinal fusion, disc replacement, or other definitive treatment if eventual diagnosis supports such treatment Physician believes that discography is clinically indicated for the purpose of surgical decision-making for the subject Pre-treatment low back pain by numerical rating scale (NRS) score > 4 (measured as average in last 24 hours on a 0-10 scale) Pre-treatment Oswestry Disability Index (ODI) > 40 (0 scale) Subject states availability for all study visits Subject is able to understand the risks and benefits of participating in the study and provides written informed consent Known osteoporosis or osteopenia, metabolic bone disorder, or history of chronic steroid use (the equivalent of 7.5 milligrams of daily prednisone use for > 6 months) Suspected painful disc degeneration (based on clinical examination and MRI findings) outside of L5/S1, L4/L5 or L3/L4 levels MRI shows disc abnormalities (listed in #3) at all 3 lower lumbar discs (L3/L4, L4/L5 and L5/S1) Abnormal neurologic exam attributable to lumbar disc disease, herniation, or lumbar stenosis Back, buttock or pelvic pain suspected to be due to spinal stenosis, spinal fractures, infection, cancer, facet arthropathy or other hip or pelvis pathology Schmorl's node or endplate disruption evident on MRI at L5/S1, L4/L5, or L3/L4 Medical history, physical examination or radiographic evidence (e.g., disc height too narrow) to suggest that either PD or F.A.D. may not be technically feasible Any previous lumbar spine fusion or disc replacement More than grade 1 spondylolisthesis as assessed by x-ray or MRI Significant clinical comorbidity that may potentially interfere with data collection or follow-up (e.g., dementia, severe comorbid illness)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Polycystic Ovary Syndrome To be included in this study, primary twins must: 1. Be a premenopausal female twin over the age 18 (this will be asked during recruitment). 2. Have a living female co-twin (this will be asked during recruitment). 3. Have a history of probable PCOS defined by having one or more of the following as self-reported in the Phase 1 PCOS survey. These traits will be confirmed during medical evaluation: 1. History of chronically irregular menstrual cycles 2. History of hirsutism 3. History of hair loss 4. Cysts in ovaries 5. Body-mass index greater than 25 6. Acne 4. Be able and willing to give informed consent. 5. Agree to undergo a medical evaluation for PCOS. To be included in this study, co-twins must: 1. Be a premenopausal female twin over the age of 18 (this will be asked during recruitment). 2. Be able and willing to give informed consent. 3. Agree to undergo a medical evaluation for PCOS Women will be excluded from the study if they are pregnant or have given birth within the past six months. Women will also be excluded if they are currently menopausal or past menopause. Women with any condition that, in the opinion of the investigators, could affect the validity of the study results will be excluded from participating. Subjects will not be excluded based on race, ethnicity or religion
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Patients with rheumatoid arthritis meeting ACR criteria Justifying anti-TNF alpha treatment (switch or first administration) To have at least 6 synovitis at the clinical examination necessary for the DAS evaluation To accept to participate in this study (informed consent signed) Minor patients Pregnancy Breastfeeding
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly The subject must give signed informed consent before any study-related activities The partner, if applicable, must give signed informed consent before administration of Somatuline Autogel The subject must be able to understand the protocol requirements The subject must have a clinical diagnosis of acromegaly due to pituitary tumor The subject must be treated with a long-acting somatostatin analogue with or without a dopamine agonist and have been on the current medical regimen for at least 3 months prior to screening and have IGF-1 levels no higher than 10% above the upper limit of the normal range for age and gender at the screening visit or be somatostatin analogue naïve (if the subject is treated with a dopamine agonist he/she must have been on the current dose for at least 3 months prior to screening) Subjects who are treated with a dopamine agonist have to stay on their current dose for the duration of the study Switch subjects must have had their last pre-study routine clinical treatment with Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment) The subject must be able to store the study medication in a refrigerator in his/her own or his/her partner's home The subject must be ≥18 years of age Female subjects of childbearing potential must use adequate contraception The subject has had pituitary surgery (adenomectomy) within 3 months prior to screening The subject has received pituitary radiotherapy within 3 years prior to screening The subject has received a GH receptor antagonist within 6 months prior to screening The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d The subject is pregnant or breastfeeding The subject has clinically significant renal or hepatic abnormalities The subject has a symptomatic, untreated biliary lithiasis The subject has uncontrolled diabetes or thyroid disease The subject has a known hypersensitivity to any of the test materials or related compounds The subject is unable or unwilling to comply with the protocol
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome Irregular menses or anovulaty cycles High free testosterone > 0.035 nmol/l or hirsutism PCO in vaginal US 1 and 2 OR 2 and 3 Age > 18 years Postmenopausal Diagnosis diabetes mellitus Use of medicine known to affect hormones measured in the project Pregnancy or planned pregnancy during study period Non-Caucasian Previous tromboembolic disease Heavy smoker > 35 years and BMI > 35 kg/m2
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly patients with newly diagnosed acromegaly age above 18 years no previous treatments for acromegaly primary surgery concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist primary treatment with lanreotide treatment duration less than 24 months
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Acromegaly Growth Hormone Deficiency for acromegaly Clinical and biochemical diagnosis of acromegaly. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status Males and females aged 18-70 years willing to give informed consent At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to into the study Systolic blood pressure < 180 mmHg, diastolic blood pressure < 110 mmHg. for GHD Clinical and biochemical diagnosis of GHD. All hormones replaced (if clinically necessary) except GH. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status Males and females aged 18-70 years willing to give informed consent At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to into the study Systolic blood pressure < 180 mmHg, diastolic blood pressure < 110 mmHg for acromegaly Change in medication in the preceding 4 weeks Patients on subcutaneous insulin therapy Hyperthyroidism Not being in sinus rhythm Unstable angina pectoris and decompensated heart failure (define as NYHA 3-4) Clinically significant valvular disease, clinically significant chronic obstructive pulmonary disease History of myocardial infarction or stroke within the last 6 months, major cardiac surgery within the last 6 months Significant history of drug or alcohol abuse or unable to give informed consent
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Ringed Sideroblasts Refractory Cytopenia With Multilineage Dysplasia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Untreated Adult Acute Lymphoblastic Leukemia Untreated Adult Acute Myeloid Leukemia Diagnosis of 1 of the following diseases by bone marrow aspiration and/or biopsy Myelodysplastic syndromes (MDS) meeting the following Must have 1 of the following subtypes Refractory anemia (RA) (no RA with 5q-syndrome) RA with ringed sideroblasts or Refractory cytopenia with multilineage dysplasia Myelodysplastic syndromes (MDS) meeting the following Must have 1 of the following subtypes Refractory cytopenia with multilineage dysplasia and ringed sideroblasts RA with excess blasts (RAEB)-1, RAEB-2 Myelodysplastic syndromes, unclassified or
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Severe Adult Growth Hormone Deficiency Over 18 years of age Confirmed severe AGHD GH response <9 mU/l (preferably <4) to insulin-induced hypoglycaemia or glucagon stimulation test plus (These tests will have taken place as part of routine management) Full, stable pituitary replacement therapy Willing to provide informed consent Unwilling to provide written consent Current GH therapy Pharmacological doses of glucocorticoids Any acute illness
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 12.0-74.0, Pituitary Diseases pituitary adenomas of more than 3 % of Ki67 labeling index surgically treated at Tohoku university and associated hospital pituitary adenomas of less than 3 % of Ki-67 labeling index surgically treated at Tohoku university and associated hospital
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-999.0, Smoking Cessation Every mother presenting her newborn for the first time in the pediatric practices will be screened. Of these, all women smoking at the date the female received verification of her pregnancy are eligible for the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-37.0, Polycystic Ovary Syndrome To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic as well as one of the following two symptoms: 1. Anovulation/oligoovulation defined as ≥ 35 days during the last year 2. Clinical signs of hyperandrogenism (hirsutism, acne) Cardiovascular disease Diabetes mellitus Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome) Estrogen/gestagen treatment during the last 3 months Breast-feeding the last 6 months Antiandrogen treatment the last 3 months
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Congenital Hypothyroidism Patients with congenital hypothyroidism due to thyroglobulin defective synthesis Patients with another disease
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-5.0, Congenital Hypothyroidism L-Thyroxine Follow-Up The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows Hypothyroidism TSH > 40 mU/L and T3 and T4 below the reference range or TSH > 40 mU/L, T3 normal and T4 below the reference range [2] Subclinical hypothyroidism TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome (1) Non-obese and obese women with PCOS between 18-40 years of age. (2) oligomenorrhea ( 8 menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free testosterone), (4) normal thyroid function tests and serum prolactin, and (5) of 21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone <200 ng/dl.41 (6) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis). (7) Signed, witnessed informed consent. (8) Ability to comply with study requirements (1) Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use of oral contraceptives, DepoProvera or Norplant.. (3) Documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) Ingestion of any investigational drug within two months prior to study onset
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values Patients who have undergone pituitary surgery less than 3 months before selection Patients previously treated with radiotherapy Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Acromegaly Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1 Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1 Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg The patient has received pituitary radiation therapy of any kind at any time prior to visit 1 The patient has received pituitary surgery within 3 months prior to visit 1 The patient's serum creatinine is higher than 150 µmol/l
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly GH nadir during a standard 75 g OGTT >= 5.0 mmol/L Pituitary tumor by MRI-scan Immediate surgery indicated by usual clinical criteria Pregnant Known adverse effects of octreotide Unfit for participation by any other reason
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Diagnosis of active acromegaly based on evidence of a pituitary tumor Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test Previous treatment with a stable dose of octreotide LAR for at least 3 months No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity Uncontrolled diabetes mellitus Pregnant or breast feeding Current gallstones History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic steatosis Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy History of investigational drugs administered or received within 30 days of study entry Known hypersensitivity to octreotide LAR Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Idiopathic Hirsutism Idiopathic hirsutism which is defined as normal levels of androgens and normal ovulation Normal serum prolactin Pregnancy Simultaneous use of other drugs for the treatment of hirsutism
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 25.0-75.0, Breast Cancer Bloody Nipple Discharge Women age 25 Women with a negative diagnostic mammogram and ultrasound Women with a history of bloody nipple discharge which can not be reproduced by the examining physician or the patient in the office Pregnant or lactating Unable to understand or sign a consent form Physically unable to sit upright and still for 40 minutes
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Psoriasis Moderate to severe palmar plantar psoriasis based on physician's global assessment (PGA) Between 18 and 70 years of age Negative urine pregnancy test at screening and at baseline Sexually active men and women of child-bearing potential must agree to use a medically accepted form of contraception (birth control) during the exclusionary medicine wash-out period and throughout the study Ability to self inject study drug or have a designee who can do so Capable of understanding and giving written voluntary informed consent Previous treatment with Enbrel® (etanercept) or similar drugs Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit Evidence of skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the study medication Receipt of any biologic medication within the previous 6 months that resulted in a decreased white blood cell count (cells to help fight infections) Ultraviolet light treatment (e.g. UVB, PUVA) within one month prior to study drug initiation Receipt of immune-suppressing drugs other than Rheumatrex® (methotrexate) or Soriatane® (acetretin) within 4 weeks prior to the first dose of study drug. Medications you would not be allowed to take during this study for example, Cytoxan® (cyclosporine), Imuran® (azathioprine), or Sulfazine® (sulfasalazine). If you remain on Rheumatrex® (methotrexate) (≤25 mg/week) or Soriatane® (acitretin) (≤50 mg/day), you must be considered to have inadequate disease control in the opinion of the investigator based on physician's global assessment. You must have been on a stable dose of systemic treatment for at least 1 month prior to the start of the study medication. You will be required to maintain a stable dose of the systemic treatment throughout the study Use of topical steroids in the past 14 days unless they have been used for longer than 14 days and the severity of disease allows entry into study Systemic steroid use (prednisone, etc) Prior or concurrent use of Cytoxan® (cyclophosphamide) Elevated liver tests; red blood cell count less than normal; decreased platelet count (cells to help with blood clotting); decreased white blood cell count (cells to fight infection); kidney insufficiency
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly patients with acromegaly currently on stable pegvisomant therapy patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study patients must not be co-treated with any other medication for acromegaly radiotherapy within the last 2 years any relevant acute disease history of hypersensitivity against any of the used drugs pregnancy or lactation abnormal baseline findings
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Pituitary Tumor patients harboring secretory or non-secretory adenomas and/or siblings and/or spouses patient without consenting siblings and/or siblings and/or spouses
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Patients with active acromegaly (based on elevated GH and IGF-1 levels) Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization Patients with compression of the optic chiasm causing any visual field defect Patients who have received pituitary irradiation within the last ten years prior to visit 1 Poorly controlled diabetic patients Other protocol-defined inclusion/
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Advanced Nonsmall Cell Lung Cancer Histologically confirmed non-small cell lung cancer Stage IIIB (effusion) or stage IV disease Must be receiving daily erlotinib hydrochloride for more than 3 months Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-85.0, Acromegaly No previous treatment for acromegaly primary surgery concomitant hyperprolactinemia requiring combined somatostatin analogues and dopamine-agonist treatment primary treatment with lanreotide
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-65.0, Brain and Central Nervous System Tumors Clinically demonstrable pituitary tumor, including either of the following subtypes ACTH-secreting adenoma Residual or recurrent disease ≥ 1 month after prior pituitary surgery Clinically demonstrable tumor, as evidenced by both of the following Elevated 24-hour urinary free cortisol (UFC) level Lack of suppression of 8 a.m. serum cortisol to < 1.8 µg/dL after administration of dexamethasone 1 mg at 11 p.m. the previous night Tumor demonstrated by MRI performed with and without contrast and/or by inferior petrosal sinus sampling with evidence of a central ACTH source Normal visual field evaluation by Goldman perimetry Hypopituitarism allowed as evidenced by any or all of the following Subnormal growth hormone (GH) response to arginine/GH-releasing hormone testing (normal response is an increase of 2-6 ng/me) Acromegaly as demonstrated by normal serum insulin-like growth factor-1 (IGF-1) level Cushing disease as demonstrated by normal 24-hour UFC cortisol level Prolactinoma as demonstrated by normal to moderately elevated prolactin levels (moderate elevations in serum prolactin [< 200 ng/mL] can occur in non-secreting tumors due to pituitary stalk displacement) clinically significant renal, hematologic, cardiac, or hepatic abnormalities within the past month other active malignancy within the past five years except basal cell carcinoma or carcinoma in situ of the cervix evidence of drug or alcohol abuse prior or current medical condition that may interfere with the conduct of the study or evaluation of its results, in the opinion of the Investigator or the Data Safety Monitoring Board compliance officer postmenopausal female receiving HRT pregnant or nursing history of immunocompromise, including known HIV positivity as measured by enzyme-linked immunosorbent assay and western blot
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acne Vulgaris years old or older Phototype greater than I Facial inflammatory acne with 15-50 inflammatory lesions and less than 50 non-inflammatory lesions (excluding the nasal pyramid) Did not receive a topical acne treatment in the last 15 days Did not receive cyclins or zinc-based treatment in the last month Did not take Diane-35 in the last 2 months. Current use of oral contraceptives is acceptable if the subject is on a stable dose for at least six months prior Day 0 Did not take oral isotretinoin for the last 12 months Did not change their cosmetic habits in the last 15 days (ex: shaving cream) Agree to participate to the entire study Less than 18 years old Phototype I With less than 15 or more than 50 inflammatory lesions on the face (excluding the nasal pyramid) With more than 50 non-inflammatory lesions on the face (excluding the nasal pyramid) Have taken 1) A topical acne treatment in the last 15 days, or 2) Cyclins or zinc-based treatment in the last month or 3) Oral isotretinoin in the last 12 months Woman: 1) Taking Diane-35, or 2) Taking an oral contraceptive for less than 6 months or 3) That are pregnant or 4) That are nursing or 5) Not using any efficient contraception method (if necessary) With a history of allergic reaction or hypersensitivity to one of the constituents of the study product With peroxide sensitivity With history of photosensitivity With history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Patients with active acromegaly [serum GH levels above 2.5 μg/liter and/or above 1 μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values] with a micro (<10 mm max tumor diameter) or macroadenoma (>10 mm max tumor diameter) Patients never treated before Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions Patients who signed an informed consent to participate to the study Patients already treated before with surgery or radiotherapy or with medical treatment Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine treatment
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly To be eligible for entry in this study, patient must Be greater than or equal to 18 years of age Have a confirmed diagnosis of acromegaly based on the following 1. Typical clinical features and 2. Mean GH concentration > 1.0 ng/mL following an oral glucose tolerance test (OGTT) and 3. Elevated serum IGF-1 levels above gender and age matched values Fall into one of the following categories: 1. Has been treated for at least the last 12 weeks with Sandostatin LAR® 10 mg or 20 mg, every 28 days with well-controlled symptoms of acromegaly and GH concentration < 2.5 ng/mL at screening or 2. Be naïve to prolonged release octreotide with a demonstrated tolerance response to a 7-day administration of Sandostatin® immediate release (50 µg s.c. t.i.d.) or 3. If previously treated with prolonged release octreotide, has stopped such treatment for at least 12 weeks prior to screening If female and of childbearing potential, must have a negative pregnancy test at screening and be using adequate means of birth control (i.e., oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm) during the study Have the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions To be eligible for entry in this study, patient must NOT If female, be pregnant or lactating Have been treated with a GH receptor antagonist (pegvisomant) within the last 12 weeks Have used a dopamine agonist within the last 30 days Have undergone pituitary surgery within the last 12 weeks Have undergone radiotherapy within the last two years Have any contraindication (hypersensitivity to octreotide formulation) or non-responders to Sandostatin-LAR® treatment Be currently treated with Sandostatin-LAR® and have symptoms of acromegaly that would justify, in the Investigator's opinion, a dose modification Be receiving Sandostatin-LAR® administration every < 21 or > 35 days Have a liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or has persistent ALT, AST > 2 X ULN, serum creatinine > 2 X ULN, serum bilirubin > 2 X ULN
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Quality of Life Acromegaly Active acromegaly Serum total IGF-I levels must have been normalized during long-term treatment with long-acting somatostatin analogs Age between 18 and 80 Any contra-indication for the use of long-acting somatostatin analogs, as e.g. the use of anti-coagulants Subjects with pituitary tumors that compress the optic chiasm Patients with insulin dependent diabetes Patients with cancer Patients with kidney or liver function disturbances Fertile female patients that refuse to take contraceptives during the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Insulin Resistance Impaired Glucose Tolerance Age > 18 Diagnosed with acromegaly Safe anticonceptive for fertile women Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH < 0.5 µg/l.) Pregnancy Liver disease Diabetes mellitus type I Magnetic or electronic implants
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-40.0, Polycystic Ovary Syndrome Insulin-resistant PCOS (Arm: PCOS Affected Women) Irregular menstrual cycle (Arm: PCOS Affected Women) Hyperandrogenism (Arm: PCOS Affected Women) Regular menstrual cycles (Arm: Normal Controls) Normal hormonal levels (Arm: Normal Controls) Lack of hirsutism (Arm: Normal Controls) Acne-free (Arm: Normal Controls) Candidates are BMI-matched and screened for insulin resistance prior to inclusion. (Arm: Normal Controls) Left handedness Acute medical illness Uncorrected thyroid disease Diabetes renal Cardiac or pulmonary insufficiency Active liver disease Neurological disease Current psychiatric illness Claustrophobia Contraindications to MRI
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Polycystic Ovary Syndrome Women in reproductive age With polycystic ovary syndrome defined by hyperandrogenism (elevated serum testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or amenorrhea (no menses in the last 6 months) after negative screening pregnancy test Pregnancy Cushing' s syndrome Late onset congenital adrenal hyperplasia Androgen-secreting tumors Uncontrolled thyroid disease Hyperprolactinemia Diabetes any Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart failure) Acute or chronic infections at baseline Renal disease
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Acromegaly The patient has given written informed consent prior to any study related procedures The patient is male or female and is aged between 18 and 75 years, inclusive Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age and sex-matched normal range for diabetic and non diabetic patients (central laboratory results) The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement Not related to the pituitary adenoma Clinically stable condition not presumed to change during the study period Not modifying the ability to evaluate visual field changes related to the macroadenoma The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study The patient is pregnant or lactating The patient has a history of, or known current, problems with alcohol abuse The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry The patient has previously been treated with a somatostatin analogue
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly The subject has given written informed consent prior to any study-related procedures The subject is male or female and is over 18 years of age The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period The subject has received radiation therapy to the pituitary gland before study entry The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome Couples Partner with sperm concentration of >=14 million/mL in at least one ejaculate with motile sperm Ability to have regular intercourse 2-3 times per week during the ovulation induction phase of study At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years, or confirmation of a intrauterine pregnancy within the past 2 years No previous sterilization procedures(vasectomy, tubal ligation) that have been reversed Wanting to seek pregnancy Chronic anovulation or oligomenorrhea defined as intermenstrual periods of >= 45 days or a total of <=8 periods per year Hyperandrogenism will be an elevated total testosterone >=50 ng/dL Hirsutism determined by a modified Ferriman-Gallwey Score >8 PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter) Current pregnancy Patients on oral contraceptives, depo progestins, or hormonal implants Patients with hyperprolactinemia defined as two prolactin levels at least one week apart >30 ng/mL Patients with known 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone (17-OHP) level <2 ng/mL and ACTH stimulation test as needed, or other enzyme deficiency Patients with menopausal FSH levels >20 mIU/mL Patients with uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML) Patients diagnosed with Type1 or Type II diabetes Patients with liver disease defined as AST or ALT >2 times normal or total bilirubin >2.5 mg/dL Patients with renal disease defined as BUN >30 mg/dL or serum creatinine >1.4 mg/dL Patients with significant anemia (Hemoglobin <10 mg/dL)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Acne Vulgaris Female Subjects 18-45 years of age who have achieved spontaneous menarche A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined Maximum of 5 nodules Willing and able to understand and sign informed consent Able to complete study and comply with study procedures Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks Use of oral antibiotics within 30 days Use of systemic corticosteroids within 4 weeks Use of oral contraceptives within 12 weeks Use of isotretinoin in past six months Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week Use of tanning booths or lamps within 1 week prior to baseline BMI >30 History of renal insufficiency History of hepatic dysfunction
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 6.0-16.0, HIV Infection Bone Mass Subject, parent, or legal guardian able and willing to provide informed consent/assent. Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymerase chain reaction or HIV culture performed at any age; 2) Age >18 months, licensed ELISA with confirmatory Western Blot Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease. Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Psoriasis Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy Patients in good general health Able to self-administer injections Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis Previous treatment with Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA) Other active skin diseases or skin infections Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix) History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB) History of moderate to severe congestive heart failure Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease History of clinically significant drug or alcohol abuse in the last 12 months
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Malignant Ovarian Epithelial Tumor Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Sex Cord-Stromal Tumor Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types Ovarian Steroid Cell Tumor Patients diagnosed with histologically confirmed recurrent ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules) Patients must have measurable disease by Response Evaluation In Solid Tumors (RECIST) Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each ?target? lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control Patients who have met the pre-entry requirements specified There are no restrictions on prior therapy; however, patients cannot have previously had treatment with bevacizumab Absolute neutrophil count (ANC) >= 1,000/?l Platelets greater than or equal to 75,000/?l Creatinine =< 1.5 x institutional upper limit normal (ULN) Patients with newly diagnosed disease Patients with serious non-healing wound, ulcer, or bone fracture Patients who have received prior therapy with bevacizumab or other inhibitors of vascular endothelial growth factor (VEGF) Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study Patients with clinically significant cardiovascular disease; this includes Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg Myocardial infarction or unstable angina within 6 months prior to registration New York Heart Association (NYHA) grade II or greater congestive heart failure Serious cardiac arrhythmic requiring medication
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Male and female patients with acromegaly Confirmed diagnosis of a growth hormone-secreting tumor Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL Patients with pituitary surgery less than 3 months prior to screening Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9% Symptomatic cholelithiasis Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Polycystic Ovary Syndrome Two of the following Ovulatory Dysfunction: Clinically defined by oligomenorrhea (menstrual cycles lasting more than 35 days) or amenorrhea (lacking of menstruations in the last 90 days). In patients with menstrual cycles between 25 and 35 days, a serum level of progesterone drawn during days 21 to 23 of cycle < a 4 ng/ml Clinical hyperandrogenism defined for the presence of hirsutism, acne, androgenic alopecia) and or biochemical (increases in total testosterone, bioavailable testosterone or free androgen index) Polycystic Ovaries: Defined by the presence, in as less one ovary, of 12 or more follicles (measuring 2 to 9 mm in diameter) and or increased ovarian volume > 10 mL) Hyperprolactinemia Hypothyroidism Other causes of hyperandrogenism like Cushing's Syndrome, congenital adrenal hyperplasia, androgens secreting tumors Drug therapy used three months previous to enrollment in the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-35.0, Miscarriage All patients were cases of first trimester missed abortion They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Breech Presentation Single pregnancy at 32-34 weeks of pregnancy Fetus in breech presentation Twins Story of preterm birth or any preterm birth risk Fetal malformations, abnormal karyotype
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Polycystic Ovary Syndrome age between 18 and 35 years diagnosis of PCOS by Rotterdam Consensus smoking, alcoholism, drug addiction current pregnancy current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device) antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia) personal history of arterial or venous thrombosis; chronic or acute inflammatory processes puerperium of 12 weeks or less
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease Acute Coronary Syndrome Age: over 18, Sex: male and female Patients who undergo clinically indicated coronary angiography and/or PCI. Patients in Group 1 (elective PCI) those presented with stable angina (ACC definition for stable angina) Coronary angiography reveals severe stenosis (>70%) that requires PCI Patients in Group 2 (elective PCI in subjects with diabetes) those who present with stable angina, or with findings on non-invasive testing (exercise or pharmacologic stimulation with imaging by nuclear perfusion imaging or stress echocardiography) in whom coronary angiography reveals severe stenosis (>70%) that requires PCI Patients in Group 2 (ACS) those presented with unstable angina or non-ST elevation myocardial infarction (as defined by the ACC) Coronary angiography reveals severe stenosis (>70%) that requires PCI Significant left main coronary artery disease Severely impaired left ventricular systolic function (EF<35%) Prior treatment with enoxaparin, Bivalirudin (or other thrombin inhibitors), Warfarin, or thrombolytic agents <48 hours Prior history of myocardial infarction (<6 weeks). Prior history of stroke (<6 weeks) Prior history of coronary intervention (<6 weeks) History of HIV/AIDS The patients will be identified in the following manner All subjects will be picked from a pool of patients diagnosed with stable angina and diabetes from the Vanderbilt Page-Campbell Heart Institute at Vanderbilt University Medical Center and undergo a complete history and physical examination Patients with acute coronary syndrome will be referred from the acute cardiology patient service at Vanderbilt University Medical Center Subjects with hematologic, renal (creatinine > 2.0 mg/dl), hepatic, inflammatory, and neoplastic disorders, and those who sustained a recent (< 1 month) myocardial infarction, ACS, or stroke will be excluded. Patients who used nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy will also be excluded
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease Acute Coronary Syndrome Diabetes Metabolic Syndrome Age: over 18, Sex: male and female Patients who undergo clinically indicated coronary angiography and/or PCI. Patients in Group 1 (elective PCI) those presented with stable angina (ACC definition for stable angina) Coronary angiography reveals severe stenosis (>70%) that requires PCI Patients in Group 2 (elective PCI in subjects with diabetes) those who present with stable angina, or with findings on non-invasive testing (exercise or pharmacologic stimulation with imaging by nuclear perfusion imaging or stress echocardiography) in whom coronary angiography reveals severe stenosis (>70%) that requires PCI Patients in Group 2 (ACS) those presented with unstable angina or non-ST elevation myocardial infarction (as defined by the ACC) Coronary angiography reveals severe stenosis (>70%) that requires PCI Significant left main coronary artery disease Severely impaired left ventricular systolic function (EF<35%) Prior treatment with enoxaparin, Bivalirudin (or other thrombin inhibitors), Warfarin, or thrombolytic agents <48 hours. Prior history of myocardial infarction (<6 weeks) Prior history of stroke (<6 weeks) Prior history of coronary intervention (<6 weeks) History of HIV/AIDS The patients will be identified in the following manner All subjects will be picked from a pool of patients diagnosed with stable angina and diabetes from the Vanderbilt Page-Campbell Heart Institute at Vanderbilt University Medical Center and undergo a complete history and physical examination. Patients with acute coronary syndrome will be referred from the acute cardiology patient service at Vanderbilt University Medical Center Subjects with hematologic, renal (creatinine > 2.0 mg/dl), hepatic, inflammatory, and neoplastic disorders, and those who sustained a recent (< 1 month) myocardial infarction, ACS, or stroke will be excluded Patients who used nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy will also be excluded
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Diabetic Neuropathy, Painful Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet Must have some sensation left in hands and feet Any partial or total amputation of an limb or digit Any previous experience with biofeedback Prior treatment for alcohol abuse Severe Psychopathology
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-999.0, Sarcoma Histologically confirmed soft tissue sarcoma Receiving treatment on clinical trial CRUK-VORTEX Underwent surgery to remove the tumor no more than 3 months ago Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No other major medical illness that would preclude study treatment No other prior or concurrent malignancy except adequately treated nonmelanoma carcinoma of the skin or in situ carcinoma of the cervix PRIOR No prior radiotherapy to the local site No prior neoadjuvant or adjuvant chemotherapy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Male and female patients with acromegaly Must be at least 18 years old Confirmed diagnosis of a growth hormone -secreting tumor Must be either a full or partial responder to octreotide demonstrated by historical laboratory values Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control Patients with liver disease Patients with symptomatic cholelithiasis Patients receiving radiotherapy for their pituitary tumor at any time before Screening
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Hypogonadotropic Hypogonadism Kallmann Syndrome GnRH Deficiency PCOS Polycystic Ovarian Syndrome Hyperprolactinemia A. Healthy Subjects All healthy subjects will meet the following normal puberty with respect to onset and pace no chronic diseases no difficulty with blood draws no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy no illicit drug use or excessive alcohol consumption (< 10 drinks/week) no history of a medication reaction requiring emergency medical care normal physical exam and laboratory studies within protocol reference ranges. Additional based on subject population: 1. Healthy Men between 21 and 40 years old normal erectile and ejaculatory function, no history of reproductive disorders
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Type 2 Diabetes Mellitus Active acromegaly due to excess GH produced by a pituitary adenoma Patients must have an elevated IGF-I compared to age and gender matched controls (as supplied by the laboratory) and fail to suppress GH to below 1 ng/ml after a standard 75g oral glucose tolerance test Type 2 diabetes mellitus, defined by elevated fasting glucose ≥ 126 mg/dl (verified by two historical measurements), or plasma glucose ≥ 200 mg/dl two hours after a 75 g oral glucose load, or a random glucose ≥ 200 mg/dl Acromegaly Group Current medical therapy for acromegaly including dopamine agonists, somatostatin analogues, or growth hormone antagonists For subjects on current therapy the following washout periods may be used Cabergoline: 4 weeks Bromocriptine: 1 week Sandostatin LAR: 3 months Short-acting octreotide: 1 week Lanreotide: 3 months Pegvisomant: 4 weeks Subjects with a history of surgical therapy for treatment of acromegaly must have verification of active disease with verified elevated IGF-I for the subjects' age and gender compared to healthy controls (as supplied by the laboratory) (two measures) as well as a failure to suppress GH to below 1 ng/ml after OGTT
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-90.0, Acromegaly Male or Female age 18-90 Diagnosed with acromegaly from a pituitary adenoma visualized by MRI, and with elevated IGF-1 levels compared to age and gender matched control values and nadir GH response to OGTT>1mg/L Having already agreed to undergo surgical resection of their pituitary adenoma prior to study entry Must provide informed consent Inability to complete the protocol due to intercurrent medical or psychiatric illness Pregnant or breastfeeding Use of insulin Use of estrogen, progesterone, testosterone or thyroid hormone will be allowed as long as the dose is stable during the study
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-45.0, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Metastatic Cancer Metastatic cancer that expresses Her-2 at greater than or equal to 2+ and assessed by immunohistochemistry (IHC) in the clinical laboratory improvement amendment (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH). 2. Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred. Subjects with estrogen receptor-positive or progesterone receptor-positive breast cancer must have progressed on or not be a candidate for anti-estrogens or aromatase inhibitors and all breast cancer patients must have progressed on or not be a candidate for an anthracycline-containing regimen and a taxane-containing regimen. 3. Patients with breast cancer must have previously received trastuzumab. Patients will not continue to receive trastuzumab during the trial period. 4. Greater than or equal to 18 years of age. 5. Willing to sign a durable power of attorney 6. Able to understand and sign the Informed Consent Document 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. 10. Serology: 1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) 2. Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 3. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. 11. Hematology: 1. Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim. 2. White blood cell (WBC) (> 3000/mm^3). 3. Platelet count greater than 100,000/mm^3. 4. Hemoglobin greater than 8.0 g/dl. 12. Chemistry: 1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal. 2. Serum creatinine less than or equal to 1.6 mg/dl. 3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 13. Left ventricular ejection fraction (LVEF) greater than or equal to 50%. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 15. Patients who have previously received anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody therapy must have a normal colonoscopy with normal colonic biopsies Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2. Active systemic infections; coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; myocardial infarction; cardiac arrhythmias; obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 5. Concurrent Systemic steroid therapy 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 7. History of coronary revascularization or ischemic symptoms 8. Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with: 1. A prolonged history of cigarette smoking (20 pack/year of smoking within the past 2 years). 2. Symptoms of respiratory dysfunction
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-28.0, Polycystic Ovarian Syndrome Insulin Sensitivity female premenopausal obesity PCOS pregnancy type 2 diabetes or impaired glucose tolerance hypothyroidism hyperprolactinaemia Cushing's syndrome nonclassical congenital adrenal hyperplasia previous (within the last 6 months) use of oral contraceptives glucocorticoids antiandrogens ovulation induction agents
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Neuroendocrine Tumors histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification locally advanced or metastatic disease not amenable to surgery with radical intent at least one measurable target lesion radiological documentation of progressive disease ECOG performance status grade <=2 life expectancy >12 weeks adequate bone marrow reserve adequate hepatic and renal function ability to comply with the protocol procedures (including geographic accessibility) written informed consent non-malignant systemic disease or conditions that precluded patients from receiving the study therapy second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Hepatocellular Carcinoma Eligible patients those with HCC based on the diagnostic of European Association for the Study of the Liver (EASL), either confirmed cyto-histologically or confirmed non-invasively (restricted to cirrhotic patients) by radiological (two coincident imaging techniques and focal lesion > 2 cm with arterial hypervascularization) or combined (one imaging technique associated with AFP, focal lesion > 2 cm with arterial hypervascularization, and AFP levels > 400 ng/ml) They have Child-Pugh grade A cirrhosis and are HBsAg-positive for more than 6 months These patients are not feasible for other conventional treatment modalities of treatment including surgery, transarterial embolization, ethanol injection, and radiofrequency ablation No systemic anti-cancer therapy with high priority is available All of the above 3 should be judged by the caring physician All intrahepatic disease must be encompassed within the radiation fields, except intrahepatic diseases outside the radiation field(s) have been controlled by other treatment modalities before radiotherapy Karnofsky Performance Scale ≧ 80 Age > 18 Adequate bone marrow function, defined as follows Absolute neutrophil count (ANC) > 1,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study Prior invasive malignancy, other than HCC, (except nonmelanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Tumor thrombosis in the main trunk of portal vein, hepatic vein, or inferior vena cava Child-Pugh grade B or C cirrhosis Extrahepatic metastasis Clinical ascites that requires diuretic treatment or paracentesis for symptom relief Serum alanine aminotransferase (ALT) level > 5X normal upper limits or total bilirubin level > 3.0 Active hepatitis (serum ALT level > 5X normal upper limits) or clinically significant liver failure Positivity of anti-HCV, pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this is necessary because the treatment involved in this study may be significantly teratogenic
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Postoperative Nausea and Vomiting Male or female >=18 years of age. 2. American Society of Anesthesiologists (ASA) physical status 1 to 3. 3. Presence of at least 2 of the following PONV risk factors female gender history of PONV and/or currently prone to motion sickness (if the subjects cannot remember their last experience of motion sickness or if they suffered from it as a child, then they will not be classified as "prone") non-smoking status (never smoked or quit >=12 months ago) 4. Outpatient undergoing elective laparoscopic gynecological or abdominal surgery 5. Surgery for which anesthesia is expected to last at least 30 minutes 6. General endotracheal anesthesia conducted as outlined in the anesthetic procedures section of the protocol 7. If a subject has a known hepatic, renal or cardiovascular impairment, he/she may be enrolled in this study at the discretion of the Investigator 8. If a subject has or may develop prolongation of cardiac conduction intervals, particularly QTc, he/she may be enrolled at the discretion of the Investigator. 9. If a subject is female of childbearing potential, she must be using reliable contraceptive measures and have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours prior to surgery on Day 1. Reliable contraceptive measures implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence. Non-childbearing potential is defined as post-menopausal for at least 2 years or documented surgical sterilization or hysterectomy at least 3 months before study start Inability to understand or cooperate with the study procedures as determined by the Investigator. 2. Women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 72 hours prior to surgery on Day 1. 3. A cancer patient who has had chemotherapy within 4 weeks prior to study entry (Screening visit). 4. Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit). 5. Has received any investigational drugs within 30 days before study entry. 6. Having taken any drug with potential antiemetic efficacy within 24 hours prior to anesthetic procedures. 7. Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia . 8. Body mass index (BMI) > 40. 9. Known or suspected current history of alcohol abuse or drug abuse. 10. Known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients. 11. Epileptic patients. 12. Any condition, which in the opinion of the Investigator would make the subject ineligible for participation in the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 12.0-54.0, Severe Nodular Acne Severe recalcitrant nodular acne, which in the opinion of the investigator is compatible with isotretinoin treatment Ten (10) or more nodular lesions (facial and/or truncal) Treatment-naïve patients without any prior exposure to systemic isotretinoin or other retinoids Age between 12 and 54 years Weight between 40 and 110 kg Negative serum human chorionic gonadotropin (hCG) pregnancy test consistent with a non-pregnant state (females only) No significant disease or clinically significant finding in a physical examination No clinically significant abnormal laboratory value No clinically significant abnormal vital sign measurement Patients presenting with stable and controlled diabetes mellitus (Types I and II) may be included in the study. However, patients should not have had a hospitalization for any diabetes related complications in the last 12 months, and must be on stable medication for the preceding 6 months. To be included in the study, the patients should have Hemoglobin-A1c values ≤ 6.5% at screening and in the test done 3 Female patients will be excluded from the study if they Are pregnant Are at high risk for becoming pregnant or likely to become pregnant during treatment Will be breast-feeding or considering breast feeding during the course of the study Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the patient including any previous history of gastrointestinal disease Patients with any skin disease or other condition that might interfere with the evaluation of recalcitrant nodular acne Patients will be interviewed using the SCID-CT current and lifetime modules for Major Depression, Mania, and Psychosis. Patients with a lifetime history of psychosis will be excluded. Patients with a history of major depressive, manic, hypomanic or mixed episodes will not be excluded unless they have had an episode during the preceding year Patients with any past or current psychotic symptoms Patients reporting any suicidal behaviour (including attempts, interrupted attempts, aborted attempts, or other preparatory behaviours), within the past year, or serious suicidal ideation in the past year, will be excluded from study participation A lifetime history of wishing to be dead, non-specific active suicidal thoughts or active suicidal ideation without intent to act will not result in exclusion
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly patients with newly diagnosed acromegaly due to GH-secreting macro-adenomas newly diagnosed, previously untreated patients with GH nadir more than 2.5 μg/L during a standard 75-g, 2-h oral glucose tolerance test (OGTT) pituitary macroadenomas (maximum diameter >1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan age between 18 and 80 yr immediate surgery indicated by clinical pregnancy contraindications to MRI scan patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Acromegaly IGF-1 ≥1.3 x upper limit normal (ULN) Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT) Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels The patient has received long acting somatostatin analogues within 6 months of study entry The patient has undergone radiotherapy at any time prior to study entry The time between pituitary surgery (if any) and study entry is less than 6 weeks The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Acromegaly Acromegaly diagnosis treated with Somatostatin analogues or surgery in treatment control treatment with GH-antagonist never treated not in treatment control
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly men and women 80 years old untreated acromegaly unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels presence of a pituitary adenoma on MRI informed consent given acromegaly previously treated contraindication to pituitary surgery associated hyperprolactinemia above 200 ng/ml visual field defect needing rapid transsphenoidal surgery contraindication to a treatment with octreotide
|
1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
|
0
|
A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 12.0-999.0, Acne Vulgaris healthy men or women, 12 years of age and older willing to participate and sign a copy of the informed consent form moderate to severe facial acne history of allergy or hypersensitivity to clindamycin or benzoyl peroxide pregnant or lactating women evidence of a clinically significant disorder receipt of any drugs as part of a research study within 30 days prior to study dosing use of systemic, topical or facial products which may interfere with study significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Vulvodynia We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated Patient symptoms will need to no or minimal vaginal discharge Patients will have a minimum Visual Analog Score for vulvar pain of at least 3/10 In order to receive bladder instillations, patients will need to have a positive potassium sensitivity test We will patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-45.0, Parturition Natural Childbirth Labor Pain women in labour and expecting a normal delivery aged > 16 who are able to make informed consent singleton pregnancy spontaneous or induced labour onset prior to elective or emergency caesarean section preterm labour pool births scheduled caesarean section
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Androgenetic Alopecia women with hair loss pre menopausal metabolic or medication or non-androgenetic causes of hair loss diffuse hair loss
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-42.0, Polycystic Ovarian Syndrome Premenopausal between 18-42 years of age Diagnosed with PCOS as defined by chronic oligo or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair &/or acne); of common medical disorders (normal thyroid function tests and serum prolactin and of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl) Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months Able to provide signed informed consent Able to comply with study requirements Willing to delay the start of clinically prescribed metformin treatment Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer) Current use of hormonal contraceptives Seeking pregnancy; use of fertility drugs within 6 months of study Current or recent (within 3 months) use of metformin Ingestion of any investigational drug within two months prior to study onset Evidence of endometrial hyperplasia or cancer upon baseline EMBx
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0
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