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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, Systemic Sclerosis Hashimoto Thyroiditis Thyroid Nodules Clinical diagnosis of systemic sclerosis non
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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): 20.0-40.0, Healthy Volunteers Men and women aged 20 years Body Mass Index (BMI) from 19.0 to 25.0 for the lean population or Body Mass Index (BMI) equal to or greater than 30 for the obese population and under 300lbs (136.07kg.) Fluent in English Females must report a normal menstrual cycle length defined as from 24-35 days, with a period lasting from 2-7 days Stable weight (+/ %) for at least three months prior to each admission and under 300 lbs (136.07kg.) Weight of > 300 lbs (136.07kg.) Patients may not have had > 550 mL of blood drawn within 8 weeks of study entry Less than 8 weeks after receiving an investigational new drug (IND). Patients must have a minimum of an 8 week washout period Left-handedness Any employee of Rockefeller University who knows the details of this study Reported history of claustrophobia Reported history of metal implants, pacemaker, IUD, braces, or tattoos less then 6 months old Reported history of smoking, chewing tobacco or use of nicotine patches within the previous 3 months Reported history of alcohol abuse/dependence Reported use of prescription medication for pain, anxiety or sleep more than once a week
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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, Abortion, Spontaneous Pregnancy Complications Subclinical Hypothyroidism Part 2: Women who had experienced a minimum of one early spontaneous abortion and between 20 and 50 years old: 80 women who have subclinical hypothyroidism defined as raised serum concentrations of TSH > 3,4 mU/l and normal levels of free T4 and T3 or TPOab-positive and 80 women who have normal levels of TSH and TPOab-negative Women with metabolic disease, diabetes or psychiatric disease Women using medicine against hypo or hyperthyroidism Women who never give birth or age more than 50 years. Part 3 Pregnant women (3rd trimester) Women with metabolic disease, diabetes or psychiatric disease Women using medicine against hypo or hyperthyroidism
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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): 15.0-50.0, Hirsutism PCOS premenopausal hirsutism or PCOS
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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, Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II papillary or follicular thyroid cancer stage 1 or 2 according to TNM system version 6 surgery and radioiodine treatment levothyroxine suppression treatment cardiopulmonary failure liver failure renal failure pregnancy drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)
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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): 19.0-999.0, Metabolic Syndrome presence of metabolic syndrome by International Diabetes Foundation referral to metabolic syndrome program at St. Paul's Hospital age > 19 years unwillingness to participate in research study unwillingness to comply with dietary intervention following a weight reducing diet abusing alcohol or other psychoactive substances on psychiatric medication associated with weight gain plans to travel during the study period food allergies or intolerances that will interfere with their adherence to either of the study diets
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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): 18.0-75.0, Goiter Hypothyroidism Weight Gain Is going to undergo hemithyroidectomy for nontoxic goiter at the department of otorhinolaryngology at Slagelse Hospital, Denmark BMI 20-40 No past thyroid diseases No medication with influence on the pituitary-thyroid axis No hormone replacement therapy No childbirth or pregnancy within the last year Not currently breastfeeding Malignant goiter, diagnosed by histological examination of the resected tissue Pregnancy
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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): 40.0-65.0, Diabetes Hypothyroidism Male or postmenopausal females Age 40-65 years Body mass index (BMI) < 40 and > 27 kg/m2 Stable dietary habits (no weight loss/gain >3 kg in the last 6 months) Stable physical activity levels for at least six months Newly diagnosed hypothyroid, non-insulin dependent type 2 diabetic patients having TSH values higher then > 4.0 mU/l and lowered concentrations of free T4 < 8.0 pmol/l Type 2 diabetic patients using sulphonylurea and or metformin therapy for at least six months with a constant dose for at least two months Hypothyroid diabetic patients due to Hashimoto disease (TPO > 100 IE/ml; Tg > 344 IE/ml), should have no auto-antibodies against glutamic acid decarboxylase (GAD), IA-2 and insulin to type 2 polyglandular autoimmune syndrome (PGAII) (to type 1 diabetes) Type 2 diabetic patients should have a HbA1c level < 8.0% Type 2 diabetic patients will be included when having no diabetes-related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy Unstable body weight Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study Medical history including active cardiovascular disease, i.e. history of coronary artery disease (i.e. history of angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting) or cardiac arrhythmias Liver disease or liver dysfunction (ALT>2.5 x increased) Impaired renal function (creatinine > 120 umol/L) Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg Hb <7.4 mmol/l (12 g/dl) in women, and <8.1 mmol/l (13 g/dl) in men Abuse of drugs and/or alcohol Contraindications for MRI scanning (please see appendix III: MRI contraindication questionnaire) Patients with history of thyroid cancer
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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, Menstrual Problem Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual diary for 6 months Women who have currently or previously had Heart attack or stroke Blood clot in a vein High blood pressure Severe liver or kidney disease Blood pressure > 135 mm systolic or >85 mm diastolic Migraine with aura Breast cancer or any genital cancer Severe chronic liver or kidney disease Women with known sensitivity to ethinyl oestradiol, progestogens
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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): 18.0-65.0, Schizophrenia Schizoaffective Disorder 65 yrs of age currently meeting DSM-IV for schizophrenia or schizoaffective disorder with onset occurring > 1 year prior to enrollment in the study score of <24 on the Reading the Mind in the Eyes Test ("Eyes Test", Baron-Cohen, et al 2001), which represents 0.5 SD below the mean in a large normative sample OR get a minimum score of "3" on at least two of the following "social" items on the PANSS ratings: suspiciousness/persecution (ideation), hostility, passive/apathetic social withdrawal, uncooperativeness, active social avoidance stable symptoms as well as being on the same medication and psychosocial therapy regimen for > 1 month current or lifetime history of schizoaffective (bipolar type), delusional, other psychotic (shared, substance-induced, due to a medical disorder) disorders, bipolar, cyclothymic, somatoform, dissociative, eating or personality disorders, unipolar major depressive episodes with psychotic features, dementia history of mania or hypomania within the past two years substance use or abuse disorder during the past 3 months (except tobacco, caffeine) treatment currently or within the past 6 months with high dose sedative-hypnotics, stimulants, chronic glucocorticoids (other medications that are adequately controlling acute or chronic disorders [e.g., hypertension, diabetes, hypo or hyperthyroidism, asthma, allergies, mild infections etc.] are allowed) debilitating or inadequately controlled medical conditions (including dialysis, HIV infection without AIDS is not exclusionary) major surgery/trauma in the past 4 months pregnancy, childbirth or breast-feeding in the past year significant physical exam, laboratory or EKG abnormalities reading level < 5th grade on the Wide Range Achievement Test (WRAT, Wilkinson 1993) inability to read English well enough to complete study questionnaires
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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, Thyroid Cancer Metastases Patients with thyroid cancer and known measurable (>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan 2. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal 3. Age >18 years 4. Previous treatment with radioiodine more than 6 months before inclusion. 5. Serum TSH level <0.5 mU/L 6. Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula > 60 ml/ml 7. Effective means of contraception for female patient, at risk of pregnancy 8. Written informed consent Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake 2. Iodine excess (< 50 μg/dl) 3. Large or diffuse bone or brain metastases 4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs 5. Patients already included in a therapeutic trial with an experimental medicine 6. Pregnancy and breast feeding patients 7. Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures 8. Treatment with antivitamin k
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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, Pain Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling Infant delivered at, or greater than 37 weeks gestation Singleton birth Speaks and understands English Access to telephone Infant not expected to be discharged home with mother Infant with congenital abnormalities that would impair breastfeeding Maternal allergy to lanolin Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff
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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): 18.0-60.0, Systemic Lupus Erythematosus Premenopausal women and males of the same body mass index and ethnicity Patients with other inflammatory disorders hepatic disease renal disease malignant 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): 18.0-80.0, Thyroid Cancer Hashimotos Thyroiditis All patients undergoing thyroidectomy for a variety of indications at University of Texas Medical Branch in Galveston between June 2011-May 2012 Age 18-80 years old History of previous radiotherapy to head and neck and History of radioactive iodine therapy
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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, Malignant Struma Ovarii Papillary Thyroid Cancer Hurthle Cell Thyroid Cancer Follicular Thyroid Cancer Tall Cell Variant Thyroid Cancer Subjects will be adult volunteers older than age 18 who underwent total thyroidectomy for the treatment of differentiated thyroid cancer, previously undergone radioactive iodine ablation of the thyroid gland remnant, with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine. The patient population will be recruited from the participants in the 77-DK-0096 natural history protocol: Studies on Thyroid Nodules and Thyroid Cancer , PI Dr.Joanna Klubo-Gwiezdzinska and from the 10-C-0102 natural history protocol: Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer , PI Electron Kebebew Significant thyroid residual greater than 5 gm as measure by ultrasound or greater than 5 percent uptake at 24 H on (123) I pre-treatment thyroid scan. 2. Renal insufficiency or estimated creatinine clearance less than or equal to 60 mL/min/1.73M(2) BSA by MDRD equation before thyroid hormone withdrawal. 3. Liver disease or ALT >2.5 times the upper laboratory reference limit. 4. Pharmacologic therapy for the treatment of psychiatric conditions. 5. History of, and/or current coronary artery disease. 6. Current history or symptoms compatible with psychosis or major depression (including history of hospitalization for depression, history of attempted suicide, history of suicidal ideation). Use of antipsychotic medications. 7. History of drug or alcohol abuse within the last year; current use of illicit drugs or alcohol abuse (CAGE>3). 8. Pregnancy (women of child-bearing potential must have a negative pregnancy test prior to inclusion) or use of hormonal contraceptives. 9. Known allergy to L-T3. 10. Current use of prescription medication or certain non-prescription medications and dietary supplements known to affect thyroid function and/or metabolism, or alter the pharmacokinetics of L-T3. 11. Inability or unwillingness to follow the low-iodine, metabolic diet or non-compliance to the L-T3 administration regimen. 12. The presence of persistent diarrhea or malabsorption syndromes that would interfere with the patient s ability to adequately absorb drugs. 13. Inability to obtain venous access for sample collection, or basal hemoglobin of less than or equal to 10 g/dL. 14. Low functional status (ECOG Performance Status > 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 Cancer Patients Age 18-65 Hypothyroid patients under treatment with levothyroxin Normal euthyroid patients with no goiter Pregnancy or lactation Severe lung or gasterointestinal disease Heart failure or renal failure
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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, Dyslipidemia Patients >18 years old With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter State of pregnancy, Breast feeding or allergy to levothyroxine
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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, Polycystic Ovary Syndrome Normal Volunteers All 1. Female patients undergoing controlled ovarian hyperstimulation (COH), transvaginal oocyte aspiration (TVA), and Saline Infused Sonography (SIS) with UL collection 2. Age <35 y/o at time of in vitro fertilization (IVF) cycle 3. Normal ovarian function defined Day 3 Follicular Stimulating Hormone (FSH) <8 pg/ml or Anti-Mullerian Hormone (≥ 1.0 ng/ml) Controls: 1. Female patients undergoing COH and TVA donating her oocytes 2. Female patients undergoing COH and TVA for male factor infertility only (i.e. no female causes of infertility) 3. Normal menstrual cycles Lean PCOS: 1. Diagnosis of PCOS by Rotterdam 2. BMI ≤ 25 kg/m2 Classic PCOS 1. Diagnosis of PCOS by Rotterdam 2. BMI > 30 kg/m2 Age ≥ 35 y/o 2. Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis) 3. Unexplained infertility
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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): 2.0-30.0, Childhood Hepatocellular Carcinoma Papillary Thyroid Cancer Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Liver Cancer Recurrent Childhood Rhabdomyosarcoma Recurrent Thyroid Cancer Recurrent Wilms Tumor and Other Childhood Kidney Tumors Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse Rhabdomyosarcoma (RMS) Wilms tumor Hepatocellular carcinoma (HCC) Papillary thyroid carcinoma (PTC) Patients must have relapsed or refractory disease (RMS, Wilms tumor, HCC, PTC) Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm) The following do not qualify as measurable disease Malignant fluid collections (e.g., ascites, pleural effusions) Bone marrow infiltration
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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, Polycystic Ovarian Syndrome Infertility Obesity Overweight Women must meet the following have been attempting pregnancy for at least 6 months is not currently pregnant has a clinical diagnosis of PCOS is not on oral medications for insulin resistance (such as metformin) or, if currently on such a medication, has been on the medication at a stable dose for at least 3 months willing not use fertility-enhancing medications over the 6-month study (with the exception of oral medications, such as clomiphene citrate, as directed by their physician) willing to be randomized to either dietary condition and able to make weekly meetings Participants should not be in this study if they meet any of the following have not been diagnoses with polycystic ovarian syndrome have been trying to conceive less than 6 months have a Body Mass Index less than 25 or greater than 45 kg/m2 are currently pregnant are younger than 18 or older than 35 years of age are a smoker are unable to come to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments don't have access to the Internet and a computer don't have access to a scale for self-monitoring weight
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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): 21.0-55.0, Healthy Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment Body Mass Index (BMI) of 23 to 33 kg/m2 and a total body weight >=50 kg (110 lbs) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated seasonal allergies) Any condition possibly affecting drug absorption (eg, gastrectomy) A positive urine drug screen
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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, Type 2 Diabetes Type 2 diabetes Age 18 years and above Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/ glinides and basal insulin analogs A1C 10% or below Capable of self monitoring glucose at least 4 x a day Previously compliant with clinical recommendations Fasting blood glucose <110mg/dl average for 3 consecutive days BMI <45 kg/m Urinary ketosis Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode Currently participating in another clinical trial Using rapid insulin insulin Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control Significant liver or heart failure
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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, Thyroiditis, Autoimmune adults 18-70 years of age having positive antibodies against thyroid peroxidase having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis having evidence of end-stage thyroiditis being a current smoker or smokeless tobacco user be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent
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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, Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Aged ≥18 years with histologically or cytologically proven advanced epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma Stage IC1 III or Stage IVA (pleural effusion only) at diagnosis. (According to new FIGO staging effective 01/01/2014) Completed cytoreductive surgery during the phase of first-line therapy including removal of bulky tumour masses and adequate surgical staging including a minimum of bilateral salpingo-oophorectomy, hysterectomy and omentectomy Completed first line platinum-based chemotherapy OR Completed first line platinum-based chemotherapy and second line chemotherapy of any type with complete response to second line treatment according to 1.1 Have developed relapse ≥6 months after platinum-based chemotherapy (in the case of second relapse, the disease free interval should also be ≥6 months) Normal CA-125 following platinum-based chemotherapy Have developed asymptomatic relapse as defined by: 1. CA125 ≥ 2xULN OR 2. Low volume radiological disease and CA125>ULN Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic (parenchymal) liver or splenic metastases, ascites or pleural effusion thought to require drainage within the next 2 months. The following are acceptable: Subcapsular liver and splenic lesions, benign lesions or cysts, any suspicious lesions that may represent metastases have to be confirmed by further imaging to be non-metastatic Currently asymptomatic and does not require chemotherapy Subject is assumed to be clinically immunocompetent and is free of clinically apparent/active autoimmune disease (i.e. no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, and rheumatoid arthritis). Note: subjects with type I or type II diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease (defined as recent flare within 6 months prior to randomisation/registration) Carcino-sarcoma/MMMT Cancer related symptoms, or disease recurrence requiring immediate treatment Patients with low volume radiological disease in any of the following sites at trial entry Accumulating ascites thought to require drainage within the next 2 months Pleural effusion thought to require drainage within the next 2 months Intraparenchymal Liver and/or splenic metastases CT scan showing bulky disease requiring chemotherapy, as judged by the investigator Major surgery/radiation therapy, immunotherapy or chemotherapy completed < 4 weeks prior to randomisation/registration Patients who are deemed as being immunosuppressed, receiving > 4 weeks parenteral or oral steroids, (nasal sprays and inhalers are permitted), or receiving immunosuppressive therapy following transplant Chronic (≥ 6 months) oral corticosteroid use except when prescribed as replacement therapy in the case of adrenal insufficiency. If previously used for ≥6 months then must have discontinued ≥3 months prior to randomisation/registration
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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, Healthy Healthy adults Must be able to swallow tablets Hypothyroid Disease Pregnant Females
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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, Hperglycemia Diabetes Mellitus Weight Gain At least 18 years of age. 2. Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy. 3. Are able to have an OGTT prior to 16 weeks gestation (if diabetes was not previously diagnosed). Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained. Pregnant women with previously diagnosed diabetes are eligible if measures of glycemia (FPG, HbA1c, glycated albumin) are completed prior to 16 weeks gestation. 4. Estimated prenatal BMI >25 kg/m2. 5. Able to commit the time required for the interventions and follow-up. 6. Able and willing to provide informed consent Contraindication to aerobic or resistance exercise (ACOG, 2002). 2. Twin or multiple gestation. 3. Severe anemia, uncontrolled asthma, uncontrolled hypertension, cardiac disease, or any condition that requires follow-up at specialty care clinics outside of PIMC (e.g., pregnancies at high risk for maternal or fetal demise). 4. Any condition that in the opinion of the investigators would interfere with consent, treatment, or follow-up
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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): 18.0-65.0, Bipolar Disorder Diagnosis of Bipolar Disorder (Type I or II), which is the primary focus of treatment Ability to give informed consent Currently ill (CGI-BP ≥ 3) Age > 18 years and < 65 years Overweight individuals (BMI > 25) Unwilling/unable to comply with study procedures Endorsed item, confirmed by patient's physician, on the PAR-Q Euthymic (CGI-BP < 3) Diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa) in the past month Diagnosis of substance dependence in the past month Active suicidality (MADRS item 9 score > 4) Pregnant (as analyzed by a urine pregnancy test) Currently receiving another psychosocial treatment Exercising regularly (i.e., 5 days per week for 30 min) Neurologic disorder or history of head trauma
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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, Polycystic Ovary Syndrome (PCOS) PCOS as defined by NIH/NICHD 1) oligo or amenorrhea (≤8 menstrual periods annually, persisting 2 years post menarche); 2) biochemical hyperandrogenism(HA), i.e.,elevated total or free testosterone concentration and/or clinical evidence of HA (defined as the presence of hirsutism); and 3) of secondary causes of ovulatory dysfunction and HA (including hyperprolactinemia, thyroid dysfunction, non-classical congenital adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency, Cushing syndrome, androgen secreting neoplasms, and androgenic/anabolic drug use) for adolescent and adult control subjects will 1) normal menstrual periods (defined as regular cycles between 22-36 days in length); 2) normal serum androgens (total/free testosterone and dehydroepiandrosterone-sulfate [DHEA-S]); and 3) absence of clinical evidence of hyperandrogenism. Additionally, adolescent controls must be 2 years post menarche Diabetes mellitus Underlying endocrine, neurologic, and/or genetic syndromes leading to obesity Congenital heart disease or abnormal resting ECG Renal or hepatic disease History of rheumatologic disorders or malignancy Use of medications or dietary supplements known to affect insulin sensitivity (i.e. metformin, corticosteroids, and oral contraceptive pills), blood pressure, or cholesterol within 3 months of study participation Investigation drug use within 3 months of study participation Pregnancy Current tobacco use
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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): 18.0-60.0, Effect of Treatment on Bone Mineral Density Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive 2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1 3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) 4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone <300ng/dL measured twice on separate days. One of the two TT levels must be confirmed at baseline. Subjects who fail this criterion will be enrolled in the placebo group. 5. LH <9.4 mIU/mL (at Visit 1 only) 6. Ability to complete the study in compliance with the protocol 7. Ability to understand and provide written informed consent Use of an injectable or pelleted testosterone within 6 months prior to study (men currently on topical products may be enrolled in the study after a 7-day washout period) 2. Use of testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study 3. Use of Clomid in the past year 4. Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study 5. Clinically significant abnormal findings at screening (Visit 1), based on the Investigator's assessment. 6. A hematocrit >54% or a hemoglobin >17 g/dL 7. Clinically significant abnormal laboratory findings at baseline (Visit 2), based on the Investigator's assessment 8. Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication. 9. Known hypersensitivity to Clomid 10. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract) 11. Abnormal fundoscopy exam such as central retinal vein occlusion 12. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study 13. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary) 14. Current or history of breast cancer 15. Subjects with a Z-score of <2 16. Hyperparathyroidism, metabolic bone disease, previous fracture of the spine, recent chemotherapy, use of medications that may influence BMD (thyroid replacement therapy, immunosuppressive therapy, prednisone or antiepileptic drugs 17. No intravenous or oral contrast agents within 7 days. 18. Subject weighs >300 pounds (>136 kg) 19. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6 20. Presence or history of known hyperprolactinemia with or without a tumor 21. Chronic use of medications use such as glucocorticoids 22. History of drug abuse or chronic narcotic use including methadone 23. Subjects with known history of HIV and/or Hepatitis C 24. Subjects with end stage renal disease 25. Subjects with cystic fibrosis (mutation of the CFTR gene) 26. Enrollment in a previous Androxal 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): 18.0-40.0, Obesity Healthy females between the ages of 18-40 (inclusive) BMI > 27 kg/m² Regular menstrual cycle (28 ± 4 days with a maximum of 4 days within-subject variation in menstrual cycle duration Weight stable (within ± 3-kg) 2 months prior to study Must use barrier contraception (e.g. male/female condom) for the study's duration Must be willing to follow the prescribed diet/exercise plan for the study's duration On hormonal contraceptives (IUD are allowed) or any other daily use of medications which can make the subject unsuitable for in the study Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.) Restrictions against participating in cardiovascular exercise and strength training Any condition, which in the opinion of the investigator makes the subject unsuitable for in the study Women who are pregnant,lactating, or planning to become pregnant during the study period
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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, Breast Cancer Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment 2. Pathologically proven lymph node positive tumor(FNAB or Core biopsy) 3. Tumor must be ER positive(eligible patients Allred score 5 and more, Modified Allred 4 and more) and HER-2 negative(IHC score is 0-1+; If IHC score is 2+, the result of FISH or SISH is negative) 4. Premenopausal women Premenopausal status as defined by Last menses within 6 month of randomization or For patients who have had a unilateral oophorectomy, E2 ≥ 20PG/mL and FSH < 30mIU/Ml within 4 weeks of randomization 5. over 20 years old 6. Pre-treatment haematology and biochemistry values within acceptable limits ANC ≥ 1.5 × 109/l Hb > 9g/dl Platelets ≥ 100 × 109/l AST/ALT ≤ 1.5 × ULN(Upper Limit of Normal) ALP ≤ 1.5 × ULN Serum bilirubin ≤ 1.5 × ULN Serum creatinine ≤ 1.5 × ULN 7. ECOG PS of 0 or 1 8. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up 9. Before any study-specific procedures, the appropriate written informed consent must be obtained Inflammatory breast cancer 2. Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment 3. Known severe hypersensitivity to GnRHa treatment 4. Bilateral invasive breast cancer 5. Other serious illness or medical condition congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent active uncontrolled infection 6. HRT within 4 weeks of starting treatment 7. Definite contra-indications for the use of corticosteroids. 8. Last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection) 9. Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution) 10. Pregnant or breastfeeding women 11. Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent)
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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): 2.0-15.0, Spinal Muscular Atrophy Children aged 2-15 years having motor weakness, hypotonia and hyporeflexia with onset noticed after 6 months of age Presence of exon7 deletion of SMNT gene. OR Normal/ mildly elevated CPK with electrodiagnostic characteristics suggestive of neurogenic weakness, normal motor and sensory nerve conduction velocities and muscle biopsy showing neurogenic atrophy and /or evidence of reinnervation SMA type I, onset before 6 months of age. 2. Severely ill and unstable patients requiring life support system. 3. Other causes like cerebral palsy, Down syndrome, connective tissue disorders, metabolic disorders. 4. Pre-existing liver damage, bone marrow depression and coagulation disorders. 5. Use of medications or supplements which interfere with valproic acid and carnitine metabolism within 3 months of study enrollment. 6. Current use of either valproate or levocarnitine. If study subject is taking valproate and carnitine then patient must go through a washout period of 12 weeks before enrollment into 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): 18.0-60.0, Pregnancy Complications Weight Gain Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous) less than 17 weeks gestation a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity) plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited able to tolerate dairy foods approval of primary care provider able to provide signed informed consent unable to understand some English type 1 or type 2 diabetes known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy severe gastrointestinal diseases or conditions any significant heart, kidney, liver or pancreatic diseases pre-existing diabetes currently smoking a depression score 12 or above on the validated Edinburgh depression questionnaire
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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, Excessive Weight Gain in Pregnancy as Antepartum Condition Obesity Weight Gain Type 2 Diabetes Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous); less than 20 weeks gestation; pre-pregnancy BMI of >25 and < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity); plans to deliver at a Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, Joseph Brant Hospital or by home birth but willing to attend research visits at the McMaster University Medical Centre site; approval of primary care provider; and able to provide signed informed consent Unable to understand some English; currently breastfeeding previous child; pregnancy resulting from in vitro fertilization; known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy; severe chronic gastrointestinal diseases or conditions; refusal to consume dairy foods due to intolerance or dislike; any significant heart, kidney, liver or pancreatic diseases; pre-existing diabetes; or a depression score above 13 on the validated Edinburgh Depression scale as that is indicative of severe depression and should be referred for treatment; currently smoking
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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): 18.0-45.0, Nipple Trauma Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma Women who were using any other form of treatment for nipple trauma; use of any topical substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple; presence of mastitis; previous history or presence of malignancies; presence of photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for the first day of data collection; women under unfavorable psycho-affective and cognitive situations which prevented assessment of the analog pain scale, photo image record. and observation of breastfeeding; women who had twins, children with gestational age less than 37 weeks, or birth weight less than 2500 grams
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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): 20.0-60.0, Hashimoto Thyroiditis Hashimoto's thyroiditis Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit) Never receive immunomodulators or immunosuppressants Planned pregnant or already pregnant women Renal insufficiency Hepatic insufficiency Anemia Agranulocytosis Thrombocytopenia Glucose-6-phosphate dehydrogenase deficiency Porphyria cutaneous tarda Allergy to 4-aminoquinolone
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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): 20.0-70.0, Hypothyroidism Clinical diagnosis of hypothyroidism with fatigue symptom Currently use of the same amount of levothyroxine over at least six months Normal serum free T4 level Current smoker Serum hemoglobin level of under 12mg/dL Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5% History of significant heart failure History of large amount of alcohol consumption Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg pregnant, or planning to be pregnant, or breast feeding women aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit serum Cr level > 2.0mg/dL
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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, Breast Cancer Bone Metastasis Pain The patient must be 18 years of age or older 2. The patient must have histologically proven breast adenocarcinoma 3. Radiographic evidence of bone metastasis is required .Acceptable studies plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging 4. The patient must have pain that appears to be related to the radiographically documented metastasis 5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket) 6. Patients must have an estimated life expectancy of 3 months or greater 7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites 8. Signed study specific informed consent 9. Karnofsky Performance Status > 40 10. Calculated Creatinine Clearance > 50 ml/min 11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00 Prior radiation therapy or prior palliative surgery to the painful site 2. Impending fracture of the treatment site or planned surgical fixation of the bone 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration
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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, Hirsutism years or older habile, understands Danish moderate to severe hirsutism prior to laser treatments succeeded minimum five laser treatments intact skin with no severe adverse events to laser treatments record of current medication and androgen hormone blood profile available Use of safe anti-conception (fertile women) Pregnant or lactating allergy toward the content of Eflornithin cream Concomitant use of immunosuppressive therapy Dementia, psychiatric disease, alcoholic
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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, Overweight Children must be between ages three and five have a mother who identifies her child as Chinese be healthy-defined as free of chronic or acute illness Mothers must identify themselves as Chinese the primary provider of the child be able to speak and read Chinese or English with a BMI >= 23.0 meet low-income requirements in the Bay Area Have acute or chronic conditions that prevent performing daily activities
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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 Cell Carcinoma Metastatic Kidney Carcinoma Stage III Renal Cell Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7 Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer [AJCC] staging) Eligible patients must be intermediate/poor risk, per the International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (Heng) criteria; patients must therefore have as one or more of the following six factors Time from diagnosis of RCC to systemic treatment < 1 year Note: systemic treatment refers to the initiation of A031203 protocol treatment Hemoglobin < the lower limit of normal (LLN) Corrected calcium > the upper limit of normal (ULN) Karnofsky performance status < 80% Neutrophil count > ULN Platelet count > ULN
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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): 0.0-17.0, Vitamin D Deficiency Thoracic Surgery Pediatric Disorders Heart Defects, Congenital Newborn (corrected gestational age between 36 weeks) up to 18 years Has CHD that will require surgery within the next 12 months CHD requiring surgical intervention with cardiopulmonary bypass Born at less than 32 weeks gestational age Corrected gestational age of less than 36 weeks Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery Patient has confirmed or suspected Williams syndrome Proposed surgery to take place at another centre (outside of CHEO)
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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): 40.0-75.0, Hypothyroidism Thyroid Diseases Endocrine System Diseases 75 years old Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months Pregnant or lactating women Severe hepatic or renal dysfunction Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism Obviously poor compliance
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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, Celiac Disease Hypothyroidism Celiac Sprue Malabsorption Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease
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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): 16.0-45.0, Diabetes Hispanic women Overweight or obese before pregnancy (BMI >25 kg/m2) 45 years old history of type 2 diabetes, heart disease, or chronic renal disease contraindications to participation in moderate physical activity or to a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis) inability to read English or Spanish at a 6th grade level >20 wks gestation current medications which adversely influence glucose tolerance not planning to continue to term or deliver at the study site pregnant with twins or triplets preterm birth (<34 wks), a miscarriage, or a still birth after enrollment or a stillbirth women who become pregnant again in the year following delivery will be censored at the time of their positive pregnancy test
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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, Thyroid Diseases patient with thyroid diseases not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery
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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, Hashimoto Thyroiditis patients newly diagnosed with Hashimoto thyroiditis Acute infection Acute or chronic inflammatory disease Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.) Hypoxic situations (chronic obstructive pulmonary disease etc.) Severe heart, kidney and liver disease Pregnancy Endocrine disorders Malignancy Usage of drug that affects thyroid hormone 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): 0.0-999.0, Congenital Hypothyroidism Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH > 15 mU / ml at screening on filter paper and / or plasma TSH> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size. Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism. If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH <5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment No pre or neonatal goitre by palpation or ultrasound thyroid negative perchlorate test (ie decreased rate of iodine captation <10% at 2h injection of perchlorate) when the thyroid gland in place No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin) Signature of free and informed consent by the patient or his legal representative Affiliation or enjoying a social security system Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin) Pre or neonatal goiter on palpation or ultrasound thyroid Test positive perchlorate (ie salting rate of iodine> 10% at 2 injection perchlorate) Patients of foreign origin returned to their country will be excluded from 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): 0.0-999.0, Hypothyroidism Suspected hypothyroidism subject Willing to comply with the trial protocol Signed informed consent document Menstrual period, bleeding hemorrhoids, hematuria Drinking or taking aspirin within 48 hours Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability Subjects who are unwilling or unable to complete the trial Subjects who do not sign informed consent form
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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): 19.0-35.0, To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come Aged between 19 to 35 years Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l Body mass index (BMI) between 19 kg/m2 and 25 kg/m2 Presence of both ovaries; ≥2 previous IVF failures Good quality embryos for transfer Endometrial thickness between 10 mm and 14 mm Polycystic ovary syndrome Endometriosis
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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, Advanced HER-2 Positive Solid Tumors Chemotherapy Refactory HER-2 Antibody Inhibitor Therapy Refactory Chemotherapy refractory HER-2-positive breast cancer, gastric cancer, non-small cell lung cancer, and chemotherapy resistant or relapsed ovary cancer Relapsed patients after anti-HER-2 using antibody or kinase inhibitor therapy Patients must be 18 years of age or older Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2 Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters: Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter). Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2) Seronegative for HIV antibody Seronegative for active hepatitis B, and seronegative for hepatitis C antibody Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test Patients must be willing to sign an informed consent Patients with life expectancy less than 12 months will be excluded Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded Pregnant and/or lactating women will be excluded Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors Patients with any type of primary immunodeficiencies will be excluded from the study Patients requiring corticosteroids (other than inhaled) will be excluded Patients with history of T cell tumors will be excluded Patients who are participating or participated any other clinical trials in latest 30 days will be excluded
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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): 18.0-39.0, Infertility, Female Infertility, Male Infertility The patient is eligible for IVF and will be treated according to the Summary of Product Characteristics (SmPC) and routine practice in participating centres. 2. The patient must be willing and able to comply with the protocol for the duration of the study. 3. The patient has given written informed consent with the understanding that the consent may be withdrawn by her at any time without prejudice for her future medical care. 4. Must be hyper-responder to antagonist according definition Ovarian, uterine or mammary cancer. 2. Tumours of the hypothalamus and pituitary gland. 3. Uterine myoma requiring treatment. 4. Ovarian enlargement or cyst of unknown aetiology. 5. A clinically significant systemic disease. 6. Abnormal gynaecological bleeding of undetermined origin. 7. Known allergy or hypersensitivity to human gonadotrophin preparations. 8. Entered previously into this study or simultaneous participation in another clinical study. 9. Age > 39 yrs, 10. BMI > 32 kg/m2, 11. Patient with no cycles: PCOS or an anovulatory patient. -
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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, Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy 1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy Body mass index (BMI) > 20 Treating physician approval to participate in study Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Diagnosis of recurrent breast cancer Women who are already participating in a formal or medically prescribed weight management program Women who have already completed more than two rounds of chemotherapy Women who are pregnant or nursing
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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, Graves' Disease -all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD clinically manifest Graves' ophthalmopathy (GO) recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias preexistent cardiomyopathy malnutrition psychiatric history that could get worse if patient remains persistently hyperthyroid unlikely to return for the planned follow-up visits unlikely to comply with the blood drawing schedule unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires
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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, Estrogen Receptor Negative HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Recurrent Breast Carcinoma Stage IV Breast Cancer Triple-Negative Breast Carcinoma Patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER2 by institutional guidelines Patients must have measurable disease (Response Evaluation in Solid Tumors version 1.1 [RECIST 1.1]) Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Life expectancy of greater than 3 months Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels All prior treatment-related toxicities must be Common Terminology for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment Absolute neutrophil count >= 1,500/mcL Platelets >= 75,000/mcL History of another malignancy Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible History of interstitial lung disease or pneumonitis History of type I diabetes mellitus; if a patient has type II diabetes, they must have a hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excluded Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline Patients who are receiving any other investigational agents Individuals with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 3 weeks after completion of local therapy; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 3 weeks prior to study enrollment History of allergic reactions attributed to compounds of similar chemical or biologic composition to trametinib monotherapy or trametinib in combination with GSK2141795 Current use of a prohibited medication; the following medications or non-drug therapies are prohibited Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed)
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/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): 18.0-999.0, Sub-clinical Hypothyroidism Hypothyroidism Euthyroidism Subjects more than 18 years old 2. Thyroid test planned in the normal health care of patients 3. Subject who has been informed about "TSH Testing" study with a complete Subject Information Sheet and who has signed a consent form 4. Subject covered by the Health Social System Subjects with hyperthyroidism (clinical symptoms : weight loss with unaltered appetite, palpitations in the absence of cardio-vascular pathology, unusual and recent nervousness) 2. Subject not covered by the Health Social System 3. Subject who already participates to another clinical research study, which might interfere with TSH Testing Study 4. Pregnant, parturient or breastfeeding mother 5. Person deprived of freedom by a judicial or administrative decision 6. Person under a legal guardianship or unable to consent (MMSE score < 20/30 for the patients for whom this test has been performed)
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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, Autoimmune Thyroiditis Age ≥18 years. 2. Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months. 3. Receiving LT4 treatment Serum-TSH ≥ 4.0 mU/L measured prior to treatment initiation 4. Written informed consent Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO). 2. Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery. 3. Previous diagnosis of non-melanoma skin cancer. 4. Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial. 5. Systemic immunomodulatory medication. 6. Other medication known to affect thyroid function. 7. Pregnancy, breastfeeding, or planned pregnancy within 18 months. 8. Allergy towards the components in the selenium or placebo pills. 9. Intake of selenium supplementation ≥ 55 μg/d. 10. Unable to read or understand Danish. 11. Lack of informed consent
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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, Obesity and Overweight Women from 45 to 75 years old Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers Signed informed consent Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period Subjects with Diabetes Mellitus insulin dependent Individuals that stop smoking in the next 12 weeks (during the study) Subjects with increased alcohol consumption (> 1 glass of vine) Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc Subjects with disorders associated with eating behaviour Subjects with drugs or supplements consumption to weight lost Subjects with physical problems complying with the recommendations of physical activity and diet indicated Subjects who refuse to perform the indicated dietary changes throughout 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): 0.0-50.0, Complication of Surgical Procedure Infant * prior surgical treatment for gut chest surgery (non cardiac) or non-surgical infants who will require a minimum of 2 weeks of non-oral formula/breast milk feedings may be receiving oxygen therapy and intravenous therapy may have previously been treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted ventilation. Maternal *must be able to read and comprehend English. Infant *infant receiving assisted ventilation
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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, Hereditary Angioedema (HAE) Healthy male and female volunteers, 18 to 55 years of age, inclusive; healthy status defined as absence of clinically significant findings in medical history or screening assessments 2. Japanese; defined as born in Japan, lived outside of Japan for no more than 10 years, and having Japanese parents and Japanese maternal and paternal grandparents 3. Body mass index of 18 to 28 kg/m2, inclusive History of, or current, clinically significant disease and/or abnormalities 2. Smoking habit in excess of 5 cigarettes per day or the equivalent within 30 days of Day 1 or inability to refrain from smoking during the study confinement period 3. Subject has current abnormal thyroid function, as defined as abnormal screening thyroid stimulating hormone (TSH) and free thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 12 weeks is permitted 4. History of drug allergy or other allergy that, in the opinion of the investigator, contraindicates participation 5. Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Female subjects who consume more than 14 units of alcohol per week or 2 units per day. (1 alcohol unit =1 beer or =1 wine (5oz/150mL) or =1 liquor (1.5oz/40mL) or =0.75oz alcohol) 6. Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches. (1 caffeine unit is contained in the following items: one 6oz (180mL) cup of coffee, two 12oz (360mL) cans of cola, one 12oz cup of tea, three 1oz (85g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine) 7. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) with the exception of female hormonal replacement therapy or hormonal contraceptives. Occasional use of over-the-counter doses of ibuprofen or acetaminophen for minor self-limited pain (eg, headaches) is also acceptable. Current use is defined as use within 7 days of the first dose of investigational product\ 8. Pregnant or lactating females
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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): 0.0-99.0, Allan-Herndon-Dudley Syndrome clinically relevant mutation in the MCT8 gene, resulting in the clinical phenotype of AHDS Major illness or recent major surgery (within 4 weeks) unrelated to AHDS Patients who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products) Known allergy to components in Triac tablets Patients that have any contra-indication for Triac 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): 21.0-60.0, Hirsutism Presence of unwanted hairs on the face 2. Skin Type I to IV (Fitzpatrick) 3. Adults older than 21 years of age but not more than 60 years of age. 4. Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence). 5. Informed consent agreement by the subject. 6. Willingness to follow the treatment schedule and post treatment care Malignant or pre-malignant pigmented lesions in the area to be treated. 2. Scarring or infection of the area to be treated. 3. Known photosensitivity. 4. Pregnancy or lactating 5. Subjects with Diabetes (Type I or II). 6. Presence of a suntan in the area to be treated. 7. Use of medication known to induce photosensitivity. 8. Subject is on anticoagulative medication or throm-boembolic condition. 9. Subjects with a pacemaker or internal defibrillator. 10. Use of two weeks prior to, and two weeks following the treatment. 11. Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment. 12. Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks 13. Subjects wearing a tattoo or permanent makeup on the area to be treated 14. Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated 15. Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated 16. Subjects with history of keloidal scar formation 17. Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM 18. Subjects with epilepsy 19. Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.] 20. Subjects with a history of skin cancer or areas of po-tential skin malignancies 21. Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
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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, Thyroid Associated Ophthalmopathies Age 18 or older Able to provide informed consent Able to swallow pills Mild thyroid eye disease requiring no past treatment other than ophthalmic drops or ointment Euthyroid: at least 2 months if on medication irregardless of thyroidectomy status; at least 6 months after radioiodine therapy; if euthyroid for the year prior to enrollment, needs normal thyroid-stimulating hormone (TSH) within last 3 months; if uncontrolled for the year prior to enrollment, needs normal TSH and free T4 within last 3 months; if TSH low, needs normal T3 and free T4 If you are currently taking any selenium supplementation, you will be asked to discontinue its usage, "wash out", for 1 month before you are enrolled Moderate or severe thyroid eye disease (based upon International Thyroid Eye Disease Society VISA form), including: grade 2 chemosis or lid edema; corneal exposure with threat of or resulting in perforation; optic neuropathy; grade 3 restriction of any extraocular muscle Double vision (diplopia) in primary or reading positions Duration of thyroid eye disease greater than 12 months (as per patient history) Drug or alcohol abuse Severe systemic illness (defined by treating physician) Pregnant or breastfeeding
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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): 18.0-35.0, Hashimoto's Thyroiditis Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody Euthyroid state by serum free T4 and TSH level within normal limit Pregnant, planning pregnant within 1 year, or lactating women Renal insufficiency, abnormal liver function test Hematologic diseases: anemia, agranulocytosis, thrombocytopenia G6PD deficiency, porphyria cutaneous tarda Allergy to 4-aminoquinoline compounds Known retinopathy or visual field defect disorders Already receive immunosuppression therapy
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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): 18.0-60.0, Diabetes Mellitus Type 1 UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV & HIV by PCR test before enrollment in the study and positivity for any of these parameters means of this patient from 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): 18.0-999.0, Metastatic Thyroid Gland Carcinoma Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); confirmation of thyroid carcinoma will be done at Memorial Sloan-Kettering (MSK) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam; tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment RAI-refractory disease on structural imaging, defined as any one of the following A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed prior to enrollment in the current study, or A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion The presence of at least one fluorodeoxyglucose (FDG) avid lesion No recent treatment for thyroid cancer as defined as No prior RAI therapy is allowed < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 millicurie (mCi) of RAI is not considered RAI therapy No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol; (previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol) No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy on this protocol History of another malignancy; exception: patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligible; MSK can consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above History of interstitial lung disease or pneumonitis Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to thyrotropin alpha (Thyrogen) Current use of a prohibited medication; the following medications or non-drug therapies are prohibited Other anti-cancer therapy while on study; (note: megestrol [Megace] if used as an appetite stimulant is allowed; thyroid-stimulating hormone [TSH] suppressive therapy is also allowed; palliative radiation therapy to non-target lesions is also allowed) Concurrent treatment with bisphosphonates is permitted; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng) Patients with the following ophthalmological findings/conditions
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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): 18.0-100.0, Obesity Metabolic Disease FOR TO or Subjects will qualify for randomization to colchicine or placebo if they meet the following Good general health. In general subjects should take no medications. However, individuals taking medications for obesity-related co-morbid conditions, who have not had changes in dosage for more than 3 months, may be included, at the discretion of the principal investigator Obesity, defined as a body mass index (BMI) greater than or equal to 30 kg/m^2, but weight less than 450 lbs in order for subjects to undergo Dual-Energy X-ray Absorptiometry (DXA) scanning Age 18 to 100 years Metabolic Syndrome defined as any 3 of the following 5 FPG greater than or equal to 100 mg/dl, or Impaired Glucose Tolerance (Glucose greater than or equal to 140 mg/dl at 2 hours of OGTT) Triglycerides greater than or equal to 150 mg/dl, or on treatment Waist Circumference: Men greater than or equal to 40 in (greater than or equal to 102 cm); Women greater than or equal to 35 in (greater than or equal to 88 cm) Reduced HDL-C: Men < 40 mg/dl; Women < 50 mg/dl, or on treatment Hypertension: greater than or equal to 130 mmHg systolic, or greater than or equal to 85 mmHg diastolic, or on treatment FOR TO OR Type 2 diabetes mellitus, as determined by either having Clear clinical diagnosis of diabetes, such as a patient in a hyperglycemic crisis or classic symptoms of hyperglycemia and a random plasma glucose greater than or equal to 200 mg/dL Two of the following three Fasting plasma glucose greater than or equal to 126 mg/dL Hemoglobin A1c greater than or equal to 6.5% An oral glucose tolerance test glucose concentration of greater than or equal to 200 mg/dL at 2 hours One of the above three (bi.-biii.) meeting the T2DM cutoff on two different days. If only one of the above three (bi.-biii.) meet the T2DM threshold during the Screening Visit, that test will be repeated on another day to determine if the subject has T2DM or not. As per ADA guidelines, The diagnosis [of T2DM] is made on the basis of the confirmed test.Moreover, because HbA1c has been shown to be higher in African Americans (AA) as compared to other races for the same glycemia, non-diabetic AA may be unfairly excluded by their HbA1c alone. Therefore, for AA subjects, if their 2 hour OGTT and fasting glucoses are in the non-diabetic range, and the HbA1c is < 7.0%, we will consider them non-diabetic Presence of a significant active or chronic illness likely to limit life span and/or increase risk of intervention, including renal (GFR less than or equal to 60 ml/min/1.73m2), cardiovascular, hepatic (other than obesity-related steatosis), gastrointestinal, immunologic, endocrinologic (e.g. Cushing syndrome), pulmonary (other than either asthma not requiring continuous medication or sleep apnea-related disorders), or other disorders at the discretion of the investigators Recent use of colchicine or anorexiant medications in the last 3 months
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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): 20.0-45.0, Polycystic Ovary Syndrome Having PCOS according to the Rotterdam Age between 20-45 years Lack of pregnancy and lactation Not having certain regime during last 3 months Non-smoking Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid Not taking supplements Being overweight (Kg / m 25 ≤ BMI) Hormone Therapy Pregnancy and lactation during the study Severe weight loss (more than 2.5 kg per month) during 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): 18.0-55.0, Healthy Volunteers Age 18-55 years, male and female Recent weight stability (< plus and minus 2 % over past 1 month) Body mass index (BMI) greater than or equal to 30 kg/m2 Able to complete daily bouts of moderate to vigorous exercise (when applicable) Written informed consent Have reserved a stay of at least 4 weeks at The Biggest Loser Resort or have enrolled in a structured meal replacement weight loss program at the Washington Center for Weight Management and Research, the National Center for Weight and Wellness, or the Johns Hopkins Weight Management Center Body weight > 400 lbs (weight limit of PET and MRI scanners) BMI < 30 kg/m2 Less than 80% of maximum lifetime weight Hypertension if (1) >160/100 (2) 140/90 to 159/99 with evidence of target organ damage (e.g. elevated serum creatinine, proteinuria, abnormal EKG, retinopathy) (3) >140/90 on antihypertensive medications Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease) Past or present history of eating disorder (including binge eating) or psychiatric disease Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
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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 Cell Carcinoma Metastatic Kidney Carcinoma Stage IV Renal Cell Cancer AJCC v7 Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy, metastasectomy or post-treatment biopsy; diagnosis must be confirmed by pathologist review of screening biopsy; the determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient Patients must have measurable disease and is defined as a lesion that can be accurately measured on the long axis with a minimum size of 10 mm or a lymph node that can be accurately measured along the short axis of a minimum size of 15 mm (computed tomography [CT] scan slice thickness can be no greater than 5 mm) Patients can have had prior treatment for RCC including prior surgery, radiation therapy, immunotherapy with interleukin (IL)-2 or interferon (but not anti-programmed cell death [PD]1 or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), target therapy with receptor tyrosine kinase (RTK) inhibitors/mammalian target of rapamycin (mTOR) inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus, and temsirolimus (but not bevacizumab) or chemotherapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Absolute neutrophil count >= 1,500/uL within 14 days of the first dose of study drug Platelets >= 100,000/uL within 14 days of the first dose of study drug Hemoglobin (Hgb) > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level) within 14 days of the first dose of study drug Total bilirubin =< 1.5 mg/dl within 14 days of the first dose of study drug Serum creatinine =< 1.5 times the upper limit of normal or estimated creatinine clearance (CrCl) > 40 mL/min within 14 days of the first dose of study drug Any other malignancy from which the patient has been disease-free for less than 2 years, except for non-melanoma skin cancer, in situ carcinoma of any site Patients who have organ allografts Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); or fine needle aspirations or core biopsies within 7 days prior to first dose of study drug Known or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) are excluded from this study; any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug; inhaled steroids and adrenal replacement steroids doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea Patients who have had a history of acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, history of stroke within the past year History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease Patients who have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
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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): 20.0-60.0, Autoimmune Thyroiditis All patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (NCT01129492) - All patients who have hypothyroidism caused by autoimmune thyroiditis included in the aforementioned trial (NCT01129492) who underwent surgery and/or therapeutic administration of radioiodine for thyroid diseases during the period between the initial assessment of patients up to the present study
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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, Vasodilation resided in the city of the Rio Grande (RS/Brazil) age over 18 years-old evaluation and medical authorization the patients that performed others cardiologic procedures with the Coronary Artery Bypass Graft
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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): 20.0-45.0, Overweight Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her subjects over 20 year informed consent Chronic or acute diseases affecting protein metabolism (diabetes, renal insufficiency, CVD, liver disease), dyslipidemia History of varicose or venous stases Recent major surgery (3 months) History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc…) Malabsorption disorders History of cancer within the past year Significant weight loss during the last 3 months Food allergies, especially cow milk protein. Pregnancy or lactation Special diets especially vegetarian, high protein (≥ 1.6 g/kg) or weight loss program Abnormal Food Frequency Questionnaire Aversion to vanilla or chocolate aromas Smoking Moderate to intense physical activity > 2 hours/week Hematocrit <40 for males and < 36 for females Blood donation within 3 months of study start and 3 months after study end Regular consumption of medication and supplements i.e. any treatment affecting thermogenesis or nutrient metabolism in general such as corticosteroids, insulin, androgens, antibiotics and nutritional supplements (multivitamins, protein shakes). Have a high alcohol consumption (more than 1 drink/day) Consumption of illicit drugs Subject who cannot be expected to comply with the study procedures, including consuming the test products. Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this 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): 18.0-45.0, Anovulation WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea") 1. Low to normal serum FSH concentrations 2. Low serum estradiol concentrations WHO II 1. Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months) 2. Normal serum FSH concentrations (<12 IU/L) 3. Absence of other causes for the cycle disturbance, including: normal prolactin concentrations (<1.0 IU/L), normal TSH concentrations (0.2 2 milliunits/L), abnormalities on ultrasonography. Within women with WHO II status, PCOS is diagnosed when at least 2 of the following are met: 1. Oligo-/anovulation 2. Clinical and/ or biochemical hyperandrogenism 3. Polycystic ovaries on ultrasonography WHO III 1. POI: defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L. 2. IOF: defined as normal ovulatory cycles with raised basal FSH > 12 IU/L before the age of 40 years. 3. TOF: defined as irregular cycles with raised basal FSH > 12 IU/L before the age of 40 years. 4. Poor ovarian response: defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins. 5. Early menopause: menopause occurring between age 40 and 45 years. 6. Hypergonadotropic primary amenorrhea: primary amenorrhea with raised basal FSH > 12 IU/L Age: younger than 18 yrs Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases)
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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, Fallopian Tube Clear Cell Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma A retrospective review of all patients entered will be performed to confirm clear cell histology; patients must have recurrent or, progressive clear cell ovarian cancer not solely based on cancer antigen (CA)-125; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; recurrence should be biopsy proven unless the tumor is located in an area deemed unsafe to biopsy by the surgeon; if a biopsy can be obtained without significant risk, then biopsy should be obtained If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required If slides of the primary tumor are not available for review, a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology; the percentage of involvement must be documented in the pathology report or in an addendum to the original report All patients must have measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) 1.1 All patients must submit unstained slides of primary or recurrent tumor for translational analysis Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by 1.1 Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease; platinum sensitive and resistant patients are eligible Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease Concomitant use of additional anti-neoplastic agents will not be allowed in this study Patients may not have received previous therapy with a MET inhibitor Human immunodeficiency virus (HIV) positive patients Patients with serious non-healing wound, ulcer, or bone fracture Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study Patients with clinically significant cardiovascular disease; this includes Poorly controlled hypertension (> 140 mm Hg and > 90 mm Hg for systolic and diastolic blood pressure [BP]) are ineligible Myocardial infarction or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure Cardiac arrhythmia requiring medication Grade II or greater peripheral vascular disease based on National Cancer Institute (NCI) Common Toxicity (CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangrene
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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): 18.0-65.0, Hypothyroidism Subjects will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months Department of Defense beneficiaries living within 60 miles of Besthesda, MD Subjects will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old. Patients scheduled for deployment will be excluded Subjects with subclinical hypothyroidism will be excluded. If we patients with subclinical hypothyroidism, it will be difficult to assess the outcomes. This is because only a very small percentage of patients with subclinical hypothyroidism benefit from thyroid hormone therapy and therefore, a cross-over study as done in this project will not show a difference between the therapies Females of child-bearing age will be screened with initial assessment for pregnancy as part of standard of care (eg history of amnenorrhea and/or positive pregnancy testing via hCG). There is no experience in using desiccated thyroid extract in pregnant women and there is no published paper in this area. Desiccated thyroid extract is rated Category-A drug in pregnancy which means there are no known risks to the fetus
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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): 6.0-18.0, Autoimmune Thyroiditis Newly diagnosed AIT Age >6 years <18 years Iodine sufficient region Children on antioxidants or antithyroid drugs Cardiac, renal and hepatic disease Children with other autoimmune and collagen diseases
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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's Disease Patients referred due to typical symptoms, believed to be related to Hashimoto´s disease, but not relieved by thyroxin substitution. Optimal thyroid substitution treatment is already provided. 2. Anti-TPO>1000 3. Hypothyroidism with a need for thyroxin supplementation 4. Written informed consent by the patient information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). The patient should be informed by a medical endocrinologist as well as a surgeon Patients <18 years of age. 2. Pregnancy. 3. Unable to comprehend information adequately to give informed consent. 4. General anaesthesiological contraindications. 5. An unexpected finding of cancer in the surgical group is not a reason for per se, but this group should be analyzed separately. It is expected that any different loading in Quality of life would bias the medically treated group
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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, Drug Interactions Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit Body mass index (BMI) between 18.5 (inclusive) to 30.0 kg / m² (inclusive) with body weight ≥ 65kg Normal thyroid function indicated by thyroid examination to total and free T3 (Triiodothyronine) , T4 (total and free Thyroxine, levothyroxine), TSH (Thyroid stimulating hormone), anti-TSH-receptor (anti-TSHR) antibody, anti-thyroperoxidase (anti-TPO) antibody, anti-thyroglobulin antibody (anti-ATA) as well as thyroid ultrasound History of clinically significant metabolic, renal, hepatic, or central nervous system disorder such as seizure, psychosis and sleep disorders History of cardiovascular diseases including arrhythmia, hypertension, ischemia, etc Known or suspected cardiovascular disease including potential risk of atrioventricular (AV) block, arrhythmia, etc. with or without a formal cardiologist consultation Subjects who had received iodine containing contrast medium within 2 months before first study drug administration Use of systemic or topical medicines or substances which might affect the study drug(s) must be avoided
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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, Heart Failure aged 18 and above survived to discharge have mortality status at 1 year post-discharge Non-index heart failure admissions during the study period will be excluded from the study sample
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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, Chronic Renal Failure Aged 18-40 years old, male or female 2. Subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination 3. The BMI is 19-25Kg/m2 (BMI = weight / height2) 4. Without anemia, white blood cell and platelet counts are normal 5. Heart, lung, liver and kidney function are normal 6. Without smoke and wine hobby 7. Subjects voluntarily signing written informed consent Allergic constitution or previous history of allergy of biological products; 2. Pregnant and lactating women; 3. Female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration; 4. Female subjects received postmenopausal estrogen therapy; 5. With malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system 6. Abnormal liver function ( AST or ALT is 2 times greater than the upper limit of the normal) 7. Hemoglobin is greater than or equal to 160g/L (male), 150 g/L (female) 8. The percentage of reticulocytes is greater than or equal to 3% 9. Serum iron protein <20ng/ml 10. Subjects who donated blood 90 days before being enrolled or received a blood transfusion therapy or participate in other drug test 11. subjects who received recombinant erythropoiesis stimulating protein or rHuEPO 3 months before being enrolled; 12. recombinant erythropoiesis stimulating protein antibody (RESP) or endogenous erythropoietin (EPO) antibody positive; 13. drugs known to have damage to some organs were given 3 months before being enrolled; 14. subjects whose HBsAg, HBeAg, anti-HIV, anti-HCV and syphilis antibody are positive; 15. researchers believe that other factors are not suitable for the trial
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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, Thyroid Gland; Node Lactation WOMAN 40 years Pregnancy longer than week 36 Single Pregnancy Planned breastfeeding No current thyroid disease Agree not to take iodine supplementation except as provided through the study Patient who is not expected to adhere to the research protocol. Plans for pregnancy within 6 months after delivery Vegans. WOMAN 40 years No current thyroid disease Agree not to iodine supplementation during the study Patient who is not expected to adhere to the research protocol Plans for pregnancy within 6 months of study entry Vegans
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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): 18.0-70.0, Thyroid Eye Disease Mild TED of less than 18 months duration (as recorded by the patient). 2. No active state (Clinical activity score of less than 3). 3. No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet). 4. Euthyroidism as a result of remission after a course of antithyroid drug (ATD) therapy, or euthyroidism for at least 2 months since commencing ATD or after thyroidectomy, or euthyroidism for at least 6 months after radioiodine therapy. Hypothyroid patients after thyroidectomy or radioiodine were replaced with levothyroxine. Euthyroidism was defined as normal serum free thyroxine, total or free triiodothyronine concentrations, and thyrotropin (TSH) levels below 4 mU/Liter Patients were kept euthyroid for the whole duration of the study. 5. Age 18-70 years TED severity of more than mild TED. 2. Pregnancy 3. Drug and/or alcohol abuse 4. Severe concomitant illness 5. Inability to comply with the study protocol 6. No informed consent 7. Use of selenium or vitamin/minerals-containing preparations in the last 3 months. 8. Developing more severe TED in the course of the trial so that requires steroid treatment
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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, Thyroid Nodules Aged 18 or above Have life expectancy of at least 6 months Have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (USG) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on Doppler USG. For subjects with more than one nodule on USG, provided that the other nodules are not >2.0cm or have suspicious features (see below), they will still be eligible Normal thyroid function (both serum thyroid-stimulating hormone (TSH) and free T4 levels within normal range) Given consent to take part in the study Have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on Doppler USG that warrant a FNAC Nodule size > 2.0cm Insisting or refusing FNAC or surgical intervention despite medical reassurance Inability to understand or communicate in Cantonese or Chinese Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire Too ill to carry out interview Refusal to give consent
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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): 70.0-999.0, Subclinical Hypothyroidism men and women aged 70 and older 2. TSH between 4.5 and 19.9 mU/L as an outpatient 3. ability to provide informed consent Laboratory Tests: 1. TSH <4.5 mU/L or >20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range 2. thyroid peroxidase (TPO) antibody positive 3. abnormal liver function tests (LFTs >3 x upper limit of normal) 4. hemoglobin <11 g/dL Surgeries or Procedures: 1. thyroid surgery 2. pituitary surgery 3. bariatric surgery 4. bowel resection involving the jejunum and upper ileum 5. radioactive iodine therapy 6. radiation treatments to head or neck Medical Conditions: 1. diagnosis of pituitary disease 2. diagnosis of amyloidosis, sarcoidosis, hemochromatosis 3. diagnosis of adrenal insufficiency 4. obesity with BMI > 35 mg/kg2 5. history of stroke 6. chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100 7. diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months 8. celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome 9. renal insufficiency with calculated glomerular filtration rate <45 cc/min 10. cognitive impairment with Mini Mental State Exam[30] <24/30 11. history of any seizures 12. unstable medical or psychological condition in the judgment of the principal investigator Medications: 1. thyroid hormone preparations 2. antithyroid drugs 3. medications that interfere with the absorption or metabolism of thyroid hormone 4. medications that interfere with the TRH stimulation test 5. proton pump inhibitors
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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, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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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): 2.0-25.0, Tumors Solid Malignant Tumors Osteosarcoma Differentiated Thyroid Cancer (DTC) Histologically or cytologically confirmed diagnosis of solid malignant tumor. 1. Cohort 1: Any solid malignant tumor. 2. Cohort 2A: Differentiated Thyroid Cancer (DTC) with one of the following histological subtypes: i) Papillary thyroid cancer (PTC). i.a) Follicular variant. i.b) Other variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hurthle cell variant of papillary carcinoma, or poorly differentiated carcinomas). ii) Follicular thyroid cancer (FTC). ii.a) Hurthle cell. ii.b) Clear cell. ii.c) Insular. c) Cohort 2B, 3A, and 3B: Relapsed or refractory osteosarcoma. 2. Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse [greater than or equal to first relapse]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy). 3. Evaluable or measurable disease that meets the following 1. Participants must have evaluable or measurable disease based on 1.1 using computed tomography (CT)/magnetic resonance imaging (MRI). 2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have subsequently grown unequivocally to be deemed a target lesion. 4. DTC participants must be 131 iodine-refractory/ relapsed as defined by at least one of the following: 1. One or more evaluable or measurable lesions that do not demonstrate iodine uptake on any radioiodine scan; or 2. One or more evaluable or measurable lesions that have progressed based on 1.1, within 12 months of 131 iodine therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre or post-treatment scanning. These participants must not be eligible for possible curative surgery; or 3. Cumulative activity of 131 iodine greater than 400 millicuries (mCi) or 14.8 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry. 5. Participants with DTC must be receiving thyroxine suppression therapy and levels of thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than or equal to 5.50 milliunits per liter (mU/L)). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH less than 0.50 mU/L). 6. Participants with known central nervous system (CNS) primary tumors or metastases who have completed brain therapy (such as radiotherapy, stereotactic radiosurgery, or surgical resection) and have remained clinically stable, asymptomatic, and off of steroids for 2 weeks prior to Cycle 1 Day 1 will be eligible. 7. Male or female participants age 2 years to less than18 years and less than or equal to 25 years for osteosarcoma subjects at the time of informed consent. 8. Lansky play score greater than or equal to 50% or Karnofsky Performance Status score greater than or equal to 50%. Use Karnofsky for participants greater than or equal to 16 years of age and Lansky for participants less than 16 years of age. 9. Life expectancy greater than or equal to 3 months. 10. Adequate bone marrow function as evidenced by: 1. absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L). 2. hemoglobin greater than or equal to 8.0 grams/deciliter (g/dL) (a hemoglobin less than 8.0 g/dL is acceptable if it is corrected by growth factor or transfusion before starting lenvatinib). 3. platelet count greater than or equal to 75 x 10^9/L. 11. Adequate liver function as evidenced by: 1. bilirubin less than or equal 1.5 times the upper limit of normal (ULN). 2. alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN. 12. Adequate renal function as evidenced by: a) Serum creatinine based on age/gender as below. If serum creatinine is greater than maximum serum creatinine for age/gender as shown in the table below, then creatinine clearance (or radioisotope glomerular filtration rate [GFR]) must be greater than 70 milliliter/minute/1.73 square meter (mL/min/1.73 m2). Maximum Serum Creatinine in milligrams/deciliter (mg/dL) for male: i. Age 2 to less than 6 years = 0.8 ii. Age 6 to less than 10 years = 1.0 iii. Age 10 to less than 13 years = 1.2 iv. Age 13 to less than 16 years = 1.5 v. Age greater than or equal to 16 years = 1.7 Maximum Serum Creatinine (mg/dL) for Female: vi. Age 2 to less than 6 years = 0.8 vii. Age 6 to less than 10 years = 1.0 viii. Age 10 to less than 13 years = 1.2 ix. Age 13 to less than 16 years = 1.4 x. Age greater than or equal to 16 years = 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating glomerular filtration rate using child length and stature data published by the CDC. b) Urine dipstick less than 2+ for proteinuria. Participants who have greater than or equal to 2+ proteinuria on dipstick urinalysis should undergo a spot protein-creatinine (P/C) ratio that should be Grade less than 2. c) No clinical evidence of nephrotic syndrome. 13. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) greater than or equal to 50%) at baseline as determined by echocardiography. 14. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: BP less than 95th percentile for sex, age, and height/length at screening (as per National Heart Lung and Blood Institute guidelines) and no change in antihypertensive medications within 1-week prior to Cycle 1/Day 1. Osteosarcoma subjects 18 to 25 years should have BP ≤150/90 mm Hg at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1. 15. Washout of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, and 2 weeks for palliative radiotherapy; 3 months from high-dose chemotherapy and stem cell rescue; 3 weeks from major surgery. Participants must have recovered from the acute toxic effects of all prior anticancer therapy before enrollment into the study. 16. Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ≥18 years. 17. Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the Investigator. Cohort 3B (Combination Expansion): Osteosarcoma subjects who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 18. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet only Numbers 6 through 17 (after progression in Cohort 2B) Any active infection or infectious illness unless fully recovered prior to dosing. 2. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study. 3. Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/ which has not recovered to Grade less than 2 per Common Terminology for Adverse Events (CTCAE) v4.0. 4. Known hypersensitivity to any component of the product (lenvatinib or ingredients). 5. Concurrent administration of any other antitumor therapy. 6. Previous treatment with lenvatinib (except for participants previously enrolled into Cohorts 1 or 2B of this study). 7. Two or more prior vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted therapies. 8. Currently receiving any investigational drug or device in another clinical trial or within 30 days preceding informed consent. 9. A clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval greater than 480 msec). 10. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib. 11. Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 3 weeks prior to the first dose of study drug. 12. Active second malignancy within 2 years prior to enrollment ([in addition to the primary tumor types specified by cohort in Criterion Number 1], but not including definitively treated superficial melanoma, in-situ, basal or squamous cell carcinoma of the skin). 13. Previous treatment with ifosfamide and Grade greater than or equal to 3 nephrotoxicity or encephalopathy (Cohorts 3A and 3B). 14. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Cohort 3B (Combination Expansion): Osteosarcoma participants who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 15. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the with the exception of Criterion Number 6
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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): 0.538-0.692, Music Therapy Infants will be included if they meet the following between 28 to 36 weeks gestational age, stable condition, not requiring any respiratory support, in an isolette or open crib, are at least one week post natal age and if their mothers have listened to music while pregnant Infant will be excluded if they are intubated and on a ventilator or high frequency ventilation, if they have a congenital anomaly that mainly affects hearing, such as craniofacial anomalies; and if they have brain anomalies associated with neurological disorders such as: grade 3-4 intraventricular hemorrhage and periventricular leukomalacia
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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): 30.0-55.0, Migraine Fibromyalgia Female 55 years Clinical diagnosis of fibromyalgia, according to the American College of Rheumatology (2010) Migraine presence, according to the of the International Headache Society (ICHD-III beta version, 2013) Any other rheumatologic disease, cardio-respiratory or cardiovascular which prevents the realization of aerobic exercise protocol Low attendance during the implementation of aerobic exercise protocol (over three consecutive fouls) Cognitive impairment or neurological disease that affects the understanding and the exercises Pregnants Body mass index ≥ 30.0 (obesity, according to the World Health Company) Patients classified with level of active or very active physical activity by IPAQ (International Physical Activity Questionnaire)
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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): 18.0-65.0, Hypothyroidism Patients of either sex, aged 18 years or above suffering from hypothyroidism (hypothyroidism was defined as serum TSH level > 5μIU/ml, serum FT3 level < 1.57 pg/ml, serum FT4 level < 0.7 ng/dL. Subclinical hypothyroidism was defined as an elevated TSH level and a normal serum FT3 and FT4 level) and need treatment (treatment is indicated in patients with TSH levels >10 µIU/mL or in patients with TSH levels between 5 and 10 µIU/mL in conjunction with goiter or positive anti-thyroid peroxidase antibodies (or both) Patients not having hepatic/renal dysfunction, Diabetes mellitus, and chronic inflammatory diseases and not taking any medications for thyroid disease Euthyroid subjects not having any significant medical disease Patients with other comorbidites which can interfere the outcome measures Patients who are already on levothyroxine therapy or taking other medications Patients with subacute thyroiditis were excluded from the study since acute inflammation could influence the measurements Pregnant and lactating mothers
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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): 12.0-39.0, Polycystic Ovary Syndrome Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL) Cushing's syndrome Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal Antidiabetic and antiobesity drugs
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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, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft
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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): 20.0-40.0, Polycystic Ovary Syndrome Women aged between 20 and 40 years. 2. Confirmed diagnosis of PCOS according to 2003 modified Rotterdam 3. According to World Health Organization standards (2010), semen analysis of the husband must meet ① or ②. ①sperm concentration ≥15*106/ml and total motility ≥40% . ② Total motile sperm count ≥9 million, i.e. semen volume*sperm density*percentage of motile sperm ≥9 million. 4. At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy. The results will be valid for 3 years if the patients do not have a history of abortion or pelvic operation of other endocrine disorders Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry Patientsdiagnosed with Type I or Type II diabetes who are poorly controlled (defined as a Hb A1c level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded. ⑤Patients with suspected Cushing's syndrome. 2) Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 2 months. 3) Acupuncture the last 2 months. 4) Pregnancy within the past 6 weeks. 5) Within 6 weeks post-abortion or postpartum. 6) Breastfeeding within the last 6 months. 7) Not willing to give written consent to the study. 8) Additional Patients with a suspected adrenal or ovarian tumor secreting androgens. 2. Couples with previous sterilization procedures (vasectomy, tubal ligation) which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that should not adversely affect recruitment. 3. Subjects who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon. 4. Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160 mm Hg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart. 5. Patients with known congenital adrenal hyperplasia. 6. Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins. 7. Patients with liver disease defined as AST or ALT > 2 times normal or totalbilirubin >2.5 mg/dL. Patients with renal disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL. 8. Patients with significant anemia (Hemoglobin < 10 g/dL). 9. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident. 10. Patients with known heart disease that is likely to be exacerbated by pregnancy. 11. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear or TCT result will be required for women 21 and over. 12. Patients with a current history of alcohol abuse. Alcohol abuse is defined as >14 drinks/week or binge drinking. 13. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol. 14. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled. 15. Patients taking other medications known to affect reproductive function or metabolism. These medications oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, Chinese herbal formula, anti-diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be two months
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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): 4.0-18.0, Hashimoto Thyroiditis Graves Disease For HT: A positive titers of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies and at least one of Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 μIU/ml and decreased or normal levels of fT4 or fT3) Increased volume of thyroid gland (goiter) Morphological changes on ultrasound of the thyroid gland For GD A positive titers of thyroid stimulating antibodies (anti-TSI) and Decreased TSH levels and increased levels of fT4 or fT3 For Controls Otherwise healthy children and adolescents, age and gender-matched with patients Absence of previously known chronic disease of autoimmune aetiology or atopy (including those with a history of chronic treatment with antihistamines, anti-inflammatory, corticosteroids or anti-epileptic drugs) Absence of a family history of autoimmune disease in first-degree relatives Not Caucasian origin or affinity among participants Age of diagnosis above 18 years Disease duration below 3 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): 0.0-999.0, Dengue Fever Stage 1 Discharge diagnosis with International Classification of Disease (ICD) code A90 - A99 Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status) Stage 2 Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive) Nil
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0
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