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The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-70.0, Lymphoma Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age <70. 6. Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen - | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-50.0, Opioid-Related Disorders Age between 18 and 60 2. Evidence of physical dependence on opioids (self-report, urine screen, physical exam) 3. Seeking treatment for opioid dependence 4. Able to attend treatment clinic 7 days/week General- 1. Poor venous access 2. Urologic conditions that would inhibit urine collection 3. Pregnancy or breastfeeding 4. Failure to agree to use a medically effective form of contraception while in the study (in women who are sexually active with a male partner and able to get pregnant). Acceptable forms of contraception for this study hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones), surgical sterility (tubal ligation or hysterectomy); IUD; Diaphragm with spermicide; Condom with spermicide 5. Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines Psychiatric- 1. Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires (Shipley Institute of Living scale estimated full-scale IQ less than 80) 2. History of schizophrenia or any other DSM-IV psychotic disorder 3. History of bipolar disorder 4. Current Major Depressive Disorder Medical- 1. Any active or untreated medical illness that in the view of the investigators would compromise participation in research 2. Allergy or intolerance to either buprenorphine or clonidine 3. Cerebrovascular disease 4. Conduction disturbances (e.g., second-degree heart block, third-degree heart block, atrial fibrillation, ventricular tachycardia) or arrhythmias 5. Myocardial infarction, or documented coronary artery disease 6. Congestive heart failure 7. Chronic renal failure, as estimated by Cr > 2.0 8. CD4 < 200 or evidence of severely compromised immune system /AIDS 9. Marked, sustained bradycardia (HR < 45 bpm) on three separate occasions 10. Marked, sustained low blood pressure (SBP <95 or DBP < 40 mm Hg) over three separate readings 11. Marked, sustained high blood pressure (SBP >160 mm Hg, DBP >100 mm Hg) over several readings, without being on antihypertensive medications. 12. ECG changes suggestive of acute ischemia, clinical important arrhythmia, left bundle branch block, or other changes that concerns the MRP will the participant. If accompanied by cardiovascular complaints such as chest pain or syncope, less specific ECG findings will also the patient. When in doubt, the ECG will be sent to cardiology on a prn basis for a manual reading. 13. Orthostatic hypotension (upon standing for 3 minutes, there is a 20 mm Hg decrease in systolic blood pressure or a 10 mmHg decrease in diastolic blood pressure accompanied by an increase by 20 bpm in heart rate) on two separate readings. Taking contraindicated medications- 1. Beta blockers 2. Tricyclic antidepressants 3. Antipsychotics 4. Mah huang 5. Yohimbe 6. Ephedra 7. Sildenafil citrate (Viagra). Sildenafil citrate doses > 25mg should not be taken within 4 hours of taking an alpha blocker or it can produce significant and symptomatic hypotension (Pfizer). Of note, Viagra, like buprenorphine, is metabolized by cytochrome P450 3A4. Ingestion of buprenorphine could potentate the effects of sildenafil citrate which could extent the period of safety to > 4 hrs from when an alpha blocker could be taken after Viagra ingestion. Family history of sudden cardiac death at age < 50 Lab Test and Lab Values: WBC* < 1,500 > 13,000 #/CUMM HCT < 33 > 49 Percent Platelets < 100 > 500 K/CUMM Sodium < 132 > 149 MEQ/L Potassium < 3.5 > 5.2 MEQ/L Calcium < 8.4 > 10.5 MG/DL Magnesium < 1.3 > 3 MG/DL <TAB> BUN > 35 MG/DL Cr<TAB> > 2.0 MG/DL <TAB> Alk Phos<TAB> > 200 U/L AST<TAB> > 200 U/L ALT<TAB> > 200 U/L GGT<TAB> > 400 U/L Albumin<TAB> < 3 GM/DL Total bilirubin > 2.0 MG/DL Direct bilirubin > 0.4 MG/DL TSH<TAB> < 0.27 > 4.2 UIU/ML <TAB> *Leukocytosis will prompt further investigation before clearance.<TAB> | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-21.0, Stage I Adrenocortical Carcinoma Stage II Adrenocortical Carcinoma Stage III Adrenocortical Carcinoma Stage IV Adrenocortical Carcinoma Histologically confirmed adrenocortical carcinoma Newly diagnosed disease within the past 3 weeks Any disease stage allowed Lansky performance status 60-100% (for patients ≤ 16 years old) Karnofsky performance status 60-100% (for patients > 16 years old) Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 75,000/mm^3 Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows 4 mg/dL (1 month to < 6 months) 5 mg/dL (6 months to < 1 year of age) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-17.0, Nonneoplastic Condition Newly diagnosed hemophagocytic lymphohistiocytosis (HLH) meeting 1 of the following criteria* Diagnosis by molecular/genetic methods Diagnosis by meeting 5 out of 8 of the following Clinical Fever Splenomegaly Laboratory Cytopenias affecting ≥ 2 of 3 lineages in the peripheral blood, including the following Hemoglobin < 9.0 g/dL (< 10.0 g/dL in infants < 4 weeks of age) Platelet count < 100,000/mm^3 | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Severe Malaria Malaria Antimalarial Drug Resistance Uncompleted malaria: Age greater than 10 years axillary, temperature greater than 37.5 degrees Celsius or history of fever, signs and symptoms of malaria (e.g. headache, body aches, malaise), asexual parasitemia greater than or equal to 10000/ul, NO of severe malaria and NO other etiologies of febrile illness (e.g., respiratory tract infection) on clinical examination, and NO history of antimalarial drug use for present symptoms. Severe malaria: Age greater than or equal to 10 years, asexual parasitemia greater than or equal to 10000/uL, NO history of antimalarial drug use for present symptoms, and any one of the following: coma (defined as Glasgow coma score less than or equal to 9 in adults, or Blantyre coma score less than or equal to 2 in children), convulsions (witnessed), prostration, severe anemia (hemoglobin less than 5 g/dL), respiratory distress, hypoglycemia (serum glucose less than 40 mg/dL), jaundice/icetrus, renal insufficiency (anuria for 24 hours or more), hemoglobinuria, state of shock (systolic blood pressure less than 50 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting Individuals who live in malaria endemic areas and are asymptomatic or have anon-malaria illness can sometimes be incidentally noted to be parasitemic, patients who are parasitemic yet are found by clinical examination to have another etiology of febrile illness (e.g. respiratory tract infection) will be excluded from the protocol, but will be treated by the Cambodian Ministry of Health staff for both malaria and their coexisting infection. Pregnant women will also be excluded from this protocol but will be treated by study physicians with guinine (first trimester) or artemisinin-mefloquine (second or third trimester) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Pregnancy Have been exposed to within 8 weeks prior to conception or at any time during pregnancy Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively) Provide verbal consent to participate in the Registry, and Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable) None | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-40.0, Healthy Volunteers healthy 18-40 years able to follow the protocol able to provide informed consent Allergy to buprenorphine Mental illness Alcohol or drug abuse Chronic pain Daily use of analgesics Chronic medicinal treatment Treatment with corticosteroids Any use of medicine 48 hours before day of trial Smoker Blood donation within 3 months before day of trial | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-21.0, Brain and Central Nervous System Tumors Neurofibromatosis Type 1 Histologically confirmed* low-grade glioma, including 1 of the following subtypes Astrocytoma variants Fibrillary, protoplasmic, or mixed Pilocytic astrocytoma, including pilomyxoid variants Pleomorphic xanthoastrocytoma Infantile desmoplastic astrocytoma Ganglioglioma Oligodendroglial tumors Mixed glioma, including oligoastrocytoma NOTE: *Biopsy not required for patients who have visual pathway tumors involving the optic nerves and/or optic radiations (i.e., not isolated to the hypothalamus/chiasm) Biopsy proven focal low-grade gliomas of the brainstem with measurable disease allowed | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-120.0, Pancreatic Cancer Histologically or cytologically confirmed adenocarcinoma of the pancreas Documented extrapancreatic metastases Radiographically measurable disease not required Gemcitabine hydrochloride-refractory disease Has undergone 1-3 prior therapies for locally advanced or metastatic disease with ≥ 1 regimen containing gemcitabine hydrochloride (alone or in combination with other agents) Treatment given in the adjuvant setting (radiotherapy and/or chemotherapy, given either concurrently or systemically) does not count as prior therapy as long as progressive disease occurs > 6 months after completion of treatment No central nervous system (CNS) or brain metastases Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 37.0-999.0, Primary Advanced Carcinoma of the Oral Cavity or Oropharynx Squamous Cell Carcinoma of the Head and Neck - Written informed consent conforming to the institutional guidelines obtained from the patient. Documented evidence of oral carcinoma or carcinoma of the oropharynx. Patients will undergo surgery, surgery and radiation or chemoradiation therapy, and will become eligible for the first vaccine between 1and 4 months after termination of conventional therapy. Adequate immune competence, as indicated by positive reaction to one or more of the DTH skin tests. Age 18 or above. Karnofsky performance status > 70% and life expectancy > eight months. Adequate hematologic function: Absolute neutrophil count > 1,000/mm3 Absolute lymphocyte count > 1,000/mm3 Hemoglobin > 9 g/dl Platelets > 100,000/mm3 h) Liver function tests: Bilirubin (total) < 1.7 mg/dl Alkaline phosphatase < 78 u/L (2 x ULN) SGOT < 54 u/L (2 x ULN) Lactic dehydrogenase < 180 u/L (2 x ULN) i) Kidney profile: Serum electrolytes Sodium 135-145 mEq/L Potassium 3.5-5.0 mEq/L Bicarbonate 21-28 mEq/L Chloride 100-108 mmol/L 2) Serum creatinine <4.5 mg/dL (3 x ULN) 3) BUN 8-25 mg/dL j) At least four weeks since any prior radiation therapy, immunotherapy, or chemotherapy One or more of the are not met. A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months. Evidence of active infection requiring antibiotic therapy. Positive HIV or Hepatitis B or C screen tests Active intracranial metastases. Previously resected intracranial disease and or previously irradiated intracranial metastases which have been stable for four weeks are eligible. History of other concurrent malignancies except basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Pregnant or lactating women. Patients requiring systemic corticosteroids (unless patient has had NO IN THE PAST 4 WEEKS). Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Chronic Lymphocytic Leukemia Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy. Indications for therapy at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (Rai stage >/= 3 or Binet stage C); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months Patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) Beta-2-microglobulin </= 4 mg/dL Adequate liver function (total bilirubin </= 2.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) </=4 x ULN) and renal function (serum creatinine </= 2.0 mg/dL and/or creatinine clearance < 30 mL/hour). Patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the Principal Investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dL and bilirubin < 6 mg/dL. Patients with Gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dL Eastern Cooperative Oncology Group (ECOG) performance status </= 2 Signed informed consent in keeping with the policies of the hospital Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment Active hepatitis B (at least one of the following markers positive: HBsAg, hepatitis B e antigen (HBeAg), immunoglobulin M (IgM) anti-HBc, hepatitis B virus (HBV) DNA) Concurrent chemotherapy or immunotherapy Pregnant patients History of HIV Symptomatic central nervous system (CNS) disease | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Hepatic Insufficiency All Groups Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening Female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom or oral contraception OR: Postmenopausal women must have no regular menstrual bleeding for at least 1 years prior to inclusion. Menopause will be confirmed by a plasma FSH level of >40 IU/L OR: Female subjects must have been surgically sterilized at least 6 months prior to screening.with supportive clinical documentation. AND/OR and MDS-specific requirement: If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 month prior to first dosing. All females must have negative pregnancy test results at screening and baseline Subjects must weigh at least 50 kg and have a body mass index (BMI) between 18 and 40 kg/m2 to participate in this study Platelet count > 50,000 X 109/L at screening and baseline. Group 1 (healthy controls) In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening; subjects without diseases/conditions Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-<140 mm Hg, diastolic blood pressure, 60-<90 mm Hg, pulse rate, 50 beats per minute (bpm) When blood pressure and pulse will be taken again after at least 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with clinical manifestation of postural hypotension Matched with a hepatic impaired patient on a 1:1 ration using the following criteria.sex, age ± 5 years, weight ± 10 kilograms, and smoking status Group 2, and 3 (hepatic impairment) All Groups Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation Donation or loss of 400 mL or more of blood within 8 weeks prior to study start Significant illness within the 2 weeks prior to study start A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome Resting heart rate < 50 bpm History of autonomic dysfunction or acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated) or clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), or a known hypersensitivity to the study drug or drugs similar to the study drug Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders Group 1 (healthy controls) Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. SGPT will have to be strictly within the normal range before GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL) A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Anemia Secondary Hyperparathyroidism Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must the most recent assessment) above 110 g/L Males or females > 18 years of age at the time of informed consent Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be > 31.8 pmol/L (300 pg/mL) and < 84.8 pmol/L (800 pg/mL) The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be > 2.1 mmol/L (8.4 mg/dL) Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before ANY study specific procedures are initiated Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1 Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator Hypersensitivity to Sensipar or any of its components Are currently breastfeeding Have had a parathyroidectomy in the 3 months before day 1 Experienced a myocardial infarction within 3 months prior to day 1 Have had a red blood cell transfusion within 3 months prior to day 1 Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets Have a disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-65.0, Healthy Volunteers of either sex, age 18 to 65 years, inclusive. 2. Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions. 3. Vital signs (BP, HR, temperature, respiratory rate) within normal range. 4. Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection. 5. A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection. 6. Female subjects of child-bearing potential must be practicing effective birth control or abstinence currently and plan to continue to do so for the duration of the study. 7. Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial. 8. Willingness and ability to sign an informed consent document Upper extremity edema. 2. Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.). 3. Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions. 4. Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs. 5. Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex. 6. Known allergy to bee or vespid venom. 7. Known coagulopathy. 8. Pregnancy or breast-feeding woman. 9. Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results. 10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.154-0.385, Diarrhea Access to telephone at home or in the immediate neighborhood. 2. Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days). 3. Parent's permission to participate in the study is available. 4. No plans to travel over the next 4 months Gestational age <37 weeks. 2. Any major physical congenital malformation. 3. Living in a household or has contact with an individual who is immunosuppressed. 4. Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness. 5. Is required to take daily medications other than vitamins or herbal "tonics". 6. Evidence of cardiovascular disease as indicated by any of the following Central cyanosis Cyanotic or apnoeic spells Features of congestive heart failure Significant heart murmur detected on physical examination 7. Evidence of gastrointestinal disease indicated by following Diarrhea in the previous 7 days Blood in the stools any time since birth 8. Evidence of neurological disease, as indicated by History of seizures any time since birth History of unconsciousness Focal deficit on physical examination 9. Evidence of liver or other reticuloendothelial disease, as indicated by any of the following | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-60.0, Type 1 Diabetes Patients with established type 1 diabetes mellitus who meet all are eligible for enrollment in the study All patients enrolled must be on insulin replacement therapy Written informed consent conforming to the institutional guidelines obtained from the patient Documented evidence of insulin-requiring type 1 diabetes of >5 years duration Adequate immune competence, as indicated by positive reaction to one or more of the common DTH skin tests that are part of the Multitest CMITM test system (Pasteur-Merieux Connaught) and as indicated by the manufacturer. Also, proof of vaccination for tetanus (no more than 10 years must have elapsed between tetanus vaccination and the onset of this study) Age 18-35 Adequate hematologic function Absolute neutrophil count > 1,000/mm3 Absolute lymphocyte count > 1,000/mm3 Hemoglobin > 9 gm/dl One or more of the are not met A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months Evidence of active infection requiring antibiotic therapy History of other concurrent diseases Pregnant or lactating women Patients requiring systemic corticosteroids Any other immune disorder including but not limited to other autoimmune diseases like rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis Pregnancy History of radiation therapy, immunotherapy, or chemotherapy Breastfeeding | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-75.0, Hypotension End Stage Renal Disease Intra Dialytic Hypotension Age 20-75 years, inclusive. 2. Presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight. 3. ECG performed up to one month before study start. 4. Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by Serum Bilirubin (Total Bilirubin (direct and indirect) 0.3-1.0 mg/dL, and Direct Bilirubin 0.1-0.5 mg/dL) Serum Albumin (>3.6 g/dL) Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)) GGT (Gamma Glutamine Trans Peptidase) 5. Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count. 6. Willingness to participate in the study and adhere to the study design. 7. Willingness to sign an informed consent form Uncontrolled hypertension >140/90 mmHg. 2. Unstable angina. 3. Abnormal ECG which may indicate acute disease 4. Variable weight gains. 5. Mental retardation. 6. Pregnancy. 7. Malignancy or other concomitant serious diseases. 8. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-60.0, Healthy age 18-60 years serum total cholesterol < 8.0 mmol/L serum triglycerides < 3.0 mmol/L ALAT < 45 IU/L ASAT < 41 IU/L amylase 35-130 U/L alkaline phosphatase 40-125 U/L bilirubin < 17 µmol/L gamma-glutamyltranspeptidase > 75 U/L (men) and < 40 U/L (women) lactate dehydrogenase 230-485 U/L use of cholesterol lowering medication high alcohol intake BMI > 30 chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction) pregnancy | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Hepatocellular Carcinoma Histologically proven hepatocellular carcinoma. 2. HCC underwent curative resection within 6 weeks before registration. 3. Grossly, the resection margin should be > 1 cm. 4. Tumors, either single, < 5 cm in size or no more than 3 for size < 3 cm. 5. Patients must have a performance status of ECOG score < 2. 6. Patients must have adequate liver reservation and adequate hemogram Pugh-Child's Score < 7 The serum total bilirubin level are < 2 mg/dl The prothrombin times are < 3 sec above normal control The platelet are > 7.5 x 104 / mm3 The WBC are > 3,000 / mm3. 7. Patient must have serum creatinine < 1.5 mg/dl 8. Cardiac function with NYHA classification < Grade II 9. HBsAg (+) . 10. Signed informed consent Patients who have non-curative resection are not eligible. 2. Resected HCCs with histologically positive margins are not eligible. 3. HCCs with radiological evidence of portal vein thrombus are not eligible. 4. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. 5. Patients with advanced second primary malignancy are not eligible. 6. Patients with pregnancy or breast-feeding are not eligible. 7. Patients with severe cardiopulmonary diseases are not eligible. 8. Patients with clinically significant psychiatric disorder are not eligible. 9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. 10. Patients who had prior lamividine and/or adefovir dipivoxil therapy are not eligible. 11. Anti-HCV positive patients are not eligible | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-65.0, Gastroesophageal Reflux Heartburn Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included Before blood will be drawn and the following blood count, liver, pancreas, kidney, thyroid and coagulation parameters will be examined Creatinine (0.5 3 mg/dl) Alc. Phosphatase (38 U/l) GGT (0 U/l) ALAT (0 U/l) Any acute or chronic disease Heartburn more than once weekly Alcohol consumption of more than 50 g ethanol-equivalent per week Smoking Known hypersensitivity against esomeprazole Benzimidazole or other ingredients of the medication Fructose-intolerance Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Contrast Induced Nephropathy individuals aged 18 years or older with stable serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography during the next 24 hours of hospitalization and were available until 5 days after the procedure for serum creatinine measurements serum creatinine levels of more than 8 mg/dl previous history of dialysis eGFR < 20 emergency catheterization recent exposure to radiographic contrast agents (within previous two days of the study) radiocontrast agent dosage needed more than 300 cc during the procedure allergy to radiocontrast agent pregnancy administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study need for continuous hydration therapy (e.g. sepsis ) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-10.0, Extraocular Retinoblastoma Patients must have histologic or cytologic verification of extra-ocular retinoblastoma; extra-ocular disease includes orbital disease, optic nerve involvement at the surgical margin, regional nodal disease, and/or overt distant metastatic disease (at sites such as bone, bone marrow, liver and/or the central nervous system); patients with trilateral retinoblastoma will also be included in this protocol Patients with a CNS lesion consistent with trilateral or stage 4b disease may be enrolled without tissue confirmation if (1) unequivocal leptomeningeal disease is present on brain or spine magnetic resonance imaging (MRI) scan and/or (2) the primary tumor is at least 2 cm in diameter, predominantly solid, and demonstrates enhancement on the post-gadolinium images; however, even in such cases surgery should be given serious consideration 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 No prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma may have been administered prior to entering this study; prior treatment (chemotherapy and/or radiation therapy) for intra-ocular retinoblastoma is permissible Peripheral absolute neutrophil count (ANC) >= 750/uL If the ANC and/or platelet count are not adequate, but due to bone marrow metastatic disease, these will be waived Platelet count >= 75,000/uL (transfusion independent) If the ANC and/or platelet count are not adequate, but due to bone marrow metastatic disease, these will be waived Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows 4 mg/dL (1 month to < 6 months of age) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Immunosuppression in Solid Organ Transplant First time recipient of deceased donor liver transplant Age 18-70 Hepatitis C virus (HCV) positive recipients For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52) Target Disease Exclusions: Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age < 12 or > 65 years d) Non heart-beating donors e) Anticipated cold ischemia time > 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative Medical History and Concurrent Diseases 1. Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation 2. Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease [MDRD]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment. 3. Subjects with known HIV 4. Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years. 5. Subjects with a history of cancer within the last 5 years Allergies and Adverse Drug Reactions a) Hypersensitivity to any medications that will be used in the protocol Prohibited Treatments and/or Therapies 1. Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease 2. Subjects who received maintenance corticosteroids at a dose of > 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease 3. Subjects who have used any investigational drug within 30 days prior to the Day 1 visit 4. Subjects previously treated with belatacept | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Methamphetamine Dependence Methamphetamine Abuse Be volunteers who meet DSM-IV for methamphetamine abuse or dependence determined using a Mini-International Neuropsychiatric Interview (MINI) and be non-treatment seeking at time of study and have a positive urine test for methamphetamine (greater than or = to 500 ng/mL) during screening Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures Have a negative urine test for methamphetamine and other drugs of abuse (opiates, cocaine, and benzodiazepines) after clinic intake before the first infusion session Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the site Principal Investigator Have vital signs as follows: resting heart rate between 45 and 100 bpm, systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg Have electrolytes (Na, K, Cl, HCO3) and hematocrit that is clinically normal (+/ of laboratory limits) Have liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) less than three times the upper limit of normal Have kidney function tests (creatinine and BUN) less than twice the upper limit of normal Have an ECG performed that demonstrates sinus rhythm between 45 and 100 beats per minute (bpm), normal conduction, and no clinically significant arrhythmias Please contact site for more information | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Respiratory Distress Syndrome Term intrauterine gestations beyond 37 completed weeks with dating calculated by their sure last menstrual period (LMP) using Negel's rule or utilizing a first trimester crown rump length ultrasound Women with a previous C/S scheduled for repeat C/S Women who are undergoing a scheduled C-Section for malpresentation Presence of gross blood in amniotic sample Hematocrit count greater than 1% on ADVIA 2120 Presence of meconium in sample Patients with oligohydramnios defined as an amniotic fluid index of less than 5 cm or polyhydramnios defined as an amniotic fluid index of more than 24 cm | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-30.0, Ewing Sarcoma of Bone Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue Newly diagnosed disease Disease confirmed by biopsy only with no attempt at complete or partial resection Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy No esthesioneuroblastoma Localized disease, including any of the following sites Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules No contralateral pleural effusions or pleural nodules Regional lymph nodes that are clinically suspicious or confirmed by biopsy No distant lymph node metastases | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 2.0-65.0, Visceral Leishmaniasis Children and adults 2-65 years of age (inclusive) of either gender Diagnosis of VL confirmed by spleen or bone marrow aspirate Clinical signs and symptoms compatible with VL Biochemical and haematological test values as follows Haemoglobin > 3.5g/100mL White blood cell count > 0.75 x109/L Platelet count > 40 x 109/L AST, ALT and alkaline phosphatase < 5 times upper normal limit Prothrombin time < 4 seconds above control Serum creatinine levels A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up Proteinuria (> 2+) A history of allergy or hypersensitivity to amphotericin B Previous treatment for VL within two weeks of enrollment into the study Prior treatment failures with amphotericin B | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-168.0, Hyperbilirubinemia Neonates born at 35 or more completed weeks of gestation with clinical jaundice and age between 25 to 168 hours Neonates with Rh hemolytic disease those requiring NICU admission for more than 24 h having major congenital malformation or having received phototherapy | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Premature Birth Mother and Father, if named on the birth certificate application, are English speaking If mother and Father are married, husband is the man identified as the father on the birth certificate application Documentation of Informed Consent for Mother and newborn. Father named on the birth certificate application must consent for newborn to participate Mother's age (and Father if named on the birth certificate application) is 18 years of age or older Infant is a singleton, inborn newborn Newborn gestational age assessment documented in the health record between 23 weeks 0/7 days and 36 weeks 6/7 days Newborn gestational age assessment documented in the health record > 37 weeks and 0/7 days Mother identifies herself as Black or African American on the birth certificate application Mother (or Father identified on the birth certificate application) refuses to sign informed consent Mother (or Father identified on the birth certificate application) does not speak English Father, identified on the birth certificate application, objects to infant's participation Husband is not the father named on the birth certificate application Mother (or Father, if named on the birth certificate application) is less than 18 years of age Mother fails to identify her ethnic group as Black or African American on the birth certificate application Mother is cognitively impaired as a result of receiving narcotic analgesia within four hours of the time the research is explained, consent explained, or the interview is conducted Mother is documented to be cognitively impaired by her physician in the medical record Father appears to be cognitively impaired at the time the research is explained, consent explained, or the interview is conducted Mother or infant has a history of blood transfusion in the last six months | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Premature Birth Fullterm group birth weight higher than 2,500 g appropriate for gestational age gestation age within 38 and 42 weeks chromosomal or congenital abnormalities Preterm group birth weight less than 1,500 g gestational age less than 37 weeks admission at the hospitals within 7 days after birth chromosomal or congenital abnormalities | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-999.0, Non-small Cell Lung Cancer (NSCLC) Age ≥20 years Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC) Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent No prior chemotherapy-containing regimens for the treatment of NSCLC Eastern Cooperative Oncology Group performance status of 0-1 Life expectancy of at least 12 weeks Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1 Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy) Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug Women pregnant or breast feeding Women with a positive pregnancy test result on enrollment or prior to study drug administration Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine) Common Terminology (CTC) Grade 2 or greater neuropathy Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible) Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-30.0, Neonatal Jaundice Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life Rh incompatibility Those given exchange transfusion/ phototherapy within 24 h of age Major gross congenital anomaly Anticipated to require neonatal intensive care or required neonatal intensive care for more than 24 h Systemic sepsis | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.038, Jaundice, Neonatal All near term (35 and 36 weeks gestational age) and term (37 to 41 weeks) babies living in Alberta Capital Health (CH) region Born at any Capital Health or Caritas delivery facility(Royal Alexandra Hospital, Grey Nuns Community Hospital, Misericordia Community Hospital, Sturgeon Community Hospital, Fort Saskatchewan Health Centre, and WestView Health Centre) Discharged home from the nursery within 96 hours of life Babies who do not live in CH region Babies born at less than 35 weeks gestational age Babies initially admitted to a Special Care Nursery (SCN) or a Neonatal Intensive Care unit (NICU) for more than 72 hours Babies born to opting-out mothers will also be excluded | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Premature Infants Preterm infants born at <28 weeks gestation will be eligible for enrollment in this study Infants with fetal malformations, chromosomal anomalies, and clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia) will be excluded, other | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Scleroderma Target Population meet American College of Rheumatology (ACR) for scleroderma have clinical evidence of active skin disease with a skin score of ≥15 have had the onset of their first non-Raynaud phenomenon feature of SSc no more than 3 years prior to screening have evidence of fibrosing alveolitis (active pulmonary fibrosis) manifested by a forced vital capacity (FVC) between 45% and 80% of predicted normal and/or diffusing capacity (DLCO) between 30% and 70% of predicted normal values have an abnormal high resolution Computed tomography (CT) scan of the chest/lungs demonstrating typical ground glass changes of alveolitis with background fibrosis have adequate renal function no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine < 3 mg/dL for both sexes, must use an acceptable form of birth control age ≥ 18 Clinically significant pleural or pericardial effusion in the previous 12 months: Grade 3 or 4. Patients with recent Grade I or II effusions or peripheral edema will be permitted to enter the study Clinically significant cardiac disease (New York Heart Association Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, cardiomyopathy, or pericardial disease Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease) Abnormal QTcF interval prolonged (> 450 msec) after electrolytes have been corrected on baseline electrocardiogram Laboratory Test Findings Hgb < 10 g/dL; platelet count < 100,000/dL; WBC < 3,000/dL; PMN < 1,000/dL; OR lymphocytes < 350/dL The presence of any of the following laboratory findings at screening: positive for antibodies to hepatitis C virus; positive for antibodies to hepatitis B surface antigen (HBsAg); serum bilirubin 2 times normal, Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST)> 2.5 times upper limit of normal Prohibited Treatments and/or Therapies use of other immunosuppressive therapies must be discontinued at enrollment, eg methotrexate, azathioprine, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, cyclosporine treatment with any other experimental or investigational drug(s) concurrently or less than 12 weeks prior to study enrollment use of anti-fibrotic agents must be discontinued at enrollment, eg colchicine, D-penicillamine, minocycline or Type 1 oral collagen | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Premature Neonates Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation Require thermoregulatory support Are able to take feeds Are presumed to be able to take oral feeds in the future Preterm infants less than 26 and 0/7 weeks gestation Preterm infants greater than 34 and 6/7 weeks gestation Infants that do not require thermoregulatory support Infants that will not be able to have enteral feeds Infants with endocrine disease Infants with congenital anomalies Infants with grade 3 or 4 intraventricular hemorrhage or other severe neurologic disability Infants requiring long-term sedation Infants that die within 7 days of birth | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Intrauterine Growth Restriction Phase I Healthy expecting mothers two weeks from their expected due dates No evidence of IUGR No evidence of fetal problems Phase II: 1. Expecting mother with a fetal diagnosis of intrauterine growth restriction (IUGR) defined by estimated fetal weight <10th percentile for gestational age 2. 24 weeks gestation Major congenital abnormalities 2. Known fetal chromosomal disorder 3. Maternal illicit drug use 4. Maternal IV and Hepatitis C infection 5. Premature rupture of membranes | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Non Small Cell Lung Cancer (NSCLC) Written informed consent conforming to the institutional guidelines obtained from the patient A diagnosis of non-small cell lung cancer (NSCLC), subjects will undergo or have had surgical resection Age 18 or above Karnofsky performance status > 70 Adequate hematologic function Absolute neutrophil count > 1,000/mm3 Absolute lymphocyte count > 1,000/mm3 Hemoglobin > 9 g/dL Platelets > 100,000/mm3 Liver function tests Subjects will be from participation in the study if any of the following apply One or more of the are not met A significant history or current evidence of cardiac disease including, but not limited to: congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrythmias or myocardial infarction within the previous six months Evidence of active infection requiring antibiotic therapy Active intracranial metastases. Patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been stable for four weeks are eligible Pregnant or lactating women. Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on study Patients requiring systemic corticosteroids (unless patient has had NO IN THE PAST 4 WEEKS) Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis Patient must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment Subject is not a candidate for complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, extended wedge resection or anatomic segmentectomy with or without sleeve resection as noted in the surgical plan | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 22.0-35.0, Influenza mothers at the beginning of second trimester (i.e. approximately 12 weeks of gestation) willing to stay in Dhaka during pregnancy and willing to admit in the clinic at delivery the gestational age will be determined by self-reported LMP, which is likely be underestimated in most cases. A two-week variation will be acceptable in this proposed study history of systemic disease previous complicated pregnancies or of pre-term delivery abortion congenital anomaly hypersensitivity to influenza vaccine or receipt of the vaccine | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-21.0, Hematologic Malignancies Age less than or equal to 21 years old; may be greater than 21 years old if a previously treated St. Jude patient and within 3 years of completion of most recent prior disease specific therapy One of the following refractory hematologic malignancies (chemoresistant relapse or primary induction failure) or diagnoses ALL AML (>25% blasts in the bone marrow) secondary AML/MDS CML in accelerated phase or blast crisis juvenile myelomonocytic leukemia (JMML) myelodysplastic syndrome (MDS) Hodgkin or non-Hodgkin lymphoma (NHL) with residual or recurrent disease following autologous HSCT, who are unable to undergo autologous HSCT due to chemo-resistant disease or inability to have an acceptable quantity of tumor-free stem cells collected (> 1 x 108 TNC/kg marrow or > 1 x 106 CD34+/kg PBS patients with a hematologic malignancy who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of medical faculty (Division of Bone Marrow Transplantation and Cellular Therapy) makes standard myeloablation prohibitive | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Parenteral Nutrition Associated Liver Disease PNALD Cholestasis Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment Signed patient informed consent Parent or guardian or child unwilling to provide consent or assent Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program Allergies or clinical conditions precluding safe use of Omegaven™ | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-48.0, Hyperbilirubinemia, Neonatal Babies may only participate if they meet all the following Is a term or late preterm baby Is at risk for protocol-defined hemolytic disease Weighs at least 2500 g (5.5 lbs) Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age Has parents/guardians who are willing to follow light precautions and sign informed consent The following will make a baby not eligible to participate Needs medications that may prolong the QT interval Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias Has an Apgar score of 6 or below at age 5 minutes Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, ABO Incompatibility Hemolytic Disease of Newborn Neonatal Jaundice Neonatal Hyperbilirubinemia written informed consent mother blood type O mother Rh + healthy infants ≥37 wks gestation ≥ 2500 gm birth weight Apgar ≥5 at 1 and 5 minutes major anomalies infants evaluated for sepsis or infants with transitional respiratory problems requiring >6 hrs observation in the NICU significant birth trauma with continued bruising and/or sequestration of blood still evident at the time of discharge known perinatal blood loss with hemodynamic consequences such as persistent tachycardia, need for fluid boluses or supplemental oxygen neonatal anemia with Hb<13.5g/dL known family history of hereditary hemolytic disease such as G6PD deficiency, hereditary spherocytosis or hereditary elliptocytosis | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Osteoarthritis of the Hip All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem. 2. Patients with hip fracture undergoing THA will also be included. 3. Patients willing and able to comply with follow-up requirements and self-evaluations | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Abortion Rate Female resident of Interior Health region seeking an abortion between January 1, 2001 and December 31, 2004 Women undergoing abortions for fetal genetic abnormalities | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Jaundice Breastfeeding Mothers of infants admitted during the study period with hyperbilirubinemia, breastfeeding at the time of admission (any amount of breastfeeding) Mothers of infants < 1 month of age at the time of admission Mothers of infants admitted with hyperbilirubinemia who are exclusively formula-fed Mothers of infants with hyperbilirubinemia of the predominantly conjugated type as this is a different disease, not associated with breastfeeding difficulties Mothers of infants with anatomical abnormalities, such as cleft lip or palate, as this would interfere with breastfeeding and require more intensive intervention Mothers of neurologically impaired infants as breastfeeding may be more difficult in this population Mother of infants who were admitted to the Neonatal Intensive Care Unit (NICU) after birth and never went home as they are likely to have other comorbidities affecting feeding Mothers of infants feeding via naso-gastric, naso-jejunal, or gastric tube Mothers of infants > 1 month of age Mothers who have had breast surgery in the past Foster mothers or adoptive mothers Mothers who do not understand English or French | 2 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 1.0-11.0, Cockayne Syndrome Pediatric patients with a documented diagnosis of CS, as suggested by clinical features and possible confirmation by genetic consultation and analysis Age of participation At least 12 months of age at the time of signing Informed Consent/Assent Female patient's age will not be greater than 10 years of age at the time of signing Informed Consent/Assent Male patient's age will not be greater than 11 years of age at the time of signing Informed Consent/Assent Severe contractures or physical deformities that in the opinion of the investigator would prevent accurate measurement of height, length and ulna length Patients that have taken growth hormone or growth hormone related medications within 12 months prior to the date of Informed Consent/Assent Known history of inborn error of hyperprolinemia (Type I or Type II) Clinical features present at the time of initial screening that are associated with the terminal phases of the natural progression of CS suggesting safe travel and completion of the study and its assessments to be unlikely as judged by the Investigator, including any of the following Continuous or intermittent dependence on supplemental oxygen at home during the prior six months Two or more hospitalizations for pneumonia during the prior 12 months A documented net weight loss of at least 10%, which has not been recovered and which includes a significant net weight loss (beyond the estimated error of the measurement) over the most recent 6 months, despite intensive nutritional support including the use of gastrostomy tube feedings Presence of scoliosis with a Cobb's angle of 30º or greater | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.5, Cleft Palate Infants with isolated cleft palate Medically fit for operation at 6 months, corrected for gestational age Written informed proxy consent One parent/carer a native language speaker in the country of residence Consent not obtained b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay Congenital sensorineural hearing loss or middle ear anomalies Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988) Where the language spoken at home is not the majority language in the country of residence | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-40.0, Healthy Healthy adult, aged between 20 to 40 years old Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest X-ray and electrocardiogram The normal range of the body mass index should between 18.5 and 24.9; body mass equals [weight(Kg)]/[height(m)]2 Normal laboratory determinations results (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO, HBsAg and Anti-HCV Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria Female subject who is using adequate contraception since last menstruation and no plan for conception during the study Female subject who is non-lactating Female subject who has negative pregnancy test (urine) within 14 days prior to the study Informed consent form signed A recent history of drug or alcohol abuse Medical history of allergic asthma or sensitivity to analogous product A clinically significant illness within the past 4 weeks Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks Ongoing peptic ulcer and constipation Planed vaccination during the time course of the study Participation of any clinical investigation during the last 60 days Regular use of any medication during the last 4 weeks Single use of any medication during the last one week Blood donation of more than 500 mL within the past 12 weeks | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 40.0-70.0, Hypertension Age: 40 to 70 years old Untreated patients or those on monotherapy of antihypertensive drugs but with uncontrolled blood pressure in the ranges of 140-160/90-100 mmHg Patients on antihypertensive medication should discontinue their antihypertensive treatment for at least 4 weeks. During the 4 weeks run-in period, all patients should have 2 clinic visits. At each visit, blood pressure will be measured 3 times consecutively. The average of these 6 readings from 2 clinic visits should be in the range of 140-180 systolic or 90-110 diastolic mm Hg. 24-h mean blood pressure should be equal to or higher than 130 mm Hg systolic and 80 mm Hg diastolic The patients should sign the consent form prior to the participation in the trial, adhere to the study design, and can visit the outpatient clinic on his/her own With life-threatening disease With myocardial infarction or stroke in the last 2 years With contraindications to a dihydropyridine calcium channel blocker Current participation in another trial or trials | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Acute Myeloblastic Leukemia For intensive chemotherapy: 1. Patients with the novo AML or secondary to MDS or previous treatment, regardless of age. 2. Signed written informed consent. 3. ECOG ≤ 2. If ECOG is greater than 2 due to AML, the patient can be included in the study. 4. LVEF > 40 % measured by means of echocardiography. 5. If background of respiratory disease (not related to the AML), risk factors or clinical for COPD, the values of functional tests, including DLCO, should be greater than 50% of the expected. 6. Bilirubin, alkaline phosphatase and ALT < of 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML). 7. Serum creatinine < 2,5 mg/dL providing that it is not due to the disease that motivates the treatment (AML). 8. In fertile aged women, negative pregnancy test and use of contraception methods are required. Any patient who does not meet the and for treatment with intensive chemotherapy can be evaluated individually when considering that could still obtain benefit from this treatment considering that could still obtain benefit from this treatment. for GO administration in patient candidates for intensive chemotherapy Same for intensive chemotherapy, including the following specifications: 1. CD33 positive (more than 5 % of the leukemic population) 2. for treatment with GO in cases of serious hepatic disease not due to AML. 3. In patients who are going to receive GO in two cycles, the second one will be only administrated if the toxicity due to the first cycle is recovered. 4. Though the GO administered dose is much lower than usual, it is recommended a period of two months between GO administration and hematopoietic stem cell transplantation (HSCT). for the modification of high dose ARA-C The dose of Ara-C in cycles containing HiDAC should be reduced in the following cases: 1. The hematopoietic recovery in the previous cycle has been longer than 28 days. 2. Presence in the previous cycles of a confluent maculopapular rash or drug-induced shedding. 3. More than 4 episodes of watery diarrhea per day. 4. Increase of 4 fold the previous normal value of aminotransferases or alkaline phosphatase in any of the cycles. 5. Total bilirubin greater than 3 mg/dL in any of the cycles. 6. Treatment with HiDAC will be definitively suspended (even that included in the BEA conditioning) when previous toxicity severe cerebellar ataxia, confusion or another sign of central nervous toxicity that has not another clear explanation Patients with blastic crisis of a chronic myeloid leukemia or other myeloproliferative syndromes evolving to acute leukemia. 2. Patients with AML in relapse. 3. Acute promyelocytic leukemia (M3 or M3v). 4. Absence of signed written informed consent. 5. ECOG ≥ 3 that it is not due to the disease that motivates the treatment (AML). 6. LVEF < 40 % determined by echocardiography study. 7. Values of respiratory functional tests, including DLCO, lower than 50% of the expected. 8. Bilirubin, alkaline phosphatase or GOT > 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML). 9. Serum creatinine > of 2.5 mg/dL providing that it is not due to the disease that motivates the treatment (AML). 10. Positive pregnancy test or not use of effective contraception in fertile aged women. 11. Previous treatment with antileukemic chemotherapy, except hydroxyurea. 12. Presence of an active neoplasia different from the AML. 13. Presence of a serious psychiatric disease. 14. Positive HIV test. 15. Any other condition which limits or dissuades from the treatment with intensive chemotherapy, especially with anthracyclines | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-1.0, Clubfoot All otherwise healthy babies who need casting for congenital clubfeet All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcers Foot Wounds The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart Subjects 18 years of age or older. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the investigator, will not interfere with the study assessments Willing to make all required study visits Able to follow instructions and perform the dressing changes at home, or, have a caregiver who can perform the dressing changes according to the protocol Willing to use the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase A history of Type I or Type II Diabetes Mellitus requiring insulin or oral hypoglycemic medications to normalize blood glucose levels. A foot wound which is Superficial, involving the full skin thickness but not underlying tissues and is 0.5 cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided) Chronic, defined as open for 30 days On a neuropathic foot, defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area Adequately perfused, defined as TcPO2 > 40 mmHg; or toe pressure > 40 mmHg, or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels) Target wound does not require debridement, or is covered with dry eschar Uncontrolled bleeding disorder Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia) Any of the following Target wound tunneling per probing and visual assessment Osteomyelitis of the target foot or wound probes to bone Target wound is on the heel Target wound is over a Charcot deformity which cannot be offloaded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 2.0-75.0, Acute on Chronic Liver Failure Hepatitis B Reactivation of chronic hepatitis B characterized by rise in ALT level >5 times upper limit of normal along with HBV DNA level >105 copies/ml (~1.8x104 IU/ml) presenting as ACLF Acute hepatic insult Jaundice (bilirubin ≥5 mg/dL) and coagulopathy (INR>1.5) Complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease Superinfection with other viruses (Hepatitis E, A, D and C) Coexistent hepatocellular carcinoma (HCC) Portal vein thrombosis Coexistent renal impairment Pregnancy Co-infection with HIV infection or Patients received previous course of any antiviral Immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 month | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-2.5, Transient Tachypnea Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor Late preterm infants (34 1/7 to 36 6/7 weeks gestational age) Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization Need for use of PPV for perinatal depression or other indications Presence of any of the following congenital malformations (diagnosed prenatally) chromosomal anomalies (diagnosed prenatally) congenital heart disease diagnosed by fetal echocardiography | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 26.0-86.0, Patients With Obstructive Jaundice Between January 2009 and January 2010, twenty consecutive patients with an equal distribution of biliary obstruction type (10 malignant and 10 benign) were included into the study Patients over 60 years of age or those with a history of co-morbid cardiac disease were initially evaluated by echocardiography Those with an ejection fraction rate <50% and left ventricular end-diastolic diameter (LVDD) over 52 mm. were excluded from the study because of the already existing left ventricular dysfunction compromising the optimisation of fluid replacement Patients with a history and serologic evidence of acute/chronic parenchymal kidney or liver disease were also excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.005, Hypertriglyceridemia Hyperglycemia All infants will be recruited who are admitted to the Neonatal Intensive Care Unit at Children's Hospital of Illinois A total of 70 ELBW infants classified as Appropriate for Gestational Age (AGA) and who are between 500 grams to 750 grams in weight at birth. Thirty-five infants will be randomized into the control group and thirty-five infants will be randomized into the experimental group Have a baseline triglyceridemia above 200 mg/dl prior to beginning the study Who are classified as Small for Gestational Age (SGA) Who have any congenial anomalies, and/or Who are septic | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.5-0.5, Iron Deficiency Anemia Cognitive Development Motor Development Birth weight >= 3.0 kg single birth no major congenital anomalies no major birth or neonatal complications no emergency c-section no jaundice requiring phototherapy no hospitalization for more than 5 days no chronic illness no iron therapy already started to received some bottle feedings by 6 months of age residence outside identified neighborhoods another infant <12 months in household infant in daycare unstable, illiterate, or psychotic caregiver | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Hyperbilirubinemia, Neonatal Jaundice, Neonatal Newborn infant admitted to normal newborn nursery Informed consent not obtained | 2 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Preterm Delivery Neonatal Complications Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length ≤25 mm, after an episode of preterm labour Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-65.0, Hepatitis C Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules Subjects must be willing to give written informed consent for pharmacogenetic testing, and able to adhere to applicable visit schedules Subjects of either gender and of any race between the ages of 18 and 65 years, inclusive, having a Body Mass Index (BMI) between 18 and 32, inclusive. BMI = weight (kg)/height (m)^2. (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.) Subjects' clinical laboratory tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator and within an allowed expanded range supplied by sponsor. However, subject's liver function test results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) must not be elevated above normal limits at Screening and on Day -1. No rescreening of liver function tests will be allowed Subjects must be free of any clinically significant disease that would interfere with the study evaluations The Screening 12 lead electrocardiogram [ECG] conduction intervals must be within gender specific normal range (e.g, ECG QTcB,measure in males ≤430 msec and QTcB measure in females ≤450 msec, PR interval ≤200 msec) Vital sign measurements (taken after ~3 minutes in a sitting position) must be within the following ranges: (Individuals with values outside of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.) 1. oral body temperature, between 35.0°C and 37.5°C 2. systolic blood pressure, 90 to 140 mm Hg 3. diastolic blood pressure, 45 to 90 mm Hg 4. pulse rate, 40 to 100 bpm Female subjects must be: 1. postmenopausal (defined as 12 months with no menses, age > 40 years and with a follicle-stimulating hormone [FSH] level of >40 u/mL, and serum E2 < 73 pmol/L), or 2. surgically sterilized at least 3 months prior to baseline (eg, documented hysterectomy or tubal ligation), or 3. premenopausal and if unsterilized must have used a medically accepted method of contraception for 3 months (or abstained from sexual intercourse) prior to the screening period, and agree to use a medically accepted method of contraception during the trial (including the screening period prior to receiving trial medication) and for 2 months after stopping the trial medication. An acceptable method of contraception includes one of the following: i. stable oral, transdermal, injectable, or sustained-release vaginal hormonal contraceptive regimen without breakthrough uterine bleeding for 3 months prior to Screening; in addition, during study use of condom and/or spermicide (when marketed in the country). ii. intrauterine device (inserted at least 2 months prior to Screening visit); in addition, during study use of condom and/or spermicide (when marketed in the country). iii. condom (male or female) with spermicide (when marketed within the country), iv. diaphragm or cervical cap with spermicide (when marketed within the country) and condom (male) Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the sponsor prior to enrollment into the trial: 1. history or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; 2. history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; 3. history of pancreatic injury or pancreatitis; 4. history or presence of liver disease or liver injury; 5. history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, blood urea nitrogen [BUN]/urea, urinary albumin, or clinically significant urinary cellular constituents ; or 6. history of urinary obstruction or difficulty in voiding Subject who has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus [HIV] Subjects who have a positive screen for drugs with a high potential for abuse (during the Screening period or clinical conduct of the trial) Subjects with a history of psychiatric or personality disorders that in the opinion of the investigator and sponsor, affects the subject's ability to participate in the trial Subjects with a history of alcohol or drug abuse in the past 2 years Subjects who have donated blood in the past 60 days Subjects who have previously received boceprevir | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-8.0, Infant, Newborn Jaundice Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum) Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost) Birth weight >2500 g Gestational age >37 weeks Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Persistent Fetal Circulation Syndrome Persistent Pulmonary Hypertension of Newborn >= 34 weeks gestational age On mechanical ventilation and/or fraction of inspired oxygen >0.50; and Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient >20 mm Hg >7 days of age | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Esophageal Cancer Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either # 1 or #2 can be met for eligibility). 2. Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established. 3. Performance score Karnofsky Performance Scale (KPS) 80-100. 4. Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation. 5. Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception. 6. Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) >2,500/uL, platelets > 75,000/uL), renal (creatinine clearance > 50 mL/min), and liver function (bilirubin <=1.5 fold the upper limit of normal and liver enzymes < 3 fold the upper limit of normal). 7. Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors >1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated) Prior radiation to the chest 2. Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure. 3. Pregnant or breast-feeding females 4. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration 5. Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-24.0, Transient Tachypnea of the Newborn Gestational age at birth 34 and 42 weeks of gestation 2. Admission to the Mount Sinai NICU during the first 24 hours of life 3. Diagnosis during the first 24 hours of life of transient tachypnea of the newborn Gestational age at birth less than 34 weeks or greater than 42 weeks at birth 2. No diagnosis of TTN made in the first 24 hours of life 3. Additional infant diagnosis of major cardiac disease 4. Additional infant diagnosis of major pulmonary disease other than TTN 5. Additional infant diagnosis of meconium aspiration syndrome 6. Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period 7. Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period 8. Observation of thick meconium in the amniotic fluid at delivery. 9. Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes pre or peri-partum. for removal from the study: (a) Additional infant diagnosis of major cardiac, pulmonary, or other disease process potentially affecting respiratory status in the neonatal period (i.e., infection, meconium aspiration, pneumothorax, congenital anomaly) present during the study period. (b) Positive test of infection (e.g. blood, CSF, or urine culture; viral DFA; microscopy) drawn from infant at any point during the study period. (c) Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes at any point during hospital stay. (d) Objective clinical signs of dehydration: (i) Newborn urine output less than 2 mL/kg/hr over a twelve hour period at any point during the study period. (ii) Newborn serum sodium less than 130 mEq/L or greater than 150 mEq/L at any point during the study period. (iii) Newborn weight loss >10% of birth weight at any point during the study period. (e) Newborn blood glucose by point-of-care testing of less than 40 mg/dL at any point during the study period. (f) Administration of exogenous surfactant at any point during the study period | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Mycoses Age 14~60 years old Allogenic hematological stem cell transplantation(HSCT) patients Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal Informed consent Evidence of proven, probable or possible fungal infection at the time of enrollment Patients were receiving anti-fungal treatment with proven SFI before transplantation A history of hypersensitivity to G-CSF or GM-CSF | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.269, Retinopathy of Prematurity Evidence for ROP that might progress and that includes any one of the following Stage 1 (zone I) Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is according to International Classification of Retinopathy of Prematurity (ICROP) 2005 (40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is not included since it will always regress spontaneously The presence of one or more of the following conditions at enrollment in the study More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [ Atrio-ventricular (A-V) block [2nd or 3rd degree] Significant congenital heart anomaly [not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect] Heart failure Hypotension (mean blood pressure <45 mmHg) Hypoglycemia (<50mg/dL) Platelet count <100000/mm3 | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Metabolic Syndrome Nonalcoholic Fatty Liver Disease Adult men or women (>18 years of age) • Liver -biopsy ( at least 1.7 cm and 4 portal tracts) performed within 6 months of breath test or planned within the next 6 weeks, providing no treatment for liver disease was given between the biopsy and the OBT Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST,ALT, GGT, Alkaline phosphatase) At least one of the features of the metabolic syndrome waist circumference > 100 cm for men, 88 cm for women triglycerides > 150 mg/dl fasting blood sugar > 110 mg/dl HDL cholesterol < 40 mg/dl blood pressure > 130/85 mm Hg No other known co-existent liver disease, excluded by appropriate serologic testing Positive studies for any of the following hepatitis C (PCR) hepatitis B (surface antigen or DNA) iron saturation > 60% + gene test for hereditary hemochromatosis antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and ALT levels>250 U/L Patient has Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl) Patient has alcohol consumption > 20 gm/day for women and > 30 gm/day for men Patient is pregnant Patient has been taking known hepatotoxic drugs e.g. (e.g.acebutolol, indomethacin,phenylbutazone,allopurinol,isoniazid,phenytoin,atenolol,ketoconazole ,piroxicam,carbamazepine,labetalol,probenecid,cimetidine,maprotiline,pyrazinamide ,dantrolene, metoprolol,quinidine,diclofenac, mianserin)• Patients that have had more than 10% reduction in body weight since biopsy Patient with known severe congestive heart failure (LVEF on echocardiogram < 20%) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Peritoneal Dialysis Pioglitazone Hypertriglyceridemia Insulin Resistance Inflammation All patients received more than one month regular continuous ambulatory peritoneal dialysis(CAPD) or intermittent peritoneal dialysis(IPD). The causes of chronic renal failure were diabetes and non-diabetes.- history of allergy to thiazolidinediones and fenofibrate; history of any sever adverse event for fibrate that can't be tolerated by the patients; patient can not be follow-up regularly; history of myocardial infarction(MI) or coronary artery bypass graft (CABG) surgery within the past 1 month, history of cerebral vascular accident (CVA) or percutaneous transluminal coronary angioplasty(PTCA) within the past 6 months; chronic use of non-steroidal anti-inflammatory drugs(NSAIDs), steroids or immunosuppressives; patient with the acute infection; patient with malignant tumor; have the evidence of severe hepatic injury (ALT/AST>100u/L).- | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-24.0, Transient Tachypnea of the Newborn gestational age ≥ 35 weeks diagnosis of TTN, defined as respiratory rate >60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates admission to the NICU at Mount Sinai hospital within first 24 hours of life gestational age < 35 weeks history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome diagnosis of major congenital pulmonary or cardiac anomalies initial CXR demonstrating air leak respiratory distress first occurring after 24 hours of life presumptive diagnosis of RDS as indicated by the need for FiO2 > 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Pregnancy Related Trauma Abruptio Placentae Singleton intrauterine pregnancy ≥20 weeks and ≤35 weeks gestational age Chief complaint of minor maternal trauma including motor vehicle accident, patient fall or assault with absence of maternal conditions outlined in Maternal shock Unstable vital signs Altered sensorium Head injury resulting in coma signs or symptoms of intraperitoneal bleeding Emergency laparotomy for fetal or maternal indications Bone fractures History of previous abruptio placenta Known or suspected placenta previa Rupture of membranes | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, NAFLD Adult men or women (>18 years of age) Liver -biopsy ( at least 1.7 cm and 4 portal tracts) performed within 6 months of breath test or planned within the next 6 weeks, providing no treatment for liver disease was given between the biopsy and the OBT Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST,ALT, GGT, Alkaline phosphatase) At least one of the features of the metabolic syndrome waist circumference > 100 cm for men, 88 cm for women triglycerides > 150 mg/dl fasting blood sugar > 110 mg/dl HDL cholesterol < 40 mg/dl blood pressure > 130/85 mm Hg No other known co-existent liver disease, excluded by appropriate serologic testing Positive studies for any of the following hepatitis C (PCR) hepatitis B (surface antigen or DNA) iron saturation > 60% + gene test for hereditary hemochromatosis antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and ALT levels>250 U/L Patient has Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl) Patient has alcohol consumption > 20 gm/day for women and > 30 gm/day for men Patient is pregnant Patient has been taking known hepatotoxic drugs e.g. (e.g.acebutolol, indomethacin,phenylbutazone,allopurinol,isoniazid,phenytoin,atenolol,ketoconazole ,piroxicam,carbamazepine,labetalol,probenecid,cimetidine,maprotiline,pyrazinamide ,dantrolene, metoprolol,quinidine,diclofenac, mianserin)• Patients that have had more than 10% reduction in body weight since biopsy Patient with known severe congestive heart failure (LVEF on echocardiogram < 20%) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Neonatal Sepsis Infants with late-onset neonatal sepsis Infants without parents' consent | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-96.0, Hyperbilirubinemia, Neonatal Healthy infants ≥ 35 weeks Neonates 36-96 hours old Exclusively breastfeeding TSB 0.1-3 mg/dl below AAP-recommended PT threshold TSB < 6 hours ago Mothers English-speaking or Spanish-speaking Infants who have already received formula Infants who have received or are receiving Level II or Level III Infants who have already lost ≥ 10% birth weight Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Splenomegaly Hepatomegaly Informed consent will be obtained from the patient or the parents before any study related procedures Patients of both gender from the first day of life The patient has a diagnosis of Gaucher disease or high-grade suspicion for Gaucher disease High-grade suspicion present, if one or more are valid: 1 Positive family anamnesis for Gaucher disease 2 Splenomegaly without identifiable cause 3 Hepatomegaly without identifiable cause 4 Anemia or thrombocytopenia without identifiable cause 5 CNS involvement without identifiable cause No Informed consent from the patient or the parents before any study related pro-cedures No diagnosis of Gaucher disease or no valid for high-grade suspicion of Gaucher disease | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.003, Hepatitis B Three types of subject: Neonates whose mothers are positive for both HBsAg and HBeAg Neonates whose mothers are positive for only HBsAg Neonates whose mothers are negative for both HBsAg and HBeAg Full-term neonates with gestational age from 37 weeks to 42 weeks Apgar scores are no less than 7 at birth Neonates with standard body temperature (auxiliary temperature < 37.1°) Neonates weighing ≥ 2,500 grams at birth Neonates with icteric index within the normal range (physiologic jaundice is permitted) Informed consent form signed by parent/guardian The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator Subject's parent has a history of family diseases such as convulsion and brain diseases Mothers have low immunologic function or a history of organ transplantation or hemodialysis Subject's parent is allergic to any composition of Hepatitis B vaccine A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection Known immunologic function damage Mothers had received gamma globulin or immunoglobulin injection during pregnancy Any congenital malformation Known or suspected to suffer from diseases such as active infection and cardiovascular disease Any condition believed by the investigator to have possible impact on trial evaluation | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-45.0, Coronary Artery Disease Healthy male subjects aged 20 years With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9} Agreement with written informed consent Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present) Subject with symptoms of acute disease within 28 days of starting administration of investigational drug Subject with known for history which affect on the ADME of drug Clinically significant active chronic disease Inadequate result of laboratory test (especially, Platelet count < 150,000, Platelet count > 350,000, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL) Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test Taking OTC(Over the counter)medicine including oriental medicine within 7 days Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication) Subject with known for hypersensitivity reaction to clopidogrel or aspirin analog Not able to taking the institutional standard meal Previously make whole blood donation within 60 days or component blood donation within 30 days | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-45.0, Healthy 45 years old, healthy adult male subject >55 Kg(Body weight) and < ideal body weight ± 20% AST or ALT > 1.25 * Upper normal range (Lab) Total bilirubin > 1.5 * Upper normal range Systolic BP >140 OR <100, Diastolic BP >90 OR <65 | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-50.0, Cocaine Dependence Subject provides signed and dated, written informed consent before any study-specific procedures are performed, including washout of any medications. Subjects will be asked to meet the food, beverage and physical activity restrictions required for the screening visit prior to signing consent. 2. Subject is a healthy adult male aged 18 to 50 years, inclusive, at the time of consent. 3. Subject has a body weight of at least 50 kg and a body mass index (BMI) in the range of 18 to 30 4. Subject has a negative prestudy urine drug screen and no history of use of illicit drugs within 12 months of the screening visit or other substances of abuse within 12 months of the screening visit. 5. Subject has not used tobacco for at least 90 days prior to screening. 6. Subject has no history of any cardiovascular disease and no clinically significant ECG results at screening. 7. Subject is negative for hepatitis C (HCV) antibodies, hepatitis B (HBV) surface antigen, and human immunodeficiency virus (HIV) at screening. 8. Subject is in good general health in the opinion of the Clinic Principal Investigator and as determined by medical history, physical examination, orthostatic vital signs (supine, sitting, and standing blood pressure and heart rate; supine respiratory rate and oral temperature), 12-lead ECG, and clinical laboratory tests at screening. Additionally, the subject's clinical laboratory test results must meet the following Within normal limits: Reticulocyte count Within upper limit of normal and not clinically significantly below the lower limit of normal: Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Gamma glutamyl transferase (GGT) Prothrombin time (PT) Activated partial thromboplastin time (aPTT) Serum troponin I Blood urea nitrogen (BUN) Creatinine Bilirubin, total Alkaline phosphatase Creatine kinase Lactate dehydrogenase (LDH) No clinically significant abnormalities: Sodium Protein, total Calcium Chloride Phosphorus Albumin Globulin Cholesterol Triglycerides Red blood cells (RBC) White blood cells (WBC) Hematocrit Hemoglobin Platelets Glucose Potassium WBC differential RBC indices Uric acid Urinalysis 9. Subject is willing to use barrier contraception with spermicide during sexual intercourse and is also willing to not donate sperm while enrolled in this study and for at least 90 days after receiving his dose of study drug. 10. Subject is willing and able to comply with study instructions and restrictions and is available to complete the study assessments as required by the protocol 11. Subject is fluent in English Subject has a history or evidence of hepatic, GI, renal, respiratory, ophthalmic, cardiovascular, hematologic, endocrine/metabolic, neurologic, immunologic, oncologic, or psychiatric illness or significant abnormalities; OR other condition(s)/surgical intervention(s) known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 2. Subject has a clinically significant abnormal ECG at screening or prior to dosing. Multiple premature atrial contractions or multiple premature ventricular contractions (PVCs), with the exception of non-clinically significant unifocal PVCs, are considered clinically significant, as are bundle branch blocks, second or third degree heart block, or any arrhythmia other than respiratory sinus arrhythmia. 3. Subject has one or more ECG parameters outside the following ranges at Screening or just prior to dosing: Heart rate less than 55 or greater than 100 beats per minute (bpm), PR interval less than 120 or greater than 180 msec, QRS duration less than 70 or greater than 100 msec, QT interval (Bazett) greater than 420 msec 4. One or more of the Subject's supine vital signs are outside the ranges specified below Systolic blood pressure: 90-140 mmHg, inclusive Diastolic blood pressure: 60-90 mmHg, inclusive Heart rate: 55-100 beats per minute (bpm), inclusive Respiratory rate: 12-20 breaths per minute, inclusive Oral temperature: 97.0-99.7 degrees Fahrenheit, inclusive 5. Subject has a history or current evidence of early cardiac repolarization. 6. Subject has a history or family history of QT prolongation, arrhythmia, or uncontrolled hypertension. 7. Subject has a history of seizure, head injury, neurosurgery or brain trauma, or a family history of nontraumatic seizure. 8. Subject has an infection of any type or clinically significant abnormality identified by the screening medical or laboratory evaluations. 9. Subject has consumed alcohol within 48 hours prior to the screening visit or is unwilling to discontinue alcohol consumption within 48 hours of being admitted to the clinic. 10. Subject has a history of significant alcohol consumption, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units, with 1 unit equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine. 11. Subject is unwilling to discontinue the consumption of caffeine containing beverages 72 hours prior to clinic admission. 12. Subject has consumed or is unwilling to abstain from consuming grapefruit or grapefruit-, poppy seed-, or quinine-containing substances, within 14 days of clinic admission. 13. Subject has used a prescription medication within 30 days prior to receiving his dose of study medication; or has used nonprescription medications, dietary supplements, or herbal supplements within 14 days of receiving his dose of study medication, with the exception of acetaminophen, which may be taken up to 24 hours prior to dosing. 14. Subject has had any acute GI illness or infection within 14 days prior to receiving his dose of study medication. 15. Subject has participated in an investigational trial within 45 days prior to receiving his first dose of study medication. 16. Subject is unable to donate blood, has a clotting disorder(s), or has donated blood or lost a significant amount of blood within 8 weeks prior to screening. 17. Subject has an unexplained weight loss or gain (greater than 10 percent) within 30 days prior to screening. 18. Subject has an allergy to or has experienced side effects with opioid antagonists 19. Subject is unable to respond to or recognize potential side effects of the study drug. This may but is not limited to, subjects with a mental illness or disorder. 20. Subject has any condition or set of circumstances not otherwise excluded that in the judgment of the Clinic Principal Investigator could interfere with the subject's ability to comply with the protocol requirements and restrictions and completion of study evaluations, or could pose safety risks to the subject. 21. Subject has performed strenuous exercise within 48 hours prior to the screening examination or refuses to abstain from strenuous exercise from the date of consent provision until the completion of the follow-up visit | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.038, Jaundice, Neonatal Subjects will be eligible to participate in the study if all of the following conditions exist: 1. At time of birth, infant is > 35 weeks gestation (or > 2.2 kg if gestational age is not available 2. Infant is < 14 days old at the time of enrollment 3. At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below the level recommended for high-risk infants per AAP guidelines or higher 4. Parent or guardian has given consent for the infant to participate Subjects will be excluded from participation in the study if any of the following conditions exist at the time of enrollment: 1. Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit. 2. Infants with a life-expectancy of < 24 hours 3. Infants requiring oxygen therapy 4. Infants clinically dehydrated or sunburned 5. Infants with a temperature < 35.5 or > 38 degrees Centigrade 6. Infants with ABE on clinical exam 7. Infants meeting the for EBT | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Sepsis Severe Sepsis Age 18 or older Suspected infection or more of SIRS Heart rate >90/min Respiratory rate >20/min Temperature >= 38° C or <= 36° C White blood count > 12,000 or < 4,000/µL or more of the following signs of end-organ dysfunction Systolic blood pressure < 90 mm Hg Mean arterial blood pressure (MAP) < 65 mm Hg GI bleed Need for urgent surgery | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Mild Cognitive Impairment Alzheimers Disease Cognitive impairment with a MMSE score of 24 or better Depression score below 9 both on MADRS and Cornell Acute or chronic disease with CRP above 10 Lewy Body Dementia or Frontal Lobe Dementia Dementia due to a known brain vascular disturbance, hemorrhage or thrombosis Patients who had not stopped their intake of vitamins and food additives the last four weeks | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 40.0-999.0, Hot Flashes Thai women, aged ≥ 40 years Peri or postmenopause Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20 Using any drugs or hormonal treatment within 1 month before enrollment BMI ≥ 30 kg/m2 Allergic to drugs or any ingredient Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL Psychiatric disease Alcohol consumption or any elicit drug use Vegetarian (may consume more phytoestrogen) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-55.0, Acute Lymphoblastic Leukemia Ph Positive Patients with Ph (BCR/ABL) positive de novo < 55 years old (it is advisable to patients over 55 years LAL07OPH protocol) Performance status 0-2 (Appendix B) may patients with performance status > 2 attributable to LAL Patients without functional impairment of organs: liver function: total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine > 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF > 50%, absence of severe chronic respiratory disease. In the event that alterations are secondary to the disease is at the discretion of the investigator to determine if the patient can be included in the trial Any other variety of LAL Patients with a history of coronary artery disease, valvular or hypertensive heart disease Patients with chronic liver disease Patients with chronic respiratory failure Renal failure not due to LAL Patients with positive HIV status No serious neurological abnormalities due to LAL Impact on overall severe (grade 3 or 4 of the WHO scale) not attributable to the LAL Pregnant or breastfeeding initial blast crisis CML | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Hyperbilirubinemia Hyperbilirubinemia Preterm infants > 33 weeks of gestation | 2 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 13.0-19.0, Type 1 Diabetes Children (diabetes exposed) from the national diabetes birth registry born between 1993 and 1999 (approximately n = 450) The same number of controls from the Central Person Register matched according to gender, age and postcode Offspring with major handicaps or chronic disease will be registered, but will not be examined Multiple pregnancies and recurrent pregnancies will not be included in the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-45.0, Healthy 45 years old, Healthy Adult Male Subject ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20% ALT or AST > 1.25(Upper Normal Range) Total Bilirubin > 1.5 (Upper Normal Range) BUN or Creatinine > Normal Range Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-65.0, Mild and Moderate Renal Impairment Male, and female subjects of non-child bearing potential, 2. Subjects were to weigh at least 50 kg to participate in the study, 3. and body mass index < 40 kg/m2 4. Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study; 5. Subjects were able to understand and sign the written informed consent; For renal insufficient subjects: 1. stable renal disease without evidence of renal progressive mild renal function: calculated CrCl of 50-≤80 mL/min moderate renal function: calculated CrCl of 30-<50 mL/min 2. Vital signs oral body temperature between 35.0-37.8 °C systolic blood pressure, 95-180 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 54-95 bpm For healthy subjects only 1. A serum creatinine with a calculated CrCl of >80 mL/min 2. Vital signs oral body temperature between 35.0-37.2 °C systolic blood pressure, 95-140 mm Hg diastolic blood pressure, 60-100 mm Hg Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics; 2. Smokers; 3. History of renal transplant at any time in the past and on immunosuppressant therapy; 4. Dialysis patients; 5. Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome; 6. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance; Other protocol defined inclusion/ | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Intrahepatic Cholestasis Pregnancy Pregnant women with intrahepatic cholestasis of pregnancy | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-35.0, Pregnancy to 35 year old pregnant women (singleton) at <=20 weeks of gestation (calculated from the LMP by study physician) Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk) Willing to provide signed and dated informed consent Women allergic (if aware) to any of the test products Women at high risk for hemorrhagic bleeding, clotting (if aware) Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production) Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-3.0, Brain Injuries Infant, Premature Neonates born more than 12 weeks preterm (gestational age up to 27 weeks and 6 days) Decision to conduct full life support Possibility to place cerebral NIRS oximeter within 3 hours after birth Obtained parental signed written informed consent A clinical decision not to provide full life support No possibility to place the cerebral NIRS oximeter within 3 hours after birth Lack of parental signed written informed consent | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.615, Postnatal Growth Disorder Neurodevelopment Gestational age < 32weeks (maternal dates or early fetal ultrasound); 2. Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h; 3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and 4. Written informed consent has been obtained from the infant's legal representative Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight 2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities; 3. Babies with enterostoma or short gut syndrome; 4. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis Bell Stage 2; air in the biliary tract or free air in the peritoneum Bell Stage 3); 5. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80; 6. Hepatic dysfunction, defined by jaundice (direct bilirubin >1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT); 7. Participation in another clinical trial that may affect outcomes of this study; or 8. Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed. Post-randomisation Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk; 2. Fluid restriction < 140mL/kg/d for ≥ 3 consecutive days; 3. Sepsis all infants with gram-negative sepsis will be removed from the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-79.0, End-stage Renal Disease The age of patient was between 18 yrs and 79 yrs The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization The level of serum albumin was below 2.0 or over 5.0 The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month The level of Body mass index was below 15 or over 30 Pregnancy | 0 |
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