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The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.038, Jaundice, Neonatal Subjects will be eligible to participate in the study if all of the following conditions exist: 1. At time of birth, infant is > 35 weeks gestation (or ≥ 2.2 kg if gestational age is not available. 2. Infant is < 14 days old at the time of enrollment. 3. Infant has an elevated TB defined as at the level recommended for high-risk infants per AAP guidelines or higher. 4. Parent or guardian has given consent for the infant to participate Subjects will be excluded from enrollment in the study if any of the following conditions exist: 1. Infants with a condition requiring referral for treatment not available at the hospital study site. 2. Infants with a life-expectancy of < 24 hours at screening enrollment. 3. Infants requiring oxygen therapy unless that can be provided while under PT. 4. Infants clinically dehydrated or sunburned at the time of screening enrollment. 5. Infants with a temperature < 36.0 or > 37.5 degrees Centigrade that does not return to normothermia within 1 hour | 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): 0.0-72.0, Neonatal Jaundice Hyperbilirubinemia All newborns ≥ 35 wks gestational age and ≥ 1800g Babies who who are < 72 hours of life Prior use of phototherapy Major congenital anomaly Babies born < 35 wks gestational age or < 1800g | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Preterm Birth Be moderate preterm infants born with gestational ages between 31-35 weeks Postnatal age from 48 hours to one week of life Clinical Stability: respiratory rate between 30-60 rpm, heart rate between 120-160 bpm, oxygen saturation (SaO2) above 89%, the absence of signs of respiratory distress (Silverman-Andersen Bulletin), no cyanosis or pallor and pain / discomfort Appropriate behavioral State: State 4 (inactive alert) or 5 (active alert) Brazelton APGAR less than 7 at 5˚ minute Rating as small for gestational age (SGA), according to gestational age ratio chart with birth weight Being in use of drugs that interfere with the state of consciousness, as sedatives preterm infants undergoing phototherapy, oxygen therapy or venous access preterm infants undergoing mechanical ventilation Intracranial hemorrhage grade III or IV or periventricular leukomalacia (diagnosed by ultrasound transfontanellar recorded in medical records) CNS infection (meningitis and encephalitis) seizure of History Necrotizing enterocolitis at the time of examination Congenital malformations, genetic syndromes, neurological disorders or diagnosed congenital infectious diseases (syphilis, toxoplasmosis, rubella, cytomegalovirus and herpes) | 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): 0.712-0.808, Jaundice Neonatal All maternal-fetal dyads must comply with all of the following at randomization Term delivery between 37 -42 weeks of gestation (estimated by ultrasound) Signed parental consent Singleton delivery Nonsmoking mothers Mothers willing to return for follow up visits Declaration of breastfeeding for at least six months The following maternal fetal dyads will be excluded 1. Preterm delivery < 37 weeks of gestation (estimated by ultrasound). 2. Isoimmune hemolytic disease. 3. Sepsis. 4. Maternal Gilbert syndrome. 5. Birth asphyxia. 6. Serious maternal hemorrhage during delivery. 7. Major congenital abnormalities. 8. Need for early cord clamping (tight nuchal cord, need for resuscitation). 9. Participation in another 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): 18.0-70.0, Metabolic Syndrome x Glucose Metabolism Disorders Dyslipidemias Obesity Aged between 18 and 70 years old Caucasian Insulin resistance (based on HOMA single-value) BMI between 25 and 50 kg/m² Metabolic syndrome: presence of at least 3 of the following Hypertension (blood pressure ≥ 130/85 mm Hg or antihypertensive treatment) Hypertriglyceridemia (triglyceridemia ≥ 150mg/dl) Low HDL-cholesterol (HDL-cholesterol < 40mg/dl for males, 50mg/dl for females) Visceral obesity (waist circumference > 102 cm for males, 88cm for females) Fasting hyperglycemia (fasting glycemia ≥ 110mg/dl) Acute or chronic progressive or chronic unstabilized diseases Alcohol consumption (more than 2 glasses per day) Previous bariatric surgery Surgery in the 3 months prior the study or surgery planned in the next 6 months Pregnancy or pregnancy planned in the next 6 months More than 30 minutes of sports 3 times per week Consumption of dietary supplement (omega-3 fatty acids, probiotics, prebiotics, plant stanols/sterols) in the month prior the study Inflammatory bowel disease or irritable bowel syndrome Diabetic gastrointestinal autonomic neuropathy (such as gastroparesis or reduced gastrointestinal motility) Consumption of more than 30g of dietary fibers per day | 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, Healthy Volunteers Both genders, between the ages of 18 and 35 years old Willing and able to provide informed consent Body Mass Index between 18.5 and 24.9 (normal) Normal blood work, according to following Leucocytes >3,000; Platelets >100,000; Hemoglobin >10.0 g/dL; AST, ALT and bilirubin < 2 times UNL; Creatinine < 2 times UNL Normal ECG and chest x-rays, at the discretion of the cardiologist and radiologist, respectively Negative urine pregnancy test (Women in childbearing age, sexually active) Willing to return for follow-up as required by the study History of psychiatric condition Pregnant or lactating women Clinically significant abnormalities on the ECG Presence of medical or social conditions that, in opinion of the investigator, may prevent the proper participation of the volunteer subject in the study or in the assessment of its outcomes Presence of an active systemic infection Subjects receiving medical treatment for any medical condition, either acute or chronic Recent (< 6 months) major surgery Recent (< 1 year) alcohol abuse or illegal drug 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): 0.5-999.0, Malaria Male or female, aged over 6 months old Acute severe P. falciparum malaria or another indication to treat with IV artesunate. Defined as one or more of the following, occurring in the absence of an identified alternative cause, and in the presence of P. falciparum asexual parasitaemia Prostration OR obtundation BCS<3 (preverbal children) or GCS<11 (adults) Convulsion in last 24 hours Suspected acidosis, manifesting as acidotic breathing Respiratory distress manifesting clinically (nasal flaring/indrawing) or oxygen saturation <92% or respiratory rate >30/min History of anuria Jaundice and/or hemoglobinuria Hemoglobin <7 g/dl or hematocrit <20% History of 2 or more doses of parenteral antimalarial treatment in the previous 24 hours History of allergy or known contraindication to artemisinins | 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, Healthy Healthy male or female subjects Preferably non-smokers or smoke less than 10 cigarettes per day Body mass index within 18 to 25 kg/m2 Normal vital signs (after 10 minutes rest): systolic blood pressure 100 mmHg, diastolic blood pressure 60 mmHg, pulse rate 60 bpm Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs Pregnant or lactating women Any major illness in the past 90 days or clinically significant ongoing chronic medical illness Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 upper limit normal), renal function test (serum creatinine > 1.4 mg/dL), etc Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV Clinically significant hematology abnormalities Clinically significant ECG abnormalities Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug History of anaphylaxis or angioedema History of drug or alcohol abuse within 12 months prior to screening | 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): 0.25-999.0, Tropical Infectious Diseases Children between ages >3 months and < 15 years old OR adults of 15 years and above 2. AND willing and able to provide written informed consent (parent's or guardian's consent for minors). In case of very sick adults not able to give consent, sampling will be done and ICF will be asked upon his/her recovery or from his/her representative in case of death. 3. AND presenting with one of the following: Recorded temperature of > 38.0°C or temperature < 35.5°C (tympanic). OR episode of fever within 48 hours prior to admission OR signs of severe clinical illness including one or more of the following Respiratory distress Prostration Altered consciousness Convulsions (one or more episodes) Clinical jaundice Signs of shock Severe malnutrition with severe anemia (hemoglobin < 5 g/dl) 4. AND Having one of the following clinically suspected infections Severe malaria Invasive bacterial infection (including pneumonia, arthritis, peritonitis, meningitis or complicated urinary tract infection, typhoid fever) • Fever episode for more than 7 days or no informed consent was given | 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): 0.0-0.082, Prematurity, Mechanical Ventilation Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations | 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): 0.0-0.333, Laryngomalacia Acid Reflux Stridor age 0 months old stridor and flexible laryngoscopy demonstrating laryngomalacia airway symptom score over 4 only has physiologic GER (I-GERQ < 16) requiring surgery for LGM other airway dz seen on flexible laryngoscopy history of or already on PPI therapy minimal/mild airway symptoms (airway score < 4) pathologic GERD (I-GERQ greater than 16) These pts cannot be randomized because this is the standard score in Pediatric GI literature strongly indicating anti-reflux meds premature birth (< 36 weeks) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Carbapenem Resistant Bacteria Infection Selection for CRE and CRAB GROUP: (all must be fulfilled) Isolation of CRE or CRAB from a clinical sample (e.g., a sample obtained in the work-up of a patient with suspicion of infection; therefore, screening samples are not considered) The patient meets the for any of the following infections (see definitions below): complicated urinary tract infection, pneumonia, intraabdominal infection or bloodstream infection (if the source of infection is any of the above, the patient will be included in both groups) Patient or his/her representative sign the inform consent if requested by the local Institutional Review Board (IRB). Patients in these groups will be included until the needed sample sizes are reached The infection is considered to be polymicrobial according to standard microbiological interpretation of culture results (except for cIAI, in which polymicrobial infections are allowed) The patient was participating in a clinical trial that involved active treatment for the infections The patient was previously included in the same cohort of this study for the same organism. A single episode of CRE or CRAB per patient can be included. Patients who suffer a CRE infection could later be included in the CRAB cohort if developing a CRAB infection and vice versa Patients with do not resuscitate orders or with a life expectancy of <30 days. Selection for CSE GROUP (all must be fulfilled) Isolation of CSE from a clinical sample (e.g., a sample obtained in the work-up of a patient with suspicion of infection; therefore, screening samples are not considered) The patient meets the for any of the following infections (see definitions below): complicated urinary tract infection, pneumonia, intraabdominal infection or bloodstream infection (if the source of infection is any of the above, the patient will be included in both groups) The infection is the same as that of the index case; in case of BSI, the source of bacteraemia must be the same as the index case classified as follows: UTI, pneumonia, intraabdominal infection or any other The type of acquisition is the same as for the index CRE case (nosocomial or community) The previous length of hospitalization before the infection onset is minus 1 up to minus 3 days the previous length of hospitalization before the CRE infection date in the CRE correspondent (up to minus 7 days if the CRE case occurred after 14 days of previous stay) The patient was admitted to the same type of service as the index case (medical, surgical, ICU, neonatal Unit, paediatric ICU, general paediatric wards) | 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, Meulengracht Syndrome Hyperbilirubinemia Unconjugated Benign Bilirubinemia Informed consent will be obtained from the patient or the parents before any study related procedures Patients of both genders older than 2 months The patient has a diagnosis of Gilbert disease or a high-grade suspicion for Gilbert disease High-grade suspicion present, if one or more are valid: 1 Positive family anamnesis for Gilbert disease 2 Hyperbilirubinemia 3 Abdominal pain 4 Irritable bowel syndrome 5 Familial nonhemolytic jaundice No Informed consent from the patient or the parents before any study related procedures Patients of both gender younger than 2 months No diagnosis of Gilbert disease or no valid for profound suspicion of Gilbert 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): 0.0-0.058, Kernicterus Newborn infant receiving treatment for neonatal jaundice Non-viable premature infants Severe congenital defects Postnatal age greater than 21 days | 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): 20.0-60.0, Healthy Volunteers Male body weight must be over 50 ㎏, Female body weight must be over 45㎏ Temperature less than 37.5 Celsius Systolic blood pressure greater than 90 and less than 180 ㎜Hg Diastolic blood pressure less than 100 ㎜Hg Heart rate between 50 to 100 beats per minute No abnormality in CBC(complete blood count) and PT/aPTT(prothrombin time /activated Partial Thromboplastin Time)Test ALT(ALanine Transaminase) Less than 65IU/L No history of bleeding and bleeding diathesis Drinking more than 3 alcoholic drinks per week Under the 12.5g/dl hemoglobin (38% packed cell volume) Positive tests for blood borne pathogens (HBV, HCV(Hepatitis C Virus), HIV, HTLV(human T lymphotropic virus)-I,II, syphilis, CMV(Cyto-Megalo-Virus), EBV(Epstein-Barr Virus)) Person who falls short of health standards, such as a patient with an infectious disease or a patient who take medication, who is prescribed by Ordinance of the Ministry of Health and Welfare as unfit to donate blood Donor taking prescription medications other than those deemed allowable by the investigator Aspirin within prior 3 days Ticlopidine within prior 2 weeks Isotretinoin, Finasteride within prior 1 month Dutasteride within prior 6 months Hepatitis B immune globulin(HBIG), Placental Extract within prior 1 year | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.5-4.917, Malaria Age between 6 and 59 months Weight ≥ 5 Kg Slide-confirmed infection with Plasmodium falciparum only (no mixed infections) Asexual parasite density between 2000 and 200000/µl of blood Measured axillary temperature ≥ 37.5°C Ability to swallow oral medication High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.) Informed consent from a parent or caretaker aged at least 18 years • General danger signs according to the WHO definition (Appendix 5.1.1) Signs of severe/complicated malaria according to the WHO definition (Appendix 5.1.2) Severe anaemia (haemoglobin < 5 g/dL) Known history of hypersensitivity to any of the study drugs Severe acute malnutrition (as defined by a weight-for-height below -3 Z-score and/or symmetrical oedemas involving at least the feet) Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration) Having received already a full course of the treatment (or one of the treatments) under study in the previous 28 days (as indicated by the parent/caretaker). Note that previous incomplete anti-malarial intake of treatments under study, or previous intake of anti-malarials not under study, are not but details of any such intake should be recorded carefully History of hypersensitivity reactions or contra-indications to any medicines being tested | 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): 0.0-60.0, Severe Aplastic Anemia Diagnosis of AA confirmed by bone marrow aspirate and biopsy, myelodysplastic syndrome and paroxysmal nocturnal hemoglobinuria were excluded. To confirm severe AA, the patient must fulfill at least two of the i) ANC<0.5×109/L,ii)PLT<20×109/L and iii) Ret<20×109/L ,in addition, ANC<0.5×109/L must be included. 2. Under 60 years old, male or female. 3. No HLA matched siblings. 4. No previous ATG treatment history. 5. Performance status score no more than 2 (ECOG criteria). 6．Adequate organ function as defined by the following criteria:ALT, AST and total serum bilirubin <2×ULN (upper limit of normal) Serum creatinine and BUN <1.25×ULN. 7. Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation. 8．Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. 9. Willingness and ability to comly with scheduled visits, treatment plans, laboratory tests, and other study procedures Presence of any condition inappropriate for HSCT. 2. Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure et al. 3．Severely allergic to biologic products. 4．Pregnancy or breastfeeding. 5．Current treatment on another clinical trail. 6．Any other condition the investigator judged the patient inappropriate for entry into this study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Pregnancy,Neoplastic Complications Any pregnant woman diagnosed with cancer within 6 weeks before her last menstrual period or 6 months after her end of pregnancy either by delivery or miscarriage Women diagnosed with cancer more than 6 months after the end of a 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): 20.0-65.0, Metabolic Syndrome patients diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 2. aged 20-65 years 3. had taken clozapine for at least 3 months 4. had at least one of the following metabolic abnormalities: BMI ≥ 24; WC > 90 cm (men) or 80 cm (women); fasting serum TG level ≥ 150 mg/dL; fasting serum HDL-C level ≤ 40 mg/dL (men) or 50 mg/dL (women); systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg; current use of antihypertensive agents; and FPG level = 100-126 mg/dL history of diabetes mellitus 2. current use of hypoglycemic or hypolipidemic agents 3. pregnancy 4. allergy to metformin 5. a creatinine level > 1.4 ng/dL 6. an abnormal liver function test result 7. chronic cardiopulmonary insufficiency | 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): 18.0-75.0, Crohn's Disease Participant is capable of giving informed consent Males or females 18-75 years of age Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female: <1.03 mg/dL]) Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63 U/L), and alkaline phosphatase (<126 U/L) Active CD defined as HBI ≥ 7 CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > mcg/g (within one month of enrollment) Have been treated with one of the following therapies** for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages Known or suspected stricturing disease producing obstructive symptoms Active Clostridium difficile infection Unwillingness to provide informed consent Allergy or intolerance to the medications used in this study History of kidney disease History of liver disease Pregnant or lactating females Baseline QTc interval on EKG > 430 in males or > 450 in females Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures | 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): 0.462-0.769, Hyperbilirubinemia Neonatal Jaundice The subject is a neonate ≥24 weeks of gestational age for whom a course of phototherapy has not started, is in progress or has been completed The subject's routine management includes TSB evaluations The subject's family are willing and able to participate in baseline and TSB measurements over 10 days Written informed consent to participate in the study has been provided by the subject or legal representative (parent or legal guardian in a clinical study involving children) The subject has Hydrops fetalis The subject has major congenital malformations, diseases or skin conditions or thickness that, in the opinion of the investigator would preclude or interfere with the use of the JM-105 | 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): 0.0-0.008, HIV Infections Mother was of legal age to provide independent informed consent for research participation and was willing and able to provide written informed consent for her and her infant's participation in this study Mother had confirmed HIV-1 infection based on testing of two samples collected at different time points. More information on this criterion can be found in the protocol At entry, infant met EFV exposure requirements, based on mother's report and confirmed by medical records if available, as follows For Cohort 1, Stratum 1A: Infant born to a mother who did not receive EFV during the eight weeks immediately prior to delivery. Note: Breastfeeding and formula feeding infants were eligible for this stratum For Cohort 1, Stratum 1B: Infant born to a mother who received EFV for a minimum of two weeks immediately prior to delivery. Note: Breastfeeding and formula feeding infants were eligible for this stratum For Cohort 2, Stratum 2A: Infants born to a mother who did not receive EFV during the eight weeks immediately prior to delivery and if breastfeeding, mother was not receiving maternal EFV. Note: Breastfeeding and formula feeding infants were eligible for this stratum For Cohort 2, Stratum 2B: Breastfeeding infants born to a mother who received EFV for a minimum of two weeks immediately prior to delivery, intended to breastfeed for a minimum of six weeks and continued to receive maternal EFV while breastfeeding. Note: Only breastfeeding infants were eligible for this stratum At birth, infant's estimated gestational age was at least 37 weeks. Note: If gestational age at birth is not documented in the infant's available birth records, study staff may assess gestational age at the earliest possible opportunity during the screening period and use this assessment for purposes of determination At birth, infant's weight was at least 2 kg. Note: If weight at birth is not documented in the infant's available birth records, study staff may assess infant weight at the earliest possible opportunity during the screening period and use this assessment for purposes of determination At entry, infant was less than or equal to 3 days old Infant had any other condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives; for example, severe congenital malformation, other medical condition, or clinically significant finding from physical examination At entry, any positive infant HIV nucleic acid test result (results are not required to be available prior to entry but any positive results obtained prior to entry are exclusionary) At entry, infant or breastfeeding mother was receiving any disallowed medication listed in the protocol Mother received maraviroc 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): 19.0-50.0, Peripheral Nueropathy Pain 50 years old, healthy male volunteers >55Kg(Body weight) and 18.5<BMI<28 AST or ALT > 3 * Upper normal range (Lab) Total bilirubin > 2.0 mg/dl Systolic BP >140 OR <90, Diastolic BP >100 OR <60 | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.005, Cow Milk Allergy Newborns Term and near term newborns (gestational age of at least 36 weeks) normal birth weight normal perinatal follow-up (physiological neonatal jaundice is not an criteria) without congenital defects Preterm newborns Congenital defects Newborn suffering from acute event | 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): 45.0-65.0, Overweight Main <= BMI < 30 kg.m2 Main ASAT <= 1,55 microkat/L ALAT <= 1,70 microkat/L gGT <= 2,55 microkat/L <= Creatinine <= 104 micromol/L (+ Bilirubin < 17,1 micromol/L (+ 7 <= Urea <= 8,3 mmol/L (+ us-CRP <= 5 mg/L (+ 70 <= Fasting glycemia <= 1,25 g/L (+ HbA1c <= 6% Medications for diabetes and/or dyslipidemia | 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): 21.0-65.0, Cigarette Smoking For Group 1: in order to participate in the study, potential subjects must: 1. Be males and females of any race between 21 and 65 years of age inclusive 2. Be current combustion cigarette smokers, defined as smoking a minimum of 10 combustion cigarettes per day for a period of at least 3 months, who smoke commercial (non menthol) cigarettes 3. Not be currently planning to quit smoking combustion cigarettes in the next 3 months 4. Have blood cotinine ≥100 ng/mL and carbon monoxide ≥10 ppm at Screening to confirm smoking status 5. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive, at Screening 6. Be healthy, in the Investigator's opinion, according to medical history; physical examination; electrocardiogram (ECG); and clinical chemistry, urine, and hematological laboratory tests 7. Be willing to refrain from using any source of nicotine other than study supplies for the duration of the study confinement period 8. Have vital signs as follows Resting heart rate between 50 and 90 beats per minute Systolic blood pressure below 150 mm Hg Diastolic blood pressure below 90 mm Hg 9. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (± 10% of laboratory limits); subjects marginally outside of this range may be eligible at the discretion of the study physician 10. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline phosphatase) less than three times the upper normal limit 11. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (± 10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females and > 90 mL/min for males 12. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant abnormalities 13. Be able to demonstrate the ability to comply with the inhalation instructions for Test Product administration (Research ENDS S TA U001 and Inhalator), visually confirmed by clinic staff at Screening visit 14. Be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to comply with the study procedure 15. Have 5-50 days of use of any ENDS product in their life and no use within 7 days before Screening 16. Have no more than 20 days of use of the Inhaler in their life and no use within the 7 days before Screening For Group 2: in order to participate in the study, potential subjects must: 1. Be males and females between 21 and 65 years of age inclusive 2. Be current daily users of a commercially available ENDS product, with e-liquids of nicotine concentration 10 to 20 mg/mL 3. Consume at least 1 mL per day of e-liquid in their ENDS product 4. Not smoke more than 2 combustion (non menthol) cigarettes per day 5. Have carbon monoxide ≤15 ppm at Screening to confirm limited smoking status 6. Have blood cotinine ≥100 ng/mL at Screening to confirm nicotine dependence 7. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive, at screening 8. Be healthy, in the Investigator's opinion, according to medical history; physical examination; ECG; and clinical chemistry, urine and hematological laboratory tests 9. Be willing to refrain from using any source of nicotine for the duration of the study confinement period 10. Have vital signs as follows Resting heart rate between 50 and 90 beats per minute Systolic blood pressure below 150 mm Hg Diastolic blood pressure below 90 mm Hg 11. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (± 10% of laboratory limits); subjects marginally outside of this range may be eligible at the discretion of the study physician 12. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline phosphatase) less than three times the upper normal limit 13. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (± 10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females and > 90 mL/min for males 14. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant abnormalities 15. Be able to demonstrate the ability to comply with the inhalation instructions for Test Product administration (Research ENDS S TA U001), visually confirmed by clinic staff at Screening visit 16. Be willing to use tobacco-flavored product 17. Be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to comply with the study procedure For Group 1 and Group 2: in order to participate in the study, potential subjects must not: 1. Have expected inability to comply with study protocol 2. Have used any of the following in the past 30 days: ultra-light, hand or roll-your-own, menthol, or unfiltered combustion cigarettes; any other form of tobacco (eg, chews, dips, pipes, cigars, hookah); or any form of nicotine replacement therapy (eg, patch, gum, lozenge, inhaler, nasal spray). 3. Be pregnant (based on serum test) or nursing (by self-report) 4. Have history or diagnosis of airway disease, including adult onset asthma or chronic obstructive pulmonary disease (including emphysema or chronic bronchitis), use of an inhaler (apart from a nicotine inhaler) in the previous 5 years, or any episodes of wheezing or bronchospasm in the previous 5 years (history of resolved childhood asthma is acceptable) 5. Have baseline spirometry values (FEV1, FVC, and FEV1/FVC) outside of the lower limit of normal as defined by Hankinson et al, Am J Respir Crit Care Med 1999; 159:179-187. 6. Have had treatment with prescription medications within 21 days or over-the-counter medication within 24 hours of the planned first product use occasion, except for oral or hormonal contraceptive therapies. 7. Have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/. 8. Have an active cough, recent or chronic, excluding "smoker's cough" 9. Have any active respiratory infection 10. Have a history of clinically significant cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, metabolic, psychiatric, or hematologic disorders 11. Have poor venous access as defined by being unable to draw samples through a catheter at the screening visit 12. Have been hospitalized within 4 weeks before Screening 13. Have received any other investigational treatment or Test Product within 30 days from randomization (or within 5 half-lives of the Test Product, if known, whichever is greater) 14. Have a history of allergic, anaphylactic, or other hypersensitivity reaction to any e cigarette , or any of the components associated with these products such as propylene glycol 15. Have any medical history or condition (including physical) considered by the Principal Investigator and/or admitting physician to place the subjects at increased risk or preclude safe and/or successful completion of the study 16. Have any history of substance abuse, including alcohol abuse within the last 3 months 17. Have a positive result for any drug of abuse (opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants, or marijuana) at screening or Day -1 18. Be cognitively impaired to a degree that would affect participation. An adequate level of reading and comprehension is needed in order to complete various forms (e.g., behavioural assessments) that are used as dependent variables 19. Have active syphilis (based on the standard confirmatory test (e.g., FTB-abs)) 20. Be undergoing HIV treatment with antiviral and non-antiviral therapy or treatment for HIV-related opportunistic infection 21. Do not actively meet the at the time of screening | 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): 15.0-999.0, Low Birth Weight Babies Preterm Babies Woman is pregnant Woman is enrolled in ongoing newborn oil massage study Not pregnant Not enrolled in ongoing newborn oil massage 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): 0.0-0.038, Hyperbilirubinemia Otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease gestational age ≥33 weeks birth weight ≥1800 g The infants should be treatable in a cradle Infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing TsB will not be enrolled | 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): 20.0-45.0, Healthy Subjects may be entered in the study only if they meet all of the following 1. Male with suitable veins for cannulation or repeated venipuncture, and must be able to swallow the study drug intact; 2. Aged between 20 and 45 years (inclusive) at the screening visit; 3. Has normal hematology results at screening visit WBC: 3.54 ~ 9.06X10^3/μL RBC: 4 ~ 5.52X10^6/μL hemoglobin: 13.2 ~17.2 g/dL hematocrit: 40.4 ~ 51.1% platelet: 148 ~ 339X10^3/μL 4. Has normal biochemistry results at screening visit alkaline phosphatase: 34 ~ 104 U/L total bilirubin: 0.3 ~ 1.0 mg/dL AST: 8 ~ 31 U/L ALT: 0 ~ 41 U/L Subjects must not satisfy any of the following 1. Has a body weight less than 50 kg and/or body mass index (BMI) less than 18 kg/m^2 or greater than 30 kg/m^2 at the screening visit. Body mass index is determined as total body weight/height^2 (kg/m^2); 2. Is not in good general health as judged by the Investigator based on medical history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at the screening visit or prior to administration of investigational product; 3. Has a history or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs at the screening visit or prior to administration of investigational product; 4. Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or prior to administration of investigational product; 5. Is a smoker and/or has used nicotine-containing products within the last 6 months prior to the screening visit; 6. Has a history of alcohol and/or drug abuse; 7. Participation of any clinical investigation during the last 60 days; 8. Blood donation of more than 250 mL within the past 12 weeks; 9. Excessive intake of caffeine containing drinks or food (more than 6 units of caffeine per day). One caffeine unit is contained in the following items: 1 (177.4 mL) cup of coffee, 2 (354.9 mL) cans of cola, 1 (354.9 mL) cup of tea, ½ (118.3 mL) cup of energy drink (e.g., B Liq. or Liq.) or 3 oz of chocolate; 10. Use of drugs with enzyme inducing properties such as St. John's Wort within 4 weeks prior to dosing; 11. Has used prescription or nonprescription medication (except for occasional use of paracetamol and nasal spray) or herbal remedies or vitamins or minerals within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to dosing; 12. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of study medication; 13. Male subjects who are unwilling to use barrier contraception in addition to having their partner use another method of contraception, for the duration of the study and for 3 months after dosing; 14. Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV); 15. Has received a blood transfusion within the last 6 months at screening; 16. Involved in the planning or conduct 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): 0.0-0.077, Breast Milk Expression Premature Birth of Newborn Infants with <1500 g birth weight Infants with< 32 weeks of gestational age Infants who will be fed with maternal milk that is fortified with eoprotin and olive oil Critical ill patients Evident severe congenital malformation Intolerance of feeding Evident gastrointestinal malformation | 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, Preterm Birth Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age Congenital defects that affect growth Inability to tolerate room air for 5 minutes without desaturation or bradycardia <1 kg birth weight Parents did not 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): 18.0-89.0, Subarachnoid Hemorrhage Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage Adults ages 18 to 89 years Anticipated length of stay ≥ 48 hours Informed consent provided by the patient or patient's designated medical proxy Pregnancy Patients receiving renal replacement therapy Brain death or imminent brain death expected ≤48 hours Patient with history of nephrectomy or renal transplant | 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): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A | 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): 0.0-0.014, Neonatal Abstinence Syndrome Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate 2. Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result 3. May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability 4. Parents give written consent prior to starting pharmacologic treatment for NAS 5. AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4 Helix or antihelix of ear is deformed and needle is unable to be placed 2. Skin condition around the ear 3. A suspected or confirmed genetic or metabolic syndrome 4. Department of Children and Families investigation results in termination of parental rights | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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, Extubation Failure Prematurity Preterm infants with gestational age between 26 weeks 0 days and 31 weeks 6 days will be included. - Presence of major congenital anomaly, 2 Presence of neuromuscular disease, 3 Need of surgery within 7 days following the extubation 4 Consent not provided or refused - | 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, Neoplasm, Trophoblastic Gestational Trophoblastic Disease Hydatidiform Mole Hydatidiform Mole, Invasive Patients are eligible if they have a histologically proven trophoblastic disease, or a diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG none | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Neonatal Thrombocytopenia Isoimmunization Maternal-fetal patients with known risk of platelet alloimmunization patients for whom suspicion of fetal cerebral hemorrhage has been advanced on ultrasound or fetal MRI signs Twin pregnancy or triple | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) 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): 0.0-0.077, Jaundice Serum Bilirubin Written or thumb print for informed consent from the parent Infant born ≥ 35 weeks of gestational age Infant who needs a routine SBR measurement Infant in stable clinical condition prior to SBR measurement confirmed by the trained nurses The participant will not be enrolled in the study if ANY of the following applies Infant who already had 1 SBR measurement done with the Bilistick system Last haematocrit measurement > 65% or no previous haematocrit measurement | 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): 0.538-999.0, Neonatal Hyperbilirubinemia Cases Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting one or more of the following Two consecutive SBR measures above the exchange transfusion threshold of the phototherapy charts for gestational age SBR levels rising > 8.5 µmol/L per hour One or more neurological signs compatible with ABE in the absence of other known neurological condition and in the presence of confirmed NH Controls Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting all of the following At least one SBR between the moderate and the severe threshold of the phototherapy charts for gestational age No SBR above the severe threshold at any time point No reported abnormal neurological signs (i.e. convulsions, abnormal cry or tone) Each case who has been discharged alive from the SCBU will be matched to one control from the same clinic, sex, gestational age, season of birth and hospitalized within the same month and the clinical and neurodevelopment of both children will be conducted once Stillborn Twins Liveborn < 28 weeks gestation Major congenital malformation Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU without SBR done or with all SBR below the moderate threshold of the phototherapy charts for gestational age | 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): 0.692-0.827, Deglutition Disorders Respiratory Aspiration Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia Infants born prematurely with a corrected gestational age of 43 weeks or greater | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Premature Infants Birth weight 500-1000 grams Reasonable expectation of survival for study duration (36 weeks postmenstrual age) Achieve any enteral feedings by 14 days of life Born at our institution or transferred from another institution within the first 24 hours of life and receive an exclusive human milk protein diet (mother's milk supplemented with donor human milk and donor human milk derived fortifier) Birth weight > 1000 grams Less than a reasonable expectation for survival for the study duration, enrolled in another clinical study that affects nutritional management Failure to achieve enteral feeds by 14 days of life Major congenital anomalies or clinically significant congenital heart disease, presence of intestinal perforation or Stage 2 NEC prior to tolerating fortified feeds Early transfer to a non-study institution Unable to participate in the study for any reason based on decision of study investigator | 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, Congenital Dyserythropoietic Anemia (CDA) Diagnosis of Congenital Dyserythropoietic Anemia (CDA), whether a genetic mutation is identified or not Evidence of congenital anemia/jaundice or a positive family history Evidence of ineffective erythropoiesis Typical morphological appearance of bone marrow erythroblasts All ages (ages 0-99) Diagnosis of cancer Myelodysplasia Secondary dyserythropoiesis: e.g.; vitamin B12 deficiency or drug-related. Note1: Patients with rare band 3 (SLC4A1) mutations recently described to be associated with dyserythropoiesis will be eligible since the mechanisms appear to involve direct participation of band 3 in the erythroblast mitosis and cytokinesis. Note2: Siblings, parents, and family members of patients with confirmed CDA diagnosis are encouraged to participate 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): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc" | 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): 0.0-99.0, Bacterial Conjunctivitis Obtained from physician office visit Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture) Informed Consent signed and dated (consent of the parents for minor patients) absence of written informed consent Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom) Pregnant or breastfeeding women Subjects that could not be evaluated partially or totally according to the protocol Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study Subjects with a hypersensitivity history to any component or analogues of the formulation product Positive drug addiction (smoking, alcoholism, marijuana) Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation incapacity to give informed consent owing to mental disorder or legal condition | 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, Preterm Delivery Single pregnancies of 28 to 33 weeks and 6 days who had been experienced for threatened or preterm labor with intact membrane Proven membranes ruptured Ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly Aneuploidy detected Had emergency condition that required for emergency delivery such as fetal distress, chorioamnionitis, prolapsed cord | 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, Intensive Care, Neonatal Neonatal Respiratory Distress Syndrome Continuous Positive Airway Pressure Breast Feeding Infant, Premature Infants cared for at Imperial College Healthcare NHS trust neonatal unit at Queen Charlottes and Chelsea Hospital and St Marys Hospital. Infants will be eligible if they are over 30 weeks of gestational age and receive continuous treatment with nCPAP or HHFNC Major congenital malformation or underlying genetic disorder signs of severe progressive respiratory distress FiO2 > 0.4 PCo2 > 9kPa Need for high CPAP > 8cmH2O Need for HHFNC with flow rate of >8litres/min Severe temperature instability, not tolerating 30 min outside the incubator CPAP or HHFNC treatment stopped | 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, Neonatal born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway born at term normal birth weight in need of advanced medical treatment | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.25, Cleft Lip and Palate Non-syndromic Infants with complete unilateral cleft lip and palate Infants less than 3 months of age Males and females Infants with displaced alveolus Patients whose parents provided written consent for the study Patients above 3 months of age Syndromic, malnourished and systemically ill infants Patients with bilateral cleft lip and palate Incomplete Cleft lip Medically compromised patients Patient's/guardians who will be unwilling to go through the PNAM 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): 18.0-999.0, KRAS NP_004976.2:p.G12R Stage III Pancreatic Cancer AJCC v6 and v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Patients must have histologically confirmed locally advanced or metastatic pancreas cancer Patients must have received at least 6 months fluorouracil (5-FU) or gemcitabine-based treatments for pancreas cancer (fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin [FOLFIRINOX], fluorouracil, leucovorin calcium and oxaliplatin [FOLFOX], 5-FU+ nal-IRI [MM-398; nanoliposomal irinotecan], or 5-FU [including capecitabine], gemcitabine-based gemcitabine plus abraxane, gemcitabine monotherapy among others) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic Kirsten rat sarcoma (KRAS) G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70% Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 75,000/mcL Patients who have received prior treatment with tyrosine kinase inhibitors (e.g. erlotinib), or anti-Epidermal growth factor receptor (EGFR) agents (e.g. cetuximab, panitumumab) Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous Patients with active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) Patients with 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 Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial; no additional workup is needed to brain metastases if the patient is asymptomatic or has no history of brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib (AZD6244) or other agents used in study Previous Mitogen-activated protein kinase kinase (MEK), RAS, or Rapidly Accelerated Fibrosarcoma (RAF) inhibitor use Patients with the following cardiac conditions are excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 21.0-99.0, Severe Sepsis All adult patients (>18 years old) admitted to ICU plus Severe sepsis defined as 2 or more or the following Temperature >38oC or < 36oC Heart rate > 90 beats per min Respiratory rate >20 breaths per min or PaCO2 <32 mmHg White cell count > 12,000/microL or < 4,000/microL PLUS presence or presumed presence of infection PLUS evidence of organ dysfunction as defined by either of the following Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) < 65 mm Hg; or on vasopressors Hyperlactatemia: Serum lactate >/= 2 mmol/L (18 mg/dL) >48hr from admission to ICU Patients who are not expected to survive >48hrs by the managing team Refusal to consent to study Allergic to glutamine or its constituents Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition Patients with a primary admission diagnosis of burns (>30% body surface area) Patients whose weight <40kg or >200kg Previous randomization to this study Enrolled in a related ICU interventional nutrition study Pregnant patients or lactating mothers with the intent to breastfeed | 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): 0.0-0.011, Neonatal Jaundice Asian full-term neonates with jaundice between 48 and 96 hours of age Patients with low-birth-weight, early onset jaundice before 48 hours of age, perinatal asphyxia, antimicrobial therapy or respiratory disorders. Patients with jaundice caused by hemolysis, or functional or anatomic obstruction. Patients who need treatments except for phototherapy | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-18.0, Diabetic Ketoacidosis Age between 0 and 18 years 2. Diagnosis of DKA: 1. Venous pH less than 7.25 2. Ketonuria as confirmed on urine point-of-care testing or urinalysis 3. Hyperglycemia (Serum glucose > 200 mg/dl) 4. Serum bicarbonate <15 mmol/L 3. PICU admission Age > 18 Years 2. Physician discretion 3. Septic or hypovolemic shock 4. Signs of life-threatening cerebral edema or multi-organ failure upon presentation to the emergency room or pediatric intensive care unit 5. Enrollment time more than 1 hr since arrival to emergency room or PICU 6. 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): 0.0-0.077, Oxidative Stress Neonatal Hyperbilirubinemia Phototherapy Complication Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life Normal blood counts and peripheral blood smears Normal reticulocytic count Breast fed newborn Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study Infant of diabetic mothers Maternal eclampsia-preeclampsia Birth asphyxia Sepsis congenital anomalies Direct Coombs'test positive Pathological causes of hyperbilirubinemia Enclosed hemorrhage Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility | 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 Newborn Infection Infants admitted to the NICU at participating sites for > 2 days until discharge Babies requiring contact precautions due to other reasons (as glove based care would be occurring) | 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, Squamous Cell of Head and Neck General Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx not amenable to curative treatment At least one measurable lesion by MRI or CT-scan according to 1.1, evaluated within 2 weeks prior to registration. Such lesion must not have been previously irradiated; if the measurable lesion(s) have been irradiated, clear progression must be documented Progressive disease after first line platinum-based chemotherapy with or without cetuximab given as palliative treatment or progressive disease within 1 year if platinum-based chemotherapy was given as a part of the multimodal curative treatment. Patients pre-treated with anti-PD1/anti-PDL1 are allowed ECOG performance status 0 -1 with a life expectancy of at least 12 weeks Tumor core biopsy from any accessible tumor at the recurrent or metastatic site available for central testing Patients must have adequate organ function, evaluated within 14 days prior to cohort allocation Hemoglobin ≥ 9 g/100 ml Neutrophils ≥ 1,500/mm3 Platelets ≥ 100,000/mm3 Unresolved and significant toxicity CTCAE version 4.03 grade ≥ 2 from previous anticancer therapy other than alopecia History of any of the following cardiovascular conditions within 6 months prior to registration myocardial infarction severe/unstable angina ongoing cardiac dysrhythmias of CTCAE version 4.03 Grade 2 or more atrial fibrillation of any grade coronary/peripheral artery bypass graft symptomatic congestive heart failure according to New York Heart Association (NYHA) Class III or Class IV significant active cardiac disease including uncontrolled high blood pressure defined as systolic ≥150 and diastolic ≥100 cerebrovascular accident including transient ischemic attack | 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): 0.0-0.027, Neonatal Abstinence Syndrome Born at Cooper University Hospital Greater than or equal to 35 weeks gestation age Admitted to the NICU or Transitional nursery Mothers admitted to using illicit substances or prescription medications (which can result in withdrawal symptoms) while pregnant and/or had a positive urine drug screen during pregnancy Babies being started on medication to control withdrawal symptoms of NAS No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.) Premature infants <35 week gestational age Infants with major congenital abnormalities Blood pressure instability Major medical conditions | 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, Colorectal Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Recurrent Colorectal Carcinoma Recurrent Pancreatic Carcinoma Stage III Colorectal Cancer Stage III Pancreatic Cancer Stage IIIA Colorectal Cancer Stage IIIB Colorectal Cancer Stage IV Colorectal Cancer Stage IV Pancreatic Cancer Stage IVA Colorectal Cancer Stage IVA Pancreatic Cancer Stage IVB Colorectal Cancer Stage IVB Pancreatic Cancer Unresectable Pancreatic Carcinoma Patients with stage IV or locally advanced unresectable gastrointestinal adenocarcinomas (gastric, gastroesophageal junction [GEJ], cholangiocarcinoma, hepatocellular, pancreas, colorectal, small intestinal tumors) who have failed at least one prior therapy (dose escalation phase) Patients with pancreatic adenocarcinoma; patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease that has failed at least one standard regimen; eight patients must have tumors that are accessible for biopsy and sign the informed consent for paired biopsy study (dose escalation phase, arm A) Patients with colorectal adenocarcinoma; patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease and have previously received oxaliplatin, irinotecan, and fluoropyrimidine; eight patients must have tumors that are accessible for biopsy and sign the informed consent for paired biopsy study (dose escalation phase, arm B) Be willing and able to provide written informed consent/assent for the trial Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1 Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale Absolute neutrophil count (ANC) ≥ 1,500 cells/µL Platelets ≥ 100,000 cells/µL Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) ≥ 60 mL/min for subject with creatinine levels > 1.5 x institutional ULN Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment Has a known history of active tuberculosis (TB) (Bacillus tuberculosis) Hypersensitivity to pembrolizumab or history of severe allergic or hypersensitivity reactions to excipients (e.g., polyethylene glycol [PEG] 300 and polysorbate 80) Clinically significant cardiovascular disease or peripheral vascular (e.g. myocardial infarction, unstable angina within 6 months of study entry), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia requiring medications, baseline corrected QT (QTc) > 450 msec or previous history of QT prolongation while taking other medications Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent Note: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting 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): 18.0-999.0, Pregnancy Trimester, Second Misoprostol Catheters Abortion, Second Trimester pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy. - | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Oxidative Stress Neonates of obstetric gestational age 23-30 weeks 2. Inborn at Parkland Hospital, Dallas, Tx 3. Resuscitation team present to initiate resuscitation Prenatally diagnosed cyanotic congenital heart disease 2. Prenatally diagnosed congenital diaphragmatic hernia 3. Prenatally diagnosed significant airway anomaly 4. Prenatally suspected hypoplasia of lungs 5. Preductal saturation cannot be measured 6. Non-viable newborns 7. Prenatally diagnosed condition due to which decision is made to limit resuscitation in the delivery room by parents and neonatologist | 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): 0.0-12.0, Respiratory Distress Syndrome, Newborn Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for in this study Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion Neonates with a genetic abnormality or congenital anatomic anomaly Subsequent Study resulting in removal from study Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus Infants that are transported out of the participating site prior to study endpoint | 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): 20.0-80.0, Metastatic Gastric Cancer Histology confirmed adenocarcinoma of stomach. 2. Stage IV (AJCC 7.0) 3. Malnourished patients with nutritional risk index (NRI) < 97.5. NRI= 1.59 x serum albumin level (g/L) + 0.417 x (current weight/usual weight) x 100 4. Adequate organ function as defined by the following absolute neutrophil count (ANC) > or =1500 cells/mm3 platelets > or =60,000 cells/mm3 hemoglobin > or =8.0 g/dL AST and ALT < or =3.0 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT< or =5.0 x ULN total bilirubin < or =2.0x ULN serum creatinine < or =2.0 x ULN or calculated creatinine clearance > or =60 mL/min 5. Male or female, age > or = 20 years and < 80 years. 6. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment. 7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Known allergy to components of studied parenteral nutrition. 2. Acute shock or collapse. 3. Known diabetic ketoacidosis 7 days prior to randomization. 4. Unstable conditions (e.g. uncompensated diabetes mellitus, acute myocardial infarction, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration). 5. General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, uncompensated cardiac insufficiency. 6. Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications) 7. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 8. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. 9. Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of the study or during the study. 10. Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment. The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate | 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): 0.0-0.082, Haemolysis Neonatal Gestational age more than or equal 37 weeks and postnatal age from 48hr-72hr. 2)Anemia with Reticulocytic count 10% 3)Serum total bilirubin around 18mg/dl perinatal asphyxia. 2)Congenital malformation. 3)Severe respiratory distress. 4)Sepsis during hospital stay. 5)Metabolic problems . 6)Gestational age less than 37 weeks | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.019, Jaundice and Sepsis in Neonates Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life Infants with asphyxia (Apgar score <3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home | 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): 5.0-6.5, Sensory Deficit Preterm Birth No neurological diagnosis gestational age < 37 weeks 78 months of age Have a neurological diagnosis (such as cerebral palsy) Grade III or grade IV intraventricular hemorrhage Have undergone major surgery in neonatal period Mental retardation | 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, Neonatal Jaundice Indication for phototherapy with single light Gestational age > 33 weeks Birth weight > 1800 grams Should be treatable in a cradle Haemolytic disease Indication for double/triple phototherapy or exchange transfusion | 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, Jaundice, Neonatal For patient level record (de-identified), diagnosed by the facility for having infant jaundice The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines | 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): 0.0-0.019, Neonatal Jaundice Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study Infants suffering from genetic, chromosomal or surgical conditions will be excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-35.0, Vaginal Delivery Age between 18 & 35 years old. 2. BMI is less than 30 3. The gestational age between 37 weeks. (calculated by LMP or 1st trimesteric U/S) 4. Singleton pregnancy. 5. History of one vaginal delivery. 6. Occiputo anterior position. 7. Active phase of first stage of labor Age (below18 or above 35). 2. Primigravida. 3. Occiputo posterior position. 4. Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section . 5. Multiple gestation. 6. Medical disorders like hypertension, DM, liver or renal diseases | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Hyperbilirubinemia, Neonatal Between 2 and 28 days old Having jaundice Gestational age between 35-42 weeks Less than 2 days or more than 28 days old Gestational age out of the range of 35-42 weeks Infants whose parents refused to cooperate Patients with sepsis and other comorbid conditions | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Sepsis Newborn Gestational age of 28 to less than 37 weeks who showed clinical symptoms and signs suggestive of early-onset sepsis (EOS, within 72 hours of birth) or late-onset sepsis (LOS, after 72 hours of birth) and received PN Neonates with Major congenital malformations Congenital heart diseases Inborn errors of metabolism Congenital infections Hypoxic-ischemic encephalopathy | 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, Obesity, Childhood Insulin Resistance Zinc Deficiency Inositol both sexes between 6 and 18 years of age obese, according to the IOTF (Cole TJ et al., 2000) pubertal stage ≥ 3 according to the Tanner stage (Tanner et al., 1961) HOMA-IR > 2,5 or insulin > 15 µU/ml Serum Zinc level in the range of normality or under the normal levels Adverse reactions to the product or component of the product (allergies…) Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-Biedl syndrome…), endocrinological obesity (Cushing syndrome, hypothyroidism) Chronic diseases, hepatic or gastroenterological diseases Medical treatment for chronic diseases Supplementation with inositol-like products or supplements containing Zinc and Inositol | 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, Neonatal Sepsis Preterm infants ( less than 37 weeks gestational age). Evidence of neonatal sepsis Infants with hypoxic ischemic encephalopath Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation | 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): 15.0-49.0, Rhesus Disease Anti-D (Rh) Antibodies Affecting Care of Mother for pregnant women Pregnant women who present to THQ Johi and DHQ Dadu for ANC At least 13 weeks gestation (assessed using self-reported first day of last menstrual period) Currently resides within one of 5 Union Council's surrounding THQ Johi and in the catchment area of DHQ Dadu at a fixed address Intends to deliver and remain in study catchment area for 1-month after the delivery of their newborn(s) Provides written informed consent Was not previously enrolled in this study during a different pregnancy for pregnant women Previously consented into this study Reported that they previously had an anaphylactic reaction to an injection of an antibody blood product Has any chronic disease related to the heart, liver, kidney, or lungs Does not currently reside within the study's catchment area Intends to deliver outside of the catchment area Plans to relocate outside of the catchment area within 1-month after the delivery of their newborn(s) Does not provide written consent for lady health visitors Working full-time at THQ Johi and DHQ Dadu as a Lady Health Visitor Verbal consent provided from LHV's direct supervisor | 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, Anemia pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l vitamin B12 deficiency anemia folic acid deficiency anemia hemoglobinopathy multiples liver disease kidney disease | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Advanced Malignant Solid Neoplasm Estrogen Receptor Negative GPNMB Positive HER2/Neu Negative Metastatic Malignant Solid Neoplasm Metastatic Melanoma Progesterone Receptor Negative Stage III Breast Cancer AJCC v7 Stage III Cutaneous Melanoma AJCC v7 Stage III Uveal Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Stage IV Uveal Melanoma AJCC v7 Triple-Negative Breast Carcinoma Unresectable Solid Neoplasm Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective For TNBC and solid tumors other than melanoma: GPNMB expression as defined by at least 25% of malignant epithelial cells or tumor stromal cells expression GPNMB at any intensity via central immunohistochemistry on archived or biopsied tumor tissue (as per standard clinical care) from an advanced/metastatic disease site; for melanoma or uveal melanoma cohort: GPNMB testing results will not be required for assessment Patients must have measurable disease, in addition to at least one lesion in a reasonably safe location for study-related biopsies; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Willing to undergo study-related biopsies as noted in study calendar: before treatment, after glembatumumab-only, and after combination therapy Prior treatment with immune checkpoint inhibitors or antibody drug conjugates are allowed For cutaneous melanoma cohort, patients should have received PD-1/CTLA-4 targeting therapy in combination and had disease progression For all other cohorts including phase Ib dose-finding, patients should have received at least one line of standard non-immunotherapy treatment Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%) Life expectancy of greater than 12 weeks Leukocytes >= 2,000/mcL Patients who have had systemic therapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to entering the study Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities >= grade 2 other than alopecia) Patients who are receiving any other concurrent investigational agents; those with history of receiving investigational cancer treatment are allowed as long as washout period is fulfilled Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; patients with treated and stable brain metastases will be allowed; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, glembatumumab vedotin, or other agents used in study; this includes sensitivity to the drugs dolastatin or auristatin History of severe hypersensitivity reaction to any monoclonal antibody 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 Participants must not have a history of life-threatening toxicity related to prior IO treatment (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or treatment specifically targeting T-cell co-stimulation or immune checkpoint pathways); i) participants with toxicities that are unlikely to recur with standard countermeasures (eg, hormone replacement treatment after adrenal crisis) are eligible Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab and glembatumumab vedotin Human immunodeficiency virus (HIV) patients should be allowed if otherwise eligible, with the following caveats | 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): 19.0-999.0, Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Age of 19 or older Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma Previously untreated with chemotherapy ECOG performance status of 2 or lesser Peripheral blood white blood cell count ≥ 3,500/uL Peripheral blood neutrophil count ≥ 1,000/uL Peripheral blood platelet count ≥ 20,000/uL Peripheral blood hemoglobin ≥ 6.0g/dL Serum total bilirubin ≤ 2.0 mg/dL Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit) Diagnosed with other malignancy within 5 years before enrollment Prior hematopoietic stem cell transplantation Prior organ transplantation Uncontrolled central nervous system involvement Congenital immunodeficiency Acquired immune deficiency syndrome (AIDS) Pregnancy Uncontrolled epilepsy Uncontrolled psychological disease Peripheral neuropathy of grade 3 or higher | 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, Infant, Premature Estimated gestational age < 36 6/7 weeks Hospitalized in the newborn ICU at University Teaching Hospital Nursed in an incubator for at least 24 hours Thought to be ready to be weaned from incubator by the clinical staff Major congenital anomalies Requiring ongoing respiratory support Suspected sepsis | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 30.0-65.0, Patients With Moderate Knee Osteoarthritis (30 - 65 Years) Male and female patients, 30 to 65 years of age inclusive, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening At screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the SOM. Sitting vital signs should be guided by the following ranges body temperature between 35.0-37.5 °C systolic blood pressure 90-139 mm Hg diastolic blood pressure 50-89 mm Hg pulse rate, 40 bpm • Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 kg/m2. BMI = Body weight (kg) / [Height (m)] Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant Pregnant or nursing (lactating) women Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and baseline PR > 200 msec QRS complex > 120 msec QTcF > 450 msec (males) QTcF > 460 msec (females) Known family history or known presence of long QT syndrome | 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): 18.0-42.0, The Study Focusses on Improving the Implantation Rate in IVF We included nulliparous patients who were < 42 years of age with body mass index (BMI) < 30 kg/m2 and normal endometrial cavity, used fresh sperm or oocytes, had two or more embryos available for transfer on day 3 post ovum pick-up (OPU), and no more than 3 previous unsuccessful ART cycles Patients with uterine fibroids, uterine anomalies, intra-uterine adhesions, and uterine polyps, patients with chronic diseases in the as uncontrolled diabetes or hypertension, or if the patient had difficult mock ET . patients with severe male factors for infertility requiring surgical retrieval of sperms were excluded 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): 0.0-999.0, End Stage Liver Disease Infection Decompensation of liver cirrhosis: 1. ALB <35 g / L; A / G <1.0 2. TBIL> 35μmol / L; 3. ALT> 1 × ULN and / or AST> 1 × ULN 4. PTA <60% 5. Ascites or hepatic encephalopathy or esophageal variceal bleeding Acute-on-chronic liver failure: 1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis 2. onset time: <4 weeks 3. Hepatic encephalopathy: with or without 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 5. Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L Chronic liver failure: 1. The basis of chronic liver disease: decompensated cirrhosis 2. onset time: - 3. Hepatic encephalopathy: with or without 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher | 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): 0.0-0.493, Biliary Atresia Completed the preliminary work up for cholestasis with suspected or inconclusive diagnosis of BA 2. Gestational Age > 36wks 3. Weight > 2 Kg 4. Age >-2 weeks-<180 days at diagnosis 5. Serum Direct Bilirubin > 2 mg/dL GGT > 100 U/L 6. Kasai operated patients for Type 3 or 4 anatomy of BA 7. Cholangiogram/porta hepatis findings diagnostic of BA 8. Liver biopsy supporting BA diagnosis Having access to liver transplantation for immediate Kasai failure 2. Prior Kasai patients 3. Major cardiac, renal, CNS malformations with poor prognosis 4. Intracranial hemorrhage 5. History of recent TPN use within the last 2 weeks of surgery 6. GI tract obstruction 7. Laparoscopic Kasai repair | 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, Healthy Volunteers Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening Body mass index ≥ 18.5 and ≤ 29.9 (kg/m2) and 55.0 and 100.0 kg (inclusive) for all cohorts Medically healthy without clinically significant (CS) abnormalities at the screening visit or Day -1, including: 1. Physical examination, vital signs including temperature, heart rate, respiratory rate, and blood pressure; 2. Triplicate electrocardiograms (ECGs) taken at least 1 minute apart with QT wave corrected for heart rate (HR) using Fridericia's method (QTcF) interval duration less than 450 msec obtained as an average from the triplicate screening and pre-dose Day 1 ECGs after at least 5 min in a semi-supine quiet rest; 3. Haemoglobin > 12.5, haematocrit 37%, white blood cell (WBC) count > 3.5, or platelet count equal to or greater than the lower limit of normal range of the reference laboratory (may be confirmed upon repeat analysis); 4. Creatinine, blood urea nitrogen (BUN), equal to or less than the upper limit of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to or < 1.5 times the upper limit of normal for the reference laboratory and confirmed on repeat analysis; results of all other clinical chemistry and urine analytes without any CS abnormality. Discussion between the PI and the Sponsor Medical Monitor is encouraged regarding any abnormal laboratory value that is outside of the normal range during the pre-dose period Be non-smokers (including tobacco, e-cigarettes or marijuana) for at least 1 month prior to participation in the study Willing and able to provide written informed consent Be willing and able to comply with all study assessments and adhere to the protocol schedule Have suitable venous access for blood sampling If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by follicle stimulating hormone or surgical sterilization i.e., tubal ligation or hysterectomy). Provision of documentation is not required for female sterilization, verbal confirmation is adequate If male, a willingness not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation). This criterion applies to males (and/or female partners) who are surgically sterile and must be followed from the time of first study drug administration until 30 days after the final administration of study drug History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant History of known or suspected Clostridium difficile infection History of seizure disorders, except for a single febrile seizure in childhood Positive urine drug/alcohol testing at screening or Day -1 Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) History of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where 1 standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 ml nip spirits, or 100 ml wine) within the previous 5 years Use of any prescription medication or any over-the-counter medication, including herbal products and vitamins within 7 days prior to randomization Documented hypersensitivity reaction or anaphylaxis to any medication Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrollment Participation in another investigational clinical trial within 30 days prior to Day 1 | 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): 0.0-0.082, Neonatal SEPSIS Very Low Birth Weight Baby Preterm Very low birth weight baby: birth weight 1-1.5 kg Both inside and outside delivered babies Gender: males and females Probable severe sepsis (septic score) Extremely low birth weight babies: < 1 kg Babies >1.5 kg birth weight Babies born with congenital malformations Full term babies IUGR babies Child with no signs of sepsis HBsAg Positive HIV Positive | 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, Arthritis, Rheumatoid Subjects enrolled into the study, where they will be administered LPS or GM-CSF challenge, must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Subjects enrolled into the study where they will not be administered LPS or GM-CSF challenge must be 18 to 65 years of age inclusive, at the time of signing the informed consent Subjects must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight must be > = 50 kilogram (kg) and body mass index (BMI) within the range 18.5-35.0 kg per square meter (kg/m^2) (inclusive) Male subjects agreeing to use contraceptive methods during the treatment Period and for at least 91 days, after the last dose of study treatment and refrain from donating sperm during this Period Capable of giving informed consent Current or chronic history of pancreatitis, diabetes mellitus or impaired glucose tolerance, gastrointestinal disease, liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), anaphylaxis, and /or anaphylactoid (resembling anaphylaxis) reactions [Sampson et al 2006], cardiac disease including clinically significant ventricular arrhythmias or long QT syndrome, renal disease where clinically significant (minor abnormalities may be permitted base on discussion between investigator and medical monitor), respiratory disease or conditions including but not limited to asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis and any current respiratory infection (childhood asthma is not an criterion), sensitivity or severe allergic responses to any of the challenge agents or cantharidin, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation; frequent vasovagal syncope, surgery requiring general anaesthetic or significant trauma in 3 months leading to study enrolment, relevant skin conditions (e.g. recent history of eczema or recurrent eczema, keloid, skin allergies, psoriasis, atopic dermatitis, and vitiligo) which in the opinion of the investigator could pose safety issues or cause interference with study procedures, sepsis, coagulation disorders, peripheral edema, lymphangitis, lymphedema, pleural or pericardial effusion, hemorrhage (eg sub-arachnoid) or hemophilia or a related bleeding disorder. - History of malignancies e.g. recurrent basal cell carcinoma, hematological malignancy. - For subjects receiving cantharidin: Presence on either forearm of tattoos, naevi, hypertrophic scars, keloids, hyper or hypo pigmentation that may, in the opinion of the Investigator, interfere with study assessments. Subjects with very fair skin, very dark skin, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments Family history of premature cardiovascular disease or long QT syndrome QT interval with Fridericia's correction (QTcF) > 450 millisecond (msec), based on averaged QTcF values of triplicate ECGs obtained over a brief recording period Unable or unwilling to refrain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study treatment until completion of the follow-up visit. Paracetamol, at a dose of <= 2 grams per day was permitted for use anytime during the study. Other concomitant medications will be considered on case by case basis The subjects have participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in the study: 30 days; 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or currently in a study of an investigational device Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Previous exposure to intravenous lipopolysaccharide (LPS) in a clinical research setting. - Alanine transaminase (ALT) >1.5x upper limit of normal (ULN) at screening Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study 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): 12.0-17.0, Non-Alcoholic Fatty Liver Disease Provision of signed and dated informed consent form 2. Provision of signed and dated assent, if indicated 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Children aged 12-17 years at the time of informed consent 5. History of clinical diagnosis of NAFLD including a, b and c below: 1. Medical history eliminating, other chronic liver diseases (for example mitochondrial diseases, hepatotoxic drugs, anorexia nervosa) 2. Laboratory studies: negative testing for hepatitis C and normal ceruloplasmin 3. Either liver biopsy confirming NAFLD or MRI > 10% steatosis within the past three years 6. ALT ≥ 54 U/L for boys or ≥ 46 U/L for girls and ≤ 250 U/L at screening visit and within past three months (prior to screening). If ALT at screening is more than two times the historic value (or a historic value is not available), the subject will be asked to repeat the ALT after four weeks. If the repeat ALT is more than 50% increased or decreased over the screening ALT a third ALT may be obtained. If a third ALT is not within 50% of the previous value then the subject is ineligible, but may be rescreened at a later date. 7. Body weight ≥ 60 kg at the time of screening 8. Able to take oral medication and be willing to adhere to the study drug regimen 9. Minimum of three months of attempted lifestyle modification to treat the NAFLD and agreement to adhere to Lifestyle Considerations (dietary improvement and physical activity) throughout study duration Heart disease (e.g., myocardial infarction, heart failure, unstable arrhythmias) 2. Seizure disorder 3. Active coagulopathy (international normalized ratio (INR) > 1.4) 4. Renal dysfunction with an estimated glomerular filtration rate (eGFR) <60ml/min/1.73 calculated using Schwartz Bedside GFR calculator for children 5. History of active malignant disease requiring chemotherapy or radiation 6. History of significant alcohol intake (AUDIT questionnaire) or inability to quantify alcohol consumption 7. Use of new medications or supplements with the intent to treat NAFLD/nonalcoholic steatohepatitis (NASH) during the 30 days prior to screening, including statin therapy. Medications or supplements (including metformin and vitamin E) that they have been on and are on a stable dose are acceptable 8. History of bariatric surgery or planning to undergo bariatric surgery during study duration 9. Clinically significant depression 10. Any girl nursing, planning a pregnancy, known or suspected to be pregnant, or who has a positive pregnancy screen 11. Non-compensated liver disease defined as cirrhosis and any one of the following hematologic, biochemical, and serological on entry into protocol Hemoglobin < 10 g/dL White blood cell (WBC) < 3,500 cells/mm3 Neutrophil count < 1,500 cells/mm3 Platelets < 150,000 cells/mm3 Total bilirubin > 1.3 mg/dL unless due to Gilbert's syndrome (subjects with a history of Gilbert's syndrome may be included if both direct bilirubin and the reticulocyte count do no exceed the upper limit of normal (ULN) [reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome]) Albumin < 3.2 g/dL INR > 1.3 Abnormal alkaline phosphatase Any history of ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma (HCC) 12. Poorly controlled diabetes mellitus (hemoglobin A1c (HbA1c) > 8%) or requiring insulin 13. Patients with type I diabetes mellitus 14. Chronic liver disease other than NAFLD 15. Patients on Cytochrome P450 3A4 (CYP3A4) inhibitors such as itraconazole or macrolide antibiotics are excluded 16. Patients who are on thiazolidinediones, fibrates or fish oils are excluded 17. Patients who are on daily prescription medications are excluded except for allergy medications, Attention Deficit Hyperactivity Disorder (ADHD) medications, asthma medications, or any other acceptable medication in the opinion of the investigator 18. Abnormal creatinine kinase levels at screening (may be repeated if the elevation is thought to be exercise related) 19. Sexually active female participants of childbearing potential and Tanner stage ≥ 4 or menstruating unwilling to utilize two acceptable forms of contraception from screening through completion of the study or unwilling to complete pregnancy tests throughout the study 20. Currently enrolled in a clinical trial or who received an investigational study drug within 90 days of screening 21. Participants who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-50.0, Liver Diseases Chronic Liver Disease volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis Subject with HIV, HBV, HCV Subject with comorbidities Subject less 18 years old Subject higher 50 years old | 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, Thrombocytopenia Neonatal newborn (term and preterm, inborn or out born) aged from 1-28 day 2. platelet count below one hundred and fifty thousands unit/liter Infant above 28 days old. 2. Newborns have platelet count one hundred and fifty thousands unit/liter | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.5, Hypothermia At least 30 weeks gestational age and less than 8kg In need of at least 48 hours incubation in a stable temperature environment Must be clinically stable Parental/legal guardian written informed consent has been given Does not require humidity regulation Parent/legal guardian must not be from a vulnerable 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): 0.0-6.0, Transient Tachypnea of the Newborn PPHN A signed form of informed consent from parents (legal guardians) 0/7 to 41 6/7 weeks of gestation The need to support postnatal breathing, no later than 6 hours of life The need for intubation in the after-birth procedures Age above 6 hours of age from birth Congenital heart defects Congenital diaphragmatic hernia Other severe congenital malformations and genetically determined syndromes, diagnosed before and after birth, associated with higher risk of respiratory failure | 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, Gastrointestinal Microbiome Newborns with jaundice treated with blue light phototherapy Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.036, Infant Nutrition Singleton birth Full-term infant (37 weeks of gestational age) APGAR score of 9 or 10 Birth weight 2500 clinically significant condition/ disorder Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula readmission to hospital (except for hyperbilirubinemia) allergy to cow's milk participation in another 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): 0.0-999.0, Neonatal Hyperbilirubinemia Gestational age w36-42 Age of newborn 48 hours or more Level of bilirubin 300-400 µmol/l Immunisation. Bilirubin >400 µmol/l. Asphyxia. Ongoing infection, weightloss > 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-40.0, Fetal Lung Maturity Respiratory Distress Syndrome in Premature Infant Singleton pregnancy, no evidence of diabetes, hypertension, smoking, BMI > 35, Hgb < 10 g/dl or other confounding variables Smoking, abnormal gestation, multiple gestatio | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Jaundice, Neonatal Phototherapy Low Risk Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and recommendations for management of premature infants under 35 weeks, adopted by the Kangaroo Mother Care Ambulatory Program Start of jaundice at a chronological age greater than 48 hours Bilirubin level ≤18 mg / dL Knowledge of blood groups of mother and child Parents are required to sign informed consent where they agree to participate in the study Parents without availability to stay in the Kangaroo Mother Care Program for at least 6 hours Extensive skin lesions due to burns or sloughing at the physical examination prior to entering the study | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Phototherapy Jaundice, Neonatal Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and management recommendations for preterm infants under 35 weeks, adopted by the newborn unit of San Ignacio University Hospital Birth weight more than 2000 grams Parents are required to sign informed consent where they agree to participate in the study Diagnosis of pemphigus, scalded skin or burns that make phototherapy difficult Patient who requires transfer for management in another institution by their health insurer | 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): 18.0-75.0, Renal Impairment Healthy female subjects of non child bearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 75 years, inclusive. 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 or clinical laboratory tests. 2. Female subjects of nonchildbearing potential must meet at least 1 of the following 1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state; 2. Have undergone a documented hysterectomy and/or bilateral oophorectomy; 3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) are considered to be of childbearing potential. 3. Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb). 4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 5. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Subjects with Normal Renal Function will Need to Meet the Following in addition - 1. Normal renal function, eGFR=>90 mL/min, based on the MDRD equation. 2. Matched for age (+/-10years) weight +/-15kg, and gender to subjects in the impaired renal function groups Subjects with Impaired Renal Function will Need to Meet the Following in Addition to Those Above 1. Good general health commensurate with the population with chronic kidney disease (renal impairment). 'Health' is defined as no clinically relevant abnormalities (with the exception of hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease, etc. as long as, in the opinion of the investigator, the subject is medically stable, is on a stable drug regimen and can abide by the meals and dietary restrictions outlined in protocol identified by a detailed medical history, full physical examination, measurement of pulse rate and 12 lead ECG as well as clinical laboratory tests (except serum creatinine and eGFR). 2. Stable drug regimen defined as not starting a new drug or changing dosage within seven days or five half lives (whichever is longer) before dosing the study drug. 3. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included). 4. Meet one of the following eGFR during the screening period based on the MDRD equation: 1. Moderate renal impairment: eGFR 30 mL/min and <60 mL/min, or 2. Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis. For subjects in all groups, the values of serum creatinine obtained at the two screening visits should not be more than 20% different -Any condition possibly affecting drug absorption (eg, gastrectomy, achlorhydria). Renal allograft recipients Urinary incontinence without catheterization. Concurrent use of any of the following food or drugs known to inhibit CYP3A4 (consult the Sponsor if in doubt whether a food or a drug falls into any of the above categories) within 7 days or 5 half lives (whichever is longer) prior to the dose of glasdegib, until the completion of the last PK sample collection. Concurrent use of any of the following food or drugs known to induce CYP3A4 (consult the Sponsor if in doubt whether a food or a drug falls into any of the above categories) within 12 days or 5 half lives (whichever is longer) prior to the first dose of trial medication until the completion of the last PK sample collection. Pregnant female subjects; breastfeeding female subjects; fertile male subjects who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the Study and for at least 90 days after the last dose of investigational product. Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > upper limit of normal (ULN) Total bilirubin level 1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is not greater than 0.5 mg/dL. For subjects with renal impairment, the following important additional are: Subjects with other clinically significant disease that may affect the safety of the subject or that may affect the pharmacokinetics of glasdegib (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Subjects with any significant hepatic, cardiac, or pulmonary disease or subjects who are clinically nephrotic. Hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease, etc is not cause for as long as the subject is medically stable and any drugs that are administered for these conditions are not expected to interfere with the pharmacokinetics of glasdegib. Screening blood pressure =>180mm Hg (systolic) or>=110 mm Hg (diastolic), following at least 5 minutes of supine rest. If initial blood pressure (BP) is 180 mm Hg (systolic) or 110 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility. Screening supine 12 lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec. If initial QTcF exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF or QRS values should be used to determine the subject's eligibility | 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): 0.0-0.583, Jaundice, Neonatal Neonatal Hyperbilirubinemia Neonatal Disorder Provision of at least one parent/legal guardian's signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Infants born after 35 weeks and 0 days of gestation 4. Infants who developed significant hyperbilirubinemia Infants who developed significant hyperbilirubinemia per BiliToolTM plot requiring phototherapy as determined by the attending neonatologist utilizing the American Academy of Pediatrics' 1. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (Bhutani Nomogram) 2. Guidelines for Phototherapy in Hospitalized Infants of 35 or More Weeks Gestation Participants will be screened on the following at the time of enrollment Perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minutes) Respiratory distress Exchange transfusion Major congenital malformations As identified throughout the course of the investigation, additional Direct-reacting component of bilirubin >2 mg/dL Glucose-6-phosphate deficiency ABO incompatibility Evidence of hemolysis | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, HER2-positive Breast Cancer HER2 Gene Mutation HER-2 Gene Amplification HER2 Positive Gastric Cancer Salivary Gland Cancer Salivary Gland Tumor Salivary Gland Carcinoma Salivary Gland Neoplasms Lung Cancer Colo-rectal Cancer Rare Diseases Solid Tumor Recurrent Gastric Cancer Recurrent Colon Cancer Recurrent Breast Cancer Head and Neck Cancer Head and Neck Carcinoma Bladder Cancer Cervical Cancer Liver Cancer Bile Duct Cancer Urologic Cancer Pancreatic Cancer Prostate Cancer Recurrent Prostate Cancer Rectal Cancer Recurrent Ovarian Carcinoma Recurrent Renal Cell Cancer Rectal Cancer Stage II Rectal Cancer Stage I Rectal Cancer Stage III Skin Cancer Mouth Cancer Lip Cancer Stage I Tongue Cancer Breast Neoplasm Malignant Primary Larynx Cancer Tonsil Cancer Palate Cancer Mucoepidermoid Carcinoma Primary Peritoneal Carcinoma Mucinous Adenocarcinoma Gastric Mucinous Breast Cancer Recurrent Cholangiocarcinoma Phase I Patients must meet the following for into the study: 1. Patients must be able to provide documented voluntary informed consent. 2. Male or female patient ≥ 18 years. 3. Histologically documented, incurable, locally advanced or metastatic cancer. 4. Evaluable or measurable HER2 positive (by ISH or NGS) disease or HER2 expressing disease. HER2 expressing is defined in this protocol as HER2 expression of ≥ 1+ determined by validated IHC. 5. Patients should have no available therapy likely to convey clinical benefit. 6. Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL. 7. Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN). 8. Creatinine clearance ≥ 50 mL/min calculated by Cockroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed. 9. ECOG Performance Status ≤ 1. 10. Women of childbearing potential and men must agree to use an approved method of birth control (e.g., hormonal, barrier) while receiving study drug, and for at least 7 months after the last dose of study drug. Women are excluded from birth control if they had had tubal ligation or a hysterectomy. 11. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. Phase II Patients must meet the following for into the study: 1. Patients must be able to provide documented voluntary informed consent. 2. Male or female patient ≥ 18 years. 3. Histologically documented, incurable, locally advanced or metastatic cancer. 4. Evaluable or measurable HER2 positive (by ISH or NGS) disease or HER2 expressing disease. HER2 expressing is defined in this protocol as HER2 expression of ≥ 1+ determined by validated IHC. 5. Regarding previous therapy: 5.1. Cohort 1: HER2 positive (IHC 2+ with FISH confirmation and Immunohistochemistry (IHC 3+) breast cancer: patients should have progressed after at least 2 previous HER2 directed regimens in metastatic disease with approved therapies. 5.2. Cohort 2: HER2 positive (IHC 2+ with FISH confirmation and IHC 3+) gastric cancer: patients should have progressed after at least 1 previous HER2 directed regimens in metastatic disease with approved therapies. 5.3. Cohort 3: HER2 low expressing (IHC 1+ and IHC 2+ without FISH confirmation) breast cancer: patients should have no available therapy likely to convey clinical benefit. 5.4. Cohort 4: all cancers other than breast cancer with low HER2 expression (IHC 1+ and IHC 2+ without FISH confirmation) and HER2 positive (IHC 2+ with FISH confirmation and Immunohistochemistry (IHC) 3+) cancers other than breast and gastric cancer: patients should have no available therapy likely to convey clinical benefit. 6. Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL. 7. Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN). 8. Creatinine clearance ≥ 50 mL/min calculated by Cockroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed. 9. ECOG Performance Status ≤ 1. 10. Women of childbearing potential and men must agree to use an approved method of birth control (e.g., hormonal, barrier) while receiving study drug, and for at least 7 months after the last dose of study drug. Women are excluded from birth control if they had had tubal ligation or a hysterectomy. 11. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo Phase I: 1. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia). 2. History of Grade ≥ 3 hypersensitivity reaction to trastuzumab. 3. History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued. 4. Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first infusion of study drug. 5. Require supplemental oxygen for daily activities. 6. Documented Grade ≥ 2 peripheral neuropathy. 7. Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks of first infusion of study drug. 8. Any experimental therapy within 4 weeks of first infusion of study drug. 9. Any major surgical procedure within 4 weeks of first infusion of study drug. 10. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis. Patients who have positive hepatitis B virus test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti hepatitis B core protein, and positive antibody to the HBsAg (anti-HBs) are not excluded. 11. Have known prior positive test results for human immunodeficiency virus. 12. Uncontrolled hypertension or diabetes. 13. Pregnancy or lactation. 14. Resting corrected QT interval (QTc) > 470 ms at baseline. 15. Left ventricular ejection fraction (LVEF) < 45% determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan. 16. Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent. Phase II: 1. Any patient who was treated in the Phase I part of this study. 2. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia). 3. History of Grade ≥ 3 hypersensitivity reaction to trastuzumab. 4. History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued. 5. Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first infusion of study drug. 6. Require supplemental oxygen for daily activities. 7. Documented Grade ≥ 2 peripheral neuropathy. 8. Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks of first infusion of study drug. 9. Any experimental therapy within 4 weeks of first infusion of study drug. 10. Any major surgical procedure within 4 weeks of first infusion of study drug. 11. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis. Patients who have positive hepatitis B virus test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti hepatitis B core protein, and positive antibody to the HBsAg (anti-HBs) are not excluded. 12. Have known prior positive test results for human immunodeficiency virus. 13. Uncontrolled hypertension or diabetes. 14. Pregnancy or lactation. 15. Resting QTc > 470 ms at baseline. 16. LVEF < 45% determined by ECHO or MUGA scan. 17. Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent | 0 |
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