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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Diabetes Mellitus Emergencies Patients over the age of 18, presenting to the emergency department with any complaint and with a glucose level> 300 mg / dL in blood tests will be included in the study Pregnant, under 18 years of age, patients who were referred to the emergency department by referral from another center, patients who received intravenous glucose treatment, patients using systemic glucocorticoids, hepatic insufficiency, renal failure, adrenal insufficiency, pancreatitis, metastatic carcinoma, patients receiving chemotherapy, patients with instability will not be taken into work
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperkalaemia Heart Failure With Reduced Ejection Fraction Adults aged ≥18 years Potassium and estimated glomerular filtration rate (eGFR) Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR Cohort 2: Normokalaemic (sK+ 3.5-5.0 mEq/L) at screening and 'at risk' of developing HK defined as either Have a history of HK (sK+ >5.0 mEq/L) within the prior 24 months and eGFR ≥30 mL/min/1.73 m2, or sK+ ≥4.5 mEq/L and eGFR 30 to 60 mL/min/1.73 m2 and/or age >75 years Symptomatic HFrEF (New York Heart Association [NYHA] class II-IV), which has been present for at least 3 months Left ventricular ejection fraction (LVEF) ≤40% Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi) (stable dose for ≥4 weeks) Not on spironolactone or eplerenone, or on low-dose spironolactone (<25 mg daily) Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF Current inpatient hospitalisation due to HF Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-20.0, Type 1 Diabetes Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic Patient's CGM cannot be uploaded to Glooko
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus Covid19 Patients 18 years or older Patients with diagnosis of COVID-19 respiratory infection Patient with recent positive SARS-COV2 infection and still positive PCR admitted of non-respiratory diagnoses Diagnosis of diabetes mellitus type 1 or type 2 Diagnosis of medication (steroid) induced hyperglycemia (persistent glucose more than 180 mg/dl) Taking insulin either SQ or IV Patient in shock Patient intubated on mechanical ventilation Patient placed on ECMO Patient taking hydroxyurea Patient taking more than 4g of acetaminophen in 24 hours or more than 1g acetaminophen in 6 hours Pregnant or nursing female patients Patients with skin lesions at the application site that may interfere with placement of the sensor Patients with known allergy to medical grade adhesive
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 Patients with T1D over 18 years of age Duration of T1D greater than 6 months Access to smartphones In those patients with CGM, the minimum time for handling the sensor before randomization will be 2 months Inability to handle smartphones or Apps to manage T1D Admission due to acute decompensation of TD1 in previous 3 months, presence of more than one severe monthly hypoglycemia, or any other circumstance that requires frequent visits and intensive diabetes education Inability to sign the informed consent
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 2.0-6.0, Type 1 Diabetes Mellitus Age between 2 and 6 years (inclusive) 2. Type 1 diabetes as defined by WHO for at least 6 months [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases which are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).'] 3. Insulin pump user (with or without continuous glucose monitoring or flash glucose monitoring system) for at least 3 months, with parent/guardian good knowledge of insulin self-adjustment as judged by the investigator 4. Treated with U-100 rapid or ultra-rapid acting insulin analogue 5. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory 6. Able to wear glucose sensor 7. Able to wear closed-loop system 24/7 8. The parent/guardian is willing to follow study specific instructions 9. The parent/guardian is proficient in English Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 2. Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment 3. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids 4. Known or suspected allergy to insulin 5. Parent/guardian's lack of reliable telephone facility for contact 6. Parent/guardian's severe visual impairment 7. Parent/guardian's severe hearing impairment 8. Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement 9. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in parts of the body which could potentially be used for localisation of the glucose sensor)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 3.0-50.0, Angelman Syndrome Smith-Magenis Syndrome X Fragile Syndrome Epilepsy Prader-Willi Syndrome Patients with one of the following rare diseases associated with : Angelman syndrome, Smith-Magenis syndrome, X Fragile syndrome, rare diseases of the cerebellum, rare epilepsies, PW-like syndromes or other rare diseases with eating disorders Patients aged minimum 3 years and maximum 50 years Patients with overweight (or obesity) and/or hyperphagic behavior Administrative problems: impossibility of giving parents or legal guardians informed information ; no coverage by a Social Security scheme
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Kidney Transplant; Complications Diabetes Mellitus, Type 2 Insulin Dependent Diabetes Age 18 or above 2. Received a kidney transplant within the past year with functioning kidney (eGFR > 30 mL/min 3. Person with Type 2 Diabetes and on insulin 4. Access to home wi-fi connection Person with Type 1 Diabetes 2. Patients taking hydroxyurea 3. Patient unable to wear the Dexcom G6 device at all times for any reason 4. Must be able to test blood glucose with meter 4x a day when on blinded CGM. 5. Presence of clinically significant visual or cognitive impairment 6. Illiterate 7. Prisoners 8. Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding 9. Presence of clinically unstable cardiovascular disease 10. Active malignancy treatment
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia Key Clinical history of T1D with > 5 years of duration At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment Stable diabetic treatment Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study Key Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-90.0, Diabetic Ketoacidosis All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned None
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-18.0, Sepsis Acute Kidney Injury Diabetic Ketoacidosis Children under 16 years and admitted to PCCU or wards in the past 5 years Diagnosis of DKA or Sepsis/severe bacterial infection/septic shock DKA defined as per the British Society for Paediatric Endocrinology and Diabetes (BSPED) guidance. Sepsis is defined based on the International Pediatric Sepsis Consensus Conference guidance (2005) 8.3 Any patients identified as above but not able to obtain case notes for any reason Patients with pre-existing kidney conditions Patients with inborn errors of metabolism
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Hyperglycemia Stroke, Acute • Patients admitted to adult neurology ward with acute stroke with Patients having hyperglycemia (capillary blood glucose ≥10 mmol/L in 2 or more occasions or having history of treatment for DM) Patients with age of 18-80 years of both sexes Patients or their attendants giving consent to take part in the study Patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic ketoacidosis) Pregnant patients Those not giving consent to participate in the study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.5-999.0, Hyperthyroidism Hypothyroidism Iodine Deficiency The categories of subjects eligible to participate in this study 1. Patients with known or suspected thyroid abnormalities (e.g. hypothyroidism, hyperthyroidism, extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS. 2. Patients with thyroid function test (TFT) abnormalities due to Non-thyroidal illness Abnormalities of serum TH binding proteins leading to euthyroid hyperthyroxinemia or hypotriiodothyronemia Genetic deficiency of thyroxine-binding globulin (TBG) Antibodies to mouse immunoglobulins leading to an artifactual elevation in the TSH ultrasensitive ("3rd generation") assay which may mimic "inappropriate" secretion of TSH. and for each group of subjects are given below. Patients with known or suspected thyroid abnormalities will be eligible to p rticipate if the individual meets all of the following 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Male or female, aged 6 months+. Hyperthyroid states but are not restricted to: 1. Graves' disease (GD) thought to result from thyroid-stimulating immunoglobulins (TSIg's), a subclass of which also stimulate eye muscle and fatty tissue producing exophthalmos (Graves' ophthalmopathy), as well as the skin in the pretibial area causing pretibial myxedema (Graves' dermopathy); 2. Subacute thyroiditis (SAT), a painful inflammation thought to result from viral infection with Coxsackie, as well as other viruses; 3. Silent thyroiditis, a painless inflammation thought to result from autoimmune attack of thyrocytes by antimicrosomal antibodies directed against thyroid peroxidase (TPO), as well as antithyroglobulin(anti-Tg) antibodies; 4. Single or multiple hyperfunctioning thyroid nodules of unknown etiology, probably resulting from the activation of certain thyroid oncogenes and/or growth factors, such as the thyrotropin (TSH) receptor (TSHR) and the a-subunit of the G protein (Ga); 5. Iodide-induced hyperthyroidism of unknown etiology; 6. Surreptitious administration of thyroid hormone (TH), usually present in patients with underlying psychiatric disease or occasionally related to patients with obesity and other eating disorders 7. Trophoblastic neoplasms, thought to result from high levels of hCG secretion, which, because of its structural similarity to TSH, causes "spillover" of action at the TSHR level; 8. "Inappropriate" secretion of TSH, which may be present either in patients with TSH- producing pituitary tumors (TSHomas) or from a non-neoplastic cause, i.e. pituitary resistance to the action of thyroid hormone (3,4). Hypothyroid states but are not restricted to: 1. Primary (or thyroidal) hypothyroidism, usually resulting from auto-antibodies to thyroid proteins, such as antimicrosomal antibodies to TPO usually associated with lymphocytic (Hashimoto's) thyroiditis (HT) or atrophic thyroiditis, or blocking antibodies to the TSHR, usually in the context of non-goitrous hypothyroidism; 2. Secondary (or pituitary) hypothyroidism, usually resulting from tumors of the pituitary of non-thyrotropic origin such, as growth hormone (GH)-secreting tumors or prolactinomas; 3. Tertiary (or hypothalamic) hypothyroidism, usually resulting from a deficiency in the hypothalamic hormone thyrotropin-releasing hormone (TRH), either of unknown etiology or secondary to a pituitary tumor; 4. Bio-inactive TSH, either relating to an endogenous abnormality of hypothalamic hormones or secondary to pituitary tumors (and usually related to abnormal glycosylation patterns of the TSH molecule); 5. Generalized resistance to thyroid hormone (RTH), a disease which has been shown to be due to abnormalities in the TH receptor, c-erbA-beta (or TR beta). The above are the principal disorders under study, but we may also investigate other abnormalities, such as extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS (among others) There are no for subjects with known or suspected thyroid abnormalities
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Hypothyroidism Thyroid Neoplasms Patients greater than or equal to 18 years of age, with well-differentiated, non-medullary thyroid cancer, including papillary (including follicular-variant), follicular, and Hurthle cell. Patients who recently have undergone a total or near-total thyroidectomy and are scheduled to undergo initial 131I diagnostic studies and ablation. Patients must have evidence of residual thyroid tissue after thyroid surgery confirmed by ultrasound or other imaging technique (e.g., a technetium [Tc 99] pertechnetate or thallium scan). Patients who have undergone thyroidectomy or other thyroid surgery at least 6 weeks prior to enrollment. All patients who have been sustained on maintenance THST for at least 4 weeks, but not longer than 12 weeks after thyroidectomy. All patients who have confirmed serum TSH levels less than or equal to 0.5 mU per liter within 7 days prior to the first Thyrogen dose, and prior to randomization. Female patients of childbearing age must have a negative serum human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and within 5 days of any 131I administration and must be following an approved method of contraception. Patients who are committed to following the protocol requirements as evidenced by providing written informed consent. Patients for whom a 131I scan is currently contraindicated because withdrawal from THST is not an option due to pituitary dysfunction or other compelling medical reasons are excluded. Patients should not have a concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease or advanced pulmonary disease) who may be too ill to adequately comply with the requirements of this study. Patients with non-thyroidal conditions known to effect 131I uptake (e.g., congestive heart failure, renal failure) are excluded. Patients should not have undergone any intravenous water soluble radiographic contrast administration within the previous 4 weeks. Patients should not have received intrathecal or cholecystographic iodinated contrast agent administration within 3 months prior to enrollment. Patients should not be taking drugs that affect thyroid or renal function (e.g., renal drugs, lithium, or corticosteroids). Patients should not be participating in another investigational drug study or in such a study within 30 days of their enrollment in this study. No patients with a recent history of alcoholism or drug abuse, severe emotional behavioral or psychiatric problems who, in the opinion of the investigator, would not be able to comply with the requirements of this study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Endometriosis Pelvic Pain Women between the ages of 18 and 45 years, who have their reproductive organs Excellent health other than a three month history of pelvic pain and documented endometriosis at laparoscopy. Chronic medications may be acceptable at the discretion of the internist associate investigator (LN). Use of antidepressants, medications for migraines and headaches, allergy medications, and treatment of bowel symptoms such as irritable bowel disease will be allowed Do not desire pregnancy for the duration of the study Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study Willing and able to give informed consent Willing and able to comply with study requirements Less than grade III overweight or BMI less than 40 kg/m(2) Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range Hysterectomy or bilateral salpingo-oophorectomy Pregnancy Lactation Use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the last 3 months Other medical or surgical treatment for endometriosis in the last 6 months Untreated abnormal pap smear or other gynecologic condition History of venous thrombosis events including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis Allergy to study drug
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Unspecified Adult Solid Tumor, Protocol Specific Patients must have a histologically confirmed diagnosis of malignancy, with evidence of metastatic disease (evaluable disease is adequate), who have not responded to standard therapy, who have relapsed, or for whom such therapy is not available Patients must have a tumor that has been shown to express CEA by immunohistochemical techniques or have had an elevated serum CEA > 10 at any point during their disease course Patients must have an anticipated survival of at least 6 months Patients must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent Patients must be ambulatory, with an ECOG performance status of 0 or 1, and must be maintaining a reasonable state of nutrition, consistent with weight maintenance WBC >= 3,000/mm^3 ANC >= 1500/mm^3 Platelet count >= 100,000/mm^3 Bilirubin =< 2 x upper limit of normal SGOT and SGPT =< 4 x upper limit of normal Recent major surgery (within 21 days) Frequent vomiting or severe anorexia Pregnant or lactating women; this requirement is due to an unacceptable high risk of CEA antibody transfer, which may be potentially harmful to the developing fetus or infant; (NOTE: women and men enrolled in the study are to practice an effective method of birth control for at least six months after their last treatment on protocol) Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis The following therapies are prohibited and may not be administered to patients being treated on this protocol: chemotherapy, hormonal therapy, biologic therapy, and immunotherapy Patients must have recovered completely from any reversible toxicity associated with their most recent therapy; typically this is 3-4 weeks for patients who most recently received cytotoxic therapy except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery Patients with clinically active brain metastasis, uncontrolled seizure disorders, encephalitis, or multiple sclerosis Patients can not have any history (past or present) of allergy to eggs or egg products Patients with history of receiving CEA-containing vaccines are excluded from enrollment into any of the 8 actual study cohorts; however, patients with metastatic disease who have progressed (as defined by objective response for solid measurable tumor; tumor marker elevation alone is not sufficient) on a CEA-containing vaccine, may be enrolled to this study as they arise if they meet the patient but will be added-in outside of the eight established cohorts, at the currently established safe dose level; additionally, these patients will receive only the rF-CEA(6D)-TRICOM vaccine (possibly along with GM-CSF if cohort 7 is the currently established safe dose level), but otherwise will be treated according to the protocol as any other patient on study; such additional patients will not count toward study accrual, determination of primary immunologic endpoints, or the determination of the MTD
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-80.0, Depression Stage I Breast Cancer Stage IIIA Breast Cancer Nutrition Stage II Breast Cancer Psychosocial Effects/Treatment Quality of Life ENTRY --Disease Characteristics- Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant metastases --Prior/Concurrent Therapy- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines alone No concurrent participation in dietary and/or exercise weight loss programs --Patient Characteristics- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No physical or mental disability that would preclude completing questionnaires No prior or concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 25.0-44.0, Obesity Eligible participants will women between the ages of 25 and 44, BMI between 25 and 35 (inclusive). Other inclusion/ Weight stable (<5% body weight change over past year) 2. No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims (e.g. fibromyalgia, chronic fatigue syndrome, metabolic disorders, recent cardiovascular event, orthopedic limitations, any drug expected to impact body weight, psychiatric disorders requiring anti-psychotic drugs) 3. Uncontrolled hypertension (systolic blood pressure over 160 and/or diastolic blood pressure over 99) 4. No history of cancer within the past 5 years, excepting non-melanoma skin cancers 5. Not currently or recently (past 6 months) pregnant 6. Not planning to become pregnant during the study period 7. Not currently or recently (past 2 months) lactating 8. No history of physician diagnosed menstrual irregularities or significant gynecologic conditions (e.g. fibroids, endometriosis) 9. Pre-menopausal 10. Current non-smokers (for at least the past 2 years) 11. Sedentary to modestly physically active (up to 3 sessions weekly of physical activity of no greater intensity than brisk walking) with no history of strength training within the past 6 months 12. Not planning to move away from the Twin Cities area over the next 2 years
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Obesity (Overweight Subjects) Volunteers will qualify if they meet the following 1. Good general health. Individuals taking medication for obesity-related co-morbid conditions will not be excluded. 2. Age greater than or equal to 18 years. 3. Body Mass Index greater than or equal to 25 kg/m(2). 4. For women with childbearing potential, a negative pregnancy test at the initial evaluation. 5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorous levels (2.3 3 mg/dl). (Normal Weight Subjects) Volunteers will qualify if the meet the following 1. Good general health. 2. Age greater than or equal to 18 years. 3. Body Mass Index 1-24.99 kg/m(2) 4. For women with childbearing potential, a negative pregnancy test at the initial evaluation. Since these subjects have to undergo DXA (dual Energy X-ray Absorptiometry) scan screening in their second visit, for safety purposes, pregnant women will be excluded from participation in the study. 5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorus levels (2.3-4.3 mg/dl) (overweight subjects) Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons: 1. A presence of major illnesses: renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication or sleep-apnea related disorders); 2. Women who are pregnant, or who are currently nursing an infant; or who are having unprotected intercourse; 3. Individuals who have a current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study; 4. Subjects who regularly use prescription medications unrelated to the complications of obesity {e.g., calcium channel blockers, diuretics (including thiazide diuretics), beta-blockers etc}. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter medications will be reviewed on a case-by -case basis; 5. Subjects who have a total calcium intake of more than 3.5 g/day on the screening calcium intake questionnaire (SCQ) or more than 3 g/day of total calcium intake on review of their 7-day food diaries; 6. Subjects who take supplement calcium in excess of 300 mg/day or vitamin D supplements in excess of 400 IU/day; 7. Recent (3 months) use of anorexiant medications; 8. History of renal stones; 9. Intentional weight change of more than 3% of body weight in the past two months. 10. Post-menopausal women who are medically advised to take calcium supplementation. 11. Subjects with iPTH greater than 75 pg/ml (Normal range: 10-75 pg/ml) when associated with a serum calcium level greater than 2.5 mmol/L. (normal range 2.05 to 2.55 mmol/L) 12. Subjects with a serum 25-(OH)-D level less than 10 ng/ml (Normal range: 10-68 ng/ml) when associated with a serum 1-225-(OH)(2)-D level of less than 22 pg/ml (Normal Range: 22-67 pg/ml. 13. Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg (Normal Weight Subjects) Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons: 1. Presence of major illnesses: renal (serum creatinine greater than 1.6), hepatic (AST/ALT greater than 3 times upper limit of normal range used in Clinical Center assays), gastrointestinal, most endocrinologic (e.g. Cushing syndrome, hyper or hyothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication or sleep-apnea related disorders); 2. Women who are pregnant, or who are currently nursing an infant; 3. Individuals who have current substance abuse of a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study; 4. Subjects who regularly use prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. Individuals taking medications for most conditions will be excluded, but medication use will be considered on a case-by-case basis. 5. Subjects who take supplemental calcium in excess of 300 mg/day or vitamin D supplements in excess of 400 IU/day. 6. Recent (3 months) use of anorexiant medications; 7. Intentional weight change of more than 3% of body weight
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, Endometrial Bleeding Periodontal Disease Regular menstrual periods for the last 2 cycles Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry Currently not using tetracycline-class antibiotics Normal Pap smear Pregnancy or breastfeeding within 2 months of study entry Chronic migraine headaches Uncontrolled high blood pressure Untreated sexually transmitted diseases Alcoholism or drug abuse within 12 months of study entry Insulin dependent diabetes Liver, kidney, or gallbladder disease Participation in another clinical trial within 30 days of study entry History of cancer History of blood clots, strokes, or heart disease
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 16.0-999.0, Cystic Fibrosis Diabetes Mellitus Diabetic glucose pattern by oral glucose tolerance test (OGTT) of >200 at 120 min. (stable and healthy at time of OGTT) Fasting glucose levels <126 Weight stable within 5% in previous 3 months Free from illness for two months Male and female 16 and older, who are done growing Willing to come in for visits every 3 months Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Thyroid Diseases Age greater than or equal to 18 years, male or female. History of total or near total thyroidectomy or hypothyroidism on replacement therapy. For non-thyroidectomized patients, at least three-year history of replacement therapy (at least 1.2 mcg/Kg LT4/body weight), and less than 5% uptake at 24H on (123)I thyroid scan while on replacement therapy. Written informed consent BMI less than or equal to 20 or greater than or equal to 30 kg/m(2). Metastatic thyroid cancer or history of thyroid cancer with high risk of recurrence requiring suppressive thyroid hormone therapy (Singer 1996). Significant thyroid residual greater than 1 mL as measured by ultrasound (limited to thyroidectomized patients) or greater than 5 percent uptake at 24H on (123)I thyroid scan while on replacement therapy (limited to hypothyroid patients not undergone total thyroidectomy). History or symptoms compatible with cardiovascular disease, including paroxysmal supraventricular tachycardia, atrial fibrillation, syncopal episodes or use of prescription medications for heart conditions, including antihypertensives. Allergy to lidocaine, isoproterenol, TRH, levothyroxine, liothyronine, Tylenol #3, oxycodone, nitroglycerin. Pregnancy or unwillingness to use non-hormonal contraception during the study. Breastfeeding Use of hormonal contraceptives or estrogen replacement therapy. Use of tobacco (smoking, chewing) for the two weeks preceding the hospital admissions (metabolic testing) Diabetes mellitus, either type I or II. Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), hypertriglyceridemia (plasma levels greater than or equal to 220 mg/dL) and/or use of antilipemic therapy. Liver disease or ALT serum level greater than two fold the upper laboratory reference limit. Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min. Use of medications/supplements/alternative therapies known to alter thyroid function. Current history or symptoms compatible with psychosis including major depression (including history of hospitalization for depression, history of attempted suicide, history of suicidal ideation). Use of antipsychotic medications History of drug or alcohol abuse within the last 5 years; current use of drugs or alcohol (CAGE greater than 3). Keloid formation (relative to skeletal muscle and subcutaneous adipose tissue biopsies). Current or previous clinically significant (requiring medical/surgical intervention) extrathyroidal manifestations of autoimmune thyroid disease (dermopathy, ophthalmopathy, arthropathy)
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Hypothyroidism Male or female subjects >18 years of age Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment Thyroxine dose ≥100 mcg/day No change in thyroxine dose in past 2 months Serum TSH of 0.1-4.8 mU/L Adequate contraceptive measures for women of childbearing age Major systemic illness affecting quality of life or likely to affect participation in the study Treatment with T3 currently or in past 2 months History of thyroid cancer requiring suppression of TSH secretion by thyroxine Ischaemic heart disease previous myocardial infarction, angina or coronary artery revascularisation Renal failure: serum creatinine >135 micromol/L Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range Bony fracture in past 3 months or Paget's disease of bone Secondary (central) hypothyroidism or hypopituitarism
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-80.0, Cancer · Histologically confirmed malignancy (excluding central nervous system malignancy) · Not a candidate for, or refuses, curative anti-neoplastic therapy · Between the ages of 18 and 80 · Symptoms of advanced cancer (loss of appetite, fatigue, weakness malaise) that are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function · Karnofsky performance status of ³40%, _<_ 80% · Normal cognition, interpreted as a Mini-Mental State Score of at least 20 · Received immunotherapy, radiation therapy or experimental therapy within three weeks · Receiving chemotherapy other than third-line, single agent therapy permitted third-line, single agent dose must be stable for at least one month · Diabetes requiring insulin or oral hypoglycemic agents · Mechanical reason to be unable to eat, or is reasonably expected to develop an obstruction during the next eight weeks · Myocardial infarction within six months of enrollment · Uncontrolled brain metastases or central nervous system disease
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Child Development Disorders Pregnancy Subclinical Hypothyroidism Pregnant female Normal TSH in second trimester Singleton pregnancy Term infant weighing 2500g or more No congenital abnormalities noted on birth record Delivery in Maine at 36 weeks or later TSH levels outside normal range in second trimester Pre-existing hypothyroidism, treated More than one fetus Premature and/or low birth weight infant Congenital abnormalities noted on birth record
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 15.0-999.0, Thyroid Diseases All patients with benign thyroid disease Unable to complete questionnaire: must be able to read and write Danish
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Graves´ Disease Thyroid Associated Ophthalmopathy Graves´ disease Adequate anticonception in women Performance status >2 Previous rituximab treatment Immunosuppressive treatment Serious concomitant disease Active infections Pregnancy / breast feeding
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 40.0-999.0, Hyperthyroidism Subclinical hyperthyroidism [TSH ≤ 0.1 mU/L, fT4 and T3 within the normal range of the own laboratory (determined 2 times in own laboratory) with an interval of at least 2 months] Endogenous cause of subclinical hyperthyroidism limited to autonomous adenoma or multinodular goiter (diagnosis made by the attending physician, based on palpation and the result of a thyroid scintigram) Informed consent Medication with anti-thyroid drugs in the last 3 months (also not allowed during follow-up); thyroid hormone in the last 3 months (allowed during follow-up, but TSH levels should be kept between 0.1 mU/L and the upper limit of normal in the own laboratory); and oral glucocorticoids in the last 3 months (allowed during follow-up when absolutely necessary, but patients in whom glucocorticoids are started cannot be evaluated with respect to changes in bone mineral density [BMD]) Radioiodine therapy in the past Iodine-induced subclinical hyperthyroidism Pituitary or hypothalamic insufficiency Pregnancy Age <= 40 years Severe non-thyroidal illness Drug abuse Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure (History of) osteoporotic fracture(s)
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Cerebral Palsy Crouch Gait cerebral palsy couch gait
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 50.0-75.0, Osteoporosis Post-menopausal women aged 50-75 years at Visit 1 (at least 5 years post cessation of menses, or FSH>20 IU/L, serum estradiol <110 pmol/L) Vertebral bone mineral density at least 2.5 S.D. below the mean of young normals. Patients must have at least 2 measurable contiguous vertebral bodies in the lumbar region, L1-L4 Ability to self administer injections Ability and willingness to give informed consent Evidence of 5 or more vertebral fractures Evidence of 2 or more vertebral fractures in the region L1-L4 Presence of significant cardiac disease as determined by history, physical examination and laboratory screens e.g. cardiac dysrhythmias Presence of significant hepatic, renal, pulmonary, gastrointestinal, hematological, endocrine, immunologic, neurological or psychiatric disease as determined by history, physical examination and laboratory screens. Specifically excluded are diseases known to contribute to osteoporosis: hyperparathyroidism, hyperthyroidism, glucocorticoid excess, hyper or hypocalcemia, Paget's disease, osteogenesis imperfecta, osteomalacia and severe scoliosis Evidence of lumbar fusions, osteophytes or excessive degenerative disease which precludes reasonable DXA measurement History or presence of cancer within the previous 5 years except for superficial basal cell and squamous cell carcinomas of the skin Treatment with any of the following therapies Any form of Estrogen within previous 6 months Prior use of Etidronate for more that 2 treatment cycles (2weeks/cycle) and/or any use within prior 6 months Any other bisphosphonate
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-68.0, Thyroid Neoplasms Patients who were at least 18 years old (male or female) Patients with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as "T2, N0 or N1, and M0" or as "T1, N1, and M0" Patients with a total or near-total thyroidectomy within 2 weeks prior to enrollment see above
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Hip Fracture Able to follow 2-step commands Stable inter-trochanteric fracture, where fixation is deemed by surgeon to be adequate, OR sub-capital fracture having undergone bipolar hemi-arthroplasty Able to stand and take a few steps with the help of an assistive device i.e. parallel bars, walker, or cane Able to walk without assistive devices Hip, knee or ankle surgery prior to hip fracture Inability to understand instructions or give informed consent Uncontrolled cardiovascular disease or hypertension, diabetes, neuromuscular disease or other musculoskeletal disease such as rheumatoid arthritis, Uncontrolled pain
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Pregnancy Hypothyroidism women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy less than 8 weeks pregnant cardiac disease, renal failure not euthyroid biochemically within 6 months pre-pregnancy
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 15.0-70.0, Autoimmune Thyroiditis Hashimotos Thyroiditis Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, Hypogonadotropic Hypogonadism Be premenopausal, between 18 and 40 years of age inclusive on the day of consent Have a clinical history of hypogonadotropic hypogonadism (World health organization [WHO] Group I type of anovulation) on the basis of congenital or acquired hypothalamic or pituitary endocrine dysfunction in the presence of qualifying screening laboratories Have no prior treatment cycles with gonadotropins or gonadotropin releasing hormone (GnRH) (gonadotropin naïve) Have discontinued estrogen-progesterone replacement therapy at least one month before the screening procedure Have primary or secondary amenorrhea Have a negative progestin challenge test performed during Screening Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 weeks before initiation of treatment Follicle-Stimulating Hormone (FSH): less than (<)5 international unit per liter (IU/L) Leutinizing hormone (LH): <1.2 IU/L (a second Baseline serum LH level will be repeated two weeks after the initial LH draw) Prolactin: < 43.3 nanogram per milliliter (ng/mL) (<1040 milli-international unit per liter [mIU/L]) Any medical condition which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug Any pre-existing medical condition which would compromise the subject's ability to conceive in vivo or to successfully complete a pregnancy Ongoing pregnancy Clinically important systemic disease (example: insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) Known infection with human immunodeficiency virus (HIV), Hepatitis B or C Ovarian enlargement or cyst of unknown etiology Abnormal gynecological bleeding of undetermined origin Previous or current hormone dependent tumor Known active substance abuse or eating disorder Known central nervous system (CNS) Lesions: In cases where hypogonadotropic hypogonadism (HH) is secondary to a CNS lesion or its treatment
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 30.0-50.0, Obesity Both genders, BMI ≥ 30 kg/m² and <40 kg/m² Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Polycystic Ovary Syndrome Probands who meet the following will be enrolled: Menses < 6 per year without confounding meds Not taking confounding medications at the time of hormone analysis, willing to be off confounding medications for required washout period, or able to provide documentation of hyperandrogenemia (without hyperprolactinemia or evidence of non-classical adrenal hyperplasia) with past laboratory tests during a time when not taking confounding medications Total Testosterone >58 ng/dl or bioavailable testosterone >15 ng/dl Prolactin <25 ng/ml Baseline 17-OHP <3 ng/ml (and stimulated 17-OHP <10 ng/ml if subject is studied on-site) Control women who meet the following will be enrolled: History of completely regular menstrual cycles. No history of hirsutism or alopecia. Control women will have a blood sample obtained 3-6 months after they have stopped lactating and resumed regular menses to ensure that they have normal T, uT and DHEAS levels. Any pregnant woman who develops gestational diabetes will be excluded from the analysis. To disorders associated with insulin resistance, control subjects will have no personal history of hypertension or hypertriglyceridemia and no first-degree relative with Type 2 DM history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-80.0, Osteoarthritis Subjects diagnosed with primary Osteoarthritis of the knee Have at least 3 months in symptom duration prior to screening visit Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain Pain walking on flat surface within specific interval prior to study start History of hypersensitivity to Allergy to Ibuprofen Use of assistive devices other than a cane or knee brace History of specified diseases/illnesses Abnormal blood tests pre-study
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Subclinical Hypothyroidism Hypothyroxinemia Pregnancy Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (<0.86 ng/dL) Singleton Pregnancy Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days Major fetal anomaly or demise 2. Planned termination of the pregnancy 3. History of thyroid cancer or current thyroid disease requiring medication 4. Diabetes, on medication (insulin, glyburide) 5. Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication 6. Receiving anticoagulant therapy 7. Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs) 8. Other known serious maternal medical complications including: 1. Chronic hypertension requiring antihypertensive medication (including diuretics) 2. Epilepsy or other seizure disorder, on medication 3. Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes 4. Cancer (including melanoma but excluding other skin cancers) 5. Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion. 6. Asthma, on oral corticosteroids 9. Known illicit drug or alcohol abuse during current pregnancy 10. Delivery at a non-network hospital 11. Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy 12. Unwilling or unable to commit to 5 year follow-up of the infant
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-99.0, Chronic Kidney Disease End Stage Renal Disease GFR by the MDRD estimate < 30ml/minute/1.73m2 or on hemodialysis Body mass index greater than 35 kg/m2, or morbid obesity Uncontrolled hypothyroidism, defined as an elevated serum thyroid stimulating hormone (THS) and a free serum thyroxine (T4) less than the lower limit of normal, when tested at baseline (Patients requiring thyroid replacement during the study may continue.) Uncontrolled hyperthyroidism, defined as a TSH less than the lower limit of normal and an elevated free T4, when tested at baseline Hemoglobin <10 Gm/dl Elevated serum transaminases (>2.0 times the upper limit of normal at baseline) Diabetes with one of more of the following: 1. Poorly controlled diabetes as defined by a HbA1C > 7.0% at baseline) 2. Proliferative diabetic retinopathy [To participate in this study, diabetic patients will need to have had a dilated ophthalmology exam within 12 months of enrollment. Individuals who already have extensive background retinopathy will need to have a dilated ophthalmology exam within the 3 months of enrollment. Patients with pre-proliferative or proliferative retinopathy will be excluded]. 3. Unwilling or unable to check blood glucose at home at least daily Currently receiving a systemic corticosteroid dose of >10 mg prednisone (or equivalent), or patient has received, for a duration > 30 days in the previous 6 months (i.e., prior to signing the informed consent form), a systemic corticosteroid dose of > 10 mg prednisone (or equivalent). (The previous use, or current use, of a topical or inhaled corticosteroid is allowed.) Currently taking or previously on an anabolic steroid or growth hormone at any dose, or for any duration, during the 12 months prior to study entry Significant end-organ disease, other than kidney disease, which, in the opinion of the investigator may pose an added risk to the patient, confound the study results, or impair the patient's ability to complete the trial Any of the following disorders within 6 months prior to baseline: 1. Acute coronary syndrome (e.g., myocardial infarction or unstable angina) 2. Coronary artery intervention (e.g., coronary bypass graft [CABG], percutaneous transluminal coronary angioplasty [PTCA]). 3. Stroke or transient ischemic neurological disorder (e.g. transient ischemic attack [TIA])
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Clear Cell Renal Carcinoma Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements Locally advanced or metastatic, histologically proven clear cell renal carcinoma Primary tumour surgically removed (some residual advanced primary tumour may remain) At least four weeks post surgery or radiotherapy First-line. No prior therapy for renal cancer except surgery or radiotherapy Measurable disease Aged 18 years or more Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care) Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease) Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L Cerebral metastases. (Known from previous investigations or clinically detectable) Previous exposure to TroVax® Serious infections within the 28 days prior to entry to the trial Known to test positive for HIV or hepatitis B or C Life threatening illness unrelated to cancer History of allergic response to previous vaccinia vaccinations Known allergy to egg proteins Known hypersensitivity to neomycin Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 1.0-30.0, T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory T-NHL For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted Prior therapy restrictions Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Pregnant or lactating females are ineligible Patients with Down syndrome are ineligible to enroll onto this study For T-NHL patients the following additional apply B-precursor lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma CNS3-positive or testicular involvement
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 16.0-80.0, Head and Neck Cancer Histologically confirmed differentiated thyroid cancer T1-T3, Nx, N0, N1, M0 disease Has undergone one or two-stage total thyroidectomy with or without lymph node dissection All known tumor resected (R0) Requires radioiodine remnant ablation Does not require mandatory recombinant thyroid-stimulating hormone No Hurthle cell carcinoma or aggressive variants, including any of the following Tall cell, insular, poorly differentiated disease with diffuse sclerosing Anaplastic or medullary carcinoma
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 14.0-61.0, Graves Disease Graves disease Anticoagulant usage Previous thyroid operation Refused to participate in this study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Differentiated Thyroid Carcinoma Hiostologically proved DTC (M0) Preoperative metastasis
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 25.0-60.0, Overweight Obesity Is <6'3" (190.5 cm) tall and weighs <300 lb (~136.3 kg) Is obese with a body mass index (BMI) >=30 kg/m^2 to <=45 kg/m^2 and with a history consistent with progressive weight gain and development of obesity not secondary to drastic or traumatic initiating events (e.g., excessive weight gain due to cessation of smoking) Is a nonsmoker (never smoked or has not smoked for at least 2 years) Does not have a clinical diagnosis of diabetes Has not had a major change in daily physical activity within 2 months prior to study start (e.g., initiation of an exercise program) Usually consumes three major meals (morning, midday, and evening) each day and rarely (less than once a week) wakes up to eat during the night Is currently enrolled in a weight loss program or plans to enroll in a weight loss or exercise program within the next 3 months Is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded Over the counter antiobesity agents including herbal supplements or prescription antiobesity agents approved for the long-term (including orlistat [Xenical] and sibutramine [Meridia]) and the short-term (including phentermine [Adipex-P, Celltech, Pro-Fast SA, Pro-Fast SR, Fastin, Oby trim, Zantryl, Teramine, Phentride, Phentercot, Obephen, Oby-cap], mazindol [Sanorex and Mazanor], methamphetamine [Desoxyn], diethylpropion [Tenuate and Tenuate Dospan], phendimetrazine [Bontril, Prelu-2, Melfiat 105, Unicelles, X-Trozine, Plegine, Adipost, Obezine, Phendiet-105, PT 105] and benzphetamine [Didrex]) treatment of obesity Systemic steroids by oral, intravenous, or intramuscular route or potent topical steroids that are known to result in high systemic absorption Alpha or Beta-Blockers, centrally acting sympathicolytic or sympathicomimetic agents, reserpin, guanethidine, etc Psychotropic medications (e.g., tricyclic antidepressants, monoamine oxidase [MAO] inhibitors, selective serotonin reuptake inhibitors [SSRIs], neuroleptics, lithium, and benzodiazepines) Hypnotic-sedative medications or medications that may affect sleeping behavior including medications containing caffeine Drugs that directly affect gastrointestinal motility, including but not limited to: metoclopramide (Reglan®) and cisapride (Propulsid®); and macrolide antibiotics such as erythromycin and newer derivatives Has received any investigational drug within 3 months before study start
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Advanced Cancer 18 years of age or older 2. Ability to speak and read English 3. Diagnosis of cancer, currently receiving treatment, receiving supportive care, or surviving after treatment 4. Self report of current experience of fatigue 5. Consent to participate 6. Patient from M. D. Anderson Cancer Center inpatient unit or outpatient clinic Inability to understand the intent of the study 2. Medical condition that would preclude participation in an interview session lasting 40 minutes 3. Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 14.0-40.0, Breast Diseases New mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. The sample of breastfeeding mothers were collected in two cohorts according delivery type. Each group consisted of 98 primipara mothers Mothers who didn't plan to use peppermint water Discharged before an interview or had preterm delivery Postpartum fever Breast infection Nipple abnormalities Age less than 18 years Twins Taking medications at night Mothers who didn't have telephone line, and who were illiterate Infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-55.0, Endometriosis Dysmenorrhea Dyspareunia The subject has voluntarily signed the Informed Consent form after having the contents fully explained, after all questions are answered and prior to undergoing any study-related procedures The subject is a pre-menopausal female at least 18 years of age at the time of screening having regular periods (21-42 days intervals) with no menopausal symptoms The subject has a diagnosis of endometriosis made via laparoscopy or laparotomy (operative report will be obtained) and still symptomatic and at least 3 months after surgery have a grade 2 and above according to Biberoglu's pain grade at screening visit (4 weeks prior initiation of treatment) or 4 out of 10 on a visual pain scale (visual analogue) Subject in good health, except for endometriosis, or has mild medical conditions that are stable and controlled. The subject has no clinically relevant hepatic, renal, cardiovascular, respiratory, endocrine, metabolic, psychiatric, neurologic (epilepsy), hematolytic (coagulopathy) and/or immunologic disease (on steroids) or disorder A subject who has received any of the hormone therapies (GnRH agonist or danazol or progestin) must meet the minimum washout requirement to be eligible. (GnRH within the last 6 months and with steroids within the last month.) After hormonal therapy has stopped, the subject must have returned to normal for at least two menstrual cycles before baseline time Serum pregnancy and urine qualitative pregnancy tests performed at screening and on baseline must be negative Unless surgical sterile by bilateral tubal ligation or vasectomy of partner, the subject agrees to use a double-barrier method of contraception during the screening period, throughout the 24-week treatment period, such as: condom plus spermicide, diaphragm plus spermicide, sponge plus spermicide, abstinence is an acceptable form of birth control Less than grade III overweight or BMI <40 kg/M2 Less than 3 months postpartum and post-lactation at the time of dosing Abnormal laboratory findings considered clinically significant if more than twice the normal range. Abnormal tests will be repeated, and if still high as stated before, subject will be excluded A previous history of significant adverse reactions to hormone, progestin or progesterone and GnRH agonist therapies Abnormal Pap smear in the last 6 months. Subjects with ASCUS (atypical squamous cells of undetermined significance) and are negative for high-risk human papilloma virus (HPV) will be eligible. Subjects that have atypical endocervical cells, and atypical glandular cells are not eligible for this study Subject has a bone density T score less or equal to 2.5, history of nontraumatic fracture, history of spinal surgery, history of fusion of lumbar region, history of severe scoliosis greater than 20 degrees
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 21.0-75.0, Breast Cancer Female Age 21-75 Diagnosed with a primary breast cancer Stage 0-IIIa Current tamoxifen or aromatase inhibitor use is allowed At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy) BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater) No contraindications to participating in a yoga program Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English Gives informed consent, agrees to be randomly assigned Plans to leave the study area within the follow-up period Is pregnant or plans to become pregnant during the study period History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis) Has practiced yoga more than 1 time per month in the past six months Current use of medications likely to interfere with adherence to interventions or study outcomes Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Chronic Urticaria Males or females from 18-70 years of age Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening Diagnosis of moderate to severe chronic urticaria Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period UAS7 ≥ 10 at the time of randomization Females of child-bearing potential or breast feeding Present or past medical conditions that could have interfered with the study results Randomized into any other omalizumab study or who had received omalizumab Received investigational drugs within 30 days of enrollment
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Subclinical Hypothyroidism Laboratory evidence of subclinical hypothyroidism (TSH levels 4-25 mU/L and normal T4 values) in at least two following tests (one month apart from each other) Recent (less than 6 months) myocardial infarction, cerebrovascular event or angiography with stent placement Serious infection in the month before recruitment Any use of contrast media in the last 6 months Loss of more than 5% of body weight during the last 6 months Cardiac arrhythmias Ejection fraction of less than 40% Active malignant diseases Previous thyroid disease and Pregnancy
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-999.0, Tratment of Multinodular Goitre Patients with multinodular goitre Aversion to any form of treatment Previous radioiodine therapy Being unable to complete a prolonged follow-up; and Having serious cardiovascular disorders
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Hypothyroidism Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis Healthy controls matched regarding sex, age and body mass index Pregnancy, breastfeeding
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-75.0, Quality of Life Depression Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months <18 år >75 år pregnant women Thyroid cancer T3 treatment Post-partum thyroiditis
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 23.0-73.0, Iron Deficiency Anemia Subclinical Hypothyroidism Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism Must be able to swallow tablets Multifactorial anemia or anemia due to other reasons Iron deficiency anemia requiring urgent intervention cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, Gİ, GU, etc. system Prior thyroid disorder and/or treatment history Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Hashimoto Disease Adrenal Insufficiency Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent • hypothyroidism of other origin pregnancy and lactation oral contraception glucocorticoid therapy during the last 2 months History of malignancy or chronic infections (Hepatitis, HIV)
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-75.0, Hypothyroidism Ages 20-75 Primary hypothyroidism on stable dose of L-T4 for > 3 months Documented elevated TSH off L-T4 Normal TSH level on usual dose of L-T4 No acute or chronic medical or psychiatric illnesses that affect thyroid function, mood or cognition No medication use that affects thyroid function, mood or cognition (oral contraceptives or estrogen therapy allowed) Normal score on screening Mini-Mental State Exam (MMSE) (to test for dementia) Normal vision by screening examination Normal hearing by screening examination Non smoker Failure to meet any of the above Inability to speak and comprehend English A history of coronary artery disease Screening hgb <10 Screening wbc > 10,000 Clinically significant abnormalities on screening metabolic set Screening LDL cholesterol > 160 Screening triglyceride > 300 Significant abnormalities on screening ECG Pregnancy or intent to become pregnant in next 6 months
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-80.0, Gastroesophageal Reflux Disease (GERD) Body weight 40 to 136 kg (88 to 300 lbs) Recent history of GERD related symptoms (at least twice weekly) confirmed during screening Recent history of 8 week PPI treatment without significant improvement Abnormal bilirubin level as assessed by Bilitec Normal esophageal pH value (pH<4.0 for <4.2% of the time calculated over a 24 hour period) Platelet count (thrombocytes) >100,000/µL Normal Hgb and Hct levels Able and willing to comply with all protocol procedures for the planned duration of the study Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline Concurrent GI or other pathology which could interfere with the course of the study (e.g., erosive esophagitis, malabsorption, cirrhosis, ascites, bleeding ulcer, diabetes, scleroderma, non-GI myopathy or neuropathy etc.) Note: patients with Barrett's esophagus (short segment defined as < 3 cm) can be included Patients with cancer or undergoing chemotherapy for the treatment of cancer Patients with a history of upper GI surgery Patients with GERD complications such as stricture of the esophagus Contraindication to continued PPI treatment Patients requiring the concomitant use of NSAIDs for the duration of the study Uncontrolled systemic disease Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medications for at least 6 months Other major physical or psychiatric illness in previous 6 months as determined by the treating physician Known hypersensitivity or contraindication to any component of the test product (study drug) or diagnostics used
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, Hypertension Sleep Apnea Syndromes Obesity We will enroll up to 180 subject in order to fulfill screening requirements and have complete studies in 120 total (60 with and 60 without family history hypertension) Gender: Male and female Ages: 18 to 40 (inclusive) Body-mass index > 33 kg/m2 Tobacco smoking or chewing Shift worker Any diseases Any prescription medications (except, oral contraceptives are permitted)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-35.0, Weight Gain Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Healthy Age: 18-50 years. 2. Sex: Men and/or non-pregnant, non-lactating women. 1. Women of childbearing potential must have negative serum β human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to each dose administration. An additional serum (β HCG) pregnancy test will be performed upon completion of the study. 2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Oral contraceptives are not to be used within 3 months prior to dosing and throughout the course of the study due to the fact that they increase serum TBG concentrations, and therefore, elevate T4. Acceptable forms of contraception the following: 1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or 2. barrier methods containing or used in conjunction with a spermicidal agent, or 3. postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy). 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women, and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1983 (See Part II Administrative Aspects of Bioequivalence Protocols). 4. All subjects should be judged normal (euthyroid) and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation, blood chemistry, serum T4 (free and total), serum T3 (total only), serum thyroid-stimulating hormone (TSH), serum thyroxine-binding globulin (TBG), hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication Institutionalized subjects will not be used. 2. Social Habits: 1. Use of any tobacco-containing products within 1 year of the start of the study. 2. Ingestion of any alcoholic, caffeine or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. 3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 4. Any recent, significant change in dietary or exercise habits. 5. A positive test for any drug included in the urine drug screen. 6. History of drug and/or alcohol abuse. 3. Medications: 1. Use of any prescription or over-the-counter (OTC) medications within the 30 days prior to the initial dose of study medication. These may but is not limited to: infant soybean formula, steroids, salicylates, preparations containing iodine, such as vitamins; oral anti-diabetic agents; all resins for lowering of cholesterol, such as cholestyramine; sucralfate, propranolol, amiodarone, phenytoin, carbamazepine, furosemide; aluminum-containing antacids, including aluminum hydroxide; rifampin, calcium channel blockers and ferrous sulfate. 2. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing. 3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. 4. Diseases: 1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. 2. Acute illness at the time of either the pre-study medical evaluation or dosing. 3. A positive HIV, hepatitis B, or hepatitis C test. 4. History of any thyroid disease. 5. Subjects with any underlying medical condition known to interfere with the absorption or metabolism of thyroid hormones. 5. Abnormal and clinically significant laboratory test results: 1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II OF 2. Abnormal and clinically relevant ECG tracing. 3. Any thyroid function test outside normal limits. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Subjects who received any surgical treatment within 6 months prior to the initial dose of study medication. 9. Subjects with known allergies or hypersensitivity to thyroid preparations or their inactive ingredients. 10. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 11. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration. 12. Consumption of products containing walnuts, cotton seed meal, soybean flour or dietary fiber within 48 hours of drug administration
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-60.0, Graves Disease Patients with newly diagnosed hyperthyroid Graves' disease If the patient had been treated previously diabetes, kidney, or liver disease
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-60.0, Obesity Diet Therapy Weight Loss Weight Gain Nutrition Therapy BMI greater than or equal to 27 kg/m(2) for the weight loss protocol but body weight less than 350 pounds to accommodate the DXA scanner BMI less than or equal to 24 kg/m(2) (and BMI greater than or equal to 18.5 kg/m(2) for the overfeeding protocols. A history of low BMI and difficulty gaining weight Age 18-60 years, to minimize potential co-morbid conditions which may indirectly affect EE. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Women who are post-menopausal will be excluded from the study as changes in their metabolism could affect the baseline measurements which are hypothesized to predict weight change Healthy, as determined by medical history, physical examination, and laboratory tests Current smoking Type 2 diabetes (according to the World Health Organization diagnostic criteria) Impaired glucose tolerance (according to the World Health Organization diagnostic criteria) for those participating in the overfeeding study arms only Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo and hyperthyroidism) Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry) Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease) Hypertension (blood pressure measurement higher than 140/90 mm Hg (overfeeding study) or 160/95 (weight loss study) on two or more occasions or use of anti-hypertensive medications) Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI or CorTemp measurements
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, PCOS Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45 Less than or equal to 8 periods annually elevated serum free testosterone concentrations normal thyroid function tests and serum prolactin of late-onset adrenal hyperplasia acceptable health based on interview, medical history,physical examination, and lab tests ability to comply with the requirements of the study ability and willingness to provide signed, witnessed informed consent Diabetes mellitus Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease high blood pressure current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc) documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism ingestion of any investigational drugs within 4 weeks prior to study onset pregnancy or lactation(less than or equal to 6 weeks postpartum)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-48.0, Hypothyroidism Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones Peri and postmenopause Pregnancy Major comorbidity Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Hypothyroidism Subjects belonging to extended family of the index case
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Thyroid Disease Healthy Subjects will be healthy male and female adult volunteers, between the ages of 18 and 65, able to provide informed consent. Patients younger than 18 are excluded as this is a purely physiologic study and we are unable to justify any potential risk. However, should our preliminary findings show potential clinically relevant benefits for children, the protocol could be modified to them. Patients older than 65 are excluded due to intrinsic differences in thyroid hormone dynamics, compared with younger subjects, which could confound study interpretation BMI less than or equal to 19 or greater than or equal to 35 Kg/m(2) 2. Hypothyroidism, or TSH levels above the normal limits (current replacement therapy or TSH greater than 4.0 mcIU/mL) 3. Hyperthyroidism, or TSH levels below the normal limits (current or previous therapy or TSH less than 0.4 mcIU/mL) 4. Autoimmune thyroid disease (as defined by a positive anti-TPO, or anti-TSH receptor antibody titer) 5. Hypertension (Blood pressure greater than 140/90 or use of antihypertensive medication) 6. Liver disease or ALT serum concentrations greater than 1.5 times the upper laboratory reference limit. 7. Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation). 8. History of, and/or current Diabetes Mellitus (fasting glucose greater than 126 mg/dL) 9. Iodine deficiency (spot urine iodine concentration less than 42 mcg/L) 10. History of, and/or current coronary artery disease 11. History of, and/or current asthma 12. History of, and/or current seizures or chronic headache 13. History of, and/or current depression 14. History of pituitary tumor 15. Pregnancy (women of child-bearing potential must have a negative pregnancy test prior to and at the time of TRH testing) 16. Known allergy to TRH 17. Current use of prescription medication or certain non-prescription medications and dietary supplements which could affect thyroid function and/or metabolism
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 17.0-44.0, Hypothyroidism TSH value >98th centile in early pregnancy Women with known hypothyroidism
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 25.0-70.0, Obesity Age 25 and over BMI of 18.5-29.99 Two localized areas of fat deposition on the upper and lower torso that have failed on self-reported diet and exercise The subject is in good health The subject has the willingness and the ability to understand and provide informed consent Under 25 years of age Pregnancy or Lactation BMI≥ 30 Subjects with known eating disorders or a history of weight loss/gain of 5 pounds or more within the past 6 months Subjects with hepatrophy, nephopathy, diabetes, hyperthyroidism, neoplasias, AIDS or other immuno-compromised illness, allergies to eggs or soy, poorly controlled hypertension, or autoimmune disease Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months Subjects with an open, non-healing sore or infection near site of injection Subjects with active eczema or psoriasis Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Obesity Weight Loss Obese Diabetes Other severe disease
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 45.0-65.0, Precancerous Condition Prostate Cancer Meets 1 of the following Patient at high risk for developing prostate cancer, due to 1 of the following risk factors Histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation Abnormality observed during digital rectal exam or transrectal ultrasonography Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at least 1 of the following Screening PSA > 4.0 ng/mL Free PSA < 18% PSA velocity > 0.75 ng/mL within the past year Healthy volunteer meeting the following Age-matched
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 15.0-50.0, Menorrhagia Criteria:Clinical diagnosis of Menorrhagia Must be able to swallow tablets Endometrial abnormality Pelvic infection Pregnancy Breast Feeding Requirement for birth control Known intolerance/lack of effect of tranexamic acid
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 7.0-999.0, Hashimoto's Disease Graves' Disease Clinical diagnosis of abnormal thyroid function (hypo or hyperthyroidism) due to autoimmune thyroid disease Lack of documentation of abnormal thyroid function or clear evidence of autoimmune etiology
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-85.0, Subclinical Hypothyroidism Subjects with subclinical hypothyroidism Patients taking L-thyroxin therapy Patients with known cardiovascular, cerebral or peripheral atherosclerotic disease
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 23.0-37.0, Osteoporosis Obesity Weight Loss Body Composition To be eligible for the study, women must be less than 3 weeks postpartum, between the ages of 25 to 40, with a body mass index (BMI) between 25 and 30 kgm-2), exclusively breastfeeding, sedentary for the past 3 months (< 3 weekly sessions of moderate aerobic activity), non-smokers, medically cleared for exercise by their physician, and agree to randomization for the study are delivery by cesarean section, have medical complications where exercise is contraindicated, or a disease that would affect hormone levels
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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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
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
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
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
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
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
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
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
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
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-999.0, Immune Thrombocytopenia (ITP) A signed and dated written informed consent Males and females ≥ 18 years of age All subjects must agree to use barrier contraception Diagnosis of ITP Subjects > 60 years must have had a diagnostic bone marrow aspiration Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs Subjects receiving steroid therapy must be on a stable dose Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN) Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1) History of clinically important hemorrhagic clotting disorder Females who are pregnant, lactating, or taking oral contraceptives History of alcohol/drug abuse or dependence within 1 year Use of the following drugs or treatment prior to Visit 1 (Day 1) Within 12 weeks alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy Within 8 weeks rituximab Within 2 weeks platelet transfusions or plasmapheresis treatment
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-95.0, Hashimoto Disease age more than 18 years inability to give a written consent other conditions and drug usage affect oxidative stress
|
2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-999.0, Breast Cancer Fatigue Age > 18 years 2. Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either breast or both breasts 3. Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel lymph node biopsy, ±axillary lymph node dissection 4. A likelihood of having radiation therapy or chemotherapy following surgery as determined by the on-site principal investigator (PI) or co-investigator 5. Signed informed consent which has been reviewed and approved by the Institutional Review Board and no condition that impairs the ability to provide informed consent (e.g. uncontrolled psychiatric illness) for the radiation therapy (RT) alone group will 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian Fractionation, +/ regional nodal irradiation. 2. No planned chemotherapy for this tumor for the RT + chemotherapy (CT) group will 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian fractionation (photons followed by a photon, electron, or mixed photon/electron boost), +/ regional nodal irradiation. 2. Planned adjuvant chemotherapy (any regimen except for biologic therapy alone) Continuous/chronic treatment with opiate/opioid analgesics for 3-6 months prior to enrollment. In addition, patients receiving radiation therapy alone who have taken opiate analgesics from their surgery within 72 hours of the post-surgery/pre-radiation therapy blood draw (at 1-6 weeks prior to the start of radiation therapy) will be removed from the study. Patients receiving chemotherapy and radiation therapy who have taken opiate analgesics from their surgery within 72 hours of the blood draw prior to cycle 1 of chemotherapy will be removed from the study. 2. Prior radiation therapy to the chest or brain 3. Patients diagnosed with Stage IV breast cancer 4. History of illegal drug use within 6 months prior to enrollment 5. At point of enrollment, diagnosis of major depression, bipolar disorder, seasonal affective disorder, or anxiety disorder for which the patient is currently taking any of the following medications: selective serotonin reuptake inhibitors (SSRIs), Tricyclic antidepressants, monoamine oxidase inhibitors, lithium, benzodiazepines, barbiturates, drugs acting on the 5-HT receptors. Patients meeting these may still enroll in the study if they are on a chronic, stable, low-dose regimen for at least 3 months prior to enrollment, as determined by the on-site PIs and co-investigating physicians. Patients having to begin on a regimen of any of these medications while on the study may continue on the study. 6. Anemia of any etiology at initial visit (Hct <33%) and the following baseline fatigue scores on the Fatigue Symptom Inventory (FSI): Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5. Patients with Hct<33% but who have no baseline fatigue (as indicated by baseline scores on the FSI as follows: average score for question #s 1-4 < 5 and average scores for question #s 5-11 < 5) are eligible to participate. 7. Endocrine disorders that can cause fatigue: Addison's disease, uncorrected hypothyroidism (patients taking thyroid replacement therapy for at least 3 months prior to enrollment patients are eligible), central endocrine deficiency, polyglandular autoimmune failure. 8. Patients with thyroid disease (hypothyroidism or hyperthyroidism) that was diagnosed within 3 months of cancer diagnosis or patients with previously stable thyroid disease who have experienced symptoms or have had to change their medication doses within 3 months of cancer diagnosis. Patients with stable disease who have no had to change medication doses within 3 months of cancer diagnosis. Patients with stable disease who have not had to change medication doses within 3 months of cancer diagnosis may enroll as long as baseline fatigue scores do not meet for exclusion. Patients enrolled in the study who have to alter doses of thyroid medications or who are newly diagnosed with thyroid disease while on the study will be removed from the study, and will not count towards our total patient accrual. 9. Uncontrolled autoimmune diseases that can cause fatigue, including fibromyalgia and fatigue syndromes. If these are controlled, enrollment or maintenance of the patient on the protocol may continue at the discretion of the enrolling principal investigator. 10. Sleep disorder diagnosed within 3 months of enrollment and the following baseline fatigue scores on the FSI: Average score for question #s 1-4 > 5; and/or average score for question #s 5-11 > 5. Patients diagnosed with a sleep disorder within 3 months of enrollment and with FSI scores < 5 on question #s 1-4 and #s 5-11 are eligible. 11. Activity-limiting heart or lung disease 12. Renal failure (BUN and creatinine should be within the normal range for the prior 6 months) 13. Baseline fatigue as indicated by the following baseline scores on the FSI: Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5. 14. Patients receiving chemotherapy or radiation therapy at any site other than Massachusetts General Hospital 15. Hepatitis or chronic liver disease (albumin <3 g/dL or >6 g/dL; ALT >60 U/L or < 5 U/L, AST > 40 U/L or <5 U/L) 16. Untreated chronic infection (e.g. tuberculosis, osteomyelitis, abscess). Patients being treated for these may be enrolled in, or continue on the protocol at the discretion of the principal investigators
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 20.0-60.0, Autoimmune Thyroiditis Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography were applied to diagnose CAT Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies Ultrasonography results consistent with CAT Patients undergoing LT4 treatment Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH) Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones CAT with normal thyroid function CAT with subclinical hypothyroidism Thyroid nodules Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation) History of Graves' disease Thyrotropin receptor antibody (TRAb) detectable Prior treatment with radioiodine Tracheal stenosis Pregnancy
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 14.0-999.0, Hypothyroidism Hyperthyroidism Outpatients with disconnected feedback control due to the following conditions Overt primary hypothyroidism with TSH level higher than 10 mU/l and FT4 concentration below 7 pmol/L (5.4 ng/L) (Partition 1) Overt primary hyperthyroidism with TSH level below 0.1 mU/l and FT4 concentration higher than 18 pmol/L (14 ng/L) (Partition 3) All other constellations, if the patient receives substitution therapy with more 1.75 µg Levothyroxin per kg of body mass (Partition 2) System in equilibrium (e.g. unchanged substitution dose over the past six weeks) Pituitary or hypothalamic dysfunction Severe illness that may be associated with euthyroid sick syndrome (non-thyroidal illness syndrome) Medication influencing pituitary function Pregnancy Missing consent for participation in the study
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 30.0-55.0, Menorrhagia Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete 2. Subjective symptom of excessive menstrual loss 3. Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months 4. At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure 5. Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner 6. Freely agree to participate in the study including all study related procedures and evaluations, and document this agreement by signing the informed consent document Pregnancy or desire for future childbearing 2. Active lower genital infection at the time of procedure 3. Active urinary tract infection at the time of procedure 4. Active pelvic inflammatory disease (PID) or recurrent chronic PID 5. Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry 6. Current or past history of cervical or endometrial cancer 7. Uterine sound measurement greater than 10cm 8. Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma 9. History of myomectomy or classical cesarean section 10. Previous endometrial ablation 11. Oral hormonal treatment in the preceding 3 months, hormone releasing intrauterine contraceptive in the preceding month, or injectable hormone treatment in the preceding 12 months 12. Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents. 13. History of a coagulopathy or endocrinopathy 14. Inability to follow up at 12 months
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 16.0-60.0, Graves' Disease Graves' disease patients. Healthy people Pregnancy. <16 years old or > 60 years old
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 35.0-60.0, Hypothyroidism Recently diagnosed hypothyroid subject (either during the period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor Subject, who has given his/her oral consent for participation Subject included in clinical trial or having participated in a clinical trial during the last 3 months Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) All contraindications to Lévothyrox
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 30.0-50.0, Overweight Healthy premenopausal women from Quebec City metropolitan area Age: between 30 to 50 years old Stable body weight (+/ kg) for at least 2 months before the beginning of the study Overweight or obesity: Body mass index [BMI] between 25 and 35 kg/m2 Preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years) Current weight corresponding to maximum weight reached during adult lifetime Women currently dieting to lose weight Taking oral contraceptives or postmenopausal status Pregnant or lactating women Under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease) Women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, …) Women who had already take part to the Health-At-Every-Size (HAES) approach
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 20.0-999.0, AITd Patients With Different Polymorphisms Autoimmune thyroid patients patients who cut Nodular Goiter in Wanfang Hospital none
|
2
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