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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal 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 Thyroid Dysfunction Hypothyroidism Pregnancy Early Singleton pregnancy Free of pre-existing thyroid disease That do not use thyroid interfering medication That did not undergo IVF treatment TPOAb negative Adolescent 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): 0.0-999.0, Offspring, Adult Lifestyle Obesity, Childhood Pregnancy Related Child Development Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District Inability to communicate in Finnish 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): 21.0-99.0, Solid Tumor, Adult All patients must sign an informed consent in accordance with local institutional guidelines. 2. Age >= 21 3. Histologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry and at least 2 measurable lesions, that is deemed unlikely to benefit from further conventional therapy, or for which no standard therapy is available. Although optional, where practicable and safe, all effort should be made by the investigator to obtain serial tumour biopsies from patients enrolled. 4. Provision of an archived tumour tissue block (or at least 10 newly cut unstained slides) where such samples exist in a quantity sufficient to allow for analysis 5. Any number of prior chemotherapy regimens will be allowed and may biologics 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1; 7. Patients must have adequate bone marrow function and organ function within 2 weeks of study treatment Adequate hematologic function defined as: (i) platelets >= 100 x 109/L in dose escalation phase, (ii) hemoglobin >= 6.21 mmol/L or 10 g/dL, (iii) ANC >= 1.5 x 109/L, (iv) WBC >= 3.0 x 109/L. Up to 5% deviation is tolerated. Transfusions and growth factors are allowed prior to and throughout the study Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN), ALT and AST < 2.5 times ULN. For patients with hepatic metastasis ALT and AST < 5 times ULN is permitted. Up to 10% deviation is acceptable Adequate renal function: estimated creatinine clearance of >= 60 mL/min, calculated using the formula of Cockcroft and Gault: (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female Amylase and lipase <= 1.5 x ULN Alkaline phosphatase limit <= 2.5 x ULN (<= 5 x ULN for patients with liver involvement of their cancer) International normalization ratio (INR) (if not on anticoagulation therapy) and partial thromboplastin time (PTT) <= 1.5 x ULN Normal TSH and ACTH 8. Females of childbearing potential who are sexually active with a non sterilized male partner must use at least 2 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + any drug combination therapy or 90 days after the last dose of durvalumab monotherapy. Non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female subjects should also refrain from breastfeeding throughout this period. Acceptable methods of contraception are as below Established use of oral, injected or implanted hormonal methods of contraception Placement of an intrauterine device or intrauterine system Patients with significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; 2. Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) <= 3 weeks prior to starting first dose of study medication 3. Participation in another clinical study with an investigational product (IP) within 30 days of the first dose of AZD5363 or matching placebo.Treatment with any of the following Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment (<= 4 weeks for previous PD-1/PD-L1) Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment, except hormonal therapy with LHRH analogues for medical castration in patients with prostate cancer, which are permitted Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort ) 4. Uncontrolled hypertension or controlled hypertension (<140/90) on more than 3 antihypertensive agents 5. Clinically significant abnormalities of glucose metabolism as defined by any of the following: o Diabetes mellitus type I o Fasting plasma glucose [fasting is defined as no calorific intake for at least 8 hours]: (i) >= 7.0mmol/L (126 mg/dL) for those patients without a pre-existing diagnosis of Type 2 diabetes mellitus (ii) >= 9.3 mmol/L (167mg/dL) for those patients with a pre-existing diagnosis of Type 2 diabetes mellitus (iii) Glycosylated haemoglobin (HbA1C) >=8.0% (63.9 mmol/mol). (iv) Requirement for insulin or more than two oral hypoglycaemic medications for routine diabetic management and control 6. Major surgical procedure within the last 28 days 7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion Subjects with vitiligo or alopecia Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Subjects without active disease in the last 5 years may be included but only after consultation with the study physician Subjects with celiac disease controlled by diet alone 8. Any of the following cardiac
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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): 18.0-105.0, Metastatic Breast Cancer Thyroid Dysfunction Age greater than or equal to 18 Male or female with diagnosis of metastatic breast carcinoma and documented history of hypothyroidism TSH level within normal range at baseline Life expectancy estimated > 3 months Ability and willingness to provide informed consent Life expectancy estimated to be less than 3 months Is currently pregnant or intends to become pregnant during the duration of the study Active angina, NYHA advanced [Class III/IV] CHF, or uncontrolled cardiac arrhythmia within 6 months of enrollment History of thyrotoxicosis History of adrenal insufficiency Hypersensitivity to any active or extraneous constituents in Triiodothyronine (T3)/liothyronine sodium
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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): 20.0-999.0, Urinary Bladder, Overactive More than 20-year-old 2. Female 3. Diagnosed with overactive bladder by bladder diary Younger than 20-year-old 2. Pregnant or planned to be 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): 18.0-80.0, Central Hypothyroidism Hypothyroidism Hyperthyroidism All participants Age 18 to 80 years BMI 19 to 35 kg/m2 Informed consent as documented by signature A) Patients with primary hyperthyroidism TSH < 0.2 mIU/l and free thyroxine (fT4) > 25 pM or fT3 > 8 pM B) Patients with primary hypothyroidism, currently not sufficiently substituted TSH > 8 milli-International unit (mIU)/l or fT4 < 10 pM C) Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range between 0.5 and 2.5 mIU/l D) Patients with secondary hypothyroidism Pituitary disease with documented secondary hypothyroidism Diabetes mellitus (HbA1c >6.5%) Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer Abuse of alcohol or illicit drugs Women who are pregnant or breast feeding Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Previous enrolment into the current study
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.442-0.635, Premature Infant Breast Milk Expression Birth weight 750-1800 grams 2. Admitted to AU NICU within 24 hours of life 3. Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score 4. Birth weight appropriate for gestational age (AGA) defined as >3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada) 5. Enteral feedings initiated within 7 days of life 6. Breastmilk diet, maternal or donor milk Renal conditions affecting electrolyte metabolism and/or excretion 2. Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele) 3. EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams 4. Apgar <3 at 5 minutes 5. Grade 3 or higher intraventricular hemorrhage (IVH) 6. Intrauterine growth restriction (IUGR), as defined as <3rd% on a gender-specific Fenton growth curve 7. Congenital anomalies including congenital heart disease or other major defect requiring surgical intervention 8. Intake of cow's milk formula or fortifier before or after the initiation of the study 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, Thyroid Cancer Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who underwent total thyroidectomy +/ neck lymph node dissection as clinically indicated are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced or presenting with distant metastases; or are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size >4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and/or lateral neck), detectable/increasing baseline/suppressed thyroglobulin (Tg) level or detectable/increasing anti-Tg antibody titers if anti-Tg antibodies are present are either RAI-naive or requiring repeated RAI therapy for locally advanced disease or distant metastases Underwent imaging with MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases Age greater than or equal to 18 years of age hour urine iodine excretion of less than or equal to 150 micro grams/24 hour -Patients with non-RAI avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096 Pregnant or lactating women Adults who are incapable of providing informed 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, PTSD in Family Members of ICU Patients Patient and family member > 18 years or older mechanical ventilation expected for more than 48 h and between day 3 and 5 from the beginning of mechanical ventilation patient having a family member speaking and understanding French, and with the ability to visit his/her relative during the ICU stay patient and his/her relative consenting to participate in the study, or obtention of family consent in case of patient incompetency Patient without family available or family not speaking or understanding French"
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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, Hypertriglyceridemia hypertriglyceridemia (150 mg/dl-900 mg/dl) Lipid lowering drugs or indication for Lipid lowering drugs LDL-cholesterol > 190 mg/dl 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, Breast Cancer Female over 18 years of age Had breast lesions detected by ultrasound No clinical symptoms such as nipple discharge, while breast lesions were not palpable Received breast surgery within one week of ultrasound examination Agreed to participant in this study and signed informed consent Patients who had received a biopsy of breast lesion before the ultrasound examination Patients who were pregnant or lactating Patients who were undergoing neoadjuvant 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): 18.0-999.0, Mismatch Repair Proficient Colorectal Cancer Pancreatic Adenocarcinoma Leiomyosarcoma Signed informed consent Age ≥18 ECOG 0-1 Have histologically/cytologically-documented, locally-advanced, or metastatic mismatch repair proficient colorectal cancer (MMRp-CRC), pancreatic adenocarcinoma (PA), or leiomyosarcoma (LMS) that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the subject and treating physician Allowable: prior immune-oncology therapy, no maximal limit to the number of prior lines of systemic therapy for advanced or metastatic disease. All prior anti-neoplastic systemic therapy, including immune-oncology, must have a 4 week wash out period. There is no limit to the number of prior anti-neoplastic systemic treatments used before trial enrolment Must have at least 1 tumor site that is amendable to tumor biopsy Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided will not be eligible for this study. Subjects who have archival tissue available, not older than 6 months and with no intervening therapies from the day of the biopsy and the initiation of the study, will also be requested to also submit this sample, but are still required to undergo a pre-treatment biopsy Consent to provide archival tumor tissue for correlative biomarker studies Must have at least 1 tumor site that is measurable by CT or MRI scan. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable and there is objective evidence of progression following radiotherapy. The biopsy lesion cannot be the same as the target lesion Life expectancy ≥ 16 weeks from proposed first dose date All cohorts Involvement in the planning and/or conduct of the study or previous enrolment in the present study Subjects with another malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ, Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Subjects with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not carcinomatous meningitis which is excluded regardless of clinical stability. Subjects with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following Measurable disease outside the CNS Only supratentorial metastases allowed No history of intracranial hemorrhage No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to Day 1 of the study No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic 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): 14.0-80.0, Pulmonary Embolism Thoracic Surgery Lung surgical patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery and stayed in ICU for at least 24 hours Cases received inferior vena filter and anti-coagulation treatment history
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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, Pregnancy Related Pregnancy Anemia Iron Deficiency Anemia Pregnancy Anaemia Iron treatment before 3 months of pregnancy Informed Consent Compliant with study procedures Iron treatment after 3 months of 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): 18.0-80.0, Nipple Sparing Mastectomy Female between ages 18-80 BMI ≤ 29 Candidate for an NSM procedure At increased risk for breast cancer and is seeking prophylactic NSM surgery Breast ptosis ≤ Grade 2 Cup size ≤ C No presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution's guidelines Current or prior history of ipsilateral in-situ or invasive breast carcinoma Previous breast surgery of the ipsilateral breast Current history of smoking or has smoked within 1 year of screening Skin conditions Uncontrolled diabetes mellitus Previous chemotherapy or radiation High risk for anesthesia or significant medical comorbidities Contraindicated for general anesthesia or surgery Known bleeding or clotting disorder Pregnant or suspected to be pregnant or is lactating
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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, Chronic Kidney Diseases Subclinical Hypothyroidism • Patients older than 18 years Patients with chronic kidney disease G2-G5 without renal replacement therapy) who attend a renal health clinic Presence of proteinuria in a test strip, 24 hours urine collection (greater than 150mg / dl in 24hrs urine) TSH <9.9uiml / L and TSH> 2.4 0uiml / L Take an IECA or ARA-2 Patients with weight> 50 kg and <80kg Accept informed consent Chronic dialysis (peritoneal dialysis or hemodialysis) Primary hypothyroidism or preexisting thyroid disease Use of levothyroxine TSH> 10uiml / L and TSH <2.5 0uiml / L Positive thyroid antibodies Ischemic heart disease in less than 6 months Cardiac arrhythmia Use Medications (Levothyroxine synthesis, see Table 2) Anxiety disorder Pregnancy
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 40.0-49.0, Polycystic Ovary Syndrome Women with PCOS aged 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea or irregular menstruation (substantially inconsistent menstrual cycle length). Subjects with fewer than 10 menses/year or average menstrual cycle length >35 days are allowed to participate if they have a compelling past history of oligomenorrhea (average menstrual cycle length >45 days or fewer than 9 menses/year) or irregular menstruation Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for (see Subjects must be willing and able to provide written informed consent Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study Willingness and ability to comply with scheduled visits and study procedures Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone [FSH] level) Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL. As an alternative, cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH >9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3 History of hysterectomy and/or bilateral oophorectomy BMI ≥ 40 kg/m2 Inability to comprehend what will be done during the study or why it will be done Being a study of older women with PCOS, children and men will be excluded Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine 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 B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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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): 21.0-45.0, Gestational Weight Gain Pregnant Women aged 21 years or older receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians approved their participation in the study Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record) Has access to a smartphone and Wi-Fi Provides informed consent to participate Multiple births Planning to move out of the area during the study period Diagnosis of any of the following conditions: diabetes outside of pregnancy, severe disease of the cardio-pulmonary system, serious gastrointestinal disease (e.g., Crohn's disease, IBD), kidney disease, lung disease (e.g., emphysema, COPD), major psychiatric disorder, thyroid disease (diagnosed in the last month), cancer (not including non-malignant skin cancer), drug and alcohol abuse, or history of an eating disorder History of bariatric surgery Use of metformin or corticosteroids Inability to speak, read, or understand English Placed on bed rest at time of enrollment >15 weeks' gestation at enrollment
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-55.0, Healthy Participants who have provided their written consent prior to any study-related activity Ethnic origin: Mexicans Body mass index from 18 to 27 kilogram per meter square (kg/m^2) Normal vital signs (includes heart rate between 50 and 100 beats per minute, respiratory rate between 12 and 20 per minute, systolic blood pressure between 80 and 129 milimeter of mercury (mmHg) , diastolic blood pressure between 50 and 80 mmHg and temperature between 36.0 degree celsius and 37.0 degree celsius. The measurement will be made according to the instructive BE-IT-005 Medición de signos vitales) Normal electrocardiogram [ECG]. No abnormalities are allowed, even though they are not relevant (PR, QRS, QT, QTcF should be within normal range; no conduction abnormalities are allowed, etcetera (etc) All values in blood and urine tests should be within the normal range or showing no clinically relevant deviation as judged by the Investigator Participants with thyroid panel results within normal range (T3 and T4 total and free, as well as thyroid-stimulating hormone (TSH) should be within the normal range) Non-smoker at least in the last 3 months Other protocol defined could apply Participation in the clinical study within 90 days prior to the first dose of the study drug History of hypersensitivity to the study drug or its excipients History or current asthma or any severe allergy (which requires hospitalization or prolonged therapy), allergy or intolerance to any food that, in the opinion of the investigator, poses a safety risk (allergy to iodine) History of cardiovascular, renal, liver, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia) conditions, mental disorder or organic abnormalities that may affect the pharmacokinetic study of the study drug Any medical or surgical condition, including findings in the medical history or clinical assessment prior to the study, that in the opinion of the investigator poses a risk or contraindication for the participants participation in the study and may affect the study objectives, conduct or analysis History or presence of alcohol abuse (average daily intake not higher than 3 units or weekly intake not higher than 21 units; 1 unit is equivalent to 340 mililiter (mL) of beer, 115 mL of wine or 43 mL of prepared drinks), psychoactive substances or chronic use of drugs Participants who have been exposed to agents knows by inducing or inhibiting the liver enzymatic systems or who have taken potentially toxic drugs within the last 30 days to the study start-up Participants who take drugs affecting the metabolism of the thyroid hormone, such as: oral contraceptives, hormonal implants, parenteral hormones, steroids, anabolic drugs, androgens, etc., or any drug affecting the levothyroxine's bioavailability such as the proton pump inhibitors or multivitamins, nutritional supplements or herbal products that may affect the study, except for the occasional use of paracetamol Participants who have been hospitalized for any reason within the 60 days prior to the study start-up or who have been severely ill within the last 30 days prior to the study start-up Participants who have donated or lost 450 mL of blood within the last 60 days prior to the study start-up
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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): 20.0-80.0, Thyroid Diseases Heart Failure diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical hypothyroidism) Unclearly diagnosed patients with autoimmune thyroid disease (subclinical hyperthyroidism, subclinical 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): 21.0-40.0, Polycystic Ovary Syndrome We will women in one PCOS subtype, those having these two symptoms Hyperandrogenism (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year. Participants must also be overweight or obese (BMI 25-50) be 21-40 years old have regular access to the internet be able to engage in light physical activity willing and able to follow the assigned intervention a non-English speaker inability to complete baseline measurements a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy) pregnant or planning to get pregnant in the next 6 months type 1 or type 2 diabetes baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal baseline renal disease defined as BUN > 30 mg/dL or serum creatinine >1.4 mg/dL baseline uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML) breastfeeding or less than 6 months post-partum planned or history of weight loss surgery
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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, Hypothyroidism Patients with Primary hypothyroidism who had stable TSH over the last 6 months prior to the study period Age between 18-70 years old Patients who planned to fast during Ramadan Patients with any end organ damage Pregnant ladies Patients with thyroid cancer Patients not adhering to medications Patients who had a clinical contraindication to observe fasting
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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 Antipsychotic Agents Pharmacogenetics Age 18 years or over Taking/compliant with clozapine antipsychotic medications Patients meeting the ICD-10 for a diagnosis of schizophrenia, schizoaffective or borderline personality disorders History of current alcohol/illicit substance dependency Unable/ unsuitable to complete the study protocol e.g. acutely ill, suicidal or aggressive patients Unable to consent to 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): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 50.0-80.0, Overweight or Obesity male and female subjects age: 50 years post or peri-menopausal Smokers and non-smokers BMI 25 to 40 kg/m2 Dietary Inflammatory Index, DII: 0 to +10 Fruit and vegetable intake <4 servings/d Adherence to a 6-week "wash-out" period Age <50 and >79.9 years Dietary Inflammatory Index, DII 1 to -10 Subjects with any kind of food allergy or histamine intolerance Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin and mineral supplements Fruit and vegetable intake >3 servings per day Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure >100 mmHg Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication
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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, Hypertension Mineralocorticoid Receptor Antagonist Healthy males and/or females 18 years to 45 years of age with a body mass index of 19 kg/m2 to 32 kg/m2 (inclusive) Laboratory results (serum chemistry, hematology, and urinalysis [UA]), liver function, and serum K+ levels within normal range Written informed consent Female participants: Negative pregnancy test and must either be surgically sterile, postmenopausal, or agree to use acceptable nonhormonal contraception All prescription or over-the-counter (OTC) medication (systemic and topical) and herbal supplements will not be permitted for 14 days before the first dose and for the duration of the study Oral, injected, or implanted hormonal contraception methods, or hormonal replacement therapy, should not have been received in the 3 months prior to the first dose, and for the duration of the study Female participants: positive pregnancy test or are breast feeding Supine systolic/diastolic blood pressure at screening, after resting for 10 min, higher than 140/90 mmHg or lower than 90/50 mmHg, confirmed after repeated testing at least approximately 1 h apart Supine pulse at screening, after resting for 10 min, outside the range of 40 to 100 beats per minute (bpm) QTcF interval duration > 450 ms for male and female obtained as an average from the triplicate screening ECGs after at least 10 min in a fully supine quiet rest Abnormal waveform morphology on any of the screening ECGs that would preclude accurate measurement of the QT interval duration Family history of congenital Long QT syndrome (LQTS), a history of surviving an unexplained drowning episode, a history of any form of syncope or loss of consciousness, or known symptomatic cardiac arrhythmias Known allergy to moxifloxacin An estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) equation lower than 90 mL/min
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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 To have freely agreed and signed the consent form, after all essential elements of the protocol have been clarified, before any procedure Body Mass Index (BMI) of the research participants must be comprised within the range of 18.50 to 27.00 No abnormal findings on medical history that, in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation Normal vital signs: heart rate between 50 and 100 beats per minute; Systolic pressure between 80 and 129 millimeters of mercury (mmHg); diastolic pressure between 50 and 89 mmHg; temperature between 36.0 and 37.0 degrees Celsius Electrocardiogram (ECG) normal (abnormalities, even if clinically not relevant, are not permitted [example {e.g.}: PR, QRS, QT, QTcF] should be within normal range, no conduction abnormalities etcetera [etc.]) All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator Other protocol defined could apply Supplementary tests results out of the values considered as normal, unless considered clinically irrelevant Research participants who are submitted to surgery before the beginning of the study will be carefully evaluated by the doctor regarding the enrollment in the study complying to an period ranging from 4 to 8 weeks Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) in pre-study tests Participants with a history of hypersensitivity/allergy to study drug or excipients, history or presence of asthma or any serious allergy (requiring hospitalization or prolonged systemic treatment), any food allergy or intolerance which in the opinion of the Investigator represents a safety risk (e.g., iodine allergy, etc.) Has participated in any experimental trial or has taken any experimental drug within 6 months previous to this study (RDC [resolution of the collegiate board] Resolution 34, dated June 3, 2008) Participants that prior to the dosing takes any other medication and had not passed at least seven half-lives of elimination of the drug, in this case, be considered by the Principal Investigator the non-inclusion of the participant in the study. Participants taking medications known to affect thyroid hormone metabolism, e.g., oral contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens, etc., or the bioavailability of levothyroxine like proton pump Inhibitors Has a history of alcohol abuse or has ingested alcohol 24 hours previous to the hospitalization period Other protocol defined could apply
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Thyroid Diseases Thyroid Cancer Patients undergoing routine diagnostic thyroid biopsy at surgery Patients are unable to provide informed consent Patients not attending for standard diagnostic biopsy for thyroid 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): 18.0-45.0, Healthy Volunteers Able to provide written informed consent. 2. Healthy non-smoking male and female subjects aged 18 to 45 years, inclusive. Health status is determined by physical examination, medical history, no clinical abnormalities in laboratory and urine analyses, normal renal function, liver enzymes less than twice the upper limit of normal (ULN), and electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits at the screening visit. 3. A body mass index (BMI) of 18 kg/m2 or greater, but less than 36 kg/m2. 4. Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable). 5. Females of child-bearing potential must have a negative urine pregnancy test on Day 1. If post-menopausal female, follicle stimulating hormone (FSH) level > 40 IU/L History of clinically significant drug allergy or anaphylaxis, including known hypersensitivity to Pinatos® or its components. 2. History of any condition(s) which might affect drug absorption, metabolism or excretion. 3. Clinical evidence or a history of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic, or other chronic disease as judged by the Investigator. 4. History of severe psychiatric disease, especially major depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease. 5. History of severe cardiac disease [e.g., New York Heart Association (NYHA) Functional Class III or IV], myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases. 6. Estimated creatinine clearance outside the normal range (</= 80 mL/min) at screening. 7. History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. 8. Evidence of alcohol and/or drug abuse within one year of screening. 9. Positive results on screen for drugs of abuse or alcohol at screening visit or Day 0. 10. History within 1 year of screening visit, or current habit, of smoking more than 10 cigarettes per day or equivalent (>3 cigars or >3 pipes-full). 11. Donated blood in the past 90 days or have poor peripheral venous access. 12. Platelets < 100,000/mm3, history of thrombocytopenia. 13. Confirmed diagnosis of chronic liver disease, for example, chronic Hepatitis B, Hepatitis C infection, auto-immune, alcoholic or neoplastic liver disease. 14. Positive serostatus for HIV, HCV, or HBV. 15. Currently pregnant or nursing. 16. Male partners of females who are pregnant. 17. History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease. 18. Participation in a clinical study with an investigational drug, biologic, or device within 3 months before receiving study drug. 19. Used any systemic medications, including vitamins and over-the-counter items, during the 14 days (or five times the elimination half-life of the medication, whichever is longer) before receiving study drug or will require their use during the study. Metabolic inducers and herbal preparations, which have been shown to produce metabolic enzyme induction or inhibition, whether as teas or formulations, are prohibited 28 days before dosing. Paracetamol 3000 mg/day will be allowed up to 2 consecutive days before dosing and during the outpatient phase of the study, as needed. 20. Unable to swallow large tablets
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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, BRAF NP_004324.2:p.V600M BRAF V600E Mutation Present Metastatic Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8 Ability to understand and the willingness to sign a written informed consent document Histologically (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC) Note: RAI refractoriness is defined as The absence of uptake of RAI on either a low-dose diagnostic whole body scan, or a post-treatment RAI scan in measurable lesions Radiographic progression of disease within 12 months of the last course of RAI treatment, or Having a cumulative lifetime administered dose of > 600 mCi of RAI Measurable disease meeting the following and confirmed by radiography review At least 1 lesion of >= 1.0 cm in the longest diameter for a non-lymph node or > 1.5 cm in the short-axis diameter for a lymph node metastasis that is serially measurable according to Response Evaluation in Solid Tumors (RECIST) 1.1 using computed tomography/magnetic resonance imaging (CT/MRI). If there is only 1 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 or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on 1.1 to be deemed a target lesion Eastern Cooperative Oncology Group (ECOG) performance status =< 1 Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational agent/device within 4 weeks of first dose of study intervention Note: Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent of device Participants with active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll Prior treatment with selective/potent BRAF/MEK inhibitors including vemurafenib, dabrafenib, encorafenib, selumetinib, trametinib, cobimetinib, binimetinib Note: Prior therapy with oral multikinase inhibitors (e.g., lenvatinib, sorafenib, cabozantinib, pazopanib, sunitinib, etc.) remain eligible for study participation Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) Participants with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease History of allergy or hypersensitivity to any monoclonal antibody History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease Previous or concurrent malignancy within 3 years of study entry, with the following exceptions
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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): 13.0-19.0, Polycystic Ovary Syndrome Puberty Disorders Ovulation Disorder Girls age 13 years, with clinical or biochemical HA (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) that are 4-6 years post-menarche Screening labs within age-appropriate normal range Volunteers who are 18-19 y old must be willing and able to provide written informed consent When the subject is a minor (i.e., age < 18 y), the subject and custodial parents must be willing and able to provide written informed assent and consent, respectively Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of study Age < 13 or > 19 y Girls ≤ 3 years and ≥ 7 years post-menarche will be excluded Being a study of androgen excess in adolescent girls with HA, men and boys are excluded Inability to comprehend what will be done during the study or why it will be done Precocious puberty (breast development before age 7) Primary amenorrhea (no menses by age 16) BMI-for-age < 5th percentile Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR 17633 DENND1A Obesity due to genetic syndrome (e.g. Prader-Willi syndrome) Cushing syndrome
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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, Autoimmune Thyroid Disease male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system
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2
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-50.0, Medial Plica Syndrome Patients between the ages of 20 and 55 Diagnosed as medial plica syndrome by MPP test and MRI imaging Did not develop cartilage damage Patients with meniscal tear, chondral injury or instability of the knee
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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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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): 30.0-70.0, Copd Obese Obesity, Abdominal COPD diagnosis, informed consent for voluntary participation in the study patient participation in any interventional study COPD exacerbation concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Postoperative Complications Recurrence Breast Neoplasms Breast Cancer BRCA1 Mutation BRCA2 Mutation Surgery Surgery--Complications Women who underwent nipple sparing mastectomy and immediate reconstruction Women with early breast cancer Women with germline BRCA 1/2 mutation or germline mutations in genetic susceptibility genes Women with interstitial mastopathy Women with risk-reducing mastectomy or contralateral mastectomy Male patients Women with stage IV disease at diagnosis Women who underwent previous breast cancer surgery Women who received prior radiotherapy for the ipsilateral breast
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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, Sleep Disorder Breast Cancer diagnosed of unilateral breast cancer (stage 0 ~III) underwent proper cancer treatment including surgery, chemotherapy, radiation therapy age : 18 ~ 45 scheduled for applying tamoxifen and goserelin need CPAP device during sleep due to sleep apnea under medication for restless leg syndrome previous history of tamoxifen irregular bedtime due to shift work diagnosed of recurrent or metastatic cancer have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems refuse to participate has musculoskeletal system and neurological damage and lesions
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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, Osteoarthritis, Hip Arthroplasty Complications Complication of Surgical Procedure Perioperative Complication Surgical Team submits patient as potentially eligible for Same Day Discharge at the time of surgical booking Excluded if the patient never has a surgical procedure despite surgical booking and preoperative assessment. All patients must undergo surgery to be included
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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, Graves Disease New GD patients without any treatment Aged of 18 to 75 years old Pregnant or lactating woman Known autoimmune disease Receiving psychotropic or hormonal drugs Taking drugs that affect the body's immune function Obviously poor compliance
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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 Age > 18 years At least 12 months after LT Obese (BMI > 30kg/m2) Acute cellular or chronic rejection within 3 months Post-LT liver or non-liver related malignancy Active viral hepatitis (B or C), autoimmune hepatitis Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis) Poorly controlled Diabetes mellitus Relapse of alcohol abuse after LT Stage 5 Chronic Kidney Disease Current 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, Advanced Solid Tumors Adequately understand the study and voluntarily sign the Informed Consent Form 75 years old Histologically or cytologically confirmed advanced solid tumors (focusing on neuroendocrine neoplasmas (NENs), biliary tract cancer, gastric cancer, thyroid cancer, small cell lung cancer, soft tissue sarcoma, endometrial cancer and esophageal squamous cell carcinoma, etc) Fail or cannot tolerate the standard therapies, or for whom no effective standard therapy is available, or refuse standard therapy Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale Have measurable lesions (according to 1.1) Agree to provide histology samples Lab tests within 7 days before first dose: 1. Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, and hemoglobin ≥9 g/dL; 2. Serum total bilirubin <1.5 times the upper limit of normal (ULN); 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 1.5 times the ULN without liver metastases; and ALT and AST ≤ 3 times ULN with liver metastases; 4. Serum creatinine <1.5 times ULN and creatinine clearance ≥50 mL/min; 5. Urine protein < 2+; if ≥2+, 24-hour urine protein <1 g; 6. International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN Have expected survival of more than 12 weeks Male or females patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injected birth control medication or intrauterine device, during the study and within 90 days after study treatment discontinuation. All female patients are considered to be fertile, unless the patient had natural menopause or artificial menopause or sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation) Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss or Grade ≤ 2 peripheral neurotoxicity caused by oxaliplatin) Other malignancies diagnosed within the previous 5 years, except skin basal cell carcinoma or skin squamous cell carcinoma or cervical carcinoma in situ Central nervous system metastases Systematic anti-tumor therapy received within 4 weeks prior to first dose, including chemotherapy, biotherapy, targeted therapy, hormonotherapy, and anti-tumor Chinese medicine treatment Radical radiotherapy within 4 weeks prior to first dose, radioactive seed implantation within 60 days prior to first dose, or Palliative radiotherapy for a bone metastasis lesion within 1 week prior to first dose Functional NENs which need to be treated with long acting Somatostatin analogues (SSAs) to control disease related syndromes, such as insulinoma, gastrinoma, glucagonoma, somatostatinoma, ACTHoma, VIPoma, accompanied by carcinoid syndrome, Zollinger-Ellison syndrome or other active symptoms Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, any other antibody acting on the T cell stimulation or checkpoint pathway or Surufatinib Previously received anti-VEGF/VEGFR targeted drugs and progressed during the treatment or within 4 months after these drugs Thyroid dysfunction with symptoms or clinical significance when screening except hypothyroidism controlled only by thyroid hormone replacement therapy, the level of TSH in patients with iodine refractory differentiated thyroid cancer is more than 0.1 mU/L (or other corresponding unit level) before the beginning of the study treatment Previously received immunosuppressive drugs except locally or temporarily used glucocorticoids
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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, Vitamin D Deficiency Women British African-Caribbean Self-reported Having African ancestral origin and migrated via the Caribbean islands, or having at least one parent with African ancestral origin that migrated via the Caribbean Living in England for >2 months Aged 18-35 or >55 years No significant health issues Pre-menopausal (regular menstrual periods) or Post-menopausal (menstrual periods stopped for longer than 12 consecutive months) BMI 18-30kg/m2 Women in perimenopause or menopause Pregnant or planning pregnancy during study period Hypercalcaemia (>2.5mmol/L) assessed and excluded at baseline Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism (osteoporosis, hormone replacement therapy, anti-estrogens treatment, antiepileptic drugs and breast cancer treatment) Regular use of sun beds Having a sun holiday one month prior to commencing study or plans for a sun holiday for more than 4 weeks within the study period Women who take vitamin D or calcium supplements (or multivitamin supplements that contain these vitamins) If potential participant agrees to stop supplement use to join the study, a wash-out period of 8 weeks prior to commencing the study is acceptable Living in England for less than 2 months
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Weight Gain Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study Adult chronic hemodialysis patient who is at least 18 years of age Average interdialytic fluid gains of 3.5% or greater of body weight for both weekdays and weekends for a 30 day period Availability of interdialytic weight gains for the 2 month period prior to enrollment into the study Access to a smartphone for use of the app and comfort with using apps on a regular basis Access to a smartphone running under either iOS or Android operating systems Sufficient knowledge and understanding of the English language to use the application available only in English (US) language Mental capacity to use and understand the fluid management app Willingness to share intake data collected with the research team Scheduled for a living related renal transplant in the next seven months Hospitalization within 30 days of entry into the study Current participation in a randomized clinical trial or in the period of another clinical trial Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate
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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): 0.5-59.0, Malaria Falciparum Malaria Vivax Malaria Above 6 months old to 59 years old Mono-infection with P. falciparum or P. vivax, with parasitemia of: P. falciparum: 1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C Ability to swallow medication Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old Informed assent from any minor participant aged 12 years; and Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years old Severe malnutrition Mixed Plasmodium species detected by microscopy Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] <110 mm) Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS) Regular medication, which may interfere with antimalarial pharmacokinetics History of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment Positive pregnancy test or breastfeeding; and Unable to or unwilling to take pregnancy test or to use contraception for women or child-bearing age and who are sexually active
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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, Hypothyroidism All healthy adult who will be diagnosed as SCH along with age ≥18 & gender-matched healthy relatives with normal thyroid function will be screened for evidence of high cardiovascular risk Hypo or hyper-thyroidism, Diabetes, Hypertension, cardiovascular disease, smokers, pregnant and lactating women. Patients who had been treated with anti-thyroid drugs, radio iodine therapy or thyroxin hormone supplement or who had under gone thyroid surgery, those with a history of thyroid cancer or head and neck malignancies. Those with history of drug use such as Contraceptive pill, Anti-depressant drugs, Corticosteroids, Anti arrhythmic drugs
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-40.0, Thyroid Gland Disease Pregnancy Complications previous infertility with known thyroidal function (TSH, anti-TPO) other endocrine pathology, such as Addison, diabetes mellitus manifest thyroidal pathology, such as Graves disease contraindication against pregnancy after repeated miscarriage (3 or more) heavy smokers (20 cig per day or more)
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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): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Nipple Lesions signed written informed consent form breast-feeding or pumping participant with painful nipple lesions years or older contraindication for the class of medical device used or intervention being performed e.g. known hypersensitivity or allergy against the medical device or class of medical device missing willingness to take part in the study hepatitis B or C positive human immunodeficiency virus (HIV) positive intake of immunosuppressive drugs epilepsy dark or tattooed skin laking German skills mamma carcinoma in past medical history severe infection (C-reactive protein (CRP) >200mg/l; leucocytes >20000/ul)
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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, Skilled Nursing Facilities Behavioral Economics Discharging units at Geisinger (Geisinger Medical Center, Geisinger Wyoming Valley Medical Center, and Geisinger Community Medical Center) Patients placed on adult medical/surgical wards Patients selected for discharge to a SNF Case managers using Repisodic to discharge patients (under the above) to a SNF Discharge date occurs after pandemic alleviation benchmark has been met (see Study Description for further details) Discharges in which the full list presented to the case manager contains no P-SNFs. Note: If a patient consistent with the above has a caretaker that is interacting with the Repisodic application for the patient's post-acute care decision, the caretaker's behavior will be used
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-55.0, Subclinical hypothyroïdism All adult patients with subclinical hypothyroidism with the level of TSH values above 4.0 mU/l.and normal values of thyroxine (T4) and triiodothyronine (T3) Diabetes mellitus Cushing hyperparathrodisim CKD .patients on corticosteroid therapy Inflammatory conditions as rheumatoid arthritis,Systemic Lupus, Crohn's disease, ulcerative colitis Haematological conditions as multiple myeloma, Myeloproliferative disorders Vitamin D deficiency Males aged more than 55 years old Postmenopausal females will also be excluded in this study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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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): 18.0-46.0, Gestational Weight Gain English-speaking pregnant (6-10 weeks) women aged 18-46 years reside in Denver, CO currently engaging in less than 120 minutes of moderate-intensity exercise per week have medical clearance to exercise during pregnancy -having conditions that preclude exercise (i.e. HCP has restricted patient from engaging in exercise according to AGOG's absolute contraindications to exercise (e.g. haemodynamically significant heart disease, restrictive lung disease, incompetent cervix/cerclage, persistent second or third trimester bleeding, placenta previa after 26 weeks gestation, premature labor during the current pregnancy, ruptured membranes, and pregnancy induced hypertension)
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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 Abnormalities ICU Acquired Weakness Patients of both sexes admitted to the general ICU of Ain Shams University Hospitals with critical illness for more than 7 days * Diagnosis of ICU acquired weakness will be made based on clinical for ICUAW and confirmed by nerve conduction studies Patients with cerebrovascular accidents, neuromuscular disorders, spine abnormalities, spinal cord or head injuries, CNS tumors, secondary thyroid disorders and electrolyte disturbances were excluded from the study. Patients receiving thyroid replacement or anti-thyroid drugs for the treatment of any throid disorder will be also excluded from the study as these drugs may alter their thyroid biochemistry
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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): 18.0-55.0, Obsessive-Compulsive Disorder Obsessive-Compulsive Behavior Schizophrenia Delusional Disorder Brief Psychotic Disorder Schizo Affective Disorder Other Psychoses Unspecified Psychosis General 1. Diagnostic ICD 10 at least one of the following ICD 10 diagnoses: 1. Obsessive-compulsive disorder ICD F42 or 2. Obsessive-compulsive behavior ICD R46.81 AND/OR 3. Schizophrenia, delusional, and other non-mood psychotic disorders, namely F20 Schizophrenia F22 Delusional disorders F23 Brief psychotic disorder F25 Schizoaffective disorders F28 Other psychotic disorder not due to a substance or known physiological condition F29 Unspecified psychosis not due to a substance or known physiological condition 2. Age: 18-55 3. Severity: Clinical Global impression (CGI): Minimum score of "4 = Moderately ill" 4. Swedish or English proficiency 5. The patient has tried at least 2 standard psychiatric medications at maximal tolerable or maximal recommended dosage for his/her current condition over a period of 6 months, but has not improved significantly 6. Medication has been unchanged for at least one month prior to study start 7. Signed informed consent 8. Use of adequate contraception 9. Radiological evidence of brain atrophy and scarring are absent 10. The clinical picture indicates active inflammatory activity (see specific below), potential for rehabilitation and time from disease and/or episode debut is no longer than 10 years. Specific 11. Acute (<12 weeks) or atypical debut, or episodes of any of the following: 1. Symptoms of encephalopathy: psychotic symptoms, including hallucinations, delusions, paranoia, disorganized speech, disorganized behavior agitation, confusion sudden change in personality as perceived by the social environment drowsiness loss of functions in daily Life cognitive problems (memory, speech, learning) emotional dysregulation 2. Focal neurological symptoms, e.g. ataxia, dystonia, myoclonus, sensory losses, paresthesia 3. Psychomotor anomaly, e.g.retardation, catatonic symptoms, parkinsonism 4. Loss of drive (sleep, appetite, libido, motivation) 5. Obsessions, compulsions (OCD/OCB), 6. Hypo or hypervigilance (for e.g sounds, emotions, other peoples´ or own behavior) 7. Sleeping disorders, AND 12. At least one of the following 1. Prodromal phase with infection or symptoms of infection (fever, malaise, etc) 2. Clinical improvement of psychiatric symptoms after treatment with anti-inflammatory medications other than antibody therapy (such as steroids, NSAIDs IVIG, plasmaphereses), or antibiotics 3. Radiological evidence of neuroinflammation (MR) 4. EEG pathology or witnessed epileptic seizure 5. Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such as one of the following: presence of oligoclonal bands elevated CSF cell count elevated albumin quotient, or elevated albumin in CSF elevated Immunoglobulin G (IgG) ratio elevated levels of neurofilament 6. Patient history of autoimmune disorder not associated with neuroinflammation, such as type 1 diabetes, rheumatoid arthritis, Sjögren´s syndrome, inflammatory bowel disease (IBD, comprising Crohn´s disease and ulcerative colitis), celiac disease, Grave´s disease, Hashimoto's thyroiditis 7. Biochemical indication of autoimmunity such as elevated serum anti-thyroid peroxidase (TPO) antibody, antinuclear antibody (ANA), anti-neutrophil cytoplasmic antibody (ANCA), rheumatoid factor (RF) or glutamic acid decarboxylase (GAD) antibodies, panel with relationship to symptom development Concomitant malignancies or previous malignancies within the last five years 14. Cannot comply with vaccination recommendations 15. History of severe allergic or anaphylactic reactions in conjunction with prior treatment with monoclonal antibodies 16. Prior antibody therapy including Rituximab (MabThera®/Rituxan®) 17. Patient has been treated with clozapine (which may have immunosuppressant effect), systemic corticosteroids or IVIG within 60 days prior to screening visit 18. Prior treatment with immunosuppressant medications (not including systemic corticosteroids and IVIG) for other medical condition 19. History of or positive screening for HIV, Tuberculosis, Hepatitis B and/or Hepatitis C (ever) 20. Heart disease such as previous heart attack, arrhythmia or heart failure, coronary insufficiency 21. Current drug, alcohol, or chemical abuse 22. Pregnancy at any time during the study 23. Known chronical significant bacterial/viral/fungal infections at infusion date 24. Diagnosis of well-established neuroinflammatory disease such as Multiple Sclerosis (MS) (ICD codes G00-G09, G35-G37) or systemic lupus erythematosus (SLE) (M32) 25. Tested positive for autoantibodies in serum or CSF associated to known and treatable neuroinflammatory disease (such as neuroborreliosis, treatable autoimmune encephalitis). Patients having completed recommended treatment without significant improvement may still be included in this study. 26. History of any illness that in the opinion of the investigator may jeopardize the ability of the patient to participate in the study. 27. Patient is enrolled in another medical trial
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 24.0-56.0, Weight Loss Glucose, High Blood LDL Hyperlipoproteinemia HDL Triglycerides High Obese (BMI ≥30) Age ≥ 18 years Male or female Smoking or not smoking Type 1 diabetes Type 2 diabetes Any other 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): 20.0-60.0, Graves' Disease in Remission (Disorder) Patients with Graves' disease who are being treated with anti-thyroid drugs (ATDs) and planned to discontinue ATDs Those who have who have continued to administer ATDs for more than 1 year Those who showed normal findings on thyroid function tests while maintaining stable doses of ATDs in the last 3 months Those who can use wearable devices and smartphone apps to work with during the research period Those with heart disease, such as arrhythmia, that can affect heart rate Those who are taking medications that may affect their heart rate Those who researchers deemed unsuitable for participation
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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, Overweight and Obesity Pregnancy Related Pregnant Women Body Mass Index between ≥25.0 kg/m2 and <38.0 kg/m2 Primiparous or Multiparous Women capable of providing informed consent and of providing consent on behalf of their child Twin or multiple pregnancies Insufficient English to understand intervention and written materials Nutritional complications i.e. previous or current eating disorder, following a special diet, in receipt of specialist dietary advice Pregnancy not viable as determined by the patient's clinical team Have been referred to another weight management service by their clinical team during pregnancy that is not part of routine antenatal care
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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, PCOS Impaired Glucose Tolerance Infertility Vietnamese women with polycystic ovarian syndrome diagnosed followed by Rotterdam (2003) having indications for infertility treatments Endocrinal abnormalities including thyroid-stimulating hormone (TSH) >5mIU/mL, serum prolactin (PRL) >30ng/mL and any other concomitant endocrinopathy such as a history of hypothyroidism, Cushing's syndrome, premature ovarian insufficiency and late-onset or non-classic congenital adrenal hyperplasia will be excluded Women who were already diagnosed as diabetes by endocrinologists
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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, Stroke, Acute Final diagnosis of stroke at discharge from hospital. - 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): 18.0-999.0, Total Knee Replacement Symptomatic osteoarthritis of the knee Primary TKA UCLA Score (University of California, Los Angeles Score)>/= 4 mMPTA: 85° Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral Minor Patient Pregnant or breast feeding woman Difference in the radius of medial and lateral condyles >2mm Previous osteotomy around the knee BMI >40 Ligament instability likely to require higher level of constraint Previous infection or inflammatory disease Any Patient who cannot or will not provide informed consent for participation 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): 18.0-70.0, Breast Cancer Female gender Age between 18 years old Patients known case of breast cancer Hemoglobin level is at least 8 g / dl Hematocrit level at least 30% The level of TSH is normal Patients known case of heart disease with unstable conditions Disabling Pulmonary Disease and History of Asthma Patients known case of severe kidney disease (Creatinine level is greater than 2mg / dl Proteinuria) The SGOT level is more than 3 times of the normal threshold Bilirubin levels is greater than 2mg / dl Positive history of hypersensitivity to saffron, Rose water and Honey Uncontrolled pain severe infection serious illness Positive history of gout or high level of uric acid
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Keratoconus Corneal Ectasia Thyroid Eye Disease For TGD patients: Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Therefore, we only included patients who did not received treatment yet For the control group, fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies patients with previous thyroid medications or replacement therapy, thyroidectomy or radioactive iodine intake participants with a history of ocular surgery or trauma, use of any topical medication or contact lens wear, patients with any corneal pathology, Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate other risk factors for KC, we also excluded participants with a history of persistent eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's syndrome, or congenital rubella. Pregnant or lactating females were also 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): 18.0-75.0, Differentiated Thyroid Cancer Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer Patients who were at 18~75 years old (male or female) Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation Serum TSH ≤ 0.5 mU/L； Women of childbearing age are HCG-negative Low iodine diet before enrollment for more than 4 weeks Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection) Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy) Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia Pregnant or lactating women Patients who are allergic to rhTSH and its excipients Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS Participated in any drug or medical device clinical trial within 1 month prior to the trial
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 20.0-45.0, Infertility Diminished Ovarian Reserve IVF Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Female aged 20 4. Regular menstrual cycles between 21 and 40 days 5. Presence of both ovaries 6. Meets for DOR by the recent ASRM/ACOG Committee Opinion 1. antimüllerian hormone (AMH) value less than 1 ng/mL 2. antral follicle count less than 5-7 and 3. follicle-stimulating hormone (FSH) greater than 10 IU/L or 4. a history of poor response to in vitro fertilization stimulation (fewer than four oocytes at time of egg retrieval) Oocyte donation cycle 2. Oocyte freezing cycle 3. Current ovarian cyst > 3cm 4. Anovulatory or oligo-ovulatory (<6 ovulation per year) 5. Previous oophorectomy 6. Exposure to cytotoxic or pelvic irradiation 7. Planned aromatase inhibitor usage during current ovarian stimulation 8. Sensitizing or ovarian stimulating therapy in the past one month Additional contraindications to this study re, as follows (because such patients cannot receive an estrogen patch): 9. Undiagnosed abnormal genital bleeding 10. Known, suspected, or history of breast cancer 11. Known or suspected estrogen-dependent neoplasia 12. Active DVT, PE, or a history of these conditions 13. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions 14. Known anaphylactic reaction or angioedema with estradiol patches 15. Known liver impairment or disease 16. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
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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, Cardiovascular Disorder Chronic Kidney Disease Metastatic Renal Cell Carcinoma Metastatic Thyroid Gland Medullary Carcinoma Stage IV Renal Cell Cancer AJCC v8 Stage IV Thyroid Gland Medullary Carcinoma AJCC v8 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8 English speaking Patient must have histologically or cytologically-proven advanced metastatic renal cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, vandetanib, or axitinib) NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then alternative non-sulfa medications can be considered in consultation with the C-BAC. Patient with a noted severe allergic reactions to medications listed in the algorithms is not necessarily excluded from this trial, as alternative medications could be considered in consultation with the C-BAC. Moreover, the patient treated with pre-existing medications that may interact with proposed BP medications is not necessarily excluded, as alternative medications exist. The clinical significance of any potential drug interactions can also be addressed with the C-BAC Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with immunotherapy is also permissible Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk as defined by one or more of the following Clinical CV disease (history of myocardial infarction [MI] acute coronary syndrome, coronary revascularization, carotid endarterectomy or stenting greater than 3 months prior to registration, peripheral artery disease, cerebrovascular accident greater than 3 months prior to registration, abdominal aortic aneurysm or heart failure [HF]) An American College of Cardiology/American Heart Association (ACC/AHA) CV risk score of at least 10% Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR] between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an eGFR < 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation Patient must have systolic blood pressure (SBP) >= 130 mmHg on two or more occasions according to any in-clinic visit in the 12 weeks prior to or during their initial 4 weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension or on pre-existing anti-hypertensive medications are eligible for enrollment. However, patient must not be on more than 3 baseline blood pressure medications at time of entry NOTE: If a patient has a single elevated SBP >= 130mmHg but not on repeat assessment, an additional SBP assessment should be performed to confirm ineligibility Patient must not have end-stage renal failure on dialysis, history of repeated hyperkalemia with a potassium > 5.5 mEq/l, or have a kidney transplant, or an eGFR < 30 ml/min/1.73 m^2 Patient must not have coronary artery bypass grafting, MI acute coronary syndrome severe/unstable angina, stroke, transient ischemic attack, clinically significant bleeding requiring hospitalization or pulmonary embolism within 3 months prior to registration Patient must not have brain surgery or radiotherapy within 2 weeks prior to registration Patient must not have uncontrolled blood pressure defined by SBP > 160 mmHg on three or more antihypertensives prior to TKI initiation Patient with an arm circumference too large (> 50 cm) or small (< 17 cm) to allow accurate BP measurement with available devices will not be eligible Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-55.0, Hashimoto aged 18-55 years confirmed autoimmune thyroiditis diagnosis at least one biological marker Anti-thyroid peroxidase (anti-TPO) antibodies or thyroglobulin antibodies (TgAb) exceeds the reference range the presence of psychotic symptoms currently receiving another form of psychological treatment under psychotropic medication neurodevelopmental disorders (intellectual disability, communication disorders, autism spectrum disorders, ADHD) neurocognitive disorders substance abuse serious legal or health issues that would prevent from regularly attending patients with autoimmune thyroiditis with biological markers within the reference range
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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): 18.0-76.0, Thyroid Nodule To have multi-nodular goiter To be a benign result in fine needle aspiration biopsy Euthyroid must be sick Must be sick over the age of 18 To accept the research Thyroid function tests non-euthyroid individuals To have a malignant result in thyroid biopsy Not giving approval To be renal failure Benign pregnant Taking blood thinning drugs
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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 Gastric Cancer Locally Advanced Gastric Adenocarcinoma Written informed consent obtained Age ≥ 18 years at time of study entry, no gender limit Participants must have histologically or cytologically confirmed adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction) At least one measurable site of disease as defined by with spiral CT scan or MRI CT or MRI showed unresectable locally advanced gastric cancer (imaging stage T4b and / or second station lymph node > 3cm or fusion mass) or limited metastatic gastric cancer with any of the following single site metastasis: 1. Retro-peritoneal lymph node metastasis (RPLM) (e.g. para-aortic, intra-aorto-caval, para-pancreatic or mesenteric lymph nodes). 2. Single or bilateral Krukenberg tumors. 3. No more than 5 liver metastases, and the maximum diameter of the lesions was less than 5 cm. 4. Adrenal metastasis. 5. Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the"Japanese Research Society for Gastric Cancer (JRSCGC)" No clinically visible peritoneal metastasis (such as CT imaging confirmation or ascites) No prior anti-tumor therapy Performance status (PS) < 2 (ECOG scale) Life expectancy of at least 12 weeks Adequate blood count, liver-enzymes, and renal function: hemoglobin≥90g/dL,absolute neutrophil count ≥ 1.5×109/L, platelets ≥100 x109/L; Total bilirubin < 1.5x upper normal limit (UNL), Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) <2.5 x ULN, if liver metastasis existed, SGOT,SGPT<2.5xULN. International normalized ratio (INR) ≤2.5 x ULN, Serum Creatinine ≤ 1 x institutional ULN or creatinine clearance (CrCl) >50ml/min (if using the Cockcroft-Gault formula ) A history of other malignancies within 3 years prior to enrollment, except for cervical carcinoma in situ or skin basal cell carcinoma that had been cured Accompanied with brain or meningeal metastasis Malignant pleural and peritoneal effusion Accompanied by gastrointestinal obstruction, gastrointestinal bleeding (fecal occult blood +++ )or perforation Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) Has an active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or with high risk (such as receiving immunosuppressive therapy after organ transplantation), but in the past two years with vitiligo, psoriasis, alopecia or Graves' disease without systemic treatment, hypothyroidism with thyroid hormone replacement therapy only and type I diabetes only need insulin replacement therapy can be enrolled Suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease and radiation pneumonia Participate in other clinical studies of drugs (subject to the use of trial drugs) within 4 weeks before the first administration, unless participating in observational (non intervention) clinical studies Used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. no more than 10mg prednisone or equivalent dose of other glucocorticoids, or short-term (no more than 7 days) use of glucocorticoids to prevent or treat non autoimmune allergic diseases Planned to receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period. Note: inactivated virus vaccine for seasonal influenza is allowed within 4 weeks before the first administration, however, live attenuated influenza vaccine is not allowed
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-70.0, Covid19 Povidone Iodine Adverse Reaction Healthy volunteers from the Boston community 2. 18-70 years of age 3. In good health, without thyroid or cardiac disease, without symptoms of COVID-19* 4. Normal baseline TSH History of thyroid or cardiac disease 2. Current BWH employee 3. Allergy or hypersensitivity to iodine 4. Positive COVID-19 mRNA or antibody test 5. Participation in any other investigational study or drug trial in which receipt of an investigational study drug occurred within 30 days prior to enrollment in this study 6. Women who are pregnant or attempting to conceive 7. Men who are attempting to conceive with their partner
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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): 19.0-49.0, Tandem Breastfeeding Being mature newborn (<37 GW) Being a mother who in third trimester The mother's lack of a health problem from a metabolic and endocrine perspective related to nutrition Absence of diagnosed psychiatric story of the mother Mother's openness to communication and cooperation Mother's volunteering to participate in the study Mother being literate Having multigravida of the mother Mother's age above 18 years Being a mother non-vegetarian Being a mother non-smoker Absence of breast trauma in mother (mastitis, abscess etc.) Mother's milk analysis at least a week before without taking any medication Having body mass index at normal values (18.5 to 24.9) pre-pregnancy (WHO, 2015) Having a condition that obstacle for breastfeeding (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles)
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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, Primary Immune Thrombocytopenia (ITP) Signed written informed consent 2. Age from 18 to 60 years old 3. Diagnosed with ITP and have a platelet count of <30 ×10^9/L on Day 1 (or within 48 hours prior to dosing on Day 1). 4. Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy. 5. Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment. 6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block. 7. No pre-existing infection within the last 1 months(including but not limited to pulmonary infection) 8. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP. 9. White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions Hemoglobin: females and males 10.0 g/dl are eligible for Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for 10. The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%. 11. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study. 12. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome. 2. Pregnant or lactating women; 3. Subjects is currently receiving treatment with another study medication. 4. Any laboratory or clinical evidence for HIV infection. 5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. 6. History of platelet aggregation that prevents reliable measurement of platelet counts. 7. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation 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): 18.0-999.0, Thalassemia Major Covid19 Patients with inherited dependent transfusion anemias (thalassemia major and intermediate, sickle cell anemia and Blackfan-Diamond anemia) or undergoing recurrent transfusion procedures (erythro-exchange in sickle cell anemia), belonging to the Rare Disease Center ASST-Monza, Hospital S Gerardo Age greater than or equal to 18 years are expected apart from patients' refusal 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): 18.0-999.0, Thyroid Diseases Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]) Participants will be invited to join the study after the decision has been made to proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid disease Pediatric patients < 18 Prior treatment with radioactive iodine (RAI) Known diagnosis of thyroid cancer Diabetic patients Patients on any immunosuppressive regiment (such as organ transplant patients or patients treated for other autoimmune condition) Pregnant patients Patients being treated for active infection Any patient for whom the surgeon feels steroids would provide a clear benefit (ie. Extremely high auto-antibody levels with a very large, inflamed thyroid gland) will be treated according to the clinical judgement of the surgeon. If a surgeon feels steroids are indicated and prescribes them, the patient will not be eligible for the trial
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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): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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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, Kōmmour Prenatal Among Marshallese Pregnant Women The are: (1) women who self-report as Marshallese, and (2) 18 years of age or older, and (3) 8-20 weeks 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): 0.0-999.0, Pregnancy Early Pregnancy Related Thyroid Dysfunction Pregnant women 2. Previously healthy known thyroid diseases
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 21.0-35.0, Mastitis Have given birth at National Cheng Kung University Hospital (NCKUH) Are Breastfeeding Are aged 21-35 Are diagnosed with early stage mastitis Have sufficient Chinese/Mandarin language skills to participate History of breast reduction or augmentation An abscess Severe physical/psychiatric impairments Presence of any malignancies
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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 Signed Informed Consent Healthy volunteers according to antecedents, clinical evaluation, biochemical tests and other complimentary tests Sex: both (male and female, homogenously distributed) Age: 18 to 50 years old BMI: 18 to 30 kg/m2 Non smokers from at least 3 months History of liver disease, kidney disease or conditions of psychiatric origin History of drug or alcohol abuse in the last two years Ingestion of other drugs the 2 weeks prior to the start of the study History of seizure disorders, depressive disorders, cardiovascular diseases, hematological, metabolic, vesicular or other, that the Principal Investigator judges clinically significant Abnormal electrocardiogram (EKG) Hypersensitivity to Levothyroxine sodium or to excipients (from formulations to test) Positive HIV test; hepatitis B and C Positive urine drug dose of abuse Having participated in another research study in the last 6 months Having donated blood within the 3 months prior to the start of the study
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1
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 0.0-999.0, Coronary Heart Disease the presence of an established diagnosis in patients with coronary artery disease unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017) The patient's refusal to participate in the study Pregnancy and lactation Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons) Acute violation of cerebral circulation History of acute or chronic psychosis The presence of concomitant acute diseases or chronic diseases in the acute stage. Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-999.0, Ankle Sprain 1St Degree Ankle Sprain 2Nd Degree Ankle Sprain 3Rd Degree Subject is aged ≥ 18 years old Subject has a recent mild OR moderate OR serious ankle sprain The current condition of his/her ankle allows the subject to resume usual physical activity Subject has been informed and is willing to sign an informed consent form Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks) Subject is affiliated to the French social security regime Non-inclusion Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury Subject has resumed regular physical activity since his/her recent injury Subject has any medical condition that could impact the study at investigator's discretion
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-60.0, Autoimmune Thyroiditis aged 18-60 years confirmed autoimmune thyroiditis diagnosis at least one biological marker Anti-thyroid peroxidase (anti-TPO) antibodies or thyroglobulin antibodies (TgAb) exceeds the reference range the presence of psychotic symptoms currently receiving another form of psychological treatment under psychotropic medication neurodevelopmental disorders (intellectual disability, communication disorders, autism spectrum disorders, ADHD) neurocognitive disorders substance abuse serious legal or health issues that would prevent from regularly attending patients with autoimmune thyroiditis with biological markers within the reference range
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-999.0, Hashimoto Disease Pregnancy Related Thyroid Dysfunction Adult HT pregnant women and adult pregnant women with nodular goiter with or whiteout previous known hypothyroidism significant pre-pregnancy comorbidity including renal failure, severe liver disease, organ transplant, cardiac failure, psychiatric conditions requiring in-patient admission, history of eating disorder. 2. unable to have e-mail address 3. unavailable written consent 4. unable understand Italian language
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 0.0-999.0, Interventions Pain Being born by cesarean section, 2. Being a term newborn, 3. Being completed the 24th hour of the postnatal period, 4. Staying with birth mother, 5. Being fed in the last half hour before the procedure, 6. Having a heel prick performed by the same nurse, 7. Giving blood on the first try (because pain level may change on the second try), 8. Having a mother who gave written informed consent Having no health problem, 2. Being underwent more than 2 invasive interventions, 3. Receiving an analgesic/sedative drug in the 8 hours before the application
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 20.0-80.0, Contrast Mammography in Pathological Nipple Discharge in diagnosis of female patients with pathological nipple discharge Patients with renal failure or with raised renal chemistry 2-patients who are allergic to contrast 2. Pregnant women
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-100.0, Chronic Kidney Disease Thyroid Dysfunction Criteria:Patients over 18 years old with CKD stages 3 and 4 were included in the study. - acute systemic inflammatory disease; 2) pituitary disease in the past or present; 3) regular treatment with amiodarone, lithium, interferon, immunosuppressive drugs and glucocorticoids; 4) previously diagnosed hypothyroidism and undergoing levothyroxine replacement. -
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-45.0, Hypothyroidism Hyperthyroidism Hashimoto Disease Graves Disease Graves' disease or Hashimoto's disease (positive thyroid autoantibody) Control group: thyroid autoantibody negative, normal thyroid function Women aged 18 to 45 in both the control group and experimental group Pregnancy and lactating women Previous or planned treatment with 131I or thyroidectomy The use of drugs affecting the thyroid function (lithium, amiodarone, interferon a, sodium nitroprusside, sunitinib, sorafenib, iodine contrast, antibiotics / antifungals / antivirals (for at least 4 weeks prior to recruitment to the study), which do not result from the treatment of thyroid disease (levothyroxine, thyreostatic drugs, glucocorticoids) Active malignancy Other autoimmune diseases Other endocrine diseases Patients with severe liver, kidney or heart failure
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 15.0-90.0, Graves Disease Untreated Graves' hyperthyroidism. (elevated serum free T4 and/or free T3 level, suppressed serum TSH level, positive anti-TSH receoptor antibody and high thyroidal radioactive iodine uptake - dropped out patients within 180 days -
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-60.0, Hashimoto Disease Psoriasis Hashimoto's Thyroiditis Clinical findings Presence of thyroid autoantibodies (anti-TPO) in laboratory tests Gray-scale Ultrasound findings. Psoriasis Presence of psoriatic lesions Psoriasis Area and Severity Index score (PASI). Healthy group: Non-obese (BMI<30) non-athletes non-pregnant or lactating women not been diagnosed with a chronic or acute disease not receiving antidepressants, drugs and supplements malignant or congenital goiter thyroidectomy
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-55.0, Thromboembolic Disorders The informed consent had to be signed before any study specific tests or procedures were done Healthy male subjects Age: 18 to 55 years (inclusive) at the screening examination/visit Race: White Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m^2 Ability to understand and follow instructions Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Known or suspected liver disorders and bile secretion/flow Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening Personal or familial history of genetically muscular diseases Known hypersensitivity to the study drugs (active substances or excipients of the preparations) Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract allergic asthma, allergies requiring therapy with corticosteroids, urticaria) or significant non-allergic drug reactions Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer) Known sensitivity to common causes of bleeding (e.g. nasal) Clinically relevant findings in the electrocardiogram (ECG) such as a second
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 0.0-999.0, Duct Ectasia Breast Benign Breast Disease females with nipple discharge / recurrent peri-ductal mastitis - suspicion or evidence of malignancy
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-65.0, Hashimoto Disease Obesity Diagnosed with Hashimoto's disease BMI over 30 kg/m2 Taking the L-thyroxine, 200 mcg of 1-selenomethionine/day, and 30 mg of zinc gluconate/day throughout the study period ---
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-65.0, Hashimoto Thyroiditis Autoimmune Thyroiditis Thyroiditis Thyroid Diseases Autoimmune Diseases Cases between the ages of 18-65 who applied to the Kosuyolu Istanbul Medipol Hospital Endocrinology and Metabolic Diseases Clinic between 2020-2021 and diagnosed as "Hashimoto Thyroiditis" by a specialist physician will be included in the study Acute infection Use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport, and metabolism of thyroid hormones Thyroid nodules Tracheal stenosis Serious illness History of exposure to ionizing radiation and/or neoplasia in the cervical region Malignancy and a history of thyroid surgery Hypothyrodism caused by postpartum thyroiditis Pregnancy and breastfeeding period Identification and diagnosis of the cases with neurological and psychiatric disorders
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 12.0-999.0, Locally Advanced Thyroid Gland Carcinoma Malignant Thyroid Gland Neoplasm Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Thyroid Gland Anaplastic Carcinoma Thyroid Gland Medullary Carcinoma Thyroid Gland Papillary Carcinoma Thyroid Gland Squamous Cell Carcinoma Patients with RET-altered thyroid cancer who present with locally advanced primary tumor, defined as T3 or T4 by imaging or invasive/bulky nodal disease, or with recurrent/residual invasive/bulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not At least 12 years of age on the day of signing informed consent Pathologic findings supporting the clinical impression of medullary thyroid carcinoma, papillary thyroid carcinoma, poorly differentiated thyroid carcinoma, or anaplastic thyroid carcinoma. Diagnosis of anaplastic thyroid carcinoma may consistent with or suggestive of terminology associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present Having an activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with Clinical Laboratory Improvement Act (CLIA), ISO/EIC, College of American Pathologists (CAP), or other similar certification that clearly denotes the presence of a RET alteration in tumor, or institutional-approved cell free DNA blood test for RET alteration Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed. The specific agent(s), duration of treatment, clinical benefit, and reason for discontinuation (e.g., progressive disease [PD], drug toxicity, or intolerance) should be documented for all kinase inhibitors the patient has been exposed to At least one measurable lesion as defined by 1.1 Surgical morbidity/complexity score of 1 to 4 (moderate, severe, very severe, or unresectable) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (age >=16 years) or Lansky Performance Score (LPS) >= 40% (age <16 years) with no sudden deterioration 2 weeks prior to study registration Absolute neutrophil count (ANC) >= 1500/uL Hemoglobin >= 9 g/dL (5.58 mmol/L) An additional validated oncogenic driver that could cause resistance to selpercatinib treatment (if known) Prior treatment with a selective RET inhibitor(s) (pralsetinib [BLU-667], including investigational selective RET inhibitor[s]) Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, or immunotherapy) within 5 half-lives or 3 weeks (whichever is shorter) prior to planned start of selpercatinib Exception: Patients with ATC No concurrent investigational anti-cancer therapy is permitted Major surgery (excluding placement of vascular access and diagnostic procedures) within 4 weeks prior to planned start of selpercatinib Exception: Patients with ATC Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment Any unresolved toxicities from prior therapy greater than Common Terminology for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum therapy related neuropathy Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-60.0, Hashimoto Disease Treatment Levothyroxine Vitamin D Deficiency women between 18-45 years old (pre-menopausal stage) men between 18-60 years old BMI between 18.5-34.9 kg/ m2 medical diagnosis of Hashimoto's thyroiditis treatment with levothyroxine (LT4) with stable dose (from four months from the start of the intervention) positive antithyroid antibody (peroxidase and/or thyroglobulin) serum 25 (OH) D levels <20 ng / ml radioiodine, thyroidectomy, antithyroid treatment disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin D metabolism disorder of kidney, liver, or bone-metabolic function Graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, Turner or Down syndrome, primary hyperparathyroidism vitamin D, calcium, complex B, omega-3 supplements pregnant or breastfeeding type 2 diabetes or dyslipidemia with drug treatment at unstable doses intense physical activity
|
2
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-65.0, Hypothyroidism Healthy The based on which, subjects in each Arm will be chosen to take part in the survey. Arm 1: Subjects from the general population who are naïve to their hypothyroid status Male and female subjects between the age of 18 years and 65 years Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve* Male and female subjects between the ages 18 years and 65 years Subjects who had symptoms of hypothyroidism, were seen by a physician and diagnosed with hypothyroidism after laboratory testing of TSH > 4.5 mIU/L within 2 weeks from the date of survey Willing to sign the SAF Willing to provide their Thyroid Function Test report that was used to diagnose Hypothyroidism. * Treatment naive diagnosed on basis lab and clinical diagnosis within last 2 weeks Arm 1: Subjects from the general population who are naïve to their hypothyroid status Individuals less than 18 years of age and more than 65 years of age Pregnant or lactating females Subjects previously diagnosed with and received treatment for thyroid diseases Subjects not willing to sign the SAF. Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve Individuals less than 18 years of age and more than 65 years of age Pregnant or lactating females Subjects previously diagnosed with and received treatment for thyroid diseases Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF. The above-mentioned will be applicable to both Face validation and Pilot survey
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-75.0, Hypothyroidism Male or female aged ≥18, ≤75 years old clear diagnosis of primary hypothyroidism Use the same dose of levothyroxine for ≥3 months The levels of thyroid function (TSH, TT4, FT4, TT3, FT3) in hospital laboratory blood tests no more than 6 weeks before participation were within the normal range regnancy or lactation women affect blood sugar, blood lipid metabolism drugs serious heart disease thyroid malignant tumor history of mental illness
|
1
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-999.0, Klinefelter Syndrome Turner Syndrome Klinefelter or Turner syndrome as confirmed by genetic testing Sufficient knowledge of the Dutch language to complete the questionnaires At least 18 years old KS: Patients not under treatment in the EMC, AMC or VUmc or no planned visits during the study period TS: No laboratory values or no questionnaires available in patient records Severe psychiatric or neurologic disorders or other reasons for inability to complete the questionnaires as assessed by the treating physician Failure to obtain informed consent
|
0
|
The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
|
eligible ages (years): 18.0-60.0, Thyrotoxicosis Hypothyroidism Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment Subjects who are able to use wearable devices, smart phones, and mobile apps Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction Subjects who are taking medications affecting heart rate Subjects with diseases affecting heart rate (i.e. arrhythmia)
|
2
|
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