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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Hypogonadism Obesity Men aged 18 to 50 years BMI > or = 30 kg/m2 Total testosterone levels <2.3 ng/ml (<8 nmol/l) or testosterone levels 2.3-3.49 ng/ml (8-12 nmol/l) and free testosterone levels <70 pg/ml LH levels <7.7 mIU / ml No evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1 Being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol Intolerance/allergy to metformin or testosterone undecanoate Previous diagnosis of diabetes mellitus (HbA1c> 6.5% or fasting glucose> 126 mg/dl or glucose> 200 mg/dl after an oral glucose tolerance test) Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs Poor kidney function: serum creatinine> 2.0 mg / dl Previous history of prostate cancer or breast cancer Active cancer of any kind History of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin> 2.0 mg / dl or GOT levels three times the upper limit of normal Central hypogonadism of organic cause Use in the past 12 months of any drug that affects the pituitary-gonadal axis Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Breast Cancer Patient age 18 years and above 2. Implant-based immediate breast reconstruction 3. Prophylactic mastectomy for risk reduction OR 4. Therapeutic mastectomy for ductal carcinoma in situ (DCIS) or early stage breast cancer where: a. Tumor size < 3cm b. Tumor to nipple distance > 2cm c. Clinically negative lymph nodes d. No skin involvement, inflammatory breast cancer or Paget's disease Previous ipsilateral breast irradiation 2. Regnault ptosis grade II or III 3. Breast size of D cup or greater 4. Active smoker 7. Are there any age
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-80.0, Hypothyroidism Neoplasms Postoperative Complications Biopsy proven head and neck cancer, as defined by AJCC staging system Treated with surgery in Edmonton, Alberta Treated with curative intent Diagnosis of sub-clinical hypothyroidism after head and neck surgery (TSH 4-10mIU/L, and free T4 10-24pmol/L) Head and neck cancer of the thyroid gland, or other subsite involving the thyroid gland Underwent previous treatment for a different head and neck cancer History of radiation therapy and or chemotherapy to the head and neck History of thyroid disease as follows Hypothyroidism Hyperthyroidism Autoimmune thyroid disease including Grave's disease and Hashimoto's thyroiditis History of thyroiditis History of diabetes mellitus History of long term steroid usage
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Healthy Main Healthy males or females (non-pregnant/non-lactating) aged 18 years A Body Mass Index (BMI) of 18-30 No clinically significant abnormal serum biochemistry, haematology and urine examination values A negative urinary drugs of abuse screen Negative HIV and Hepatitis B and C results No clinically significant abnormalities in 12-lead electrocardiogram (ECG) No clinically significant abnormalities in blood pressure or pulse No allergy or sensitivity to clonidine or any of its excipients Current or past medical condition that might significantly affect the pharmacokinetic or pharmacodynamic response to clonidine Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days Pathological condition of the oral cavity that would affect administration via the buccal route Raynaud's disease or other peripheral vascular disease Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion) Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction Symptomatic postural hypotension evident on screening History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-75.0, Postsurgical Hypothyroidism Hypothyroidism TSH in the ideal reference range (0.4-4.0 milli-international units per liter (mIU/L)) Planned thyroidectomy for nodular thyroid disease or low-risk differentiated thyroid cancer (<4cm, no ETE, no expected use of RAI or suppressive levothyroxine therapy) History of psychiatric illness (major illness as defined by DSM IV: major depression, schizophrenia, mania, etc). Patients prescribed chronic medications for psychiatric illness, those taking benzodiazepines or anti-seizure medication Estrogen therapy that is new within the last 6 weeks or if the dose has been changed within the last 6 weeks Positive thyroid antibodies Chronic use (>4 weeks) of concomitant medications that could affect cognition and memory (including sedative hypnotics, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, Topamax, benzodiazepines, etc.) Pregnancy Steroid therapy Persistent cancer of any type or other major medical illness
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Malignant Melanoma, Metastatic Histologically confirmed diagnosis of melanoma Stage III or stage IV metastatic melanoma Disease that is measurable. This is defined as lesions measuring at least 10mm on radiologic imaging. For lymph node disease, the lesion must measure at least 15 mm or have been biopsied and shown to contain melanoma. Skin or mucosal lesions that are not measurable on radiologic imaging but measure at least 10mm on clinical exam are also acceptable. (See Section 13.2 for detailed definition of measurable disease) Disease is termed unresectable or the patient refuses resection The Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better Age ≥18 years. This is due to the limited data with pembrolizumab in children younger than 18 years of age Normal organ and marrow function as defined below Aspartate aminotransferase (AST) (SGOT) or alanine aminotransferase (ALT) (SGPT) ≤2.5 × institutional upper limit of normal (≤5 x upper limit of normal for patient with liver metastasis) Total bilirubin within 1.5 x institutional level of normal or direct bilirubin ≤ upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN) Hemoglobin ≥ 9.0g/dL or ≥5.6mmol/L Prior therapy with anti-PD-1 antibody The patient has symptomatic brain metastases. Asymptomatic brain metastases are permitted provided that there is no steroid requirement, no more than 4 metastases detected on standard MRI imaging, no metastatic brain lesion that is > 3 cm in size, and no lepto-meningeal disease Patient has not recovered to Grade 0-1 from adverse events due to prior chemotherapy, radiation, or biological cancer therapy (including monoclonal antibody (mAb)) The patient is not recovered from minor or major surgery and is less than 4 weeks from major surgery prior to starting treatment with pembrolizumab Significant auto-immune disease requiring hospitalization within the past two years or any history of life-threatening auto-immune disease Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency Concurrent use of any other investigational agents Active central nervous system metastasis and/or carcinomatous meningitis causing symptoms Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy Active autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents with the exceptions of replacement dose steroids for adrenal insufficiency, vitiligo, resolved childhood asthma/atopy, intermittent use of inhaled steroids, local steroid injections, hypothyroidism stable on hormone replacement, and Sjogren's syndrome
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-75.0, Breast Neoplasms Within 2 years of completion of adjuvant therapy, with the exception of hormone therapy, for early stage (0-IIIA) BrCa Baseline participation of < 60 min of weekly pre-planned PA Physician permission for moderate PA participation 4)Able to read and write English Able to attend in-person exercise training sessions and physiologic assessments at prescribed intervals Plans to join a weight-loss or exercise program within 9 months) Current pregnancy or planned pregnancy within 9 months) Planned surgery during study; 4) not willing to be randomized
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-45.0, Abortion, Spontaneous women with more than three consecutive unexplained pregnancy losses before the 20th week; 2. Chinese Han Population; 3. Patients who signed informed consent Patients who had other high-risk factors which might relate with recurrent miscarriage, including: (1) Parental karyotype abnormalities: significant rearrangements (e.g. balanced translocations and mosaics) were considered abnormal. If either the patient (or her partner) had an abnormal karyotype, it was considered a parental karyotypic abnormality; (2) Genital tract abnormalities: Any congenital anatomical deformation of the genital tract was considered abnormal; intrauterine adhesions, endometriosis and hydrosalpinx were also considered abnormal; (3) alloimmune disorder; (4) Endocrine abnormalities: prolactin (PRL) level >25 ng/ml, testosterone level >2.6 nmol/L, thyroid-stimulating hormone level <0.30 mU/L or >4.5 mU/L, free thyroxine (FT4) level <8.36 nmol/L or >29.6 nmol/L and free triiodothyronine (FT3) level <1.84 nmol/L or >7.39 nmol/L. Glucose level > 126mg/dl; (5) Autoimmune disorders: Any positive results of Anti-cardiolipin antibodies (ACA-IgG/IgM/IgA), anti-nuclear antibodies (ANA-IgG), anti-endometrium antibodies (AEA-IgM), anti-ovary antibodies (AOA-IgM), anti-sperm antibodies (ASA-IgM), antithyroidin(TG-Ab), anti-thyroid peroxidase antibody(TPO-Ab) and/or anti-chorionic gonadotropin hormone antibody; (6) Hypercoagulation state: D-dimer levels >260 ng/ml, fibrin degradation products (FDP) levels >5 mg/L or anti-beta 2-glycoprotein I (anti-beta 2-GP1) levels >15 U/ml; (7) Negative RH blood groups; (8) Abnormal semen routine results of patients husband. 2. Patients with serious diseases; 3. Patients with administration of contraceptive pills; 4. Patients participated in other randomized clinical research; 5. Patients could not be followed-up of a long time or had poor compliance; 6. Patients with other factors that would affect the study result
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 4.0-18.0, Autoimmune Thyroiditis A positive titer of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies (TPO and / or Tg> 60 IU / ml) and at least one of Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 micro-units per milliliter (mcU/ml) and decreased or normal levels of fT4 or fT3) Increased volume of thyroid gland (goiter) Morphological changes on ultrasound of the thyroid gland Presence of another chronic disease or autoimmune disease or being under medication Age of diagnosis above 18 years
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 32.0-51.0, Malignant Neoplasm of Thyroid Heart Diseases Thyrotoxicosis on Thyroxine Therapy thyroid cancer group 1. age less than 45 years old when receiving total or near-total thyroidectomy, 2. serum level of TSH<0.1 mU/L in the intermediate -risk or TSH<0.3 mU/L in the low recurrence-risk group over 2 years before study entry, 3. receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4. no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy control group 1. the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2. within the reference range of serum TSH (0.3-4.6 mU/L), 3. no history of structural heart disease, arrhythmia, or cardiac symptoms, 4. no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension who had arrhythmia in electrography or history of cardiac disease
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Cognitive Impairment Newly diagnosed differentiated thyroid carcinoma Undergo thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer Followed by TSH-suppressive therapy 6 /12 months Current or past disorder/disease of the central nervous system or medical condition impacting cognitive functioning Head trauma history with prolonged loss of consciousness Epilepsy, dementia, or learning disability Current or past psychotic-spectrum disorder or current major affective disorder Current substance abuse/dependence Daily tobacco and alcohol use Whole brain irradiation or surgery Prior cancer diagnosis or chemotherapy treatment Active autoimmune disorder Insulin-dependent diabetes
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 30.0-55.0, Type 2 Diabetes Healthy Overweight -All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following Ethnic background: Caucasian BMI: 25 to 40 kg/m2 Fasting blood glucose > 7 mmol/L Fasting Hemoglobin A1c > 7% Consume mainly typical Western diets daily Having obtained his/her informed consent Lean non-diabetic healthy subjects must comply with the following Ethnic background: Caucasian BMI: 20 to 25 kg/m2 Fasting blood glucose < 5.5 mmol/L Diabetic and healthy (same BMI) subjects representing one or more of the following are excluded from participation in the study Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators People actively take cortisol or dexamethasone should be excluded from the study People under a-amylase/a-glucosidase inhibitors should be excluded from the study. However, patients under metformin can be accepted for this study Patients under metformin suffering from gastrointestinal side effects within a 6-month time period prior to the trial Regular consumption of fermented dairy products Vegetarians Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment HIV seropositive Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-80.0, Colorectal Cancer Who will get surgical resection for colorectal cancer Who has diagnosed with diabetes Who met the for testing of diabetes in asymptomatic adult individuals for testing for diabetes in asymptomatic adult individuals overweight (BMI>25 kg/m2*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C >5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD) Previously exposed to surgery or chemotherapy for colorectal cancer Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence Presence of CNS metastasis Not able or willing to give informed consent Any patients judged by the investigator to be unfit to participate in the study
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, PCOS Premenopausal women between 18-45 years of age and BMI less than 42 Diagnosed with PCOS by Rottadom Adequate hepatic, renal, Cardiac and hematological functions Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study Stable weight for last two months (Change of weight<3kg) Male Post menopausal women Women with hysterectomy Hyperprolactinemia Patients with congenital adrenal hyperplasia Patients suffering from Cushing's syndrome Acute or chronic Medical illness including Hepatic, Cardiac or renal insufficiency, COPD,Gastrointestinal Disorders Uncontrolled Hypertensive or known Diabetics on drugs Use of oral contraceptives or HRT for last three months Smoking or drug addicts or with psychiatric illness
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-35.0, Infertility Age: 20-35 years 2. Diagnosed as primary infertility. 3. Duration of marriage more than 1 year. 4. Controls should be normal fertile women aged 20 years had no history of treatment for infertility or thyroid disorders Age: above 35 years old. 2. Women with ovarian dysfunction (PCO, post ovarian surgery). 3. Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Diabetes Mellitus Hypothyroidism Hyperthyroidism Goiter Thyroid Nodule Obesity Patients from counties with at least 5 endocrinology referrals waiting appointment Patients referred from primary care physicians Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity) Patients from counties with more than one hundred endocrinology referrals waiting appointment
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 5.0-18.0, Thyroiditis Hashimoto For patients Subjects 5 to 18 years old First diagnosis of hypothyroidism due to Hashimoto's thyroiditis (high levels of serum antithyroid autoantibodies (antiTPO, anti-TgAb). For Controls Healthy individuals 5 to 18 years old BMI for age between 15th and 85th percentile (z-score between -1 and +1) For patients Presence of euthyroidsm, subclinical hypothyroidism, hyperthyroidism Pre-existing medical treatment for clinical hypothyroidism Taking other medications (eg growth hormone, corticosteroids) in the last 3 months Taking food supplements (eg omega-3 fatty acids, amino acids) in the last 3 months Concomitant endocrine, metabolic, degenerative and / or chronic diseases other than obesity (eg diabetes, hyper / hypo-cortisolemia, cardiovascular diseases, kidney diseases, myasthenia, neurological diseases, psychiatric disorders eg anorexia nervosa, cancer, anemia, celiac disease, chromosomal abnormalities eg syndrome Turner, Down, etc) Participation in any daily organized physical activity (sport), more than 1 hour per day Presence of menstrual disorders in adolescent girls Having any kind of nutrition/dietary intervention (eg weight loss diet, hypocaloric, ketogenic, low-protein diet), in the last 6 months. For Controls Presence of any form of thyroid disease
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Breast Carcinoma Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 months after the first histologic diagnosis of invasive breast cancer A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy) Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study Bilateral breast carcinoma is allowed provided diagnoses are synchronous that is, within 3 months of one another and at least one of the two breast carcinomas meet the and neither Her-2 positive or inflammatory No evidence of metastatic disease 1.2 Her-2 negative, defined as In-situ hybridization (ISH) ratio of < 2.0 (if performed) Immunohistochemistry (IHC) staining of 0-2+ (if performed) Deemed to not be a candidate for Her-2 directed therapy. 1.3 Eligible tumor-node-metastasis (TNM) Stages
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Colon Cancer Liver Metastases Liver Neoplasms Liver Diseases Secondary Malignant Neoplasm of Liver Malignant Neoplasm of Large Intestine Metastatic to Liver Hepatectomy Surgery Patients fulfilling all of the following may be enrolled in the study Male or female patients above 18 years of age Patients with multifocal CRLM with a FLR/TLV (Total Liver Volume)< 30% OR a FLR/BW (Bodyweight) ratio of < 0.5 Patients with colorectal primary tumor not yet resected may be included as long as the extrahepatic disease may be cured surgically (liver first strategy) Patients with lung metastases may be included in the study as long as the lung metastases are potentially curable by resection by judgment of a thoracic surgery consultant Chemotherapy response according to regression or stable disease The indication for surgery should be discussed at a multidisciplinary tumor board attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists Written informed consent given by the patient after discussing the trial with the patient in a language he/she understands For women of chlidbearing age: Not currently breastfeeding; usage of effective contraception if sexually active; not pregnant and agreement not to become pregnant during the 12 months thereafter. A negative pregnancy test before into the trial is required for women, who are not yet menopausal, had their last menses within less than 12 months or have not had uterus and or ovaries removed surgically or undergone tubal ligation The presence of any one of the following will lead to of the participant Male or female patients under 18 years of age Unilobar tumorload qualifying the subject for a standard hepatectomy Patients with multifocal CRLM with a FLR/TLV > 30% OR a FLR/BW ratio of > 0.5 Patients with a baseline FLR of less than 15% Patients with extrahepatic metastatic disease (except potentially resectable lung metastases) Patients not having received chemotherapy before study enrollment If the liver biopsy prior to enrollment or the first liver biopsy in stage I shows fibrosis (Metavir stage ≥F3) or >30% macrosteatosis Significant concomitant diseases making the patient unsuitable for major liver surgery by the judgment of the physicians involved
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Breast Mass Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study Unable to give informed consent breast abnormality greater than one quadrant
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-99.0, Graves Disease Graves' disease :patients treated for Graves' disease, the diagnosis date less than 4 months Control : patients cared for nodules or goiter Patients undergoing immunosuppressive therapy including corticosteroids
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Adrenal Insufficiency Healthy individuals not using any corticosteroids Patients with clinical suspicion of primary or secondary adrenal insufficiency. -Patient suspicious of having an enzyme defect ( 21 hydroxylase deficiency) giving hirsutism -Use of corticosteroids
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 22.0-999.0, Disorder of Nipple Breast Neoplasms female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge clinical decision to have contrast enhanced MRI male gender non-English speakers age < 21 years lack of capacity to give legally effective consent
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Functional Pancreatic Neuroendocrine Tumor Malignant Somatostatinoma Merkel Cell Carcinoma Metastatic Adrenal Gland Pheochromocytoma Metastatic Carcinoid Tumor Multiple Endocrine Neoplasia Type 1 Multiple Endocrine Neoplasia Type 2A Multiple Endocrine Neoplasia Type 2B Neuroendocrine Neoplasm Non-Functional Pancreatic Neuroendocrine Tumor Pancreatic Glucagonoma Pancreatic Insulinoma Recurrent Adrenal Cortex Carcinoma Recurrent Adrenal Gland Pheochromocytoma Recurrent Merkel Cell Carcinoma Somatostatin-Producing Neuroendocrine Tumor Stage III Adrenal Cortex Carcinoma Stage III Thyroid Gland Medullary Carcinoma Stage IIIA Merkel Cell Carcinoma Stage IIIB Merkel Cell Carcinoma Stage IV Adrenal Cortex Carcinoma Stage IV Merkel Cell Carcinoma Stage IVA Thyroid Gland Medullary Carcinoma Stage IVB Thyroid Gland Medullary Carcinoma Stage IVC Thyroid Gland Medullary Carcinoma Thymic Carcinoid Tumor VIP-Producing Neuroendocrine Tumor Well Differentiated Adrenal Cortex Carcinoma Zollinger Ellison Syndrome Pathologically confirmed metastatic unresectable well differentiated (low grade and intermediate grade) neuroendocrine tumors (Ki-67 < 20% and mitotic rate < 2 per 10 high power field) that demonstrate progressive disease (by serial computed tomography [CT] or magnetic resonance imaging [MRI] scans) in past 12 months including Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree or thymus Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas) Pheochromocytomas Gastrinomas (Zollinger-Ellison syndrome) Multiple endocrine neoplasia (MEN type I/II) Adrenal carcinomas with NET markers by immunohistochemistry (IHC) or serum Somatostatinoma VIPoma (vasoactive intestinal peptide) Merkel cell tumors Prior chemotherapy with combination of capecitabine (or 5-flourouracil [5-FU]) "and" temozolomide (or dacarbazine [DTIC]) will be excluded; patients can have had prior therapies up to 3 prior chemotherapy regimens such as streptozocin, anthracyclines, irinotecan, etoposide, or a platinum agent including single agent capecitabine (or 5FU) or temozolomide (or DTIC) History of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide or DTIC will be excluded (i.e. anaphylaxis or anaphylactoid reactions) Patients who have active or uncontrolled infection or serious medical or psychiatric illness preventing informed consent or on intensive treatment Patients with brain metastases are excluded Patients with uncontrolled seizures or any neurological conditions resulting in increased risk for seizures are not eligible for study entry Patients with documented central nervous system (CNS) ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical symptoms, will be excluded from study participation Patients with a history of the arterial or venous thromboembolism within =< 12 months of study entry are not eligible Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy are excluded from the study Patients with another active malignancy within the past five years except for carcinoma in situ of cervix or in situ carcinoma of the bladder or non-melanomatous carcinoma of the skin Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Acinar Cell Carcinoma Adenoid Cystic Carcinoma Adrenal Cortex Carcinoma Adrenal Gland Pheochromocytoma Anal Canal Neuroendocrine Carcinoma Anal Canal Undifferentiated Carcinoma Angiosarcoma Apocrine Neoplasm Appendix Mucinous Adenocarcinoma Bartholin Gland Transitional Cell Carcinoma Basal Cell Carcinoma Bladder Adenocarcinoma Breast Metaplastic Carcinoma Cervical Adenocarcinoma Cervical Clear Cell Adenocarcinoma Cholangiocarcinoma Chordoma Colorectal Squamous Cell Carcinoma Desmoid Fibromatosis Endometrial Transitional Cell Carcinoma Endometrioid Adenocarcinoma Esophageal Neuroendocrine Carcinoma Esophageal Undifferentiated Carcinoma Extrahepatic Bile Duct Carcinoma Extramammary Paget Disease Fallopian Tube Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Fibromyxoid Tumor Gallbladder Carcinoma Gastric Neuroendocrine Carcinoma Gastric Squamous Cell Carcinoma Gastric Undifferentiated Carcinoma Gastrointestinal Stromal Tumor Gestational Trophoblastic Tumor Giant Cell Carcinoma Intestinal Neuroendocrine Carcinoma Intrahepatic Cholangiocarcinoma Lung Carcinoid Tumor Lung Sarcomatoid Carcinoma Major Salivary Gland Carcinoma Malignant Odontogenic Neoplasm Malignant Peripheral Nerve Sheath Tumor Malignant Solid Neoplasm Malignant Testicular Sex Cord-Stromal Tumor Metastatic Malignant Neoplasm of Unknown Primary Minimally Invasive Lung Adenocarcinoma Mixed Mesodermal (Mullerian) Tumor Mucinous Adenocarcinoma Mucinous Cystadenocarcinoma Nasal Cavity Adenocarcinoma Nasal Cavity Carcinoma Nasopharyngeal Carcinoma Nasopharyngeal Papillary Adenocarcinoma Nasopharyngeal Undifferentiated Carcinoma Oral Cavity Carcinoma Oropharyngeal Undifferentiated Carcinoma Ovarian Adenocarcinoma Ovarian Germ Cell Tumor Ovarian Mucinous Adenocarcinoma Ovarian Squamous Cell Carcinoma Ovarian Transitional Cell Carcinoma Pancreatic Acinar Cell Carcinoma Pancreatic Neuroendocrine Carcinoma Paraganglioma Paranasal Sinus Adenocarcinoma Paranasal Sinus Carcinoma Parathyroid Gland Carcinoma PEComa Peritoneal Mesothelioma Pituitary Gland Carcinoma Placental Choriocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma Pseudomyxoma Peritonei Rare Disorder Scrotal Squamous Cell Carcinoma Seminal Vesicle Adenocarcinoma Seminoma Serous Cystadenocarcinoma Small Intestinal Adenocarcinoma Small Intestinal Squamous Cell Carcinoma Spindle Cell Neoplasm Squamous Cell Carcinoma of the Penis Teratoma With Somatic-Type Malignancy Testicular Non-Seminomatous Germ Cell Tumor Thyroid Gland Carcinoma Tracheal Carcinoma Transitional Cell Carcinoma Ureter Adenocarcinoma Ureter Squamous Cell Carcinoma Urethral Adenocarcinoma Urethral Squamous Cell Carcinoma Vaginal Adenocarcinoma Vaginal Squamous Cell Carcinoma, Not Otherwise Specified Vulvar Carcinoma Patients are eligible under ONE of the following For all cohorts except the gestational trophoblastic disease (GTD) (Cohort #47), patients must have histologically and/or biochemically confirmed rare cancer and must be able to submit specimens; to be eligible for the GTD cohort: patients must have disease confirmed by quantitative serum beta-human chorionic gonadotropin (hCG) within 28 days prior to registration and must be able to submit blood specimens (tissue submission is not required for patients who will be registered to the GTD cohort [Cohort #47]); NOTE: Subsequent to site's Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" to register to S1609 OR FOR WITH PD-L1 (COHORT #50) ONLY: All solid tumors (excluding lymphoma) are allowed for the PD-L1 amplified cohort if they have PD-L1 amplification; patients may be considered for registration to the PD-L1 amplified cohort (Cohort #50) with the confirmation of at least one of the study chairs; PD-L1 amplification is defined as having deoxyribonucleic acid (DNA) copy number of equal to or greater than six by any of the following Clinical Laboratory Improvement Act (CLIA)-approved lab; (Immunohisochemistry [IHC] and fluorescence in situ hybridization [FISH] are not allowed); the assay must be done at or after the diagnosis of advanced disease, but PRIOR TO NOTE: patients with PD-L1 overexpression by IHC or PD-L1 amplification by FISH do not quality for this cohort; OR FOR IN EAY131 "NCI-MATCH" PRIOR TO EAY131 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to receive EAY131, "NCI-MATCH" therapy Patients who do not qualify for one of the histologic cohorts and are not on the ineligible histology list may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email NOTE: The "Not Otherwise Categorized" Rare Tumors cohort was permanently closed to accrual on 3/15/2019 Patients who are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis NOTE: The "Tumor of unknown primary (Cancer of Unknown Primary; CuP" cohort was permanently closed to accrual on 12/22/2017 Patients must also meet one of the following Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other are met; OR Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible Patients are not eligible if they have had or are planned for solid organ transplant Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before registration to S1609 Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load and no residual hepatic impairment are eligible Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with prednisone dose >= 10 mg); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia gravis, multiple sclerosis or glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years is permitted; short-term steroid premedication for contrast allergy is permitted Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3) Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated Patients must not have symptomatic interstitial lung disease or pneumonitis
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 2.0-30.0, Adrenal Cortex Carcinoma Alveolar Soft Part Sarcoma Central Nervous System Neoplasm Childhood Clear Cell Sarcoma of Soft Parts Clear Cell Sarcoma of Soft Tissue Ewing Sarcoma Hepatoblastoma Hepatocellular Carcinoma Osteosarcoma Recurrent Adrenal Cortex Carcinoma Recurrent Alveolar Soft Part Sarcoma Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Hepatocellular Carcinoma Recurrent Malignant Solid Neoplasm Recurrent Osteosarcoma Recurrent Primary Malignant Central Nervous System Neoplasm Recurrent Renal Cell Carcinoma Recurrent Rhabdomyosarcoma Recurrent Soft Tissue Sarcoma Recurrent Thyroid Gland Medullary Carcinoma Refractory Ewing Sarcoma Refractory Malignant Solid Neoplasm Refractory Osteosarcoma Refractory Primary Malignant Central Nervous System Neoplasm Refractory Rhabdomyosarcoma Refractory Soft Tissue Sarcoma Renal Cell Carcinoma Rhabdomyosarcoma Solid Neoplasm Thyroid Gland Medullary Carcinoma Wilms Tumor Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) Patients must have a body surface area >= 0.35 m^2 Patients must have recurrent or refractory disease, or newly diagnosed disease with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse Ewing sarcoma Rhabdomyosarcoma (RMS) Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS]) Osteosarcoma Wilms tumor Rare tumors Medullary thyroid carcinoma (MTC) Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control-during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim) Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib) Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Hematological Malignancy Hematological cancer Ongoing chemotherapy Ability to eat by mouth Informed consent Lack of the ability to understand the informations given Lack of the ability to understand the conditions of the experiment
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 6.0-40.0, Type 1 Diabetes Lipoatrophy Patients with type 1 diabetes and documented lipoatrophy at injection sites on CSII treatment Age between 6 and 40 years (both inclusive, see rationale for the of minors above) Signed informed consent form from patients or from parents/their guardians if children/youths <18 years Patients must be willing to undergo all study procedures Patients with previous use of insulin glulisine Patients requiring corticosteroids as treatment medication. NOTE inhaled corticosteroids are allowed Patients suffering from severe chronic disease other than T1D or genetic disorder (i.e. Down syndrome etc.) Pregnant or lactating women Patients participating in other device or drug studies History of drug or alcohol abuse within the last five years prior to screening Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures History of severe or multiple allergies Treatment with any other investigational drug within 3 months prior to screening Progressive fatal disease
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Thyroid Cancer Postsurgical Hypothyroidism Age > 18 years Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II Planned total or near-total thyroidectomy Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively Normal serum TSH within 12 months preceding surgery AJCC Stage III or greater Undifferentiated, Anaplastic or Medullary Thyroid Cancer Planned postoperative TSH goal other than 0.1-0.5 mU/L History of gastrointestinal malabsorption or gastric bypass surgery Pregnancy Use of medications that alter the absorption or metabolism of levothyroxine Prior use of levothyroxine
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-60.0, Impaired Glucose Tolerance Hypogonadism Inclusion/ History normal pubertal development stable weight for previous three months no active illicit drug use no history of a medication reaction requiring emergency medical care no difficulty with blood draws. Physical examination: • systolic BP < 140 mm Hg, diastolic < 90 mm Hg, Laboratory studies: (per MGH reference ranges) normal hemoglobin, unless hypogonadal then no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (as men and women with hypogonadism have lower hemoglobin levels off of treatment) hemoglobin A1C < 6.5% BUN, creatinine not elevated AST, ALT < 3x upper limit of normal
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 21.0-70.0, Overweight interested in losing weight and have a body mass index (BMI) 30-45 kg/m2; 2. ages 21 to 70; 3. able to provide informed consent; 4. physician's approval of his/her patients to participate; 5. non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight clinically diagnosed diabetes, or an HbA1c ≥ 6.5%; 2. an acute coronary event within the previous 6 months; 3. pregnant or lactating; 4. plans to move out of the area within the 12-week study period; 5. diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease); 6. following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program; 7. previously had bariatric surgery; 8. currently using weight loss medication; 9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating); 10. unable to provide consent
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc"
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-60.0, Multiple Sclerosis Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0 5, 4) Low or low-normal T < 499ng/dL and 5) FSS scores of >3.6 Prostate specific antigen > 2.5 (<49yr of age) or >3.5 (age >50yr of age), 2) baseline hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6) screening T level >500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot perform study tests, 13) inability to undergo MRI, 14) current or expected use of amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue scores (e.g., expected changes in spasticity, sleep, or depression medications)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 30.0-50.0, Fibromyalgia being female age between 30 and 50 years have an ovulatory cycle height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of 18.5 to 29.9 kg / m2 present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current of the American College of Rheumatology is at least 6 months without any physical exercise do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except FM not having diabetes mellitus and uncontrolled blood pressure they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity Not having psychiatric illness or having malignant tumors not attend for more than two consecutive exercise sessions at any time and for any reason expressing an intention to leave the study present a health problem that prevents them from continuing to carry out the proposed exercises
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, Polycystic Ovary Syndrome to 45 years Patients diagnosed with PCOS according to Rotterdam criteris (for the study group) Patients without PCOS and menstrual irregularities (for the control group) Absence of significant abnormalities on physical examination except hirsutism No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy Normal thyroid function and prolactin level Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease Pregnant Ovarian tumors Endocrine diseases (Cushing disease, 21-Hydroxylase enzyme deficiency, thyroid dysfunction,hyperprolactinemia,diabetes) Chronic diseases (renal insufficiency, cardiovascular, hepatic disease) Oral contraceptive use, anti-androgenic,glucocorticoid, anti-hypertansive- anti-diabetic drug use Smoking or alcohol use
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-70.0, Thyroid Cancer Distress Depression Anxiety Fatigue Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer 2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines < 19 or ≥ 70 years old 2. Communication difficulties or inability to complete the necessary investigations and questionnaires 3. Inability to understand purpose of the study or disagree of participation 4. Past history of psychiatric treatment or diagnosis 5. Lactation or pregnancy 6. Past medical history of other cancer diagnosis or treatment 7. Any of severe comorbid medical conditions according to ASA score ≥ 3
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 19.0-999.0, Pain, Postoperative Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre History of severe respiratory, renal or hepatic disease Previous spine surgery Known allergy to local anaesthesia Those who experience dural tear during operative procedure
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, RET-altered Non Small Cell Lung Cancer Medullary Thyroid Cancer RET-altered Papillary Thyroid Cancer RET-altered Colon Cancer RET-altered Solid Tumors Lung Neoplasm Carcinoma, Non-Small-Cell Lung Thyroid Diseases Thyroid Neoplasm Thyroid Cancer, Papillary Carcinoma, Neuroendocrine Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Disease Carcinoma, Bronchogenic Bronchial Neoplasms Endocrine System Diseases Endocrine Gland Neoplasm Head and Neck Neoplasms Adenocarcinoma, Papillary Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasm Digestive System Disease Gastrointestinal Disease Colonic Diseases Intestinal Disease Key Diagnosis during dose escalation (Phase 1) Pathologically documented, definitively diagnosed non-resectable advanced solid tumor All patients treated at doses > 120 mg per day must have medullary thyroid cancer (MTC), or a RET-altered solid tumor per local assessment of tumor tissue and/or blood Diagnosis during dose expansion (Phase 2) All patients (with the exception of patients with MTC enrolled in Groups 3, 4, and 9) must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below Group 1 patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy Group 2 patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion not previously treated with a platinum-based chemotherapy, including those who have not had any systemic therapy. Prior platinum chemotherapy in the neoadjuvant and adjuvant setting is permitted if the last dose of platinum was 4 months or more before the first dose of study drug Patient's cancer has a known primary driver alteration other than RET. For example, NSCLC with a targetable mutation in EGFR, ALK, ROS1 or BRAF; colorectal with an oncogenic KRAS, NRAS, or BRAF mutation Patient has any of the following within 14 days prior to the first dose of study drug: 1. Platelet count < 75 × 10^9/L. 2. Absolute neutrophil count <1.0 × 10^9/L. 3. Hemoglobin < 9.0 g/dL (red blood cell transfusion and erythropoietin may be used to reach at least 9.0 g/dL, but must have been administered at least 2 weeks prior to the first dose of study drug. 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) if no hepatic metastases are present; >5 × ULN if hepatic metastases are present. 5. Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease. 6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min. 7. Total serum phosphorus >5.5 mg/dL QT interval corrected using Fridericia's formula (QTcF) >470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome Clinically significant, uncontrolled, cardiovascular disease Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms Clinically symptomatic interstitial lung disease or interstitial pneumonitis including radiation pneumonitis Patients in Groups 1-5 and 7 (Phase 2) previously treated with a selective RET inhibitor
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Thyroid Obesity Insulin Resistance Autoimmune Thyroiditis Obesity (BMI > 40 kg/m2) 2. Age: 18-65 Diagnosis of obesity secondary to primary endocrine or systemic disease (e.g. Cushing's syndrome) 2. Evidence of clinically relevant thyroid disease 3. Chronic systematic inflammatory disease (e.g. rheumatoid arthritis) 4. Pregnancy 5. Treatment with anti-inflammatory drugs (e.g. corticosteroids) 6. Type 1 diabetes mellitus
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Hypothyroidism older than 18 years capable of consent able to fill in a questionnaire in italian thyroidectomized serum thyroglobulin levels below 0.2 ng/ml and antibodies anti-thyroglobulin undetectable (below normal range) well treated taking stable doses of levothyroxine in tablets, in the previous 3 months TSH suppressive therapy pregnancy cardiac arrhythmias severe liver, kidney or bone diseases ongoing steroids treatment ongoing or in the previous 12 months treatment with bone anti-resorptive, amiodarone, colestyramine or iron
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 45.0-75.0, Men Diet Modification Obesity Overweight Life Style Weight Loss Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Heart Failure Subclinical Hypothyroidism Aged 18 years or older, male or female Systolic heart failure with New York Heart Association (NYHA) class II-III Left ventricular ejection fraction (LVEF) less than 40% by echocardiography during screening and randomization SCH (TSH: upper limits of normal (ULN) -10mIU/L, and FT4 level within reference range) Having received standard HF therapy for at least 2 weeks, having reached target dose or max tolerable dose Provided informed consent Acute heart failure or acute exacerbation of chronic heart failure within the past 2 weeks Scheduled cardiac resynchronization therapy or heart transplantation History of malignant tumor or life expectancy under 12 months Already on medications that may affect thyroid function (L-T4, carbimazole, propylthiouracil, amiodarone, lithium) Pregnancy and lactation period Participation in another clinical trial within the past 30 days Contraindication or intolerance to evidence-based therapy for CHF, such as beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s) Untreated adrenal insufficiency Untreated pituitary insufficiency
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 30.0-70.0, Overweight Obesity BMI 27-35 kg/m2 Hb≥120g/l Serum thyroid stimulating hormone (TSH) ≤4.00 mIU/L Plasma low density lipoprotein cholesterol <5.3 mmol/L Plasma triglycerides ≤1.8 mmol/L Signed informed consent Freezer capacity for 2 weeks bread provision Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study Unable to complete satisfactorily the 3-day weighted food record at screening visit 2 Unable to lose 0.5 kg or more during the run-in period for men and women not having menstruation during the run in period Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.) Using e-cigarettes (regardless of nicotine content) Following any weight reduction program or having followed one during the last 6 months prior to visit 1 Diastolic blood pressure 105 mm Hg at visit 1 Systolic blood pressure 160 mm at visit 1 History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Polyoma Virus Infection Thyroiditis, Autoimmune Major Patient Age ≥ 18 years Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto Patients must have signed informed consent Affiliation to a social security scheme Minor Patients Patient under tutorship or curatorship
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-39.0, Recurrent Pregnancy Loss having a diagnosis of RPL (two or more consecutive or non-consecutive first-trimester losses) 2. be.ing aged 18-39 years at randomisation 3. trying to conceive naturally 4. willing and able to give informed consent they were unable to conceive naturally (as confirmed by urinary pregnancy tests) within 1 year of recruitment or before the end of the randomisation period in the trial, whichever came earlier 2. they had antiphospholipid syndrome [lupus anticoagulant and/or anticardiolipin antibodies (immunoglobulin G or immunoglobulin M)]; other recognised thrombophilic conditions (testing according to usual clinic practice) l they had uterine cavity abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy) 3. they had abnormal parental karyotype 4. they had other identifiable causes of RPL (tests initiated only if clinically indicated) such as diabetes or systemic lupus erythematosus 5. they had any contraindications to Levothyroxine use
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Autoimmune Diseases Chronic Lymphocytic Thyroiditis Patients participating in PHRC 2005 "involvement of enteroviruses in TLC pathogenesis" of TLC: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes of controls: absence of significant lymphocyte infiltrate Persons refusing to participate in research
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, Pregnancy Related Thyroid Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future Males Younger than 18 or older than 45 years old More than 10 weeks pregnant at enrollment Iodine deficient Pregnant with more than one baby (i.e., twins, triplets, etc.) NOT taking thyroid hormone medicine before becoming pregnant Levels of thyroid hormone in blood have been too low or too high in the past 6 months Treated with radioactive iodine in the past year
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Hepatitis B HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-38.0, Chronic Endometritis Patients who provide their written informed consent after having been informed of the all study aspects IVF or ICSI cycles with own oocytes, with blastocyst transfer (day 5 or 6 of stage development) Women with age comprised between 18 and 38 years (both included) Body mass index: 18.5 km/m2 (both included) Adequate ovarian reserve > 8 antral follicles (RFA) and/or Antimüllerian hormone (HAM)> 1 ng / mL Concentration of spermatozoa > 2 million sperm/ml Congenital or acquired uterine pathologies Endometriosis Patients with IUDs in the last 3 months Patients who have taken prescribed antibiotic treatment in the last 3 months Any disease or medical condition that could be unstable or could endanger the security of the patient and her compliance in the study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 16.0-999.0, Thyroid Nodule Thyroid Cancer Thyroid Diseases Thymic Carcinoma Patients will be eligible for registry enrollment if they are undergoing thyroid nodule work-up Patients will not be eligible for registry enrollment if a work-up beyond clinical evaluation is not indicated
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Metastatic Thyroid Gland Carcinoma Poorly Differentiated Thyroid Gland Carcinoma Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8 Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 Thyroid Gland Anaplastic Carcinoma Unresectable Thyroid Gland Carcinoma Histologically confirmed anaplastic thyroid or poorly differentiated thyroid carcinomas Patients deemed to have unresectable locoregional disease or metastatic disease. Patients who are unwilling to undergo surgery or external beam radiation are also eligible Patients with poorly differentiated thyroid cancer must have at least one target lesion by version 1.1. This is not a requirement for ATC patients Total bilirubin =< 1.5 x upper limit of normal (ULN). Total bilirubin: 3 x ULN for patients with Gilbert's syndrome Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) / alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases) Serum creatinine =< within 1.5 x ULN Absolute neutrophil count (ANC) >= 1.0 x 10^9 /L Platelets (PLT) >= 100 x 10^9 /L For patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable international normalized ratio (INR) during the 28 days immediately preceding initiation of study treatment Subjects must be willing to undergo tumor biopsy prior to and after treatment with atezolizumab, unless in the opinion of the treating physician, a biopsy is not feasible or safe Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus on stable insulin regimen, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll For patients not receiving therapeutic anticoagulation: INR or partial thromboplastin time (aPTT) > 1.5 x ULN within 28 days prior to initiation of study treatment Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents. Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met: Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose, and no history of severe immune-related adverse effects from anti-CTLA 4 (National Cancer Institute [NCI] Common Terminology for Adverse Events [CTCAE] grade 3 and 4) Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. However, patients with past or resolved hepatitis B virus (HBV) should be monitored for reactivation by a specialist. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) Pregnant or lactating women. All pre-menopausal women being screened must have a negative serum pregnancy test within 14 days prior to commencement of dosing. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year. Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician Untreated brain metastases Chemotherapy within 21 days of enrollment with the exception of paclitaxel or nab-paclitaxel (Abraxane). Patients who have received one course of these agents prior to study entry are eligible. (One course of weekly paclitaxel or nab-paclitaxel is 3 doses. One course of every 3 week dosing of paclitaxel or nab-paclitaxel is 1 dose). Patients who have received prior radiosensitizing chemotherapy are eligible The use of corticosteroids is not allowed for 10 days prior to initiation of atezolizumab except patients who are taking steroids for physiological replacement. Inhaled or topical steroids, and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease. This does not apply to patients receiving steroids as pre-medications for paclitaxel administration Grade >= 2 uncontrolled hypertension (patients with a history of hypertension controlled with anti-hypertensive medication to Grade =< 1 are eligible)
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Mental Health Wellness 1 Current resident within the Neurosurgery Program in the Department of Neurological Surgery at the University of Wisconsin-Madison, provided they are willing to participate based on completion of informed consent. Participants will likely be young adults in relatively good health status resident within the Neurosurgery Program in the Department of Neurological Surgery at the University of Wisconsin-Madison ability to participate in light activity, and being willing to participate Unable to participate in planned activities those not willing to participate non-resident department employees
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 2.0-5.0, Overweight Nutrition Disorder, Child Weight Change, Body 5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development - Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Advanced Adult Hepatocellular Carcinoma Child-Pugh Class A Stage III Hepatocellular Carcinoma Stage IIIA Hepatocellular Carcinoma Stage IIIB Hepatocellular Carcinoma Stage IIIC Hepatocellular Carcinoma Stage IV Hepatocellular Carcinoma Stage IVA Hepatocellular Carcinoma Stage IVB Hepatocellular Carcinoma Participant must have histologically or radiographically confirmed hepatocellular cancer (HCC) that is advanced or metastatic and if archival tissue is available, have archival tissue submitted for PD-L1, PD-L2 testing Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred > 28 days prior to enrollment Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 60%) Child-Pugh class-A liver function Absolute neutrophil count (ANC) >= 1,500/ mcL Hemoglobin >= 8.5 g/dL Platelets >= 75,000/ mcL Total bilirubin =< 2.0 mg/dL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 X ULN Serum Creatinine <= 1.5 upper limit of normal (ULN)or Creatinine clearance > 50 mL/minute if serum creatinine is elevated above 1.5 X ULN One prior line of therapy that may a PDL1 blocker allowed, no prior sorafenib or PD1 blocker allowed Participants who have had radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Any evidence of bleeding diathesis (patients on therapeutic warfarin or heparin will be excluded) Participants with a history of variceal bleed within 6 months prior to enrollment Known human immunodeficiency virus (HIV)-positive participants (even if on combination retrovirals, participant will be excluded Participants with chronic autoimmune disease Participants with known brain metastases should be excluded from this clinical trial Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Has known history of, or any evidence of active, non-infectious pneumonitis Pregnant or nursing female participants
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-39.0, Fertility Disorders Regular cycles (between 25-34 days) In vitro fertilization indication for male cause, unexplained infertility or tubal factor Both ovaries Thyroid-stimulating hormone(TSH) < 2,5 mU/L Anti-Müllerian hormone (AMH) between 1-5 ng/ml Body Mass Index (BMI) < 30 Ovarian surgery Endometriosis Endocrinology or metabolic disorder Polycystic ovary syndrome (PCOS) Poor Ovarian Response (according to Bologna criteria)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Overweight Obesity Have at least one child up to 18 years of age residing in the household Primary grocery shopper for the household No health conditions or food practices that substantially limit food choice Not currently pregnant Consent to the study design Male < 18 years of age Not a mother, or children not living with subject in their household No children below the age of 18 years of age Not the primary grocery shopper for their household Health conditions or food practices that substantially limit food choice Currently pregnant
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Healthy Men Male Contraception Men who meet all the following are eligible for enrollment in the trial: 1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening. 2. 18 to 50 years of age (inclusive) at the time of the enrollment visit. 3. BMI ≤ 33 calculated as weight in kg/ (height in m2). 4. No history of hormonal therapy use in the three months prior to the first screening visit. 5. Subject agrees to use a recognized effective method of contraception with any female partner during the course of the study. 6. Subjects agrees to refrain from donating blood or plasma during the study period and from participating in other investigational drug studies. 7. Subjects agrees to refrain from excessive alcohol consumption during the study period. (No more than 15 drinks per week and no alcohol consumption within 24 hours of a study visit.) 8. Subjects agrees to refrain from significant changes in their current exercise regimen during the drug exposure period. 9. No known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance. 10. In the opinion of the investigator, subject can comply with the protocol, understand and sign an informed consent and HIPAA form Men who meet any of the following are NOT eligible for enrollment in the trial: 1. Men participating in another clinical trial involving an investigational drug within 30 days prior to the first screening visit. 2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site. 3. Clinically significant abnormal physical or laboratory findings at screening. 4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, per local laboratory normal values. 5. Abnormal serum chemistry values at screening, per local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL. 6. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual. 7. Use of androgens within 3 months before the first screening visit except for long acting, intramuscular testosterone undecanoate which will require a wash out period of 6 months prior to randomization. 8. Ongoing use of body building substances including nutritional supplements. 9. Systolic BP > 135 mm Hg and Diastolic blood pressure BP > 85 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 minute intervals and the mean of all measurements be used to determine eligibility. 10. Clinically significant abnormal EKG or a QTc interval of > 450 msec. 11. PHQ-9 score of 15 or above. 12. History of hypertension, including hypertension controlled with medication. 13. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis. 14. Benign or malignant liver tumors, active liver disease or known non-alchoholic fatty liver disease (NAFLD) 15. History of breast carcinoma. 16. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease. 17. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness. 18. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit. 19. A serious systemic disease such as diabetes mellitus. 20. History of known, untreated sleep apnea. 21. Partner is known to be pregnant. 22. Men desiring fertility within the first 24 weeks of study participation. 23. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single dose. 24. Subjects taking anticonvulsants. 25. Subjects taking recombinant human growth factor (HGH). 26. Subjects with a hematocrit greater than 55%. 27. Previous participation in this clinical trial or any trials of 11-Beta MNTDC. 28. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, Menstrual Cycle Abnormal PCOS Overweight Obesity Aged 18-45 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>35 days); or Previous diagnosis of PCOS from a primary care provider Weight >300lbs Currently pregnant or breast feeding History of ovarian surgery Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months Evidence of reproductive aging as assessed by the principal of STRAW+10 stages
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-55.0, Adrenal Insufficiency Healthy males and females between 18 and 55 years of age, inclusive (at screening). 2. A body mass index (BMI) of 18 to 30 kg/m2 (inclusive) 3. No clinically significant abnormal serum biochemistry, haematology or urine examination values, as defined by the Investigator. 4. A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test could be repeated at the discretion of the Investigator. 5. Negative human immunodeficiency virus (HIV) and hepatitis B and C test results. 6. No clinically significant abnormalities in the 12-lead ECG, as defined by the Investigator. 7. No clinically significant deviation outside of the normal ranges for blood pressure and heart rate measurements, as defined by the Investigator. 8. Male participants (unless anatomically sterile or abstinence from sexual intercourse was in line with preferred and usual lifestyle) and sexual partners were to use an effective contraception method during the study and for 3 months after the last intervention, for example Established use of oral, injected or implanted hormonal contraceptive Intrauterine device or intrauterine system Condom and diaphragm with spermicide. 9. Female participants of childbearing potential (unless abstinence from sexual intercourse was in line with preferred and usual lifestyle) with a negative pregnancy test at screening and on admission, and willing to use an effective method of contraception from the first dose until 3 months after the last intervention, for example Established use of oral / injected / implanted hormonal methods of contraception Intrauterine device or intrauterine system Barrier methods: condom + occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 10. Female participants of non-childbearing potential with negative pregnancy test at screening. For the purposes of the study, non-childbearing was defined as being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). Menopausal status was confirmed at screening by demonstrating that levels of follicle stimulating hormone (FSH) fell within the respective reference range. In the event a participant's menopausal status had been clearly established (for example, the participant indicated she had been amenorrhoeic for 10 years) but FSH levels were not consistent with a post-menopausal condition, determination of was at the Investigator's discretion following consultation with the Sponsor. 11. Participants were available to complete both study periods and the follow-up visit. 12. Participants satisfied a medical examiner that they were fit to participate in the study. 13. Participants were able to read and understand the ICF and provide written informed consent to take part in the study A clinically significant history of gastrointestinal disorder likely to influence drug absorption. 2. Receipt of any medication other than acetaminophen within the 14 days prior to dosing (including topical steroids, vitamins, dietary supplements or herbal remedies). 3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. 4. Receipt of any vaccination within the previous one month. 5. Presence of infections (systemic fungal and viral infections, acute bacterial infections). 6. Current or previous history of tuberculosis. 7. A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone. 8. Meeting any of the contraindications for Cortef® and/or dexamethasone, as detailed in the USPI and Summary of Product Characteristics (SmPC). 9. A clinically significant history of drug or alcohol abuse. 10. Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function). 11. Participation in a New Chemical Entity or marketed drug clinical study within the previous 3 months or, five half-lives of study drug, whichever is the longer period. (NB. the three-month washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). 12. Participants who had consumed more than 2 units of alcohol per day within the 7 days prior to the first dose or had consumed any alcohol within the 48-hour period prior to the first dose. 13. Donation or receipt of equal to or greater than 450 mL of blood within the previous three months. 14. Participants who smoked (or ex-smokers who had smoked within the 6 months prior to the first dose). This included e-cigarette and shisha users. 15. Participants who worked shifts (i.e. regularly alternated between days, afternoons and nights). 16. Vegetarians, vegans or those with other dietary restrictions which meant they were unable to consume the standardised high-fat breakfast (applicable to Part 2 only)
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-65.0, Overweight and Obesity Weight Loss Men and women who are overweight or obese (BMI ≥25 kg/m2) Want to lose weight, want to enroll in the study and are willing to sign the informed consent form Anticipate being able to meet the study requirements for food habits and study meetings, and anticipate remaining in Bissau for the study duration Between the ages of 20 to 65 years Non-pregnant women, and those who do not intend on becoming pregnant during the course of the study A doctor or nurse has signed a note approving participant in the weight loss intervention after seeing a copy of the handout with title "Instructions for Bissau Weight Loss Pilot Project", and a copy of his/her approval is given to the research staff Report food allergies or intolerance or health conditions that would prevent consumption of provided and recommended foods Participation in another concurrent nutrition research study If premenopausal (<55 years of age), they are pregnant or intend to become pregnant during the course of the study, or are not using a birth control method to prevent pregnancy
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 40.0-75.0, Pharmacokinetics Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2 Body weight of at least 50 kg at screening Good health as determined by evaluations Negative serum pregnancy test Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL Subjects who are peri-menopausal and experiencing at least one of specified symptoms of menopause (eg, hot flashes, mood swings, night sweats, and others) Negative urine test for drugs of abuse Negative urine test for HIV antibody, HBsAG, and HCV at Screening Women of child-bearing potential must agree to consistently practice contraception throughout the duration of the study and continue to do so for 1 year after receiving study drug by one of the following methods: abstinence, condom, diaphragm or cervical cap with spermicide, intrauterine device or male partner had previously undergone a vasectomy as declared in medical history Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study Concomitant medication that can affect bleeding Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant Subjects with QTcF interval duration >470 milliseconds History of alcoholism or drug addiction within 1 year prior to Day 1 History of allergy or a known sensitivity to product components of fulvestrant Test and Reference formulations Creatinine clearance <60 mL/minute based on the Cockcroft-Gault equation Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to Day 1
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 21.0-999.0, Gestational Diabetes Weight Loss Diet Habit Female aged 21 years and above Plans to deliver in NUH Diagnosed with GDM antenatally (between 24-34 weeks gestation) defined using the 2013 World Health Organization (fasting plasma glucose = 5.1 mmol/L, plasma glucose at 1H <10 or plasma glucose at 2H post 75gm glucose load of =8.5 mmol/L) Has a smartphone and able to independently use a smartphone app Willing to provide a blood sample Able to give written informed consent Able to speak and read English Subjects with type 1 and/or type 2 diabetes (including suspected cases diagnosed by an abnormal oral glucose tolerance test in the 1st and early 2nd trimesters of pregnancy) drugs that affect glucose or lipid metabolism (e.g. systemic steroids, metformin, insulin, statins, orlistat) terminal or life threatening condition physical or mental condition that would prevent completion of a majority of study instruments
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-34.0, Polycystic Ovary Syndrome Patients' ages 20 to 34 years BMI 18-25 kg/m2 PCOS was diagnosed according to Rotterdam 2003 (two are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant) Hysterosalpingography and husband semen analysis were normal in all subjects All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions Previous uterine, tubal or ovarian surgery Contraindications to laparoscopy and general anesthesia Pregnancy before the first post-operative menstrual cycle
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Cardiovascular Diseases Coronary Artery Disease angiographically documented coronary artery disease in at least one major epicardial vessel myocardial infarction coronary revascularization (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or coronary artery stent) heart failure unstable angina pectoris heart transplants with either cardiac resynchronization therapy or implantable defibrillators inability to comply with guidelines for participation in exercise testing and training significant limiting and/or unstable comorbidities that would prevent full participation
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-55.0, Diet Therapy BMI between 30-45 kg/m2 healthy subjects regular meal consumption no celiac disease no menopause woman with a BMI <30 or >45 kg/m2 having diabetes, hepatic or kidney diseases having an eating disorder having celiac disease menopause woman
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-88.0, Hypothyroidism Normal TSH on levothyroxine therapy pregnant or 6 months post partum 2. Current or previous thyroid cancer 3. Congenital hypothyroidism 4. any tobacco use 5. prescribed proton pump inhibitors 6. prescribed steroids 7. taking armour thyroid, naturethroid, or any dessicated thyroid hormone 8. Unstable medical conditions (CKD, Cirrhosis etc) 9. pituitary disease
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 4.0-18.0, Tonsillectomy Subject is male or female age 4-18 years of age 2. Patients undergoing total tonsillectomy with or without adenoidectomy or tympanostomy tubes 3. Patients with obstructive sleep apnea or recurrent tonsillitis requiring tonsillectomy. 4. The patient or caregiver is able to provide written informed consent. 5. Patients with American Society of Anesthesiologist (ASA) physical status 1 or 2 Subjects with complex medical conditions or craniofacial abnormalities 2. Subjects with known personal or family history of bleeding disorder 3. Subjects with cognitive or developmental disorders 4. Subjects currently taking corticosteroids for other medical conditions, or who have taken corticosteroids within 2 weeks of surgery 5. Subjects who are wards of the state 6. Subjects who have had an organ transplant 7. Subjects who are on other immunosuppressant medications 8. Subjects with diabetes mellitus 9. Non-English Speakers or English as a second language 10. Subjects undergoing intracapsular tonsillectomy 11. Subjects with American Society of Anesthesiologist (ASA) physical status greater than 2. 12. Pregnancy
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-75.0, Knee Osteoarthritis Umbilical Cord Bleeding ① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. - ① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for such as suffering from other concomitant diseases.-
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-50.0, Patient Compliance i. Clinical diagnosis of primary hypothyroidism patients with fatigue symptoms ii. Age : From 20 to 50 years iii. Levothyroxine treatment: receiving for at least 6 months iv. Serum free thyroxine level: 0.80-1.80 ng/dl v. Serum Thyroid-stimulating hormone level: 0.35-5.50 µIU/ml ( µIU = micro international unit) - i. Patients with Hypothyroidism 20 years and 50 years ii. Acute or chronic liver diseases iii. Anaemia iv. Clinical diagnosis of Diabetes mellitus. v. Cardiovascular disease ( such as heart failure, arrhythmia and uncontrolled hypertension ) vi. Patients with psychological disorders (such as depression, anxiety disorder, schizophrenia, alcoholism or fatigue disorder due to other systemic diseases) vii. Patients having serious infections or terminal illness (such as tuberculosis, HIV or malignant tumor ) viii. Autoimmune diseases ( such as rheumatoid arthritis, Systemic lupus erythematosus or multiple sclerosis) ix. Patients with impaired renal function x. Pregnant or planned to be pregnant xi. Nursing mothers -
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Pregnancy Thyroid Autoimmune Disease Iodine Deficiency Selenium Deficiency healthy women before 10 weeks of gestation signed informed consent form pre-existing thyroid disease pregnancy after assisted reproductive technologies known hypersensitivity reaction to iodine or selenium, or other components of dietary supplement used in the study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Hypercholesterolemia Have given written informed consent 2. Males or females aged 18 to 70 years old at the time of first dosing 3. Have a body mass index (BMI) of >25.0 and ≤ 45.0 kg/m2 at Screening 4. Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L The use of any anti-dyslipidemia agent within 28 days prior to dosing 2. History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L 3. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening 4. Significant peripheral or coronary vascular disease 5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg 6. Primary hypothyroidism (thyroid stimulating hormone [TSH] > upper limit or normal [ULN] and free T4 < lower limit of normal [LLN]), primary subclinical hypothyroidism (screening TSH > ULN and free T4 within normal limits [WNL]), or secondary hypothyroidism (screening TSH < LLN and free T4< LLN) at Screening 7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Nipple Wounds Postpartum breastfeeding mothers for healthy babies, who will meet the following Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling caused by breastfeeding or pumping. - Mothers having the following will be excluded from the study Mothers with diabetes (it is known that diabetes impacts on wound healing and to avoid any credibility questions linked to this it is considered prudent to leave mothers with diagnosed diabetes out of the study) Mothers with skin allergies or taking medications for skin allergies Psychiatric patients who cannot give consent Mothers with grade IV nipple sores Mothers with skin diseases thrush Stephen Johnson Disease Psoriasis Pampigos Mothers who will not undergo the full clinical follow-up program and will not arrive for at least one follow-up meeting will be excluded from the study. -
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-30.0, Polycystic Ovary Syndrome PCOS group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum [calculated] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction Control group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum [calculated] free testosterone concentration) General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism) Capable of and willing to provide informed consent Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period Inability/incapacity to provide informed consent Males will be excluded (hyperandrogenism is unique to females) Age < 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children) Age > 30 years (since ovarian reserve may decrease beyond age 30) Obesity resulting from a well-defined endocrinopathy or genetic syndrome Positive pregnancy test or current lactation Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and/or anovulation Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly) Total testosterone > 150 ng/dl, which suggests the possibility of virilizing ovarian or adrenal tumor DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation > 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Microbiota Aged 18 to 65 years GD was clinical diagnosed and thyroid function returned to normal HT was clinical diagnosed and thyroid function is normal Pregnancy Lactation Cigarette smoking Alcohol addiction Hypertension Diabetes mellitus Lipid dysregulation BMI > 27 Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Weight Gain Pregnancy Related Singleton gestation Primary prenatal care at MetroHealth Medical Center Planning to deliver at MetroHealth Medical Center Any not met Prior diagnosis of eating disorder Inadequate knowledge of English language
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Obesity temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (>35) who refuse surgery or are at high risk for surgery temporary weight loss treatment for a patient without indications for surgery (BMI > 29) none
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Overweight and Obesity Body mass index (BMI) between 25-45 kg/meters-squared one or more cardiovascular risk factor (type 2 diabetes, hypercholesterolemia, or hypertension) currently in another active weight loss program taking weight loss medication currently pregnant, lactating <6 months post-partum plan to become pregnant during the next 12 months a medical condition that would affect the safety of participating in unsupervised physical activity inability to walk 2 blocks without stopping
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Nipple Disorder Nursing mothers aged 18 years or older 2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales 3. Having given birth to a healthy, full-term child 4. Performing exclusive breastfeeding 5. Newborn with no oral, palatal or maxillofacial abnormalities 6. Newborn weighing between 2500 and 4000 grams History of psychological disorder 2. Presence of mastitis 3. Bacterial or fungal infection in breasts 4. Use of breast pump or plastic nipple
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-85.0, End Stage Renal Disease Maintenance hemodialysis therapy for end-stage renal disease Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia) >30 days since dialysis initiation Ability to provide informed consent Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment Expected survival <6 months-to allow trial completion Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months Prisoners or cognitive disability preventing informed consent Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement Existing pacemaker, implantable monitor or defibrillator which precludes device placement Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-45.0, Breastfeeding Inverted Nipple Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples 2. Able to read and write 3. Singleton or twin pregnancy An inverted nipple is defined as a condition in which the nipple is pulled inward into the breast instead of pointing outward, classified according to Han and Hong [11] Women with grade 3 inverted nipples 2. Previous breast surgery affecting the breast anatomy 3. High risk pregnancies 4. Medical conditions that could interfere with breastfeeding such as critical maternal condition 5. Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip &/or palate 6. Women choosing artificial milk as their preferred infant nutrition
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, Contraception Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care. 2. Between 18 and 40 years inclusive at the enrollment visit. 3. Weight ≥ 80 kg. 4. Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception. 5. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended 6. If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use; 7. Willing to avoid use of any hormonal or intrauterine contraception until the end of the study; 8. For women with a recent history of Depo Provera use, the most recent injection must have been at least 6 months before study entry, and the subject must have had at least one normal menstrual cycle (2 consecutive menses); 9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, condom breakage (including condoms lubricated with spermicide), or other barrier contraceptive method failure; 10. Have a negative urine pregnancy test at time of screening 11. Reports all acts of unprotected coitus since her prior menses are within 72 hours prior to enrollment; 12. Willing to abstain from further acts of unprotected intercourse until the end of the study; 13. Give voluntary, written informed consent, and agree to observe all study requirements including being available for follow up for at least the next 4 weeks; 14. Accepts that the risk of pregnancy with oral EC is greater than that following placement of a copper IUD for EC Be currently pregnant (positive high-sensitivity urine pregnancy test); 2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding; 3. Desire to use hormonal systemic contraception within 5 days of study drug use 4. Have had a female sterilization procedure; 5. Have a partner with a history of vasectomy; 6. Current inability to tolerate oral medication; 7. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year. 8. Have known liver disease; 9. Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers. 10. Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment. 11. Have a current need for exogenous hormones. 12. Have concomitant use of strong CYP3A4 inhibitors (as identified by the FDA) or inducers at the time of or planned use within 3 days of dosing; 13. Use any medications that can interfere with the metabolism of hormonal contraceptives; take antibiotics that can interfere with metabolism of hormonal contraceptives at the time of or planned use within 3 days of dosing of the study drug; or use any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications). 14. Current or recent (within one month) participation in any other trial of an investigational medicine or device or planning to participate in another clinical trial during this study. 15. Have a history of a bariatric surgery procedure associated with malabsorption. 16. Live outside of the catchment area of the study site. 17. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug. 18. Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-85.0, Idiopathic Pulmonary Fibrosis In order to be eligible to participate in this study, the patient must meet all of the following Diagnosis of either definite or possible IPF according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) Signed informed consent DLCO ≥ 30% predicted and FVC ≥ 50% predicted 6 minute walking test ≥ 150 m Adults ≥ 18 years Being clinically stable Absolute decline in DLCO & FVC should be less than 10% in the past 6 months A potential patient who meets any of the following will be excluded from participation in this study if: Participation in an official rehabilitation program < 4 months before start of the study Musculoskeletal disorders Severe cardiac diseases (ejection fraction < 30%, daily angina, or otherwise specified by treating cardiologist) Unable to understand informed consent Other conditions that hamper the use of tele-rehabilitation Non-Danish speaking. Unwillingness to implement the protocol
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Cracked Nipple During Lactation Normal spontaneous delivery Pregnancy weeks between 37-42 Single birth Initiated breastfeeding Presence of crack in the nipple Medication applied to the nipple The maternal health condition that may interfere with breastfeeding The infant with congenital abnormalities that would impair breastfeeding The infant attained low birth weight or other to intensive care unit
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Hyperprolactinemia Subfertility Subclinical hypothyroïdism Undergoing care through subfertility services at UHCW Referred and seen in subfertility services between January 2014 to October 2017 Identified as having had at least one episode of hyperprolactinaemia within the study period (Jan 2014 to January 2017) Referred outside of study period Hyperprolactinaemia reading outside of study period
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Recurrent Ovarian Carcinoma Patients ≥ 18 years old 2. Life expectancy ≥3 months 3. Signed informed consent and ability to comply with treatment and follow-up 4. Histologically confirmed diagnosis (cytology alone excluded) of high grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. 5. Breast Cancer (BRCA) mutational status is known (germline or somatic) 6. Relapsed disease more than 6 months after the last platinum dose 7. No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen 8. At least one measurable lesion to assess response by v1.1 criteria. 9. Mandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. 10. Two additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or "de novo" tissue sample for biomarkers must also be available. 11. Performance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1 12. Normal organ and bone marrow function Haemoglobin ≥10.0 g/dL Absolute neutrophil count (ANC) ≥1.5 x 109/L Lymphocyte count ≥0.5 × 109/L Platelet count ≥100 x 109/L Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) Serum albumin ≥2.5 g/dL Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case they must be ≤5 x ULN Serum creatinine ≤1.5 x institutional ULN or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum. 2. Ovarian tumors of low malignant potential or low grade 3. Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS) 4. Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered (Grade ≥ 2) from the effects of any major surgery at randomization 5. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1 6. Administration of other chemotherapy drugs, anticancer therapy or anti-neoplastic hormonal therapy, or treatment with other investigational agents or devices within 28 days prior to randomization, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, or anticipation to do it during the trial treatment period (non-investigational hormonal replacement therapy is permitted) 7. Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomization or patients who have not completely recovered (Grade ≥ 2) from the effects of previous radiotherapy 8. Current or recent (within 10 days prior to randomization) chronic use of aspirin (>325 mg/day) or clopidogrel (>75 mg/day) 9. Clinically significant (e.g. active) cardiovascular disease 10. Resting ECG with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome 11. Left ventricular ejection fraction defined by multigated acquisition/echocardiogram (MUGA/ECHO) below the institutional lower limit of normal 12. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression 13. History or evidence upon neurological examination of central nervous system (CNS) disorders (e.g. uncontrolled epileptic seizures) unless adequately treated with standard medical therapy 14. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease 15. Uncontrolled tumor-related pain 16. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed 17. Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab 18. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications 19. Pregnant or lactating women 20. Simultaneously receiving therapy in any interventional clinical trial 21. Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies 22. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 23. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial 24. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis 25. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis 26. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) 27. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 28. Active tuberculosis 29. Administration of a live, attenuated vaccine (including against influenza) within 4 weeks prior to Cycle 1, Day 1 or anticipation that it will be administered at any time during the treatment period of the study or within 5 months after the final dose of atezolizumab. 30. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 31. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation or allergy to any of the other drugs included in the protocol or their solvents (including to Cremophor®) 32. Patient has received prior treatment with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor in the recurrent setting or has participated in a study where any treatment arm included administration of a PARP inhibitor in the recurrent setting, unless the patient is unblinded and there is evidence of not having received a PARP inhibitor. Patients that received PARP inhibitor as front line are eligible for the study. The duration of exposure to PARPi following front line therapy needs to be ≥18 months for BRCA mutated patients and ≥ 12 months for BRCA wild type patients. 33. Patient has had any known ≥Grade 3 hematological toxicity anemia, neutropenia or thrombocytopenia due to prior cancer chemotherapy that persisted >4 weeks and was related to the most recent treatment 34. Patient has any known history or current diagnosis of Myelodysplasic syndrome (MDS) or Anaplastic Myeloid Leukemia (AML) 35. Previous allogeneic bone marrow transplant or previous solid organ transplantation 36. Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment 37. Participant has any known hypersensitivity to niraparib components or excipients
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 16.0-45.0, Acne Vulgaris Thyroid Dysfunction Patient with acne vulgaris from females only with different ages (starting from 16 years) , BMI groups Female patients with clinically diagnosed thyroid disease Female patients receiving isotretinoin or minocycline in the last 6 months Female patients who were subject to radiotherapy or surgery in neck region
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Thyroid Cancer Thyroid Cancer, Medullary Differentiated Thyroid Cancer Papillary Thyroid Cancer Follicular Thyroid Cancer Poorly Differentiated Thyroid Gland Carcinoma All histologically or cytologically confirmed diagnosis of thyroid cancer, other than anaplastic or stromal-cell derived cancers Participants with differentiated thyroid cancers (DTC) must have negative thyroglobulin antibodies Measurable disease meeting the following and confirmed by central radiographic review At least 1 lesion of ≥ 1.0 centimeter (cm) in the longest diameter for a non- lymph node or ≥ 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to Response Evaluation in Solid Tumors (RECIST) 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of ≥ 1.5 cm Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease (substantial size increase of ≥ 20%) within 12 months to be deemed a target lesion Participants must show evidence of disease progression comparing (a) scan in screening and (b) historical scan obtained within 12 months prior to signing informed consent, according to 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans Participants with DTC must not be eligible for possible curative surgery and must be radioiodine (RAI)-refractory / resistant as defined by at least one of the following One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan One or more measurable lesions that has progressed by 1.1 within 12 months of RAI therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre or post-treatment scanning Participants who have received any anticancer treatment (including Chinese herbal medicine specified for the treatment of tumor) within 21 days or any investigational agent within 30 days prior to the first dose of study drug. This does not apply to the use of TSH-suppressive thyroid hormone therapy Major surgery within 21 days prior to the first dose of study drug Palliative radiation therapy within 14 days prior to the first dose of study drug Participants having > 30 mg/mL urine protein on urine dipstick testing (Participants with urine protein < 1 g/24 hour (h) will be eligible) Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of Lenvatinib, Sorafenib, Cabozantinib, or Vandetanib Significant cardiovascular impairment: history of (a) congestive heart failure greater than New York Heart association (NYHA) Class II, (b) unstable angina, (c) myocardial infarction, (d) stroke, or (e) cardiac arrhythmia associated with impairment within 6 months of the first dose of study drug Bleeding or thrombotic disorders (Treatment with low molecular weight heparin is allowed) Radiographic evidence of major blood vessel invasion/infiltration Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 21 days prior to the first dose of study drug Active infection (any infection requiring systemic treatment)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Healthy Men and Women from 18 to 50 years old Diagnosed as healthy after a clinical examination BMI from 18 to 30 kg/m2 Not smoking for at least 3 months To sign the informed consent Not having participated in a similar study for at least 4 months Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition Hematologic disorders, specially anemia and polycythemia Permanent or temporal pharmacological therapy, prescribed or not Smoking for the last 3 months Alcohol drinker more than once a week Drug abuse Drug hypersensitivity Angioedema or anaphylaxis history Pregnancy or breast-feeding HIV o Hepatitis B diagnosed
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Weight Gain Very preterm infant ( <32 weeks at birth) On full enteral feeds for more than 2 weeks (full feed is defined at the time of reaching 120 ml/kg/day with no parenteral nutrition used) Poor weight gain (<15 g/kg per day) despite optimization of energy and protein intakes by RDs (calories intake: 125-135 Kcal/kg per day and protein: 4-4.5 g/kg per day) Mothers have enough milk supply (>150% of infant's daily needs) Congenital anomalies Small for gestational age infants (< 10th percentile) at birth
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-100.0, Keratoconus Patients with KC Patients who cannot give an informed consent Patients who cannot provide needed samples for any reason
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-35.0, Postpartum Thyroiditis Observation group Pre-pregnancy tests for normal thyroid function (FT3, FT4, TSH) First pregnancy between the ages of 18 to 35 years old Early screening (1-12 weeks of pregnancy) initial screening TPOAb positive，thyroid function FT3, FT4 normal, TSH<4.78mIU/ L 2. Control group Pre-pregnancy tests for normal thyroid function (FT3, FT4, TSH) and antibodies First pregnancy between the ages of 18 to 35 years old Early pregnancy (1-12 weeks of pregnancy) initial screening negative thyroid-related antibody and thyroid function FT3, FT4 normal, TSH< 4.78 mIU/L Combined with other autoimmune diseases (such as systemic lupus erythematosus, etc.) Type 1 diabetes Gestational diabetes Primary screening TRAb positive Previous patients with Graves, subacute thyroiditis,chronic hepatitis Artificial pregnancy Suffering from liver and kidney dysfunction and other major diseases Have a history of adverse pregnancy Pregnant women with premature birth, miscarriage, intrauterine dysplasia and other unhealthy pregnancies withdrew from observation
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Diabetes Hyperglycemia Steroid-induced Experimental Group 1. Males or non-pregnant females between the ages of 18-50 years being followed in the Diabetes Center. 2. Type 2 Diabetes for ≤ 1 year and only on metformin 3. BMI 24.0-35.0 kg/ m2 4. HBA1c ≤ 9.0% Patients on any other antidiabetes medication. 2. Patients with impaired renal function (estimated Glomerular Filtration Rate (GFR) less than 60 ml/min based on results from Cerner). 3. Patient who have received glucocorticoid therapy within six months of study. 4. Patients who do shift work. 5. Blood glucose level ≥ 250 mg/dl on finger-stick at clinic visit. 6. Signs or symptoms of infection. Control Group 1. Males or non-pregnant females between the ages of 18-50 years in good physical health as determined by medical history, physical examination, and screening blood tests 2. Normoglycemia defined by fasting plasma glucose < 5.6 mmol/L (or 100 mg/dL) and 2h glucose <7.8 mmol/L (or 140 mg/dL) after a 75 g OGTT 3. BMI: 22.0 0 kg/m2 Presence of any disease or use of any medication 2. Patients with a first-degree relative with Type 2 Diabetes 3. Patients who smoke 4. Patients with history of steroid use in previous 6 months. 5. Patients who do shift work 6. Signs or symptoms of infection. 7. Patients with recent changes in weight or physical activity
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Head and Neck Cancer Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-55.0, Behavior and Behavior Mechanisms Information Literacy female at birth and identify as female aged 18-55 report unprotected vaginal or anal sex with a male partner OR any injection drug use in the past 6 months live or have sex in a high risk area or are recruited into the study by someone who lives or has sex in a high risk area understand and read English not known to be HIV-infected are willing to consider a daily pill with low rates of mild side effects to prevent HIV have access to a mobile phone report at least one of the following as 'yes' or 'do not know': current male partner who injects drugs or has sex with men; current male partner who is HIV infected; current male partner who was incarcerated in the last 6 months OR report at least one of the following as 'yes': shared injection equipment in last 6 months; in methadone, buprenorphine or suboxone treatment program in past 6 months; exchange sex for money, drugs, other goods in last 6 months; powder cocaine, crack use, methamphetamines, or ecstasy >1x/week in last 6 months; Chlamydia, syphilis, gonorrhea diagnosed or newly diagnosed genital herpes in last 6 months; alcohol abuse in last 6 months (defined as a score of 2 or higher on the CAGE36); has 3 or more male partners currently using PrEP
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Overweight Obesity Have at least one child up to 18 years of age residing in the household Primary grocery shopper for the household No health conditions or food practices that substantially limit choice Not currently pregnant Consent to study design Male < 18 years of age Not a mother, or children not living with subject in their household No children below the age of 18 years of age Not the primary grocery shopper for their household Health conditions or food practices that substantially limit food choice Currently pregnant
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-65.0, Primary Hyperparathyroidism Study group, cases with a Primary Hyperparathyroidism Control group consists of healthy adults with the similar demographic characteristics as study group The presence of osteoarticular deformities Walking with assist device Having a neurological disease that may affect the performance To have significant and irreversible visual deficits The body mass index (BMI) is greater than> 40 kg / m² There is an inability to prevent any of the tests Individuals with cancer history and chemotherapy (over the last 5 years) Plasma creatinine level> 150 µmol / L Use of Cinacalcet or Etalpha Having a history of diabetes mellitus
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Metastatic Urothelial Carcinoma MTAP Negative Patients must have histologic confirmation of MTAP-deficient metastatic urothelial carcinoma. MTAP-deficiency must be verified by institutional Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemistry (IHC). Histological variants such as glandular, squamous, sarcomatoid, micropapillary, plasmacytoid, and small cell changes will be allowed for this trial if these tumors are MTAP-deficient Patients can be considered for second line of therapy (after chemotherapy or immune checkpoint inhibitor with PD-[L]1 agent) or for third line of therapy (can have previously received chemotherapy and immune checkpoint inhibitor with PD-[L]1 blockade). Any prior intravesical therapy is allowed and does not count as a prior line of therapy Patients who received methotrexate-containing chemotherapy (e.g. methotrexate/vinblastine/adriamycin/cisplatin [MVAC]) as neoadjuvant therapy or first-line systemic therapy at least 12 months prior will be allowed for this trial All patients must have measurable disease by Response Evaluation in Solid Tumors (RECIST) version (v)1.1 and tumors of sufficient sizes for biopsy. In general, liver and lung lesions should be at least 1.0 cm, and patients with lymph node-only disease should have lesions of >= 1.5 cm in shortest dimension. Patients with disease confined to bone may be eligible if a measurable lytic defect is present. The study principal investigator (PI) is the final arbiter in questions related to measurability. Patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN), or =< 5 ULN if documented liver metastases are present Total bilirubin =< 1.5 x ULN, except subjects with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin =< 3.0 mg/dL Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Hemoglobin >= 9 g/dL (may have been transfused) Platelets >= 100 x 10^9/L Primary central nervous system (CNS) malignancies or CNS metastases, including leptomeningeal metastases, are not allowed. Subjects with previously treated brain metastases will be allowed if the brain metastases have been stable for at least 4 weeks following prior treatment and no ongoing steroid requirement Any other malignancy from which the patient has been disease-free for less than 2 years, except for non-melanomatous skin cancer, controlled localized prostate cancer, in situ carcinoma of any site Women who are pregnant or breastfeeding or intend to become pregnant during their participation in the study Presence of third space fluid which cannot be controlled by drainage. For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing. However, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy Known or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's granulomatosis) are excluded from this study Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroids doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease History of primary immunodeficiency Patients who have prior organ transplantation, including allogeneic stem-cell transplant Vaccinations within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines True positive test results for hepatitis A, B, or C during screening
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, in Vitro Fertilization under 40 years of age normal thyroid and prolactin hormone levels a basal follicle stimulating hormone (FSH) level <10 mIU/mL body mass index (BMI) of 19-30 kg/m2 a history of ovarian surgery, endometriosis, uterine anomaly any endocrine disease including congenital adrenal hyperplasia smokers use of any medications and hormones in the last 3 months
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0
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