topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
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): 0.0-0.022, Neonatal Jaundice Hyperbilirubinemia All newborns at the pediatric and maternity-ward with visible jaundice Gestational age of 32 weeks or more Older than 24 hours Younger than 8 days Neonatal jaundice within 24 hours or after 8 days Hemolysis present based on maternal history (for example irregular erythrocyte antibodies) Bilirubin encephalopathy Newborns during/after phototherapy Large congenital anomaly at forehead/sternum Serum bilirubin-value is already known before admission to the pediatric ward;those newborns are to be admitted because the serum bilirubin-level has reached the phototherapy or exchange transfusion limit | 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, Maternal Vitamin D Status Neonatal Bone Quantitative Ultrasound Measurements mother-baby pairs birth week 35-42 Jewish and Arab women that read and understand Hebrew large neonatal congenital defects | 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): 6.0-18.0, Hemiparesis Neonatal Stroke Ischemic Stroke Hemorrhagic Stroke Thrombotic Stroke A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix). 2. Cerebral infarction spares the transcallosal pathways. 3. Cerebral injury confirmed by brain MRI or CT 4. Ages 6-18 years inclusive The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus. 2. Infarction of the cortical motor areas. 3. Presence of a brain tumor or suspected neurodegenerative disease. 4. Intractable epilepsy or a history of poorly controlled epilepsy. 5. Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines) 6. Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale) 7. Disorders causing hallucinations, delusions, or excessive anxiety or depression. 8. Pre-existing chronic pain syndromes including intractable headache and chronic daily headache. 9. Pregnancy. 10. Any sensorimotor or cognitive impairment that prevents valid responses on study measures. 11. Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum 12. All patients and parents must be naïve regarding the effects and sensations of rTMS (i.e., patients and/or parents with prior exposure to TMS will be excluded). 13. Subject has had a recent neurosurgical procedure involving the brain. 14. Subject suffered traumatic brain injury that places the subject at risk of seizures | 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, Normal Healthy Subjects Subjects must be adults (> 20 years old) in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations. 2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm 3. Fasting blood glucose < 100 mg/dL. 4. Body weight must be above 50 kg for men and 45 kg for women and within 20% of ideal body weight. 5. Negative urine drug screen at clinic check-in before each dosing 6. Able to sign informed consent prior to study. 7. Able to communicate well with the investigator and comply with the requirements of the study. 8. Pregnancy tests (female only): negative reaction Use of any prescription or over the counter medication within 14 days prior to investigational products administration; with the exception of acetaminophen (not more than 2 g/day) or vitamins. 2. A plan to take concomitant medications while enrolled in the study, with the exception of acetaminophen (not more than 2 g/day) or vitamins. 3. Presence of any acute or chronic medical condition within 2 weeks prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. Evidence of impaired renal function as indicated by clinically significant abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria) as judged by the investigator. Evidence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an clinically significant abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBs Ag, or HCV Ab as judged by the investigator. 4. Hemoglobin less than 12 g/dL 5. Participation in any clinical investigation within 2 months or 5 half-lives, whichever is longer, prior to investigational products administration. 6. Donation or loss of more than 500 mL blood within 3 months prior to investigational products administration. 7. Subject is known for HIV infected. 8. Known allergy or hypersensitivity to amphotericin B or its analogs. 9. History of drug or alcohol abuse within 12 months prior to investigational products administration ; current consumption of alcohol in excess of 28 units/week (one unit is 6 oz of beer, ½ oz of hard liquor, or 2 oz of wine) 10. Subjects who, in the opinion of the investigator, should not participate in the study or may not be capable of following the study schedule for any reason. 11. Consumption of more than 36 to 40 oz (1.1-1.2 L) of caffeine-containing beverages per day 12. Consumption of any products containing grapefruit in the 3 days before clinic check-in | 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, Adolescent Idiopathic Scoliosis Patients presenting to the primary and co-investigator's facilities will be offered into the study if they meet the following Patient age < 21 years Male or female Diagnosis of Adolescent Idiopathic Scoliosis Any Lenke Classification type Underwent surgical correction of the spinal deformity with a fusion Are due for their 10 year post-operative visit Patients will be excluded from study if they meet the following Neuromuscular co-morbidity | 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): 0.0-72.0, Blood Pressure Pediatrics Infant, Newborn Cardiology Infants with gestational age > or = 35weeks and birth weight > 2500g, who are hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence of sepsis. If a blood culture was drawn due to the presence of maternal risk factors (e.g. maternal fever, prolonged rupture of membranes), patients will be included only if the blood culture result is negative and in case of intrapartum antibiotic treatment, ancillary blood tests (CBC with differential, CRP) are also within the normal range Infants with gestational age < 35weeks or birth weight < 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected | 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, Preterm Infant Infants of both genders Hospitalized The parent of the infant agreed to participate by signing an informed consent form Infants admitted hospital within 72 hours after birth(gestational age<37 weeks) Birth weight <= 2000g No PN support contraindications Parenteral nutrition for 14 days or more The parent of the infant is to sign an informed consent form prior to enrollment Receiving PN before screening EN caloric>10% Obstruction jaundice Suspected or identified biliary tract atresia Neonatal hepatitis Infants with liver markers >2 times normal levels Infants with renal markers >2 times normal levels Congenital metabolic situations Identified as having major chromosomal disease CMV, virus hepatitis and syphilis infection | 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, Pregnancy Complications Weight Gain Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous) less than 17 weeks gestation a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity) plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited able to tolerate dairy foods approval of primary care provider able to provide signed informed consent unable to understand some English type 1 or type 2 diabetes known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy severe gastrointestinal diseases or conditions any significant heart, kidney, liver or pancreatic diseases pre-existing diabetes currently smoking a depression score 12 or above on the validated Edinburgh depression questionnaire | 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, Hepatitis B Chronic Infection Pregnancy Pregnancy At least 18 years of age Negative Human Immunodeficiency Virus (HIV) serology Positive HBsAg and hepatitis B e antigen (HBeAg) tests Gestational age of 28 weeks (+ or days) as determined by obstetrician Alanine Aminotransferase (ALT)≤30 U/L, confirmed ≤60 U/L on a subsequent blood draw Agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic Understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis History of tenofovir treatment at any time, or any other anti-HBV treatment during the current pregnancy Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula Dipstick proteinuria>1+ (>30 mg/dL) or normoglycemic glucosuria confirmed on two separate occasions Positive serology for Hepatitis C infection less than 12 months prior to enrollment Evidence of pre-existing fetal anomalies incompatible with life Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study Concurrent participation in any other clinical trial without written agreement of the two study teams | 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): 0.577-0.673, Idiopathic Hyperbilirubinemia Neonatal Hyperbilirubinemia Prematurity Baby born between 30 to 34 6/7 weeks gestational age (GA) at birth and admitted to NICU 2. Baby with physiologic hyperbilirubinemia requiring phototherapy by current NICU criteria. 3. Parental permission Babies less than 30 weeks GA or greater than 34 6/7 weeks GA 2. Non-physiologic hyperbilirubinemia: (1) positive Coombs test and (2) hematocrit < 5th percentile for GA (see Jopling J, Henry E, Wiedmeier SE, Christensen RD, Reference. Ranges for Hematocrit and Blood Hemoglobin Concentration During the Neonatal Period: Data From a Multihospital Health Care System. Pediatrics 2009; 123(2):e333 -e337.) and (3) ABO or Rh incompatibility. 3. Any infant with bilirubin level within 2 mg/dL of exchange transfusion. 4. Any infant who has phototherapy started prior to reaching light level (prophylactic) 5. Baby with any GI abnormalities such as NEC, intestinal perforation, gastroschisis, omphalocele, malrotation and or volvulus, duodenal atresia, intestinal strictures/adhesions, imperforate anus. 6. Any infant begun on triple or greater phototherapy at time of initiation of treatment. 7. Any infant judged by the attending physician to be placed at increased risk by study participation | 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): 0.577-0.654, Premature Birth of Newborn Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed). 2. Gestational week 30-34 Congenital major malformation (e.g. congenital heart disease). 2. Chromosomal abnormality (e.g. Down's syndrome) 3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC 4. Milk allergy 5. Chronic disease (e.g. oxygen treatment) | 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): 19.0-40.0, Pregnancy Singleton pregnancy Maternal age 19-40y Early stage of pregnancy(15-18 weeks) and late stage of pregnancy(33-36 weeks) In good health (free of chronic/acute illness, full range of physical mobility) Healthy pre-pregnancy body mass index Subjects outside the age range of 19-40y Women pregnant with more than one child Body mass Index less than 18.5kg/m2 or greater than 25 kg/m2 less than 18 months between current pregnancy and last pregnancy History of spontaneous abortion,pre-term birth, preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy related jaundice Existing metabolic disease Substance dependance (i.e. alcohol, cigarette, illicit drugs) Allergic to eggs and egg protein Severe nausea and vomiting during 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): 0.0-999.0, Stroke Ischemic stroke(unilateral, onset within 7 days, without previous stroke history) Vital sign stable Upper extremity motor function impairment(brunnström stage I~III) with pacemakers Seizure history Serious dysrhythmias Poor cognition function(MMSE<13) | 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, Inadequate; Pulmonary Ventilation, Newborn Infant, Very Low Birth Weight birth weight less than 1,500 grams Clinical history of respiratory distress syndrome treated with surfactant Chronological age greater than or equal to seven days hours post-extubation or greater Medically stable per primary medical team Receiving ventilatory support on one of the following systems via nasal pharyngeal tube or nasal prongs:continuous positive airway pressure (CPAP), intermittent mechanical ventilation (IMV), or neutrally adjusted ventilatory assistance (NAVA) Receiving ventilatory support via high flow nasal cannula if the flow is large enough to provide a positive end expiratory pressure (PEEP) of 6 as defined by PEEP of 6 = 0.68 * weight (kg) + 0.92 Capillary blood gas via heel stick within 24 hours that demonstrates a pH of less than or equal to 7.35 and/or a partial pressure of carbon dioxide (pCO2) greater than or equal to 45 mmHg Severe congenital abnormalities Grade III or IV interventricular hemorrhage | 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, Prostate Cancer Provision of written informed consent 2. T2c-T3b N0 M0 (biopsy、 bone scan、 CT、 MRI) 3. No Metastasis (bone scan、 CT、 MRI) 4. PSA level>10ng/ml 5. Histological or cytological confirmation of prostate cancer 6. Able to understand and comply with the requirements of the study Having been treated with external radiation therapy or chemistry therapy. 2. Clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs. 3. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of normal (ULN) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s) 4. In the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease). 5. Contra-indications (eg, known or suspected allergy) to GnRH antagonists or excipients(non-active ingredients of investigational product). 6. Treatment with a non-approved or investigational drug within 30 days before study entry. 7. Bibulosity or drug abuse | 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): 0.0-0.417, Neonatal Early-onset Sepsis Neonatal Late-onset Sepsis Infants undergoing a sepsis evaluation in the NICU They have a major life-threatening congenital malformation The attending neonatologist has objections to the infant participating 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): 0.167-999.0, Severe Malaria Patients (= 2 months old) admitted to one of the study sites and treated for severe malaria with IV quinine in the first part of the study and patients treated with IV/IM artesunate in the second part of the study will be included. Patients need to fulfill the WHO for severe malaria and must be unable to take oral treatment (WHO, 2010, WHO, 2011). In addition all participants need to give their informed consent Conditions: Positive rapid diagnostic test (RDT) for Plasmodium falciparum HRP2 or lactate dehydrogenase and/or a positive blood slide (thick smear). Patient will be considered to be positive if one of the two tests is positive. In case of negative result of both tests, the patient will not be enrolled in the study and will receive care according to the usual routine practice in the hospital/health center in question. Definition of severe malaria according to WHO (WHO, 2010): In a patient with P. falciparum asexual parasitaemia and no other obvious cause for the symptoms, the presence of one or more of the following clinical or laboratory features classifies the patient as suffering from severe malaria: Clinical features (hospitals and health centers) impaired consciousness or unrousable coma prostration, i.e. generalized weakness so that the patient is unable walk or sit up without assistance failure to feed multiple convulsions more than two episodes in 24 h deep breathing, respiratory distress (acidotic breathing) circulatory collapse or shock, systolic blood pressure < 70 mm Hg in adults and < 50 mm Hg in children clinical jaundice plus evidence of other vital organ dysfunction Complementary Laboratory findings (hospitals only) severe anaemia (Hb < 5g/dl, packed cell volume < 15%) Patients with known serious adverse reactions to quinine and artemisinin derivatives or patients who have received adequate antimalarial treatment 24 hours before admission will not be included in the study. Women with known or suspected pregnancy in all trimesters will not be included in the study and will be treated with quinine infusions according to the new national DRC guidelines (Programme Nationale de Lutte contre le Paludisme, 2012). According to current routine procedures determination of pregnancy will be done by medical anamnesis and/ or by a positive pregnancy test | 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): 0.577-0.654, Physiologic Changes Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with 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): 1.0-999.0, Non Traumatic Splenic Rupture All patients where review of the medical records indicates non-traumatic rupture of the spleen Patients with antecedent trauma | 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): 0.0-6.0, Transient Tachypnea of the Newborn Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery Diagnosis of TTN Parents signed informed consent Meconium aspiration syndrome Respiratory distress syndrome Congenital heart disease Non respiratory disorders causing tachypnea | 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, Diabetes Diabetes Mellitus, Type 2 Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2) Treatment with at least 1000 mg metformin per day with/without other OADs at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to Visit 1 Insulin-naïve subjects HbA1c above or equal to 7.5% by central laboratory analysis Body mass index (BMI) below or equal to 35.0 kg/m^2 Female who is breast-feeding The receipt of any investigational product within 4 weeks prior to Visit 1 Any contraindication to insulin detemir according to the domestic labelling Anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [MAO] inhibitors) Clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product Any conditions that the investigator judges would interfere with trial participation or evaluation of the results | 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): 0.0-0.008, Retinopathy of Prematurity Neonatal Cholestasis Infants below 32 gestational age and requiring parenteral nutrition Infants with congenital anomalies, infants above 32 gestational 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): 0.0-999.0, End Stage Kidney Disease Cardiac and hemodynamic stability Absence of severe musculoskeletal impairment Increased musculoskeletal weakness Vital signs within normal range for exercise Desire/motivated to exercise Clearance from nephrologist and Kinesiologist Compromised cardiac profiles Hemodynamic instability Severe bone disease Medical conditions which contraindicate exercise | 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, Gastro-intestinal Infections Infections With Fever Healthy newborn infant Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation) Age of infant is ≤ 13 days at the time of enrollment Birth weight ≥ 2500g and ≤ 4500g For the FF groups: The infant's mother has elected not to breastfeed For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age Having obtained his/her legal representative's informed consent Congenital illness or malformation that may affect normal growth (especially immunodeficiencies) Significant pre-natal and/or post-natal diseases Perinatal antibiotic or infants on antibiotics at the time of Infants whose mother has had an acute infection during the last month of pregnancy Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study) Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment Newborn whose parents / caregivers cannot be expected to comply with treatment Newborn currently participating in another interventional clinical 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): 0.0-0.25, Unilateral Complete Cleft Lip Complete unilateral cleft lip infant Signed informed consent Incomplete unilateral cleft lip infant Association of other craniofacial anomalies | 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): 0.0-72.0, Jaundice, Neonatal Hyperbilirubinemia, Neonatal Term and near term infants ≥35 and ≤ 43 weeks gestational age (GA), age 0-48 hours with antibody (ABO) or rhesus factor (Rh) incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours with G6PD deficiency 2. Parental or guardian consent 3. Birth weight ≥ 2500 grams 4. At or above the age-specific threshold for initiating phototherapy (PT) per the American Academy of Pediatrics (AAP) guidelines based on measurement of total serum bilirubin (TSB) 5. Parents agree to observe light precautions for 10 days post treatment Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin 2. Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 3 times ULN 3. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN 4. Any other clinically significant abnormalities on screening laboratory evaluation [including electrocardiogram (ECG)] that in the opinion of the investigator makes the patient unsuitable for the clinical trial 5. Apgar score ≤6 at age 5 minutes 6. An unexplained existing rash or skin erythema 7. Prior exposure to PT 8. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto's disease is not exclusionary) 9. Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment 10. Any abnormal auditory or ophthalmologic findings on screening physical exam 11. Treatment or need for treatment in the neonate with medications that are photoreactive or may prolong the QT interval (erythromycin ointment for eye prophylaxis is permitted), or family history of Long QT syndrome 12. Known porphyrias or risk factors for porphyrias, including family history 13. A maternal history of systemic lupus erythematosus 14. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding 15. Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the patient a suitable candidate for participation in the clinical trial 16. Significant congenital anomalies or infections 17. Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life 18. Persistent hypoglycemia (blood glucose <40 mg/dL) 19. Temperature instability defined as temperature consistently (3 consecutive times) <36 degrees centigrade (ºC) and/or >37.5 degrees centigrade (ºC) axillary 20. Use of intravenous immunoglobulin (IVIg) or albumin prior to study drug administration 21. Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics) 22. Use of photosensitizing drugs or agents 23. Unwillingness of parents/guardians to adhere to recommendations regarding light precautions 24. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial 25. Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial | 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): 21.0-70.0, Acute Alcoholic Hepatitis Ability to provide informed consent by subject or appropriate family member 2. Age between 21-70 years 3. Recent alcohol consumption > 50 g/d for > 6 months, continuing within two months before enrollment 4. At least 2 of the following symptoms or signs of acute alcoholic hepatitis: Anorexia, nausea, RUQ pain, jaundice, leukocytosis, hepatomegaly AND 5. Elevation of AST > 80 U/L, but < 500 U/L at the time of admission or within 3 days of baseline visit; AST > ALT and ALT < 200 U/L; total bilirubin > 3 mg/dL AND 6. Liver biopsy showing alcoholic hepatitis (steatohepatitis) OR ultrasound of liver showing increased echogenicity OR CT scan showing decreased attenuation of liver compared to spleen OR MRI showing fatty liver (decreased signaling intensity on T1 weighted images). If the liver biopsy (done within 60 days of inclusion) confirms diagnosis of AAH then e will be waived. 7. Model for End-Stage Liver Disease (MELD) <20 8. Willingness to utilize two reliable forms of contraception (both males and females of childbearing potential) from screening through the first six weeks of study Hypotension with BP < 80/50 after volume repletion 2. Pregnancy; incarceration; inability to provide consent or lack of appropriate family member 3. Signs of systemic infection: Fever > 38o C and positive blood or ascites cultures on appropriate antibiotic therapy for > 3 days within 3 days of 4. Acute gastrointestinal bleeding requiring > 2 units blood transfusion within the previous 4 days 5. Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test or history of treatment for tuberculosis; history of any malignancy including hepatocellular carcinoma; known HIV infection 6. Treatment with corticosteroids or other immunosuppressive medications including specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors for > 3 days within the previous 3 months. 7. Evidence of acute pancreatitis: CT evidence and/or amylase or lipase > 5 X upper limit of normal 8. Serious cardiac, respiratory or neurologic disease or evidence of autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease, hemochromatosis, secondary iron overload due to chronic hemolysis, alpha-1-antitrypsin deficiency 9. Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl | 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, Pharmacokinetics of Novel Curcumin Formulations Safety of Novel Curcumin Formulations healthy volunteers with routine blood chemistry values within the normal ranges overweight (BMI >30 kg/m2) metabolic and endocrine diseases pregnancy lactation drug abuse use of dietary supplements or any form of medication (with the exception of oral contraceptives) smoking frequent alcohol consumption (>20 g ethanol/d) adherence to a restrictive dietary regimen physical activity of more than 5 h/wk | 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, Protection Against Total cholesterol > 5.2 mmol/L LDL cholesterol > 3.4 mmol/L Triglyceride > 2.26 mmol/L CRP > 2 mg/L Intake of drugs or dietary supplements Pregnant women and breastfeeding mothers Smokers Previous illnesses such as heart attack, cancer or dementia Addiction | 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, Non-small Cell Lung Cancer The cohort consists of approximately 250 patients. As a rule of thumb 5-10 events per variable are needed to avoid overfitting a model. To model 6 clinical variables + 9 biomarker variables 75-150 events are needed. Assuming a two-year survival of 40%, the calculated (constant) hazard rate is 0.46 per year. With an rate of 50 patients per year, and a follow-up time varying between 0.5 and 4 year, at the time of analysis (November/December 2013) it is expected that there will be 138 events available for analysis | 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, Pregnancy Criteria:• Non-anomalous singleton Nulliparous (no prior delivery after 20 weeks) Presenting at ≥37 weeks of gestation Presenting for anticipated induction of labor or spontaneous labor (regular contractions for more than 2 hours), but cervical dilation less than 4 cm Rupture of membranes Expected to deliver at one of the participating hospitals • Not in the Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma) Diabetes mellitus-gestational or pre-gestational Enrollment in another randomized clinical trial Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia) Hypertension (chronic or pregnancy induced) before randomization HIV (human immunodeficiency virus) Placenta previa / 3rd trimester bleeding Renal insufficiency (serum creatinine > 1.5 mg/dL) Restrictive lung 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): 2.0-10.0, Malaria Severe Malaria Age 2 to 10 years, inclusive 2. Resident of Kenieroba 3. Uncomplicated malaria* 4. P. falciparum density 10,000 70,000/micro L, inclusive 5. Willingness to participate in the study as evidenced by informed consent of the child s parent or guardian 6. Ability to swallow oral medication Uncomplicated malaria: axillary temperature >37.5oC or history of fever in the past few days and no of SM (see next paragraph) and no other etiologies of febrile illness (e.g., respiratory tract infection) on clinical examination. Severe P. falciparum malaria: parasitemia of any density and any one of the following: coma (Blantyre coma score less than or equal to 2), convulsions (witnessed by investigator), severe prostration, severe anemia (hemoglobin less than or equal to 6 g/dl), respiratory distress, hypoglycemia (serum glucose less than or equal to 40 mg/dl), jaundice/icterus, shock (systolic blood pressure less than or equal to 70 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting Severe malaria 2. Any medical condition or history, including allergy to AS, AQ, artemether or lumefantrine, that poses a risk to the prospective participant 3. Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease) 4. Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary risks to study participants (e.g., severe malnutrition, acquired or inherited immunodeficiency) 5. Requirement for any medication for any concurrent illness or condition 6. Participation on cohort study #13-I-N107 7. Repetitive vomiting | 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): 1.0-18.0, Solid Tumours Key Subjects must be at least 1 and less than or equal to 18 years of age at the time of study entry Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse a) Rhabdomyosarcoma, b) Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor), c) Ewing Sarcoma / Peripheral Primitive Neuroectodermal Tumor (PNET), d) Osteosarcoma, e) Neuroblastoma (Measurable), f) Neuroblastoma (Evaluable), g) Hepatoblastoma Patient must have disease that has either relapsed or is refractory to prior therap Patients who will be receiving the tablet formulation must have a body surface area (BSA) >= 0.84 m^2 (square meter) at baseline Patients must have radiographically measurable disease (with the exception of neuroblastoma), Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm) Patients with neuroblastoma who do not have measurable disease but have iodine-131 - meta-iodobenzylguanidine positive (MIBG+) evaluable disease are eligible Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2. Use Karnofsky for subjects >= 16 years of age and Lansky for subjects <= 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Pregnant or breast-feeding women are not eligible for this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Negative pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method beginning at the signing of the informed consent until at least 2 weeks after the last dose of the study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate. Study drug may also potentially be secreted in milk and therefore breastfeeding women are excluded. Males (including those who have had vasectomies) with partners who can become pregnant will need to use birth control while on this study, as will their partner. Men are advised to use condoms during sexual intercourse while on study drug and continue to use adequate contraception for at least 2 weeks after the last dose of protocol therapy Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible Patients who are currently receiving more than one anti-hypertensive medication (Grade 3) or whose blood pressure is not well controlled are not eligible for study enrollment Patients must not be on therapeutic anticoagulation (Warfarin [coumadin] and/or low molecular weight heparin are prohibited). Prophylactic anticoagulation (i.e. intraluminal heparin) of venous or arterial access devices is allowed Patients receiving drugs with a known risk of torsades de pointes are not eligible Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment Patients who are unable to swallow tablets or liquid are not eligible Patients who have an uncontrolled infection 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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): 0.0-0.231, Congenital Cytomegalovirus Infection Sensorineural Hearing Loss Treatment group and refusal control group Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both ears) Age at time of is ≤ 12 weeks after birth Born at ≥ 37 weeks gestational age Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin Parental signed informed consent. Historical control group Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both ears) Age at time of is > 13 weeks after birth Born at ≥ 37 weeks gestational age Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin Treatment group and refusal control group Previously noted (≤ 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested. For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin Treatment with other antiviral agents or immunoglobulins Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested at t=0). Historical control group Previously encountered (≤ 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin Treatment with (val)ganciclovir Treatment with other antiviral agents or immunoglobulins | 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, Advanced Chronic Liver Disease Urinary Infection Pneumonia Cholangitis Other Bacterial Diseases Cirrhotic patients with age ≥18 years Diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization Patients with uncomplicated urinary infections or suspected bacterial infection will require the presence of signs of systemic inflammation: at least 1 diagnostic criterion of systemic inflammatory response syndrome (SIRS) and serum CRP levels ≥1 mg/dl (10 mg/L). This criterion will not be required for the rest of infections Analytical data of renal and/or liver dysfunction (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l, serum bilirubin ≥4 mg/dl). Patients with pneumonia or documented bacteremia (positive blood cultures) will require the presence of at least 1 of these analytical to be included in the study. Patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will require 2 or more for > 72h after infection diagnosis Pregnancy Acute or subacute liver failure without underlying cirrhosis Septic shock Severe acute respiratory distress syndrome (Pa02/Fi02 ≤ 100) Active or recent variceal bleeding unless controlled for > 48h Ongoing type-1 HRS (past IAC criterion: serum creatinine ≥ 2.5 mg/dl) Type-3 ACLF (defined according to the Canonic Study criteria) Hemodialysis or other renal replacement therapy Evidence of current malignancy (except for hepatocellular carcinoma within Milan or non-melanocytic skin cancer) | 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, Adult Cholangiocarcinoma Advanced Adult Hepatocellular Carcinoma BCLC Stage C Adult Hepatocellular Carcinoma BCLC Stage D Adult Hepatocellular Carcinoma Hilar Cholangiocarcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma Recurrent Childhood Liver Cancer Recurrent Extrahepatic Bile Duct Carcinoma Recurrent Gallbladder Carcinoma Stage II Gallbladder Cancer Stage III Childhood Hepatocellular Carcinoma Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IV Childhood Hepatocellular Carcinoma Stage IV Distal Bile Duct Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer Unresectable Extrahepatic Bile Duct Carcinoma Patients must have histologically or cytologically documented carcinoma primary to the intra or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation in Solid Tumors [RECIST] 1.1) PRIOR/CONCURRENT Patients must have completed any prior chemotherapy at least 21 days prior to registration and have recovered from any of the effects AND Patients must have experienced progression to no more than 1 prior regimen of systemic chemotherapy for advanced biliary cancer OR Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence Patients must not have been treated with prior MEK inhibitors; prior 5-FU or capecitabine treatment is allowed only if given as a radiosensitizer concurrently with radiation therapy at least 12 weeks prior to registration or if given as part of any adjuvant therapy regimen >= 12 months prior to study enrollment Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy (including herbal or natural supplements) for treatment of cancer while on this treatment protocol For patients who have received prior cryotherapy, radiation therapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following must be met | 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, Hypoxic Ischaemic Encephalopathy Infants will be eligible for for the trial if the St Michael's hospital standard for cooling and additional for xenon administration are met. St Michael's hospital standard for standard hypothermia treatment of 72 hrs: A: Neonates born at greater than 36 weeks gestation (estimated or clinical assessment) with at least ONE of the following: 1. Apgar score of ≤5 at ten minutes after birth 2. Continued need for resuscitation, including tracheal or mask ventilation, at ten minutes after birth 3. Acidosis, defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 minutes of birth less < 7.00 4. Base deficit ≥16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood). If the infant meets criterion A then assess for neurological abnormality using criterion B and C (by trained personnel): B: Moderate or Severe encephalopathy as evidenced by any of the following: 1. Altered state of consciousness (reduced or absent responses or pathological irritability and hyper responsive and at least ONE or more of the following: 2. Hypotonia 3. Abnormal reflexes including oculomotor or pupillary abnormalities 4. Absent or weak suck 5. Clinical seizures, as recorded by trained personnel And C: At least 30 minutes duration of amplitude-integrated electroencephalography (aEEG) recording that shows abnormal background aEEG activity. The decision to cool is based on the worst 30 min section of the aEEG, not the best [35] or seizures (clinical or electrical) thus meeting ONE of the following: 1. Normal background with some (> 5 min) electrical seizure activity 2. Moderately abnormal activity (upper margin of trace >10μV and lower margin <5μV) 3. Suppressed activity (upper margin of trace <10μV and lower margin of trace <5μV) 4. Definite seizure activity Additional for xenon: Before being considered for additional inhaled xenon therapy via the breathing gas mixture, the infant would need to meet further additional entry (all must be met): 1. Intubated, ventilated, sedated, being cooled 2. ≤ 5 hours old 3. Any seizures under control 4. Weight > 2nd centile for gestational age 5. Stable cardiovascular parameters; Mean arterial pressure >40mmHg. 6. Oxygen requirement via mechanical ventilator ≤ 40%. 7. Positive End Expiratory Pressure (PEEP) requirement ≤ 8cm H2O 8. Arterial (preferable)/capillary/venous pCO2 within acceptable range (<7kPa) 9. Postnatal age ≤ 5 hours 10. Absence of major congenital abnormalities, imperforate anus and in particular any bowel obstruction, congenital abnormalities suggestive of chromosomal anomaly or other syndromes that brain dysgenesis. Congenital syndromes affecting the brain should be excluded when diagnosed for cooling in the CoolXenon3 study: 1. Infants expected to be greater than 3 hours of age at the time of starting cooling treatment. 2. Futility. Where prognosis is considered to be hopeless e.g. no cardiac output for 20 minutes | 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 Total Occlusion of Coronary Artery Subject shows the presence of at least one coronary chronic total occlusion (CTO), either with or without the presence of one or more other diseased coronary arteries. This CTO must be located in a native coronary artery and have a visually estimated stenosis of 100%, corresponding with Thrombolysis in Myocardial Infarction (TIMI) flow 0. Following the operators judgment, this occlusion is present for more then 3 months Subject will be/is treated percutaneously for one or more CTOs via the hybrid techniques Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after PCI procedure to assess any complications and clinical status) The occlusion is considered to be less than 3 months present Subject is treated via PCI without application of the hybrid algorithm and/or use of the CrossBoss™ and Stingray™ technology (Bridgepoint Medical, Inc.) Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation | 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): 18.0-85.0, Stroke Able to provide informed consent Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging Fugl-Meyer Motor Score 19-55 in involved upper extremity Approval from patient's primary care physician Age between 18 and 85 years Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment Serious cardiac arrhythmia Hypertrophic cardiomyopathy Severe aortic stenosis Cardiac pacemaker Pulmonary embolus Other medical or musculoskeletal contraindication to exercise Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment 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): 20.0-999.0, Stroke Heart Attack TIA Cardiovascular Diseases Participants who underwent self-selected, private screening program held by Life Line Screening Adult participants over the age of 20 Participants who filled in appropriate health questionnaire and signed relevant consent part of their questionnaire Cohort observation cases: participants with significant carotid artery disease (>50% stenosis) detected by duplex ultrasound and/or AF Cohort observation controls: Participants without CAS detected by Duplex ultrasound or AF Those who are unable to give informed consent Participants under 20 years old Participants who filled in the health questionnaire incompletely | 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, Stroke First ever ischemic or hemorrhagic stroke or former stroke without any residual motor impairment weeks post stroke Impaired arm motor function but some residual arm motor activity as defined by a score of less than 52 on Action Research Arm Test (ARAT), and the ability to execute at least 20 degrees of active shoulder extension and abduction against gravity Severe cognitive impairment defined as < 20 on Mini Mental Status Examination Orthopedic impairment, limiting mobility substantially or causing pain Visual disorders limiting the ability to comply with treatment regimen < 18 years Unable to give 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): 18.0-999.0, Carcinoma, Non-small Cell Lung For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC) For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC Have either measureable or nonmeasurable disease as defined by the Response Evaluation in Solid Tumors (RECIST v1.1) Have adequate organ function including Hematologic: Absolute neutrophil count (ANC) 1.5 x 109/liter (L), platelets 100 x 109/L, and hemoglobin 8 gram/deciliter (g/dL) Hepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment are eligible Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 3 to 4 months after the last dose of trial treatment (as appropriate) Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG. Additional For Part C History or evidence of cardiovascular risk including any of the following History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association | 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): 0.0-0.308, Malaria Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows: Bacillus Calmette-Guérin (BCG), and first dose of oral polio (OPV) and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/ weeks Birth weight less than 2.5kg Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual Any signs of acute illness as judged by the PI or other delegated individual Axillary temperature of greater than 37.5 °C Clinically significant congenital abnormalities as judged by the PI or other delegated individual Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual Weight for age z-scores below 2 standard deviations of normal for age History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone History of splenectomy Haemoglobin less than 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks 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): 18.0-44.0, Labor Fast Singleton, vertex presentation at term (gestational age range; 37-41weeks) primigravid and multigravid women without any chronic and pregnancy-induced diseases The cases with premature rupture of membranes, preeclampsia, eclampsia, placental abruption, placenta previa, abnormal placental attachment, twin pregnancy, non- cephalic presentations, previous uterine surgery and cephalopelvic disproportion | 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): 0.0-0.205, Premature Birth Preterm infants between 25-28 weeks gestation Ventilated for respiratory distress syndrome (RDS) Extubated to NCPAP for at least 72 hours Major congenital Chromosomal anomalies | 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 Study Population: Patients, followed in our clinics for cardiovascular disease (CVD) prevention, fulfilling diagnosis for metabolic syndrome (MetS) will be recruited. will require a 2 step process as described. STEP 1: Initial screening; BP, weight and fasting blood samples will be obtained. 1. Men and women, >18 years, meeting the for clinical diagnosis of MetS, according to the International Diabetes Federation (IDF) harmonized definition, where any 3 of the 5 following risk factors cut points constitutes a diagnosis of MetS: 1. Elevated waist circumference: Population and country-specific definitions; Health Canada recommends males 102 cm and women 88cm. 2. Elevated triglycerides: 150 mg/dL (1.7 mmol/L). 3. Reduced HDL: 40 mg/dL (1.0 mmol/L) in males; 50 mg/dL (1.3 mmol/L) in females or treated. 4. Elevated BP: Systolic 130 and/or diastolic 85 mm Hg or treated. 5. Elevated fasting glucose: 100 mg/dL (5.6 mmol/L), or HbA1c ≥6.2%, or treated. 2. Willing to provide informed consent. STEP 2: Baseline plaque volume ≥50 mm3 by 3D US, to ensure sufficient detectable plaque. This will be measured after consent (at Step 1), but prior to randomization/enrolment (Step 2) Individuals who have had a change in statin and/or diabetes medication therapy or dosing in the last three months; 2. Who are actively having an unstable arrhythmia, angina or heart attack (untreated and/or unstable patients): symptomatic heart failure (NYHA 2 or greater); renal failure (GFR <50 mL/min/1.73m2); 3. Known severe abnormal blood biochemistries: Na <100 or >150 mmol/L, K <2 or >5 mmol/L, Total Serum Ca >3 mmol/L; 4. Known severe liver disease: AST >100 U/L, ALT >80 U/L, or a diagnosis of cirrhosis (Child Pugh Class A to C); 5. Known severe anemia: HgB <70 g/L; 6. Have endocrine disorders, e.g. Cushing's disease, hyper or hypo-thyroidism; 7. Any condition expected to limit survival to less than six (6) months (ex. malignant tumor); 8. A condition limiting adherence to study procedure (i.e. alcoholism, drug addiction, known poor adherence, severe mental disorder); 9. Concomitant treatment with: anticonvulsants; L-C or derivatives; Acenocoumarol (Sintrom) and Warfarin (Coumadin) anticoagulants and vitamin K antagonists; >1g fish oil; and/or thyroid treatment; 10. A seizure disorder or at risk of seizure (CNS mass or medications that lower seizure threshold); receiving treatments for cancer or HIV infection (secondary L-C deficiency); 11. Currently pregnant or breastfeeding; 12. A history of allergy or intolerance to L-C or derivatives; 13. Vegetarians (do not eat animal flesh) due to potential for altered L-C metabolism; 14. Patients who have had a carotid surgery (ie. endarterectomy (CEA) or stent) or who are scheduled to receive carotid surgery during the 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): 18.0-65.0, Dementia Delirium Healthy adult volunteers (18-65 years old) willing to undergo a general health screen consisting of blood pressure, heart rate, respiratory rate, height, weight, temperature, and electrocardiogram will be identified The below parameters must be met to be consider an adult healthy to volunteer for in this study Blood pressure less than 160/99 mmHg and greater than 105/50 mmHg Heart rate between 50-100 beats per minutes Respiratory rate between 10-30 breaths per minute Temperature between 34 °C and 37.5°F Corrected QT interval of < 470 msec Liver function tests less than 1.5 times the upper limit of normal Estimated creatinine clearance (estimated by Cockcroft Gault formulation) greater than 60 mL/min Female participants will complete a urine pregnancy test that must result in a negative finding 1. Allergy to quetiapine, Lipoderm or polyethylene glycol 2. Currently taking quetiapine 3. Pregnant, planning to become pregnant or breast feeding 4. Over or under 30% of ideal body weight 5. History of or active cardiovascular disease (except hypertension meeting the for blood pressure), severe kidney disease (i.e. needing dialysis), or liver disease 6. History of schizophrenia, bipolar disorder, substance use disorders (but excluding nicotine use disorders and stable unipolar depression (See below)) 7. Unstable unipolar depression, defined as hospitalization for depression within 1 year or changes to an antidepressant regimen within 6 months 8. History of seizure or seizure disorder 9. Parkinson's disease, Huntington's disease, tardive dyskinesia or other diagnosed movement disorder 10. History of/or active hematologic/oncologic illness 11. Dementia 12. Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome 13. History of organ transplant 14. History of gastric bypass 15. Contraindications for suppository administration 16. With Ostomy, chronic diarrhea 17. Diabetes, type 1 or type 2 18. Prolong corrected QT interval (>470 msec) or history of congenital long QT syndrome 19. Open wound(s) or unhealed wound(s) at topical medication application site (anterior forearm) 20. Active or latent tuberculous and currently prescribed pharmacotherapy treatments 21. Currently prescribed or taken with in the last 7 days, medications which have a known interaction with quetiapine or compound the risk of adverse events associated with quetiapine | 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 Singleton term pregnancy: gestational age ≥37 weeks 2. Nulliparous women 3. Neuraxial anesthesia: epidural or combined epidural-spinal anesthesia Preterm: gestational age <37 weeks (preterm infants have an a priori risk for adverse outcomes, which is driven more by gestational age than the timing of maternal pushing in the second stage) 2. Multiple gestation (incidence of multiple gestation is small and there are unique delivery considerations) 3. Multiparous women 4. Non-reassuring fetal heart rate tracing (will be an indication for expedited delivery) 5. Contraindication to vaginal delivery including: non-vertex presentation, placenta previa, prior classical cesarean, etc. 6. No neuraxial anesthesia: epidural or combined epidural-spinal anesthesia (subjects without adequate pain control tend to push involuntarily and cannot delay pushing) 7. Pregnancy complications requiring expedited delivery: severe preeclampsia, placental abruption, maternal cardiac disease 8. Fetal head visible at the introitus at complete cervical dilation | 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, Diabetes Mellitus Type 1 UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV & HIV by PCR test before enrollment in the study and positivity for any of these parameters means of this patient from the study | 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): 0.635-999.0, Uncomplicated Neonatal Hyperbilirubinemia Newborns with gestational age >33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis) Liver disease | 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): 0.673-0.808, Neonatal Hyperbilirubinemia Newborn infants ≥ 38 gestation weeks without or with risk factors of severe icterus (G6PD or pyruvate-kinase deficiency, red blood cells membrane defects, hemoglobinopathies, cephalohematoma or significant bruising, decreased breastfeeding) newborn at 35 and 38 gestation weeks without risk factor of severe icterus (qs) hyperbilirubinemia to deal according to the curves of indication of phototherapy of the APP on 2004 no opposition of parents opposition of parents newborn infants less than 33 weeks newborn infants at 35 or more weeks of gestation with risk factors of severe icterus Jaundice in first 12 hours Hyperbilirubinemia > 340 µmol/L whatever is the age | 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, Sepsis Severe Sepsis Age ≥30 days old and weighing at least 3 kg or more on the day of enrollment into the study 2. Required hospitalization as decided by the attending physician 3. Documented by attending physician that an infection is the primary cause of illness leading to the hospitalization. These can be infections due to any pathogens (bacteria, viruses, fungi and parasites). 4. Presence of Systemic Inflammatory Response Syndrome (SIRS): 4.1 For adults (≥ 18 years old), any combination of a minimum of any 3 of the following 20 parameters Fever or hypothermia (Core body temperature defined as >38.3 C or <36.0 C) Tachycardia (heart rate >90 beats per minute) Tachypnea (respiratory rate >20 per minute) Arterial hypotension (systolic blood pressure (SBP) <90 mmHg, mean arterial pressure (MAP) <70 mmHg, or SBP decrease >40 mmHg) White blood cell (WBC) >12,000 u/L or <4000 u/L or immature forms >10% Platelet count <100,000 u/L Altered mental status with Glasgow Coma Score (GCS) <15 Hypoxemia (Pulse Oximetry Level <95) Ileus Admitted to the study site hospital for this current episode for more than 24 hours before enrollment Hospitalized for this current episode for more than 72 hours at another primary/referring hospital Prior to this current episode, the subject was admitted to any hospital within the last 30 days An underlying pre-existing condition is thought to have led to or contributed to this sepsis episode. For example, sepsis is considered to be directly attributable to existing non-infectious conditions such as stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma Prior to enrollment, it is documented by the attending physician that hospital acquired infection is associated with the cause of the sepsis or severe sepsis The subject has been enrolled into this study or another sepsis study before | 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): 65.0-999.0, Hypertension Age ≥ 65 years Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period Written informed consent Secondary hypertension Malignant hypertension (retinal haemorrhage, exudates or papillary oedema) Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm Heart rate < 50 bpm Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV) Angina pectoris or myocardial infarction Cardiac surgery within the past 3 months prior to start the wash-out period Stroke within the past 6 months prior to start the wash-out period Renal insufficiency defined as creatininaemia > 2mg/dl | 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): 21.0-55.0, Pain Healthy male with normal vital signs: systolic blood pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 50 mm Hg and < 90 mm Hg; pulse 50 to 100 beats per minute; respiratory rate 12 to 20 breathes per minute 2. Between the ages of 21 and 55 years of age 3. Able and willing to give informed consent 4. Able to comply with all study procedures 5. Have adequate hematologic function as evidenced by the following screening results White Blood Cell (WBC) >3,500/mm3 and < 12,000/mm3 Platelet Count > 150,000/mm3 and < 540,000/mm3 Hemoglobin > 12.5 gm/dL and < 20.5 gm/dL. Have adequate liver function as evidenced by the following screening results Aspartate transaminase (AST) ≤ 60 IU/L Alanine transaminase (ALT) ≤ 83 IU Alkaline Phosphatase ≤ 150 IU/L Total Bilirubin ≤ 1.2 mg/dL Prothrombin Time (PT) < 1.2 upper limit of normal (ULN); Partial Thromboplastin Time (PTT) < 1.2 ULN. 6. Electrocardiogram (ECG) within normal limits as determined by the PI 7. Have adequate renal function as evidenced by the following screening result: Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula >60 ml/min. Urinalysis demonstrating < +1 glucose, +1 ketones, and +1 protein 8. Negative urine test for substances of abuse, including opiates, per clinical research unit (CRU) standards 9. Negative serology tests for HIV, hepatitis B surface antigen and hepatitis C virus antibody 10. Body Mass Index (BMI) 19.0 to 32 kg/m 11. Cold pressor screening results as follows: 1) pain tolerance of > 20 seconds and <120 seconds Oral temperature > 38°C or history of current illness 2. History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal) 3. History of cirrhosis or laboratory evidence of liver disease 4. Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit, grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice or grapefruit-related juices, or other medication, within 7 days of study drug administration and until the end of the study 5. History of previous anaphylaxis, severe allergic reaction to Tramadol, codeine, or other opioid drugs 6. Use of monoamine oxidase (MAO) inhibitors (including linezolid), Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, and prescription or over-the counter (OTC) medications known to induce or inhibit drug metabolism, including cytochrome P450 2D6 (CYP2D6), and other drugs that may affect the serotonergic neurotransmitter systems including, but not limited to, triptans, dextromethorphan, tricyclic antidepressants, bupropion, lithium, tramadol, dietary supplements such as tryptophan and St. John's Wort, and antipsychotics or other dopamine antagonists. These restrictions are to be maintained from 14 days before study day -1, until the subject completes the study 7. Any other unstable acute or chronic disease that could interfere with the evaluation of the safety of the study drug as determined by the principal Investigator in dialogue with the Sponsor Medical Monitor 8. Unlikely to comply with the study protocol 9. Known or suspected alcohol or drug abuse within the past 6 months 10. Received another investigational agent within 4 weeks of Day 0, or within five half-lives of Day 0, whichever is longer; or receiving any other investigational agent during this study 11. Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol, or obscure interpretation of the trial data | 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, Sepsis SIRS SIRS is considered to be present when patients have more than one of the following clinical findings body temperature >38°C or <36°C heart rate >90 min-1 respiratory rate of >20 min-1 or a Paco2 of <32 mm Hg and a white blood cell count of >12,000 cells µL-1 or <4,000 µL-1 2. new empiric antibiotic therapy is initiated, indicating the suspicion of infection. Accepted for SIRS will be used for the Medical Intensive Care Unit and Surgical Intensive Care Unit populations, with appropriate age-specific vital signs definitions to help make the definitions relevant for the Pediatric Intensive Care Unit population a code status of "do not resuscitate" 2. absence of initiation or expansion of antibiotic therapy despite meeting for sepsis 3. presence of an immunocompromising condition. An immunocompromising condition will be defined as one of the following human immunodeficiency virus (HIV) infection with a t-helper cell (CD4) count <200 cell/mm3; 2) immunosuppressive therapy after organ transplantation neutropenia (<500 neutrophils/mm3) active chemotherapy within the 3 months preceding or diagnosis of cystic fibrosis. These all represent conditions in which antibiotic use is much less likely to be decreased regardless of the results of a biomarker and are consistent with used in past studies of the impact of biomarkers | 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, Head and Neck Squamous Cell Carcinoma (HNSCC) Pathological stage I-IVa HNSCC The subject must have a complete removal of the primary HNSCC lesion with negative gross and microscopic margins. Documentation of margins by frozen sections at surgery is recommended. Patients who have already had surgery and have available banked tumor samples can be enrolled AFTER surgery At least 18 years of age 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 Patients 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 arrhythmias or myocardial infarction within the previous six months Evidence of ongoing or active infection requiring antibiotic therapy Active intracranial metastases. Patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been clinically 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 per standard of care prior to the surgery for tumor removal. A second pregnancy test must be performed 7 days prior to the first vaccination and must be negative. 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 patients have had no corticosteroids within 4 weeks prior to start of study) Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis Patients who 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 No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to registration | 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): 20.0-60.0, Diabetes Obesity 20 to 60 years of age (inclusive) on the date the informed consent document (ICD) is signed; 2. A body mass index (BMI) from 28 kg/m2 to 50 kg/m2 ; 3. Previously diagnosed for at least 6 months with T2DM according to World Health Organization (WHO) criteria; 4. C-peptide > 1 ng/mL (0.3 nmol/L); 5. Able and willing to comply with procedures required by the protocol; and 6. Able to comprehend and sign or, if illiterate, leave their thumb impression on the study ICD History of T2DM for a duration > 10 years; 2. History of drug and/or alcohol abuse within 2 years of Screening Visit; 3. Any previous major GI surgery (e.g., any GI surgery with a resection, etc.). Previous GI surgery allowed appendectomy, gall bladder surgery, liver biopsies, and endoscopic procedures; 4. Scheduled concurrent surgical, non-endoscopy, procedure from Visit 1 through the end of Visit 3; 5. Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant one year or sooner after the surgery; 6. Psychiatric disorders that may affect compliance with the clinical study, including dementia, active psychosis, severe depression, or history of suicide attempts; 7. Any of the following conditions: 1. Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years; 2. End stage renal disease; 3. Abnormal results from glutamic acid decarboxylase autoantibodies (GADA) or protein tyrosine phosphatase-like protein (IA-2A) testing; or 4. Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders; 8. Participation in any other clinical study (not to registries or survey-only studies) within 30-days or 5 half-lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of 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): 0.0-2.167, Neurological Development After Exposition to an Antenatal Nuchal Translucency - Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR ultrasound abnormality neck restraint by sonographers referents replay after the initial shots (the notion of transience of the pathology of the neck being allowed) with in all cases gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between 45 and 84 mm Thickness of the neck> 95th percentile of the standard set for the crown-rump length according to the team Nicolaides ultrasound Clichés meet quality (score ≥ 5 at least 2 major criteria) normal karyotype or not done Morphological Ultrasound second quarter normal or minor abnormalities Consent signed holders of parental authority for monitoring up to 2 years and neurodevelopmental assessment at the end of follow-up Affiliate or benefit of a social security scheme Multiple Pregnancy Prematurity less than 32 SA Birth weight less than 1500 grams Discovery of a chromosomal abnormality on karyotype not made prenatally Withdrawal of consent intercurrent Event may be the cause of abnormal psychomotor development: fetal distress cause of hospitalization, prenatal viral infection for control group Newborn who did not have enlarged nuchal translucency and with normal antenatal ultrasound Matching each child the "nuchal group" on Maternity Birth: matching the child witness in the University Hospital of the same region as motherhood in which the child with nuchal group is born gestational age: the child matched group must belong to the same group of gestational age than neck the child with nuchal group | 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, Jaundice hyperbilirubinemia asphyxia cerebral dysgenesis | 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): 18.0-40.0, Respiratory Syncytial Virus Infections Pregnant women must meet all of the following to be eligible to participate: 1. ≥18 and ≤40 years-of-age. 2. Singleton pregnancy of 33 to 35 weeks gestation on the day of planned vaccination. 3. Good general maternal health as demonstrated by Medical history (including history of adverse reactions to prior vaccines and allergies) Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones Clinical laboratory parameters including normal blood urea nitrogen, creatinine, ALT, AST, total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count; and serologic of infection with hepatitis B (HBV) and C (HCV) viruses and HIV (as required). Note that normal ranges for vital signs and clinical laboratory parameters will be based on third trimester values published in Sheffield et al. [2013] and/or reference ranges for the third trimester of pregnancy of the central laboratory. 4. Documentation that fulfills one of the following Detailed (level II) second trimester or later anatomic ultrasound with no significant anatomic or growth abnormalities identified; OR Routine second trimester or later ultrasound with no significant anatomic or growth abnormalities identified, PLUS at least one of the following Normal first trimester screening (based on ultrasound + serum analytes); or Normal cell-free fetal DNA; or Normal chorionic villus sampling (CVS) or amniocentesis; or Normal second trimester maternal serum quadruple screen; or Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following 1. Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose >500µg per day of beclamethasone or fluticasone, or >800μg per day of budesonide. 2. Pre-pregnancy body mass index (BMI) of ≥35 or <18.5. 3. Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias. 4. Hepatic or renal dysfunction. 5. Established diagnosis of seizure disorder, regardless of therapy. 6. Auto-immune disease or known immunodeficiency syndrome. 7. Endocrine disorders, including (but not limited to) hyperthyroidism, untreated hypothyroidism, and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control. 8. History of major gynecologic or major abdominal surgery, including bariatric surgery. 9. Known HIV, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study. 10. Primary genital herpes simplex (HSV) infection during the current pregnancy. 11. Current alcohol or drug abuse. 12. Documentation that current pregnancy results from fertility treatments, rape, or incest. 13. Documentation that the infant will be a ward of the state or be released for adoption. 14. Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs. 15. History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy. 16. Untreated red blood cell allo-immunization. 17. Prior stillbirth or neonatal death, or multiple (≥3) spontaneous abortions. 18. Prior preterm delivery ≤34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth. 19. Greater than five (5) prior deliveries. 20. Previous infant with a known genetic disorder or major congenital anomaly. 21. Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine. 22. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in criterion #1. 23. Any other physical, psychiatric or social condition which may, in the investigator's opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data | 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, Carcinoma, Neuroendocrine Written informed consent in accordance with federal, local, and institutional guidelines Age ≥18 years Patients must have a tissue diagnosis of any of the following Small cell lung cancer (SCLC) or poorly differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NET) Poorly differentiated metastatic neuroendocrine tumors of unknown primary origin Measurable disease: Any primary and/or metastatic mass reproducibly measurable in one or two diameters by 1.1 parameters by cat scan (CT) scan Objective evidence of tumor progression within 4 months prior to study entry, as defined by serial cat scan (CT) per 1.1 criteria. (At least a 20% increase in the sum of diameters of target lesions. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) Patients must have received at least one prior line of chemotherapy and must have exhausted any other standard-of-care treatment option Prior radiation and surgery is allowed. At least 3 weeks should have elapsed from surgery, chemotherapy, hepatic embolization/ chemoembolization or radioactive isotopes (i.e. Yttrium 90). In any case, disease progression must be documented after treatment Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Patients who are pregnant or lactating Patients with the following tumor types: lung carcinoid, pheochromocytomas, paragangliomas, medullary thyroid carcinomas, any other tumors with neuroendocrine features not listed in the Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤3 weeks prior to C1D1 Major surgery ≤3 weeks prior to C1D1 Unstable cardiovascular function Congestive heart failure (CHF) of NYHA Class ≥3 OR Myocardial infarction (MI) within 3 months Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study Known to be human immunodeficiency virus (HIV) seropositive Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV RNA) or HBsAg (HBV surface antigen) | 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): 0.0-22.0, Adrenoleukodystrophy Batten Disease Mucopolysaccharidosis II Leukodystrophy, Globoid Cell Leukodystrophy, Metachromatic Neimann Pick Disease Pelizaeus-Merzbacher Disease Sandhoff Disease Tay-Sachs Disease Brain Diseases, Metabolic, Inborn Alpha-Mannosidosis Sanfilippo Mucopolysaccharidoses Patients must be age ≥1 week to <21 years. 2. Patients must have one of the following inherited metabolic diseases detected by enzyme or mutation analysis, and confirmed by repeat testing on a separately obtained sample: Adrenoleukodystrophy (ALD) Batten Disease Hunter Syndrome (MPS II) Krabbe disease (Globoid Leukodystrophy) Metachromatic Leukodystrophy (MLD) Niemann Pick disease type A or B Pelizaeus-Merzbacher disease (PMD) Sandhoff disease Tay Sachs disease. Alpha Mannosidosis Sanfilippo (MPS III) 3. Patients must have neurologic evidence of their disease, either clinically or via neuroimaging or neurophysiological testing. Examples of evidence of neurologic involvement but are not limited to the following Abnormal EEG, Brainstem Auditory Evoked Response (BAER), and/or Visual Evoked Potentials (VEP) Abnormal brain MRI, ie. increased Loes score (measure of white matter damage, demyelination, and brain atrophy) and/or abnormal corticospinal tracts as assessed by MRI with diffusion tensor imaging (DTI) Three or more of the early clinical markers: problems sleeping, increased activity, behavior difficulties, seizure-like activity, chewing behavior, inappropriate bladder training, inappropriate bowel training. 4. Patients must have adequate organ function as measured by Renal: Serum creatinine < 2.0 mg/dl Hepatic: Hepatic transaminases (ALT/AST) < 5 x normal, bilirubin < 2.0 mg/dl (except in patients with Gilbert's disease or newborns with physiological or breast milk associated jaundice) Cardiac: Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction of normal value for age). Patients with acquired or congenital cardiomyopathy may receive melphalan as a substitute for cyclophosphamide Pulmonary: Pulmonary function tests demonstrating FVC, FEV1, and DLCO ≥ 60% of predicted in patients who can complete the testing. If patient cannot perform PFT's, an O2 sat must be >90% on room air. 5. Patients must not have a suitable fully matched, non-carrier sibling or related bone marrow donor. 6. Patients must have an available, suitably matched, banked UCB unit in a two-compartment configuration (see graft selection in section 5.2). 7. Patients must have a performance status as follows: Lansky ≥ 40%, or Karnofsky ≥ 40%. 8. Patients must have a life expectancy of ≥ 6 months Prior organ, tissue, or stem cell transplant within 3 years of study entry. 2. Prior participation in any gene or regenerative cell therapy study. 3. Inability to have an MRI scan or lumbar puncture. 4. Intractable seizures. 5. Chronic aspiration. 6. Bleeding disorder. 7. Evidence of HIV infection or HIV positive serology. 8. Uncontrolled bacterial, viral, or fungal infection at the time of pre-UCBT cytoreduction. 9. Inability to obtain patient's, parent's or legal guardian's consent. 10. Requirement of ventilatory support. 11. Pregnant or breastfeeding. 12. Active concurrent malignancy, or receiving concurrent radiotherapy, immunosuppressive medications, or cytotoxic chemotherapy | 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 Healthy adult male or female subjects between 20 to 45 years of age Body weight within 80 to 120 percentages of ideal body weight and higher than or equal to 50 kg for male subjects and 45 kg for female subjects Acceptable medical history and physical examination including no particular clinically significant abnormality in x-ray and ECG results within six months prior to period I dosing.no particular clinical significance in general disease history within two months prior to period I dosing Acceptable vital signs within normal limits or considered by the investigator or physician to be of no clinical significance at screening, which includes pulse rate, blood pressure and body temperature Acceptable clinical chemistry determinations within normal limits or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes AST , ALT ,GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride Acceptable hematology within normal range or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets Acceptable urinalysis within normal limits or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein Female subjects of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators or surgically sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on the subject Have signed the written informed consent to participate in the study A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic systems or psychiatric disease as determined by the clinical investigator A clinically significant illness or surgery within four weeks prior to Period I dosing as determined by the investigator History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant Known or suspected history of drug abuse within lifetime as judged by the investigator History of alcohol addiction or abuse within last five years as judged by the investigator History of allergic responses to acyclovir, valacyclovir or any other related drugs Evidence of chronic or acute infectious diseases Female subjects demonstrating a positive urine pregnancy screen prior to the study Female subjects who are currently 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): 0.0-25.0, Diffuse Intrinsic Pontine Glioma (DIPG) for Newly Diagnosed Patients with diffuse intrinsic pontine glioma (DIPG) Diagnosis: Patients with newly diagnosed DIPG, defined as tumors with a pontine epicenter and diffuse involvement of the pons who undergo a biopsy are eligible. Patients with disseminated disease are not eligible, and MRI of the spine must be performed if disseminated disease is suspected by the treating physician Enrollment within 28 days of the date of radiographic diagnosis Age ≤ 25 years Karnofsky score ≥ 50 for patients ≥ 16 years of age and Lansky score ≥ 50 for patients ≤15 years of age. Patients who are unable to walk because of paralysis but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Organ Function Requirements Adequate Bone Marrow Function Defined as Peripheral absolute neutrophil count (ANC) ≥ 1000/mm 3 Platelet count ≥ 100,000/mm 3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) Hemoglobin ≥ 8 g/dl (can be transfusion dependent) for Newly Diagnosed Patients with DIPG Patients who are currently taking any anti-cancer directed therapy. Steroids are not considered anti-cancer therapy Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to 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): 18.0-35.0, Preterm Labour Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor). 2. Women who present with viable pregnancy (between 28 and 37 weeks' gestation), and having a threatened preterm labor (which is defined as ≥ 2 uterine contractions at 28-37 weeks' gestation, The onset of labor may be determined by documented uterine contractions (at least one every 10 minutes) and ruptured fetal membranes or documented cervical change with an estimated length of less than 1cm or cervical dilation of more than 2 cm. Threatened preterm labor may be diagnosed when there are documented uterine contractions but no evidence of cervical change Multiple pregnancy. 2. Documented uterine anomalies. 3. Oligohydramnios and polyhydramnios . 4. Medical disorders as Diabetes mellitus and hypertension. 5. Preterm premature rupture of membranes. 6. Conditions that may have an influence on immune reaction e.g. history of chorioamnionitis. 7. Smoking as a risk factor for preterm labor. 8. Patients having Autoimmune disorder as it may affect Uterine NK( natural killer ) cells level | 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): 0.0-45.0, Infants of Diabetic Mothers (understood to only abstemious women) 1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies 2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies 3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies 4. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies) 2. . Mothers who had a positive drug screen at any point during their pregnancy (and their babies) 3. . Babies whose mothers suffered a placental abruption during their pregnancy. 4. . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic visits prior to admission for delivery) 5. . Non-English-speaking mothers 6. . Babies who pass meconium in utero. 7. . Babies born with multiple congenital anomalies or abdominal wall defects | 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, Infant, Premature, Diseases The were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g were severe neonatal pathology such as birth complications, GI malformations, chromosomal abnormalities, known immunodeficiency, hydrops foetalis, a central venous catheter and the use of antifungal drugs or probiotics | 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 Healthy adult male or female subjects between 20-45 years of age Body weight within 80-120% of ideal body weight and higher than or equal to 50 kg for male subjects and 45 kg for female subjects Ideal body weight (kg) = [height (cm) × 0.7 for male subjects Ideal body weight (kg) = [height (cm) × 0.6 for female subjects Acceptable medical history and physical examination including: no particular clinically significant abnormality in X-ray and ECG results within six months prior to study. no particular clinical significance in general disease history within two months prior to study Acceptable vital signs (within normal limits or considered by the investigator or physician to be of no clinical significance) at screening, which includes pulse rate, blood pressure and body temperature Acceptable clinical chemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study, which includes AST (SGOT), ALT (SGPT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride (TG) Acceptable hematology (within normal range or considered by the investigator or physician to be of no clinical significance) within two months prior to study, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator) A clinically significant illness or surgery within four weeks prior to study (as determined by the investigator) History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant Known or suspected history of drug abuse within lifetime as judged by the investigator History of alcohol addiction or abuse within last five years as judged by the investigator Have a personal history or family history of drug allergy Subjects demonstrating a positive meropenem skin test screen prior to the study Evidence of chronic or acute infectious diseases Female subjects demonstrating a positive urine pregnancy screen prior to 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): 18.0-999.0, Sepsis Severe Sepsis Septic Shock Presenting to MTRH Casualty Department for acute medical care Suspected infection, in the judgment of the managing clinician At least 2 of the following: axillary temperature >37.5°C or <35.5°C or core temperature >38.0°C or <36.0°C; heart rate >90 beats per minute; respiratory rate >20 breaths per minute; or systolic blood pressure <100 mmHg Lack of basic language skills in either English or Kiswahili Pregnancy Congestive heart failure or valvular heart disease (as a known prior diagnosis or in the judgment of the managing clinician) Need for immediate surgery (within 6 hours) in the judgment of the managing clinician Inability to consent to study participation and lack of accompaniment by a family member or other surrogate who can provide 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): 18.0-35.0, Upper Respiratory Tract Infections Age: 18-35 years Parity: any but with history of previous normal delivery Weight: Body Mass Index greater than 18.5 but less than 35 Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric conditions Current pregnancy: Uneventful progression of pregnancy General health: Normal health related functional status during pregnancy Singleton pregnancy as determined by clinical examination and/or by ultrasonography Cephalic presentation as determined by abdominal clinical examination Expected to have normal pregnancy related outcome Written informed consent Medical history: Known history of diabetes, hypertension, or any systemic disorder Gynecological history: History of major gynecological problem/treatment Complications in previous pregnancy Previous obstetric cholestasis Previous acute fatty liver disease Conditions during current pregnancy 1. RhD negative mother 2. APH/Placental abruption 3. Placenta Praevia 4. Unstable lie 5. Multiple pregnancy 6. Pregnancy induced hypertension (systolic > 140 mm of Hg, diastolic > 90 mm of Hg) 7. Severe pre-eclampsia or eclampsia 8. Gestational diabetes 9. Onstetric cholestasis 10. Current history of drug/alcohol abuse 11. BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by HB level (< 7 gm/dL), and oedema 12. Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD) 13. History of taking antibiotic within 3 weeks prior to this study 14. Patient unwilling to comply with study protocol | 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, Neonatal Hyperbilirubinemia Written or thumb print informed consent from the mother during pregnancy Neonates who are born to mothers who followed antenatal care at SMRU antenatal clinics Neonates who are born in a SMRU clinic OR neonates who are born outside SMRU but visit a SMRU clinic within 48 hours after birth OR neonates who are born outside SMRU and present with neonatal jaundice at any moment in the first 8 days No written or thumb print informed consent from the mother during pregnancy Neonates who are born to mothers who did not follow antenatal care Neonates < 28 weeks gestation Neonate born outside SMRU and present > 48 hours after delivery without jaundice | 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, We Will Focus on Assessing the Clinical Performance of the BiliCare Device Signed parental informed consent 2. Gestational Age >=24 weeks Less than 24 weeks of pregnancy at delivery 2. Bruising at the point of measurement on both ears 3. Birthmarks at the point of measurement on both ears 4. Hematomas at the point of measurement on both ears 5. Excessive Hairiness at the point of measurement on both ears 6. Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours | 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): 0.167-999.0, Acid Lipase Deficiency Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type Cholesterol Ester Storage Disease Informed consent will be obtained from the parents before any study related procedures Patients of both gender older than 2 month The patient has a diagnosis of Wolman disease or a high-grade suspicion for Wolman disease High-grade suspicion present, if one or more are valid Positive family anamnesis for Wolman disease Vomiting, diarrhea Malnourishment, difficulty growing and gaining weight Enlarged liver and spleen (hepatosplenomegaly), which causes a distended abdomen Low muscle tone (hypotonia) Anemia x-ray reveals calcified adrenal glands No Informed consent from the parents before any study related procedures Patients of both gender younger than 2 month No diagnosis of Wolman disease or no valid for profound suspicion of Wolman 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): 0.0-0.25, Apnea Our study population will infants who meet the following (1) Born at greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea, bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other discharge (i.e. feeding maturity, temperature regulation, etc.) so that apnea/bradycardia/desaturation remains the final discharge issue. As our intent will be to study infants for whom hospital stay is prolonged as a result of presumed apnea of prematurity will (1) comorbidities associated with an increased risk of apnea, including neurologic abnormalities such as congenital CNS malformations, seizures, or intracranial bleeds, anatomic abnormalities of the airway, significant congenital heart disease, residual lung disease requiring respiratory support, infectious disease including sepsis, pneumonia, or meningitis, chromosomal abnormalities, and drug withdrawal; (2) prolonged hospitalization for an indication other than apnea, bradycardia and/or oxygen desaturation such as feeding immaturity, temperature instability, or phototherapy; (3) transfer to an outside hospital; (4) provider concern with caregiver ability to safely operate and comply with home monitor use | 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, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women Prisoners | 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): 18.0-99.0, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache | 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): 18.0-85.0, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise | 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, Cleft Lip Cleft Palate Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate Birthplace in south-east region of Norway Scandinavian speaking parents Parents of infants with CLP who are referred to the hospital after the first measure point Birthplace outside south-east region of Norway Non-scandinavian speaking parents | 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, Nocturia Healthy males aged 18 to 45 Have a body mass index between 18 and 29.9 kg/m2 (weight: ≥50 kg and ≤100 kg) No clinically significant medical history Ability to comply with the requirements of the study Provide written informed consent Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be below or equal to upper level of normal (ULN). Otherwise liver enzymes should show no clinical significant abnormalities. Total bilirubin should not exceed 1.5 x ULN. Liver enzymes will be re-tested only once before randomization if required Be judged by the Investigator to be in good health based on medical history (in particular, no congestive heart failure, ischemic heart disease, valvular heart disease, significant pulmonary disease, renal failure, edematous disorder, liver disease, gastric disorders, porphyria, diabetes mellitus or hereditary disorders of carbohydrate metabolism), physical examination, vital sign measurements and laboratory safety tests Agree to refrain from the consumption of grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats containing products beginning 1 week prior to administration of the initial administration of trial drug, throughout the trial Use of any prescribed medication or St John's Wort within 14 days (or 5 half-lives if this is longer) or over-the-counter medication (except paracetamol) within 1 week of dosing. Specific medication not to be taken within 2 weeks of (before or after) administration of itraconazole is described in the Summary of Product Characteristic for Sempera® | 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 Patients are birth to 7 days post-natal age Present in Minneapolis or St Paul ED during the pre-implementation or implementation period with a chief complaint of jaundice Children born prematurely Concern for sepsis or bacterial infection In-born error of metabolism Metabolic disease Positive newborn screen (e.g. Sickle Cell Disease, Cystic Fibrosis) | 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): 0.0-17.0, Respiratory Insufficiency Hypoxia All patients who are receiving HFNC for hypoxia Age: 1 day (> 38 weeks GA neonate or older) to 17 years i. Patients who have congenital heart defects. ii. Patient who the medical team feels may require urgent escalation of non-invasive therapy or imminent intubation. iii. Patients who are on FIO2 > 0.6 at the highest level of flow offered within the study. iv. Patients who are immunocompromised and/or status post bone marrow transplant v. Patients who are on vasoactive support to maintain blood pressure or heart rate vi. Patients with a known airway anomaly, e.g. Pierre-Robin, tracheomalacia. vii. Patients less than 38 weeks gestational age viii. Patients less than 3 kilograms ix. If the EIT band/electrodes are not able to be properly positioned on the chest due to size/weight limitations x. If the medical team feels that the patient is not appropriate to enroll in the study based on medical, social or emotional concerns | 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): 0.0-0.096, Premature Brain Oxygenation Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven days old Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than 30% Not requiring inotropic support On full enteral feeds Babies with major congenital abnormalities Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound | 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, Jaundice, Obstructive all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum | 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, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft | 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, Late Onset Neonatal Sepsis Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis (LOS) at admission or during their NICU stay and receive meropenem for at least four days Acute or chronic renal failure Hypersensitivity or allergy to meropenem | 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, Homozygous or Compound Heterozygous POMC, LEPR or PCSK1 Gene Mutation Written informed consent Homozygous or compound heterozygous (different gene mutation on both alleles) POMC, LEPR or PCSK1 gene mutation Obesity (BMI > 30 kg/m2; + 2 BMI SDS) No other therapeutic option, which might cure the patient (e.g. bariatric surgery (see chapter 8)) Negative Pregnancy test Highly effective contraception in women (defined as pearl index < 1), if necessary also for partners of test persons) No participation in other clinical trials according to AMG (Arzneimittelgesetz) (2 months before and after) at the time of this trial Normal or minimally elevated blood pressure (measured in 24RR monitoring or similar methods) according the guidelines of the ESH (European Society of Hypertension) and Deutsche Hochdruckliga: systolic > 159 mmHg/diastolic 99 mmHg sufficient kidney and liver function (Creatinine, ALT, AST) normal values Alanine-Aminotransferase (ALT) (female): < 31 U/l Pregnancy or Breastfeeding All contraindications against study medication (including auxiliary substances) Interactions with study medication Participation of the patient in a clinical study within the last 2 months Intolerance against albumin Concomitant diseases, impaired organ functions, except for known, concurrent GI disorders or other clinical findings expected in PCSK1 or LEPR gene disorders Renal insufficiency (Creatinine > 0,95 mg/dl (female), > 1,17 mg/dl (male)) Impaired liver function (Bilirubins > 1.2 mg/dl) Neurological / psychiatric diseases HIV Infection | 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): 0.0-0.769, Parental Infant Bonding Cardio-respiratory Stability in Preterm NICU Infants Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks. 2. Infants at least 7 days of life to allow for transition to extrauterine life. Parental 1. Agreement to the study with signed Informed Consent Form and HIPAA Authorization 2. Visits on a regular basis (at least 3 times per week) 3. Is literate (able to read) Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team, 2. infants with congenital hearing loss, 3. chromosomal abnormalities, 4. infants not expected to survive. Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case) - | 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, Liver Disease Fatty Liver For the entire cohort Male or female aged > 18 years Ability to provide informed consent For group 1 subjects (NAFLD) Biopsy-proven NAFLD within 2 years prior to screening, OR The presence of at least two of the following Suggestion of liver fat by an imaging study (ultrasound, CT scan, MRI or MR spectroscopy) performed in the 6 months prior to screening Elevated aminotransferase levels (ALT > 31 U/L for men or > 19 U/L for women, or AST > 30 U/L) on at least two occasions in the 6 months preceding enrollment Presence of the metabolic syndrome, defined according to the modified AHA/NCEP as the presence of at least three of: i. Abdominal obesity, defined as waist circumference > 102 cm for men or > 88 cm for women ii. Elevated triglycerides (> 150 mg/dL) or the use of medication to lower triglycerides iii. Reduced HDL cholesterol (< 40 mg/DL for men or < 50 mg/dL for women) iv. Elevated blood pressure (> 135/80 mmHg) or use of medication for hypertension v. Elevated fasting glucose levels (> 100 mg/dL) or use of anti-diabetic medication For the purpose of the presence of overt diabetes mellitus type 2 will be considered equivalent to the presence of the metabolic syndrome, even if the other are absent. For group 2 subjects (non-NAFLD metabolic syndrome) Evidence of metabolic syndrome Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to 19 U/L for women, or AST less than or equal to 30 U/L) at screening Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency 2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment > 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible. 3. Estimated average alcohol consumption > 30 g/d for men or > 20 g/d for women in the 6 months prior to enrollment, or binge-drinking behavior . 4. Gain or loss of > 10% body weight within the 6 months prior to enrollment. 5. Decompensated liver cirrhosis, defined as a past or present occurrence of a decompensation event (variceal bleeding, ascites, spontaneous bacterial peritonitis, encephalopathy or hepatocellular carcinoma or by albumin < 3 g/dl, PT > 3 seconds above the upper limit of the norm, platelet count < 70,000 or total bilirubin > 2 mg/dL (in the absence of Gilbert s syndrome). 6. Pregnancy or lactation 7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen 8. Disorders interfering with substrate absorption such as gastric bypass surgery, malabsorption disorders, use of orlistat or bile acid sequestrants, or extensive small bowel resection. 9. Diabetic patients requiring insulin treatment 10. Lactose intolerance or allergy to Ensure or one or more of its components 11. Hyper/hypothyroidism 12. Inability to remain sedentary for 4 hours, or to remain for 26-30 hours in the metabolic chamber 13. Inability to obtain vascular access for the required blood samples | 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): 0.0-18.0, Cerebral Palsy Cerebral palsy neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb) PSF from 2008-2012 at Phoenix Children's Hospital GMFCS IV or V Diagnosis other than CP GMFCS I-III Previous spine deformity 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): 0.0-0.833, Plagiocephaly Craniosynostosis Diagnosis which requires helmet therapy treatment Under 10 months of age Children who do not need helmet 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): 18.0-45.0, Healthy Provide the singed informed consent form (ICF) 2. Healthy Chinese male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests) 3. Aged ≥18 and ≤45 years 4. Body mass index (BMI) ≥19 and ≤28 kg/m2 5. Weight ≥50 and ≤80 kg 6. Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation 7. Subjects must agree that they and their female spouse/partners will use reliable contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential from the time of the administration of investigational product (IP) until the completion of the study 8. Do not smoke or smoke fewer than 5 cigarettes daily within three months prior to screening; do not drink or drink less than 14 units of alcohol within six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine) Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases 2. Clinically significant abnormalities in laboratory test results 3. Previous exposure to any monoclonal antibody or current use of any biologics 4. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients 5. Use of prescription or non prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking IP (whichever is longer). Herbal supplements must be discontinued 28 days prior to the IP 6. History of a blood donation within 3 months prior to the administration of IP 7. Have participated in any other clinical study within 3 months prior to the administration of IP 8. Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies 9. Have a history of drug abuse 10. Unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits or improbability of completing the whole clinical study, etc | 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, Neonatal Hyperbilirubinemia Full-term newborns with jaundice after 3-7 days of birth, total bilirubin in serum or transcutaneous bilirubin is between 100umol/L and 257umol/L, and start taking Yinzhihuang oral liquid, dose: 3ml per each time, 3 times per each day, during the period, measuring bilirubin from skin one time every 24 hours; 2. Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8; 3. lineal consanguinity are all the native residents from Guangdong or Guangxi; 4. The enzyme activity of G-6-PD will be detected and collected from all the neonates subjects; 5. Informed consents of all the neonates subjects are needed. Note: Icterus testers are Minolta 105 type. Measurements of bilirubin are from three location, inluding forehead, chest and abdomen. The value of bilirubin will use the average value from the three location, and the unit is umol / L Neonates with inherited metabolic diseases; 2. Neonates with congenital malformation of liver and gallbladder; 3. Neonates with asphyxia, hypoxia, acidosis, sepsis, high fever, low temperature, low protein, low blood sugar, etc. which may lead to bilirubin encephalopathy; 4. History of oxidation drug exposure(e.g. honeysuckle bath) | 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, Hemorrhage Premature Infants Newborn Hydrocephalus GM-IVH group: for GM-IVH group: born at gestational age (GA) 24-32 weeks; < 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI) for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection. 2. PHH group: for PHH group: born at gestational age (GA) 24-37 weeks < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI. 3. HC group: for HC group: born at gestational age (GA) 24-32 weeks; < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar >7 at 5 min for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. 4. VC group: for VC group: < 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI | 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): 20.0-999.0, Gastrointestinal Stromal Tumour (GIST) An eligible subject must fulfill all of the following Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written IC Pathologically confirmed gastrointestinal stromal tumours All patients had received imatinib or sunitinib Pathological confirmed c-kit exon 17 mutation At least one measurable lesion in a non-irradiated area or allowed to be tracked whether there are circumstances recurrence by computed tomography (CT) or magnetic resonance imaging (MRI) Aged > 20 years old Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy greater than 12 weeks Adequate bone marrow function: 1) Absolutely neutrophil count >= 1.5 x10^9/L or white blood cell count (WBC) >= 4x10^9/L; 2) Hemoglobin >= 9 g/dL; 3) Platelet count >= 100x10^9/L Subject will not meet any of the following Major surgery within four weeks prior to entering the study Patients with central nervous system (CNS) metastasis, including clinical suspicion Patients who are under active or uncontrolled infections Patients who with unstable angina (angina symptoms at rest, new-onset angina (begun within the last 3 months) or myocardial infarction history 6 months before entry Cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) Congestive heart failure New York Heart Association (NYHA) class 2 Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication Patients who are pregnant or with breast feeding | 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 Hyperbilirubinemia Bilirubin-Induced Neurological Dysfunction (BIND) Subjects must meet all of the following to be considered eligible for study enrollment soon after birth or re-admission (for phototherapy) Parental informed consent Male and female newborns with a GA ≥ 28 wks with a birthweight ≥ 1000 g including infants with GA ≥ 35 wks with a birthweight ≥ 2500 g who are clinically deemed at risk Enrollment at age less than 14 days and more than 6h None | 2 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.