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A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 5.0-999.0, Rheumatic Heart Disease Mitral Stenosis Cases Diagnosis of rheumatic heart disease based on one of World Heart Federation definite echocardiographic World Heart Federation borderline echocardiographic and history of acute rheumatic fever Mitral stenosis with valve area less than 2.0 cm2 Previous surgery for rheumatic heart disease Age less than five years Inability to give consent New Controls Healthy individual living in a community where cases were identified Past medical history or systems suggestive of rheumatic heart disease, acute rheumatic fever or other valvular heart disease Age less than five years Inability to give consent | 1 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 5.0-17.0, Juvenile Idiopathic Arthritis Diagnosis of JIA (ILAR classification) Age 5 to 17 years Ability to speak/read French or English; one caregiver per child will be recruited Presence of pain, defined as: pain reported by the child and/or caregiver, and/or joint tenderness and/or stress pain in at least 1 joint during physical examination performed by rheumatologist. Pain reported by the child/caregiver is not a prerequisite because some children develop behaviors and guarding postures to avoid pain Absence of anticipated change in treatment. If, during the study, a change in treatment is necessary, the change will be recorded but the child will not be withdrawn Stable dosages of medications and absence of intra-articular corticosteroid injections for 4 weeks prior to enrolment confirmed by child's rheumatologist No current MT Systemic arthritis with quotidian fevers Acute infection Open skin lesion Fibromyalgia Sleep apnea Medications: anticoagulants, muscle relaxants, analgesic medications (acetaminophen allowed) Pregnancy | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 18.0-50.0, Patellofemoral Pain Syndrome Age between fifteen and thirty-five years Presenting unilateral PFPS with six months of evolution Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.) Patients with previous knee surgeries Chronic pain with more than one year of evolution Pregnancy or suspected pregnancy Application of intra-articular steroids in the three months prior to their evaluation Patients with meniscal injuries Ligament or intra-articular knee structures Degenerative diseases such as diabetes Rheumatoid arthritis OA of the knee, hip or ankle History of dislocation or subluxation of patella | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 5.0-16.0, Rheumatic Heart Disease Acute Rheumatic Fever Schoolchildren aged 5 to 15 years Written informed consent | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 6.0-16.0, Rheumatic Fever Rheumatic heart disease with recommended strep prophylaxis less than one year from first diagnosis refusal to take the tablets | 1 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 18.0-999.0, Arthritis Vasculitis Healthy volunteer or Recent diagnosis of rheumatoid arthritis within 1 month or New diagnosis of giant cell arteritis within 1 month or New diagnosis of anti-neutrophil cytoplasm antibody associated vasculitis within 1 month or Flare of anti-neutrophil cytoplasm antibody associated vasculitis within one month Unable to provide written informed consent | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 25.0-40.0, Theca Lutein Cyst of Left Ovary Criteria:Sub-fertile women with confirmed diagnosis of pelvic endometriosis women with Pelvic inflammatory disorders and other forms of benign cysts | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 18.0-50.0, Healthy Male and female healthy adults ages 18 to 50 years inclusive Good general health as determined by screening evaluation no greater than 42 days before the first immunization For women of childbearing age, use of adequate birth control from enrollment until 180 days after the last injection Written informed consent, after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization Any chronic illness, whether or not active treatment is required Any immunodeficiency (congenital or acquired) Any history of cardiac pathology (acquired or severe/persistent congenital) Any history of congenital malformation syndromes associated with congenital heart disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g. Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g. Noonan's) Any history of clinical manifestations of auto-immune or systemic diseases (inflammatory disorders, e.g. JRA, SLE, Kawasaki disease; inborn errors of metabolism, e.g. Fabry; connective tissue disorders, e.g. Marfan syndrome; neuromuscular disorders, e.g. Friedreich ataxia; endocrine-metabolic disorders, e.g. hypothyroidism; hematologic disorders, e.g. sickle cell anemia) Any history of acute rheumatic fever (ARF), post-streptococcal glomerulonephritis (PSGN), undiagnosed acute self-limiting polyarthritis (swelling, heat, redness or tenderness or pain and limitation of motion in >2 joints), or chorea (purposeless, involuntary rapid movements of the trunk and/or extremities) Any previous echocardiogram suggestive of cardiac pathology Any immediate family history (parents, siblings) of ARF, PSGN, self-limiting polyarthritis, chorea, or a collagen-vascular disease such as Lupus or Sjögren's syndrome Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 18.0-999.0, Pancreatic Cancer Histological documentation of primary adenocarcinoma of the pancreas Surgically eligible for tumor resection with curative intent Age ≥18 years ECOG PS 0 or 1 Adequate bone marrow function (ANC ≥1,500; Hgb >9; Plt >100) Adequate renal function (Cr <1.5 ULN) Total bilirubin ≤1.5 x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN (values post biliary stenting allowed for eligibility) Signed, written informed consent Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded Patients with M1 disease or a history of M1 disease Patients with any type of recurrent pancreatic adenocarcinoma Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer Previous treatment with any other compound that targets CD40 Concurrent treatment with any anticancer agent outside of this protocol Prior allogeneic bone marrow transplant History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis,. (Vitiligo is allowed) History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure History of deep venous thrombosis or migratory thrombophlebitis (Trousseau) | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 2.0-17.0, Juvenile Idiopathic Arthritis Male or female aged 2 to <18 years. *IMPORTANT NOTE * Initial enrollment in the study will be limited to subjects ≥6 years of age and subjects weighing ≥15 kg. Following enrollment and PK analysis of subjects to <6 years of age with JIA in the ongoing Phase 1 PK study (A3921103), enrollment will be opened to this age group. The Sponsor will notify investigator sites when it is permissible to enroll subjects 2 to <6 years of age, as well as the corresponding dosage for this age group Must meet International League Against Rheumatism (ILAR) JIA diagnostic for one of the following categories with active disease for at least 6 weeks Extended oligoarthritis Polyarthritis (RF+) Polyarthritis (RF) Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment Psoriatic arthritis Enthesitis related arthritis. Subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF, systemic JIA with active arthritis but without active systemic features) must have a minimum of 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) at baseline to be eligible for study entry Subjects with psoriatic or enthesitis related arthritis must have a minimum of 3 active joints (an active joint is defined as a tender/painful and/or swollen joint) at baseline to be eligible for study entry Treatment with stable doses of Non Steroidal Anti inflammatory Drugs (NSAIDs), oral glucocorticoids (at a maximum dose of 0.2 mg of prednisone equivalent per kilogram per day or 10 mg per day for 2 weeks before baseline, whichever is lower), or methotrexate (10 mg and 20 mg per square meter of body surface area for 3 months before baseline) are permitted Subjects with any of the following characteristics/conditions will not be included in the study Previous JIA treatment with tofacitinib Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment) Persistent oligoarthritis Undifferentiated JIA Infections Latent or active tuberculosis (TB), or any history of TB Chronic infections Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug Any treated infections within 2 weeks of Baseline visit | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 45.0-999.0, Osteoarthritis, Knee Osteoarthritis, Hip years of age or older McMaster employee Sedentary job (stand or walk for <1/3 of work day) Able to safely climb two flights of stairs Hip pain Hip pain during internal rotation and hip flexion Knee pain Less than 30 minutes of morning stiffness in the knee Crepitus in the knee with active range of motion Bony enlargement around the knee Any other forms of arthritis Osteoporosis-related fracture History of patellofemoral symptoms Active non-arthritic hip or knee disease Hip or knee surgery Use of cane or walking aid Unstable heart condition Neurological conditions Hip, knee or ankle injuries in past 3 months Physician-advised restriction to physical activity | 0 |
A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. | eligible ages (years): 18.0-999.0, Psoriatic Arthritis Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification for Psoriatic Arthritis (CASPAR) Must be starting or any approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilars) as a first, second or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy for PsA at the time of enrollment into the observational study or within a maximum 1-month window after the baseline visit Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Participant is starting or a TNFi therapy as fourth or further line of biologic treatment Participant is unwilling or unable to participate in long-term data collection Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point Participant is currently enrolled in an interventional study | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-60.0, Heart Diseases Obesity Vascular Diseases Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 17.0-999.0, Liver Cancer Histologically confirmed primary hepatocellular carcinoma (HCC) Completely resected disease with clear margins No residual disease by postoperative CT scan No metastatic disease Age and over Performance status Karnofsky 60-100% Life expectancy Not specified | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Recurrent Thyroid Cancer Stage IVA Follicular Thyroid Cancer Stage IVA Papillary Thyroid Cancer Stage IVB Follicular Thyroid Cancer Stage IVB Papillary Thyroid Cancer Stage IVC Follicular Thyroid Cancer Stage IVC Papillary Thyroid Cancer Histologically confirmed papillary thyroid or follicular thyroid carcinoma Differentiated disease Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI All metastatic disease foci =< 10 mm in all dimensions Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L No known brain metastases Performance status | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Total or near total thyroidectomy performed for papillary or follicular thyroid cancer R0-1 resection, no macroscopic cancer left behind at surgery Physically and emotionally able to undergo radioiodine treatment A written informed consent Pregnancy Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Benign Nontoxic and Toxic Goiter Graves' Disease Healthy volunteers with an intact thyroid gland Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography Patients with toxic nodular goiter Patients with Graves' disease Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion) Prior 131I treatment Alcohol, medicine or drug abuse Pregnancy or lactation No safe contraception Participation in another clinical trial Allergic reaction towards rhTSH Fine needle biopsy without valid diagnostic for benign disease Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin Incontinence | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves´ Disease Thyroid Associated Ophthalmopathy Graves´ disease Adequate anticonception in women Performance status >2 Previous rituximab treatment Immunosuppressive treatment Serious concomitant disease Active infections Pregnancy / breast feeding | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Toxic Nodular Goitre Graves' Disease Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter Age < 18 yrs Allergy to anti-thyroid drugs Substernal or large (> 100ml) goiter Severe endocrine ophthalmopathy Pregnancy or lactation Suspicion of thyroid malignancy Unsafe contra-conception Physical or mental condition that hinders corporation | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Toxic Nodular Goitre Graves Disease Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves’ disease or toxic nodular goiter Age < 18 yrs Allergy to anti-thyroid drugs Substernal or large (> 100ml) goiter Severe endocrine ophthalmopathy Pregnancy or lactation Suspicion of thyroid malignancy Unsafe contraconception Physical or mental condition that hinders corporation | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-40.0, Obesity healthy males Normal weigh, e.i. BMI between 18,5-25 kg/m2 age 18-40 years donation of blood 3 monhts prior or during the study gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease smoking consumption of more than 21 alcoholic drinks/week elite athletes on mediation diet supplements | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 40.0-65.0, Obesity BMI greater than 30 African American 46 years old bariatric surgery within the previous 5 years | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 21.0-60.0, Graves Ophthalmopathy Confirmed TED (as defined by Bartley and Gorman19) Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum) Exophthalmos (Hertel measurement of at least 20mm) Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles) Optic nerve dysfunction (abnormal visual acuity, colour vision, pupillary reaction or perimetry not attributable to other causes) Thyroid dysfunction or abnormal regulation in association with any one of the following -Exophthalmos Extraocular muscle involvement Optic nerve dysfunction Previous treatment for TED Oral steroids (e.g. immunosuppressive dose) for last 3 months, radiotherapy Intravenous pulsed steroid or methrotrexate therapy Medically unfit to receive I/V high-dose pulsed methylprednisolone or methotrexate History of cardiac arrthymias, recent acute myocardial infarction History of seizure History of acute bleeding peptic ulcer History of pulmonary tuberculosis, Hepatitis B carrier, Hepatitis C positivity, HIV Uncontrolled diabetes or hypertension (to be eligible for the trial, random blood glucose must be < 11.1 mmol/L and blood pressure must be 140/90 or lower#. If above these limits, patients can be treated and reviewed at 2 weeks for enrolment when are met provided the patient does not have optic neuropathy) | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Aging Balance Sleep Males and females Aged 18 to 35, or 60 to 85 Lived at Denver altitude or higher for at least one year Stable treated diseases: thyroid dysfunction (including hypothyroidism and hyperthyroidism), hypertension, hypercholesterolemia, urinary incontinence, prostate enlargement, gastroesophageal reflux disease, irritable bowel syndrome Aged 36 to 59, under 18, or over 85 BMI less than 18.6 or greater than 30 kg/m2, women below 95 pounds regardless of BMI Sleep duration is less than 5 or more than 9 hours Sensitivity to sleeping medications Night work in the preceding 6 months Transmeridian travel (across more than 2 time zones) in the last 1 month Bone mineral density DXA T-score of less than -1.75 Orthostatic intolerance Prior history of falls in past year Prior history of injurious fall in past 5 years | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 0.0-999.0, Thyroid Neoplasms Thyroid Nodules Graves Disease Goiter Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University Patients with cervical lymph nodes metastases requiring neck dissection Patients that tissue pathology shown anaplastic carcinoma Patients with clinical or laboratory indicators of coagulation disorders | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Carcinoma, Islet Cell Carcinoma, Pancreas Well-differentiated advanced/metastatic pancreatic islet cell tumor Tumor has shown progression within the past year Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial growth factor] angiogenic inhibitors Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 14.0-61.0, Graves Disease Graves disease Anticoagulant usage Previous thyroid operation Refused to participate in this study | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-75.0, Subclinical Hypothyroidism Hyperthyroidism Thyroid Dysfunction patients with subclinical hypothyroidism or hyperthyroidism patients with thyroid nodules and normal thyroid function patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone patients who had thyroid surgery or radioiodine therapy patients with NYHA class 3 or 4 heart failure | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 0.0-999.0, Thyroid Cancer histologically confirmed differentiated thyroid cancer status after total thyroidectomy status after subsequent high-dose radioiodine treatment regular follow-up by a board-certified dentist a minimum follow-up of 1 year after radioiodine therapy anaplastic thyroid cancer | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-50.0, Obesity healthy meals BMI 24-31 kg/m2 age between 18-50 years hemoglobin >8 mmol/L donation of blood 6 months before and under the study milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease use of dietary supplements 3 months before and under the study smoking elite athletes use of medication | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 0.0-999.0, Hyperthyroidism Cardiovascular Diseases Atrial Fibrillation Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002 Controls: age and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-999.0, Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; ≥ 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Advanced Cancer Anorexia Weight Loss Insomnia Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS Patients > 18 years of age Karnofsky Performance score of > 40 at time of into study Ability to provide informed consent and comply with study procedures Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/ days), 8 (+/ days), 16 ( +/ days), and 22 (+/ days) and return to outpatient clinic for evaluation on days 15 (+/ days), and 29 (+/ Patients who have known dementia or delirium at time of enrollment as determined by a physician Known hypersensitivity to any ingredient of Mirtazapine Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting Ongoing use of tube feeding or parenteral nutrition Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment Pregnancy or lactation or unwillingness to use contraceptives A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation Patients on chronic use of benzodiazepines are excluded | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 2.0-999.0, Graves' Disease Graves' disease patients | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-65.0, Stroke Immobilization Myofacial Pain Hyperthyroid Myopathy Normals Healthy individuals Stroke a first stroke (i.e., a unilateral, ischemic hemispheric stroke) within the previous one to two months, ability to cooperate and follow simple commands, and gastrocsoleous strength in the affected lower extremity of between trace and 50% of normal Immobilization immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain Myofascial Pain history of pain in trapezius confirmed by clincal examination. The examiner will perform snapping palpation over the MFTP. If a localized, transient contraction is observed, the response is considered to be positive and the subject will be considered eligible for entry into the study Hyperthyroid Myopathy clinical assessment in combination with a serum hormone profile of increased Free Thyroxine (FT4) and Triiodothyronine (T3) in the face of suppressed levels of Thyroid Stimulating Hormone (TSH) | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-75.0, Dyslipidemia Signed informed consent Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following Non-nursing and non-pregnant 12 months prior to enrolment Not of child bearing potential ie, either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone (FSH) levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization Atorvastatin not more than 20 mg/day or Simvastatin not more than 40 mg/day LDL-cholesterol > 3.0 mmol/L (Week -1) Subject able and willing to comply with all study requirements At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study Cholesterol lowering agents other than the defined statins History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator Chronic (> 3 months) pain condition requiring daily medication with pain killers Glycosylated haemoglobin (HbA1c) > 7.0% Diabetes requiring medication other than metformin Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting ECG, eg, QTc interval > 450 msec Body Mass Index of ≥ 40 kg/m2 Resent history (< 3 month) of stroke or transient ischemic attacks History of seizure disorder, except febrile convulsions | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Turner Syndrome Turner syndrome verified by karyotyping untreated hypothyroidism or hyperthyroidism present or past malignant diseases clinical liver disease treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids) | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-60.0, Graves Disease Patients with newly diagnosed hyperthyroid Graves' disease If the patient had been treated previously diabetes, kidney, or liver disease | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-60.0, Electric Stimulation Therapy Obesity Weight Loss Eating BMI greater than or equal to 30 kg/m(2) Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules. Additionally, while the risks of TDCS are minimal, there haven t been studies showing how TDCS might affect the growing brain Healthy, as determined by medical history, physical examination, and laboratory tests Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals) Weight stable (plus or minus 5 percent) for last 3 months Weight less than 350 lbs, as this is the weight limit of the DXA machine Type 2 diabetes (according to the World Health Organization diagnostic criteria) Endocrine disorders (Cushing s disease, pituitary disorders, and hypo and hyperthyroidism) Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for 1 week before study entry) Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease) Hypertension (blood pressure measurement higher than 140/90 mmHg on 2 or more occasions or use of anti-hypertensive medications) Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 times normal) Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or overt proteinuria) | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Healthy Body mass index (BMI) < 30 kg/m2 Age 18-45 yr; or Age 65-85 yr Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.) Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo or hyperthyroidism; hypertension) Body mass index > 30 kg/m2 Age <18 yr, 45-65 yr or > 85 yr Those performing >1.5h of exercise/wk | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves Disease Hyperthyroidism Graves hyperthyroidism in remission after ATD Age < 18, severe concomitant disease | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Helicobacter Pylori Infected Patients Thyroid Cancer Patients Hyperthyroidism Adult patients between the ages of 18 and 80 Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I) Patients who provide informed consent Patients without diagnosed thyroid disease Patients who are pregnant or breast feeding Patients who have received previous treatment for H. pylori infection Patients taking proton pump inhibitors Patients with recent or current use of antibiotics Patients allergic to iodine (131I) | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-80.0, Atrial Fibrillation Heart Failure Age ≥ 18 years, < 80years NYHA II-IV symptoms Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as ≤ 35% by radionuclide ventriculography) Documented AF lasting for at least 7 days (persistent or permanent AF) CRT or ICD device implanted in the previous 6 months AV nodal ablation within previous 3 months Prior AV nodal ablation or complete heart block with a single chamber pacemaker Contraindication to anticoagulation Persistent thrombus in the left atrium despite anticoagulation Active malignancy Cerebrovascular accident within the previous 6 months Reversible causes of AF including thyroid disorders, alcohol, recent surgery Reversible causes of heart failure including acute myocarditis or alcohol Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves Disease Hyperthyroidism Adult patients with a clinical diagnosis of Graves Disease Patients who have selected surgical resection as treatment of their Graves Disease Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid Patients deemed unfit for surgery by operating surgeon or anesthesist Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-65.0, Goiter Criterion a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes multinodular goiter involving posterior aspect/s of thyroid lobe/s suspicion of thyroid cancer previous thyroid surgery thyroiditis subclinical or clinically overt hypothyroidism or hyperthyroidism pregnancy or lactation age < 18 years or > 65 years ASA 4 grade (American Society of Anesthesiology) inability to comply with the follow-up protocol | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Thyroid Cancer for patient participants Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi [subtotal] with completion thyroidectomy)on or after September 1, 2009 Age at time of first thyroid cancer surgery must be at least 18 years or older The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) Must be able to communicate in spoken and written English Must be able to use a computer Must be able to provide informed consent on one's own (without any need for translation) for patient participants Participants not meeting Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma Prior radioactive treatment for thyroid cancer Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study for the physician feedback component of this study Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Multinodular Goitre Grave's Disease Thyroid Nodule multinodular goiter Grave's disease thyroid nodule thyroid carcinoma reoperative surgery | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Thyroid Neoplasm Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (less than 1%) on radioiodine scan or are unresponsive to radioiodine therapy. Unresponsiveness to radioiodine therapy is defined as a patient s thyroglobulin not falling to less than 2ng/ml within 6 months after previous radioiodine ablative treatment Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies. Patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging. (The presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease. However, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive.) Within 18 months of enrollment, patients must have had an RAI scan, showing no or therapeutically insignificant RAI uptake (less than or equal to 1%) Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions Greater than or equal to 18 years of age Must be able to understand and sign the Informed Consent Document Clinical performance status of ECOG less than or equal to 1 Life expectancy of greater than three months Allergy to valproic acid Current coexisting malignancy other than basal cell carcinoma Women of child-bearing potential who are pregnant or breastfeeding Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately Active systemic infections, coagulation disorders or other major medical illnesses Patients taking tolbutamide, warfarin, zidovudine, benzodiazapines, clonazepam, diazepam Seizure disorder | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 16.0-60.0, Graves' Disease Graves' disease patients. Healthy people Pregnancy. <16 years old or > 60 years old | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 8.0-90.0, Hypothyroidism Exophthalmos a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 15.0-85.0, Thyrotoxicosis Peak Systolic Velocity of Superior Thyroid Artery Thyroiditis Graves Disease newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range is willing to be enrolled unwilling taking antithyroid drug or beta receptor blocker taking foods or medicine rich in iodine in 8 weeks women with pregnant or lactation | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-55.0, QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis Potential Effect of Selenium New diagnose of autoimmune thyrotoxicosis biochemically proven with increased thyroxin low TSH and elevated TRAb/or positive scintigraphy Age 18 Willing to participate - No previous head trauma No difficulties with swedish language No medication which could affective neuropsychological testing No planned or ongoing pregnancies Normal intellectual capacity No severe ophthalmopathy, or other severe disease | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-64.0, Irritable Bowel Syndrome Patients meeting the Rome III Diagnostic Loose (mushy) or watery stools within the last 3 months Abdominal discomfort and/or pain during their non-menstrual period Patients with a history of surgical resection of the stomach, small intestine or large intestine Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) Patients with a history or current diagnosis of colitis ischemic Patients with a current diagnosis of enteritis infectious Patients with a current diagnosis of hyperthyroidism or hypothyroidism Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study Patients with a history or current diagnosis of malignant tumor Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-40.0, Healthy Middle-aged Subjects Age Range Was 18 to 31 Years Caucasian Whites Males and Females healthy middle-aged subjects volunteers with systemic or ocular diseases | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 40.0-69.0, Overweight and Obese by BMI women aged 40-69 overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance state a commitment to losing weight speak and read English able to communicate over the telephone able to use a computer with minimal assistance and complete electronic forms and surveys have access to and are able to access the Internet commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention have or are willing to obtain an email account have access to a DVD player diagnosed with Type 1 diabetes diagnosed with Type 2 diabetes and require insulin ≥ 10% weight loss in last six months enrolled in a weight loss management program enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation taking medications that affect weight loss or weight gain other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Thyroid Nodule Goiter Thyroiditis Graves Disease The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 12 months of follow-up The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease Patient has calcitoninemia < 9 ng/pl Patient has normal calcemia Patient has PTH level between 5 ng/l and 75 ng/l The subject has a normal laryngeal mobility The patient is participating in another study The patient is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding The patient is not available for 12 months of follow-up Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node Lymph node metastasis strongly suspected clinically and/or sonographically | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves Ophthalmopathy Clinical diagnosis of Graves Orbitopathy Clinical activity score higher than 2 Must be able to swallow tablets sight-threatening Graves Orbitopathy Diplopia in primary gaze Macrolide allergy or intolerance | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 2.0-16.0, Paediatric Thyrotoxicosis All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels) Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation) McCune Albright Syndrome Previous episodes of Thyrotoxicosis Known allergic response to any of the study medication or ingredients as per SmPC Previous participation in this study | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 23.0-45.0, Pregnancy Complicated by Hyperthyroidism Hypothyroidism in Pregnancy Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later healthy pregnant women in control group were directed for cordocentesis due to age Any other chronic diseases | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Papillary Thyroid Carcinoma Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck Radioiodine-refractory disease Life expectancy > 6 months Able to swallow and retain oral medication Normal organ and marrow function Pregnant or breastfeeding Previous treatment with a specific BRAF or MEK inhibitor Receiving any other study agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias Taking herbal remedies Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-37.0, Infertility Obesity Indication for IVF/ICSI for the couple Woman's age >18< 38 years at randomization First, second or third IVF/ICSI treatment BMI > or = 30.0 <35.0 kg/m2 Willing to participate and to sign informed consent Diabetes mellitus treated with insulin Oocyte or sperm donation planned Preimplantation genetic diagnosis (PGD) treatment planned Azoospermia known at randomization Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires) QEWP-R questionnaire indicating binge eating disorder for the woman Previous participation in the study | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Lacrimal Apparatus Disease Thyroid carcinoma Previous thyroidectomy Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic) Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL Lacrimal gland / ocular trauma Radiation therapy for other diseases or radiotherapy of head and neck Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves' Hyperthyroidism Age 18 years or older Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the date Written informed consent Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period Previous treatment with radioactive iodine Current ATD treatment having been received for more than two months Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide Allergy towards the components in the selenium and placebo pills Pregnant or breast-feeding women Intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet) Unable to read and understand Danish Lack of informed consent | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-70.0, Obesity Major Depressive Disorder Dysthymic Disorder Cardiovascular Disease Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2 Age 18 years old Presence of current major depressive disorder or dysthymic disorder At least 2 CVD risk factors, as characterized by the metabolic syndrome, including Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm) Fasting blood glucose 100 mg/dL Blood pressure 130/85 mm Hg Triglycerides 150 mg/dL Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL) Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.) Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months Weight loss of 5% or more in past 6 months Enrollment in weight reduction program in prior 3 months Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.) Severe depression or severe impairment of functioning as judged by the assessor or PI Presence of active suicidal ideation Diabetes Alcohol/drug abuse/dependence | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 21.0-65.0, Overweight and Obesity age 21 to 65 BMI 25 to 45 sleep 7 hours or less most nights use of medications affecting sleep sleep apnea shift work | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-80.0, Hypothyroidism radioiodine therapy after total thyroidectomy in differentiated thyroid cancer age over 18 kidney failure, liver failure, heart failure infection inflammation autoimmune disease other chronic disease | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 6.0-9.0, Hyperthyroid A-For the child born to hyperthyroid mother during pregnancy oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age B-For hyperthyroid mother during pregnancy oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyroïd at the time of the entry in the study C-For the child born to euthyroid mother during pregnancy oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age D-For euthyroid mother during pregnancy Euthyroïd at the time of the entry in the study A-For the child born to hyperthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study B-For hyperthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study C-For the child born to euthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study D-For euthyroid mother during pregnancy oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Subclinical Hyperthyroidism Atrial fibrillation or AV-nodal reentry tachycardia Fulfills for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect) Admitted for ablation for the first time Has left blood samples for thyroid status (TSH, free T4, free T3) Atrial flutter Overt hyperthyroidism | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-65.0, Obesity, Morbid volunteers from Central Norway if female: taking oral contraceptives or post-menopausal body mass index 30-45 kg/m2 stable weight (<2kg variation in the last 3 months) not currently dieting to lose weight Pregnancy breast feeding drug or alcohol abuse within the last two years current medication known to affect appetite or induce weight loss enrollment in another obesity treatment program history of psychological disorders history of eating disorders history of diabetes type 1 or 2 gastrointestinal disorders (particular cholelithiasis) kidney -, liver -, lung | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 21.0-75.0, Focus of Study: Prevent Pulling Sensation and/or Swallowing Difficulty in Patients Received Total Thyroidectomy. Age 21-75 Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication Undergoing total thyroidectomy Previous neck surgery Previous neck radiotherapy Patients with a known history of keloids Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies Patients with advanced disease that would require radical or modified neck dissection Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-45.0, Healthy Pharmacokinetics of ASP7991 Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration Body weight: ≥50.0 kg, <80.0 kg BMI: ≥17.6, <26.4 Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication A deviation from normal range of 12-lead ECG (QT evaluation) A deviation from the normal range in clinical laboratory tests Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL History of drug allergies Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury) Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone) | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves' Disease Out-patients 18 years of age or over, who have given written informed consent to participate in the study Diagnosed with Graves' disease Received radioiodine for treatment of Graves' disease Had a minimum of 12 months follow-up after RI Most recent RI dose 5 years ago or less at the time of enrollment Patients unable to give informed consent Age 17 years or younger Cause of thyrotoxicosis other than Graves' disease Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 45.0-999.0, Hypertonia Resistant Hypertension > 140 / > 90mmHg age : 45 + Regular monitoring of blood levels considered pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent Men and Women derailed diabetes renal impairment , renal creatinine clear <50 ml Non austherapierte cancer / tumor patients Non adjusted thyroid dysfunction BMI> 35 LVEF <limit ( " 35% " ) Peripheral AVK ( ABI measurement ) > Stage II | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 25.0-55.0, Obesity MRI compatibility 55 yrs old 40 BMI weight stable right handed MRI incompatibility left handed | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Other Impaired Renal Function Disorder Normal Renal Function Abnormal Renal Function Renal metastasis | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-85.0, Hyperthyroidism Hypothyroidism informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 25.0-70.0, Pre-diabetes Obesity Age 25 years and 55 years Overweight or obesity status BMI>25 kg/m2 Pre-diabetes. The from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an in the screening Informed consent required Ethnic group No restrictions Based on interview and/or questionnaire, individuals with the following problems will be excluded Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder) Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol Laboratory screening: If all of the above are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation ONLY IF the glucose tolerance test meets the entry for the study, the remaining samples are sent to the local laboratory for a safety check, with the following Hemoglobin concentration below local laboratory reference values (i.e. anemia); Creatinine >1.5 times Upper Limit of Normal (local laboratory reference values); Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values); Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age After LCD phase (in adults): Failure to reach at least 8% weight reduction during the LCD phase. This leads to from the intervention | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-55.0, Obesity Diabetes Cardiovascular Disease Aged 18 to 55 years BMI ≥ 25 kg/m2 BMI < 40 kg/m2 and weight ≤ 300 lbs (136 kg) Medical clearance from a primary care provider Plans to matriculate as a student at Framingham State University or work on campus throughout the academic year of enrollment in the study Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions Willingness to eat in the dining hall Willingness to abstain from consuming alcohol during participation Change in body weight exceeding ±10% during prior year Recent adherence to a special diet Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport) Chronic use of any medication or dietary supplement that could affect study outcomes Current smoking (1 cigarette in the last week) Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months) Physician diagnosis of a major medical/psychiatric illness or eating disorder Abnormal blood glucose, TSH, CBC, BUN, Creatinine ALT greater than 150% of the normal upper limit Plans for a vacation during the study that would preclude adherence to prescribed diet | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-60.0, Asthma years of age or older Known Asthma The exacerbation is defined as moderate or severe Not currently enrolled as an active participant in another clinical trial of a medical therapy or device The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy years of age or older Known thyroid disorders Subject where thyrotoxicosis is suspected Known heart disease Heart rate > 140 | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-55.0, Hyponatremia -Triathletes with previous experience in half-ironman -Potential participants (triathletes) with a previous history of muscle disorder, cardiac or kidney disease or those taking medicines or supplements during the two prior weeks were discarded | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Graves' Disease Thyroid Disease Hyperthyroidism Adults ≥ 18 years Diagnosis of Graves Disease Appointment with endocrinologist to discuss treatment options for Graves Disease Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment) | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-65.0, Obesity Male or Female 65 years old (inclusive) Weigh less than 350 lbs Body mass index (BMI) between 25-43 kg/m2 Willing to fast for 10 hours prior to examination Right handed Diagnosis (by self report) of diabetes Diagnosis (by self report) of neurological condition Current or past alcohol or drug abuse problem Smoking Have internal metal medical devices including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, metal fragments in your eye, or non-removable metal jewelry such as rings Unable or unwilling to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-55.0, Oxidative Damage Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html Subjects have to achieve a classification of "local class" based on age-graded time USA Track & Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study http://www.usatf.org/statistics/calculators/agegrading/ For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc…) for the duration of the study The will be the following Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association Subjects who are not able to run 5-km in the time required for their age and gender Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium) Subjects that are taking prescription medications with the exception of birth control Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Hypothyroidism Subclinical Hypothyroidism Hyperthyroidism Subclinical Hyperthyroidism Graves Disease Hashimoto's Thyroiditis Iodine Deficiency Genetic Susceptibility Aged equal or more than 18 years old at the time of sampling Malaysian citizen Respondents who did not give consent | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 0.0-999.0, Thyroid Goiter Thyroid Carcinoma Multinodular Goiter Graves Diseases Patients affected by benign thyroid disease undergoing thyroidectomy | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-60.0, Graves Ophthalmopathy Graves Disease Eye Diseases Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Hyperthyroidism Autoimmune Diseases Immune System Diseases Clinical diagnosis of Graves' Orbitopathy Mild GO According to statemnt, patients with mild GO usually have any one or more of the following：mild soft tissue involvement, exophthalmos＜18mm, temporary, or no diplopia Clinical activity score lower than 3 Being euthyroid for at least 1 month before the date of No previous specific therapy for GO, except for local measures in 1 month before the date of Written informed consent is obtained moderate-sever Graves' Orbitopathy Sight-threatening Graves' Orbitopathy Clinical activity score ≥ 3 Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females Uncontrolled diabetes or hypertension History of mental / psychiatric disorder Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility) Renal impairment (Urea and Creatinine levels must be within normal range) Doxycycline allergy or intolerance | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Goiter, Nodular Thyroid Nodule Graves' Disease Hyperparathyroidism Patient ≥ 18 years old Surgical indication for parathyroidectomy or thyroidectomy Patients < 18 years old Patient with history of chronic opioid use Patient with chronic pain syndromes Patient with allergy to marcaine | 1 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-999.0, Graves Disease Patients with Graves disease | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-65.0, Graves' Disease Group A: Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) definition hyperthyroidism: TSH decreased, FT4 and /or FT3 increased definition Graves': diffusely enlarged thyroid gland either by palpation or echograpy, and/or homogeneous thyroid uptake at scintigraphy, or positive TSHRAb first episode or recurrence of Graves' hyperthyroidism minimal or no eye signs, defined as lid retraction / lid lag but no other signs Planned treatment with antithyroid drugs either titration regimen or block-and-replace regimen for 18 months Group B. Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) with overt signs of GO as defined by Mild GO: patients whose features of GO have only a minor impact on daily life insufficient to justify immunosuppressive or surgical treatment. They usually have only one or more of the following: minor lid retraction (<2 mm), mild soft tissue involvement, exophthalmos <3 mm above normal for race and gender, transient or no diplopia, and corneal exposure responsive to lubricants) Moderate-to-severe GO: Patients without sight-threatening GO whose eye disease has sufficient impact on daily life to justify the risks of immunosuppression (if active) or surgical intervention (if inactive). Patients with moderate-to-severe GO usually have any one or more of the following: lid retraction R2 mm, moderate or severe soft tissue involvement, exophthalmos >3 mm above normal for race and gender, inconstant, or constant diplopia Sight -threatening GO: Patients with dysthyroid optic neuropathy (DON) and/or corneal Previous or planned treatment with 131I or thyroidectomy (A&B); sight threatening GO requiring decompression (B); drugs interfering with the natural course of GO (A&B): steroids, immunosuppressants, thiazolidinediones, antibiotics / antifungals / antivirals (both topical and systemic for at least 4 weeks prior to recruitment to the study); acute diarrhea illness (gastroenteritis for at least 4 weeks prior to recruitment to the study); Drugs interfering with thyroid function (A&B): amiodarone, lithium, iodine supplements; Drug or alcohol abuse (A&B); no informed consent (A&B); Age less than 18 (A&B); Pregnancy (A&B) | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 3.0-55.0, Xerostomia Hyperthyroidism Thyroid Cancer Patients who have been treated with radioiodine therapy Patients who have never received radioiodine therapy (negative control group) Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way | 2 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-70.0, Ophthalmopathy, Thyroid-Associated ◦Man or woman between 18-70 years TAO with CAS of ≥ 4 (less than 3 months) Euthyroid for at least 6 weeks Dysthyroid optic neuropathy (DON) Ulcerative Keratitis Previous treatment with steroids for TAO (do not prophylaxis for TAO in connection with radio iodine treatment) Previous Treatment with Rituximab (MabThera®) Positive Hepatitis B or C serology Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization History of recurrent significant infection or history of recurrent bacterial infections Patient who may not attend to the protocol according to the investigators opinion Pregnancy or lactation Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease) | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 8.0-999.0, Obesity Eating Behaviors Healthy Volunteers Volunteers will qualify if they meet the following criteria Age 8 17 years Weight, height and BMI greater than or equal to 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standard Cognitively capable of completing study procedures (FSIQ greater than or equal to 70) Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses) Individuals will be excluded (and provided treatment referrals as needed) for the following reasons History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and/or cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities hypertension (defined by age sex and height specific standards, and fasting hyperglycemia consistent with diabetes (fasting glucose > 126 mg/dL) Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls Current and regular use of tobacco products and/or alcohol | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Stage IVA Thyroid Gland Follicular Carcinoma Stage IVA Thyroid Gland Papillary Carcinoma Stage IVB Thyroid Gland Follicular Carcinoma Stage IVB Thyroid Gland Papillary Carcinoma Stage IVC Thyroid Gland Follicular Carcinoma Stage IVC Thyroid Gland Papillary Carcinoma Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); note: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 12 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigator Measurable disease; (NOTE: a malignant lymph node is considered measurable if 1) it is noted to be RAI-avid on radioactive iodine imaging [diagnostic or post-therapy whole body scans acceptable] and it measures >= 1 cm in the long axis, 2) it is pathologically proven to be involved with thyroid cancer [by cytology or pathology] and it measures >= 1 cm in the long axis, or 3) its short axis is >= 1.5 cm when assessed by computed tomography [CT] scan) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 Able to swallow and retain orally-administered medication with no clinically significant gastrointestinal abnormalities that may alter absorption Absolute neutrophil count (ANC) >= 1500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin > 9.0 g/dL Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate transaminase (AST) =< 2.5 x ULN (or =< 5x ULN in presence of liver metastases) therapy =< 6 months prior to registration; note: A diagnostic study using < 10 mCi of 131I is not considered 131I therapy External beam radiation therapy =< 28 days prior to registration; note: previous treatment with radiation is allowed if the investigator judges it will not compromise patient safety on the study Having been treated with a total cumulative (lifetime) 131I therapeutic activity > 800 mCi (excluding 131I activity administered for diagnostic scans) Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) =< 28 days prior to registration Prior exposure to mitogen-activated protein kinase kinase (MEK), RAS, or RAF inhibitors (note: previous exposure to sorafenib is allowed) OR history of hypersensitivity to selumetinib, thyrotropin alpha (Thyrogen), or any excipient agents Unresolved toxicity > Common Terminology for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia Cardiac conditions as follows Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy) Left ventricular ejection fraction < 55% measured by echocardiography Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-79.0, Thyroid Neoplasms patients with differentiated thyroid cancer recently underwent total thyroidectomy (within 6 months) pathological T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci) T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle) T1-3N1a : 3 or less micrometastatic lymph node differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer more than 2cm size of tumor gross extension (strap muscle or more) Number of dissected lymph node <3 thyroid cancer with distant metastasis previous remote history of thyroid cancer surgery history of cervical external beam radiation therapy previous history of comorbid cancer renal insufficiency (Ccr <30ml/min) women with pregnancy or breast feeding | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 18.0-999.0, Cardiac Arrest Unconscious (Glasgow Coma Scale ≤6) ≥18 years old Admitted in ICU after successful resuscitation from CA Treated with TH targeted to 33°C unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability) Traumatic or neurological origin of CA Previous cerebrovascular disease Facial trauma affecting the orbits and/or eyeballs Previous history of ocular pathology such as exophthalmia, glaucoma or cataract | 0 |
A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. | eligible ages (years): 20.0-85.0, Graves' Disease aged between 20 and 85 years euthyroid Graves' disease Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study | 1 |
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits. | eligible ages (years): 18.0-60.0, Depressive Disorders Depression Must meet for Major Depression Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically participants from trials involving pharmacologic antidepressants Cannot be receiving other treatments or require immediate clinical attention | 2 |
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits. | eligible ages (years): 18.0-60.0, Mood Disorder Bipolar Disorder Depression MDD Seventy subjects (ages 18 to 60) with MDD will be selected who additionally meet for one of 3 subgroups A) MDD, Currently depressed with FPDD, as defined by DSM-IV for recurrent MDD, currently in a major depressive episode, who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder B) MDD, Currently in remission with a history of FPDD, defined as a period of at least six months with no more than one clinically significant symptom, and during which time subjects were not taking an AD agent. Subjects will thus meet the historical for recurrent MDD (DSM-IV). We will also require that subjects previously had a least one antidepressant drug trial, to ensure that the severity of previous episodes warranted treatment C) MDD, Currently depressed, non-FPDD. To assess the specificity of the findings in MDD to FPDD, a sample meeting for MDD, currently in a depressive episode, but not FPDD will also be imaged Forty five subjects (ages 18 to 60) who meet DSM-IV for bipolar disorder and are currently in a major depressive episode. Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry LOW RISK One hundred and four subjects (ages 18 to 60) who have not met for any major psychiatric disorder. The control subjects will have no known first or second degree relatives with mood disorders Ten subjects (ages 18 to 60) with probable Cushing's Disease will be recruited who have both clinical and biochemical evidence of hypercortisolism (including urinary free cortisol excretion higher than the upper limit of normal (greater than 248) nmole/day, and marked central adiposity, cutaneous atrophy, proximal myopathy, and large purple striae). The diagnosis of probable Cushing's Disease will also have been established prior to referral via CRH and ACTH (n equals 12; ages 18-50). These females are recruited, screened and diagnosed by collaboration under protocol number 81-M-0126, previously approved by IRB, entitled 'The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavioral Disorders', principal investigator, David Rubinow, M.D. As described in that protocol these subjects must have a regular menstrual cycle lasting 21 Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Subjects being scanned at two points or the same point twice in their menstrual cycle must not have taken birth control pills for at least 6 months prior to scanning. However, effective medications will not be discontinued for the purposes of this study. Instead, subjects will be recruited who are not currently receiving psychotropic drugs. Subjects will also be excluded if they have serious suicidal ideation or behavior psychosis to the extent that the ability to provide informed consent is in doubt medical or neurological illnesses likely to affect physiology or anatomy a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria) current pregnancy current breast feeding general MRI previous exposure to ecstasy (i.e. MDMA) which has neurotoxic effects on 5-HTT expressing neurons Subjects beyond age 50 are excluded from the MRMD sample due to peri-menopausal status and subjects beyond age 60 are excluded to reduce the biological heterogeneity encompassed by the MDD since depressives whose age-at MDD-onset is later than 60 have a far greater likelihood of having MRI correlates of cerebrovascular disease than age-matched, healthy controls or age-matched, early-onset depressives | 2 |
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits. | eligible ages (years): 18.0-999.0, Depressive Disorder Signed the informed consent Meet for major depressive disorder without psychotic features Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel Have had at least one other major depressive episode prior to the one being experienced at study entry You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry Any women who are pregnant or breast feeding If you have any serious medical illnesses other than major depressive disorder If you have previously participated in a clinical trial for duloxetine Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders | 1 |
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits. | eligible ages (years): 18.0-999.0, Seasonal Affective Disorder Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern Patient has a current or past history of seizure disorder or brain injury Patient has a history or current diagnosis of anorexia nervosa or bulimia Patient has recurrent summer depression more frequently than winter depression Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders Patient has initiated psychotherapy within the last 3 months | 1 |
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