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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): 0.442-0.615, Weight Gain Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days Birth weight less or equal to 1500 g Minimum enteral intake of 150-160 mL/kg/d fortified HM Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry Infants with weight z-score < -2 SD, based on the Fenton growth chart (Fenton 2013) Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine Cholestasis (total bilirubin > 5 mg/dL or 85 umol/L and direct bilirubin > 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT) Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.) Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.) Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g NEC grade above or equal to 2 Uncontrolled sepsis Suspected or documented maternal substance abuse | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.027, Preterm Infant Nourished with donated or artificial breast milk Term of the certain child Child whose post-natal age is less than or equal to 10 days at the time of Eutrophic child Child of a non-diabetic mother Clinically stable child Stop Control Positive Airway Pressure (CPAP) nasal for 48 hours No analgesic or sedative drugs since birth Child not presenting a gene syndrome, a progressive neurological disease, a malformative pathology, a cleft lip and palate Child whose two parents or legal representatives have accepted their child's participation in this study, and have signed informed consent Hypotrophic child greater than 5th percentile on the curves Milk-fed child of a mother born to her own mother Child over the age of 10 days Child with grade 3-4 intraventricular hemorrhage, periventricular leukomalacia, or ulcerative necrotizing enterocolitis | 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): 0.0-0.14, Bronchopulmonary Dysplasia Neonatal infants who fulfil all of the following will be enrolled: 1. Subjects of postnatal age between 3 to 30 days. 2. Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks. 3. Subjects with birth weight between 501g to 1249 g. 4. Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study. 5. A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening. 6. A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment. 7. Written informed consent has been provided by the subject's parents, legal guardians, or a legal representative, who agree to comply with all of the study procedures, including those in the long-term safety surveillance period Neonatal infants who meet any of the following will be excluded: 1. Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA). 2. Have a known genetic syndrome. 3. Have a condition that makes them ineligible for participation in this study, as determined by the investigator. 4. Have C-reactive protein (CRP) >30 mg/L; or any infections including pneumonia, sepsis, or shock. 5. Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3). 6. Have active pulmonary hemorrhage or air leak syndrome. 7. Have abnormal hepatic (AST, ALT >150 U/L or direct bilirubin >2 mg/dL or total bilirubin >15 mg/dL) or renal function (serum creatinine >1 mg/dL or oliguria). 8. Are known to be infected with HIV or CMV. 9. Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation. 10. Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation. 11. Are currently participating in any other interventional clinical trial | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.333, Feeding Behavior Late-Onset Neonatal Sepsis Preterm babies below 33 weeks (32+6) weeks of gestation Birth weight <1500 g Preterm babies with congenital anomalies Preterm babies with congenital infection like pneumonia Babies born in other hospitals Babies of single mothers with unknown partners Confirmed immunodeficiency disorder Inborn Error of Metabolism Parental refusal to participate Preterm babies who have overt bleeding | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-18.0, Secondary Hyperparathyroidism Chronic Kidney Disease Dry weight ≥ 7 kg during screening Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of enrolment Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) for subjects ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for subjects 28 days to < 2 years of age obtained from the central laboratory during screening Dialysate Ca level ≥ 2.5 mEq/L during screening SHPT not due to vitamin D deficiency, per investigator assessment Anticipated or scheduled parathyroidectomy or kidney transplant during the study period Subject has received a parathyroidectomy within 6 months prior to randomization Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Allergic Rhinitis Adverse Drug Event Quality of Life Aged between 18-70 years old Patients with history of allergic rhinitis based on ARIA guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion) Patients with moderate allergic rhinitis was diagnosed by physicians Have no nasal septum perforation, nasal polyp or sinus surgery Have no serious medical conditions: Heart disease, Liver disease, Renal disease, Hypertension, Peptic Ulcer and Gastroesophageal reflux disease (GERD), severe Asthma, Tuberculosis Have normal range of Hematology test for Liver and Renal function No Pregnant or Lactation Do not taking a medicine constantly Volunteers are willing to participate this study Allergic reactions to Prapchompoothaweep remedy and Loratadine Allergic reaction to dairy products Have severe urticaria and anaphylaxis Have a serious condition of immunodeficiency disease: HIV in the previous month before being recruited in the study Participate 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): 0.083-3.0, Difficult Intubation Pediatrics 3 years old (1-36 mounts) pediatric patients Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway 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): 0.0-0.5, Plagiocephaly Plagiocephaly, Nonsynostotic Plagiocephaly, Positional Sign of positional plagiocephaly Infants below 6 moths age No neurological disorders No infectious diseases No respiratory diseases No other treatments | 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, Parkinson Disease Diagnosis of classic PD with history of clinically meaningful response to levodopa Disease duration >15 years since diagnosis Hoehn & Yahr stage >IV "on" or "off" levodopa Consent signed by subject, if possible If subject is cognitively impaired, consent signed by power of attorney or legally authorized subject representative Assent from the study subject, if possible Stable dose of all medications for 60 days prior to Day 1 of first week of study Atypical parkinsonian syndrome (e.g., never responded to levodopa, and/or atypical signs) Acute or unstable medical condition such as heart disease, kidney and liver failure History of HIV, hepatitis B and C Use of moderate to strong CYP 3A4 modulators (see both inhibitors and inducers in Appendix BB) | 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, Cholestasis in Newborn Infant Biliary Atresia Patients with jaundice Healthy volunteers Subjects who do not agree with study protocol | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 15.0-30.0, Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition all women who become pregnant during a 9-month period in a set of Nagarpalikas and Gaunpalikas in Sarlahi District, Nepal Women who do not intend to deliver their child in the study area Women who are allergic to milk, nuts or soy Women who are unwilling to commit to daily consumption of the nutritional supplement if they are randomized to an active treatment arm Women who refuse to 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): 0.0-0.019, Patent Ductus Arteriosus After Premature Birth Hyper Bilirubinemia Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study Babies with congenital heart disease Infants with major structural anomalies and infants who can not undergo echocardiography before or after 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): 0.0-999.0, Pancreas Cancer Group 1: Includes all patients presented by pancreatic cancer with clinical, radiological, laboratory diagnosis and pathological diagnosis. Group 2: A: Healthy individual B: Individual with benign diseases such as benign hepatopancreatobiliary conditions as gall stones, obstructive calcular jaundice, chronic pancreatitis and benign gasrtrointestinal as ulcer and polyp Patients recently operated for pancreatic cancer patients diagnosed to have another type of cancer (Breast, gastric or colorectal) High risk group of another type of cancer Patients with disseminated cancer | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-70.0, Hypertension Genetics Hypertension The subjects evaluated in this protocol are hypertensive and carry the Striatin rs254093 risk allele or both Striatin rs888083 and rs6744560 risk alleles. Most will be recruited from the HyperPATH cohort. The HyperPATH cohort was developed under a SCOR in Hypertension program. This program has demographic data and DNA on more than 4000 subjects. Currently, nearly 2000 of them have undergone an extensive phenotyping protocol. All hypertensive medications have been stopped for 4 weeks before study except agents that interfere with the renin-angiotensin-aldosterone system (RAAS) are stopped for three months and amlodipine and/or hydrochlorothiazide is added if necessary for blood pressure control until one month before study initiation. Then each subject is studied twice on a diet consisting of 100 mmol potassium, 800 mg calcium, isocaloric, 2500 ml. The two times they are studied are after one week of a liberal sodium diet (200 mmol) and after one week of a low sodium diet (10 mmol). Blood is obtained supine, upright and after a 3 ng Ang II infusion and a norepinephrine dose response curve. BP and renal plasma flow are assessed in response to the diet and the Ang II infusion and 24 hour urines are collected on each diet. An oral glucose tolerance test is performed on each subject and blood is obtained for DNA. In addition to hypertensives, the nearly 2000 intensively studied cohort consists of 75 individuals in 10 families, 225 sibling pairs with hypertension, 525 normotensive individuals without a family history of hypertension or diabetes before the age of 60, and 250 type II diabetic subjects with or without hypertension. On most of the 4000 subjects serum, plasma, urine and DNA is available for measurements and analyses. Currently the data set consists of approximately 2100 data points of demographic data, family history, biomarkers, and genotypes. The subjects have been recruited from Boston MA, Salt Lake City UT, Paris France, Rome Italy and Nashville TN. The demographics consists of the following: 52% male, 18% of African descent, 3% Asian descent, age 17-66, hypertension stage 1-2, diet or oral medication controlled diabetes (80% of the total diabetics). A few subjects will be recruited from advertisements on the Internet and in local newspapers, from fliers and postings in the hospital, through mailings to households located in the Boston areas and through patient registries at Brigham and Womens Hospital. As an example of the richness of these sources is the Research Patient Data Registry (RPDR). RPDR is a centralized clinical data registry of 2.8 million Brigham and Womens Hospital and Massachusetts General Hospital patients. With approval of the Institutional Review Board, investigators may use the RPDR Data Acquisition Engine to obtain medical record information for patients with a specific diagnosis. Patients who meet for a specific study can be identified. Potential research subjects may be contacted by his/her physician to inform the patient of the possibility of participating in a research study and to provide the patient with the information for contacting the study personnel. Investigators from Brigham and Womens Hospital may apply to use the RPDR. RPDR contains over 90,000 hypertensives, ages 17-65 years with 13.5 % of African descent and 52.8 % women. We reported in our studies using the HyperPATH cohort that there was no racial, age or ethnic differences in the salt sensitive blood pressure responses related to Striatin allele variants. Thus, an equal number of females and males and the same proportion of Africans as in the HyperPATH cohort will be studied. Subjects in HyperPATH and those recruited for the new study in this project will have the similar characteristics. The range in age is >17; however, it is anticipated that the clear majority will be between the ages of 40 and 60 years. Hypertensive patients previously treated will be weaned off medications for two-four weeks except agents that interfere with the renin-angiotensin-aldosterone system (RAAS) are stopped for three months and amlodipine and/or hydrochlorothiazide is added if necessary for blood pressure control until one month before study initiation. Thus, these subjects will match the characteristics of subjects recruited in HyperPATH. They must have a diastolic blood pressure between 95 and 105 mm Hg off medication in each of three screening visits. Subjects with diastolic blood pressures greater than 105 mm Hg or systolic blood pressures greater than 180 mm Hg will be excluded. Subjects with only elevated systolic blood pressure (but diastolic less than 95 mm Hg) will be excluded because such subjects were not in the HyperPATH cohort. Based on individual statements, subjects with current excessive alcohol use (greater than 12 oz/ETOH/week) or recreational drug use will be excluded. Subjects taking other medications (except thyroid supplements) or weighing more than 150% of an ideal body weight will be excluded. Subjects with other major cardiovascular diseases, diabetes, asthma, or other major medical illness will be excluded. Subjects who smoke will be excluded. In addition, subjects must have normal values for the following screening tests: CBC, serum electrolytes, liver enzymes, TSH, urinalysis, 24-hour urine excretion of catecholamines and cortisol, and ECG. Specifically, estimated GFR must be > 60 ml/min and serum potassium < 5.0 mmol/l. Subjects with hypokalemia while on diuretics will be evaluated for hyperaldosteronism before in this study. Cushings syndrome will be ruled out clinically, and with a 24-hour urine cortisol if there is clinical uncertainty. For the more difficult question of renal artery stenosis, we will perform renal artery digital subtraction angiogram in patients with hypertension and a two-component abdominal bruit. Patients with greater than 50% renal artery stenosis will be further evaluated, but excluded from this study. Subjects with a known sensitivity to any of the agents, such as amlodipine or eplerenone will be excluded. Women who are pregnant will be excluded and will be dropped from the study if they become pregnant during the study because eplerenone has not been approved for use in pregnancy and the activity of the RAAS is dramatically altered by pregnancy. The screened, eligible hypertensives will enter a two-week single blind placebo washout phase. Pill count will be used to determine compliance. Those with BP between 145-170/90-109 mmHg and pill count between 80-100% will enter the randomized phase, counseled regarding salt intake, and randomized double blindly into one of our two treatment arms. We will recruit approximately 105 individuals to have 45 individuals in each drug group for analyses. This assumes that we will have 10-15% non-completers. 1. rs2540923A allele carrier OR both Striatin rs888083 and rs6744560 risk allele carrier 2. ages >17 years; 3. hypertension as defined by primary physician; 4. not on more than two anti-hypertensives; 5. normal renal, metabolic, electrolyte, complete blood cell count, and lipid profile laboratory tests; 6. if on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or mineralocorticoid receptor antagonist, needs to be washed out for 3 months known cardiac disease other than hypertension 2. renal, circulatory or neurologic diseases 3. diabetes; smoking 4. secondary hypertension as indicated by history, physical examination or screening blood and urine tests; any drug therapy, except for anti-hypertensives and replacement thyroid medication | 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, Bilirubinemia -Ful term ,Body weight (≥2.5kg). 2 total serum bilirubin range(≥18mg/dl to≤25mg/dl). 3-Non -haemolytic type of jaundice. 4-Ratio of conjugated bilirubin :unconjugated bilirubin is 1:5 Body weight ≤2.5kg. 2 Evidence of haemolysis. 3 Obvious features of dehydration. 4- Major congenital malformation . 5 Baby received already IV fluid for any reason. 6- Septicemia . 7-GIT functional or organic obstruction | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-999.0, Head and Neck Cancer age 20 or above Diagnosed with Head and neck cancer Completed radiation or chemotherapy since at least 4 weeks ago normal physical exam Eastern Cooperative Oncology Group (ECOG) performance status 0 Life expectancy > 3 months Normal kidney function evidenced by serum creatinine, blood urea nitrogen (BUN), no kidney stone, no history of renal dialysis Normal liver function evidenced by serum bilirubin, aspartate transaminase (AST), alanine amino transferase (ALT) not pregnant or breastfeeding no psychiatric symptoms unable to communicate reject to take Nutri-jelly unable to refrain from vegetable intake for 3 days prior to the test take paracetamol during 2 days prior to the test body weight less than 35 kg or higher than 65 kg oral infection such as Candidiasis interfering with normal oral intake | 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, Osteoarthritis Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests Affected by any other acute or chronic underlying 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): 18.0-55.0, Pulmonary TB Males and females 18 to 55 years of age. 2. In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration. *Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm, systolic blood pressure ≤140 mmHg and >89 mmHg, diastolic blood pressure ≤90 mmHg and ≥60 mmHg. NOTE: Athletically trained subjects with a pulse ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator. 3. Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count, hemoglobin, and platelet count. 4. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. 5. Urine dipstick for protein and glucose (negative to trace protein are acceptable). 6. Women of childbearing potential* in sexual relationships with men must agree to practice acceptable contraception** for the 30-day period before Day 0 through 90 days after the last study injection. *Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year of the last menses if menopausal). Post-menopausal defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml. **Includes, but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 7. Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. 8. Provide written informed consent before initiation of any study procedures. 9. Willing to abstain from donating whole blood or blood derivatives until 90 days after the final study injection Previous exposure to ID93 vaccines or experimental products containing GLA-SE. 2. History of treatment for active or latent tuberculosis infection. 3. History or evidence of active or documented latent tuberculosis, or positive QuantiFERON®-TB Gold test. 4. Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis. 5. Received a tuberculin skin test within 3 months (90 days) prior to randomization. 6. History of autoimmune disease or immunosuppression. 7. Used immunosuppressive medication (e.g., oral or injected steroids) within 3 months prior to randomization (inhaled and topical corticosteroids are permitted). 8. Received any investigational drug therapy or investigational vaccine within past 6 months prior to randomization, or planned participation in any other investigational study during the study period. 9. Received investigational TB vaccine at any time prior to randomization. 10. Received any vaccine within 30 days prior to the first study vaccination and no planned immunizations between Day 0-84 or Day 210-224 due to the washout period prior to immunology blood draws. 11. History or laboratory evidence of immunodeficiency state including but not limited to laboratory indication of HIV-1 infection at screening. 12. History of allergic disease or reactions, likely to be exacerbated by any component of the study vaccine. 13. History of allergic reaction to kanamycin-related antibiotics. 14. Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens. 15. Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms. 16. Known or suspected alcohol or drug abuse within the past 5 years. 17. Smokes 1 pack or more of cigarettes per day. 18. History of keloid formation or excessive scarring. 19. History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy. 20. Received a blood transfusion or immunoglobulin within the past 3 months prior to randomization. 21. Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month prior to randomization. 22. Presence of any febrile illness, oral temperature of >100.4 °F/38.0 °C within 24 hours of study injection administration. Such subjects may be re-evaluated for enrolment after resolution of illness. 23. Positive serum (at screening visit only) or urine pregnancy test at screening or within 24 hours prior to study injection for women of childbearing potential. 24. Breastfeeding at any time throughout the study. 25. Rash, tattoos, or any other dermatological condition on the upper anterolateral arm that could adversely affect the vaccine injection site or interfere with its evaluation. 26. BMI <18 or >35 kg/m2. 27. Any medical or neuropsychiatric condition which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting. 28. Cancer or treatment for cancer within 3 years of study injection administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible. 29. Subjects unlikely to cooperate with the requirements of the study protocol | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-1.0, Neonatal Hypoglycemia Infant, Small for Gestational Age Macrosomia, Fetal Intrauterine Growth Restriction Premature Infant Neonatal; Hypoglycemia, Diabetes, Maternal Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery Infants of diabetic mothers (any type of diabetes) Late Preterms (34 weeks' gestation) Low birth weight (< 2.5 kg ) or Small for gestational age Large for gestational age (> 4 kg or > 90th centile on Fenton's growth chart) Major congenital abnormality including severe cleft lip and palate Babies requiring NICU admission immediately after birth Babies less than 34 weeks of age Babies whose parents refused to 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): 18.0-65.0, Fetal Surgery Myelomeningocele Congenital Diaphragmatic Hernia Women/partners eligible for one of the two fetal surgery procedures studied (open fetal surgery for spina bifida closure, tracheal balloon occlusion for congenital diaphragmatic hernia (Fetoscopic Endoluminal Tracheal Occlusion, FETO), as clinical care Have given written informed consent for participation Women less than 18 years or over 65 years of age Partners less than 18 years or over 65 years of age Women or their partners who are unable to communicate in either English or the local language (if different) | 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): 0.0-0.137, Neonatal SEPSIS Sepsis was defined as a positive blood culture in infants with clinical and laboratory findings of infection. Manifestations of sepsis poor suckling, sleepiness, respiratory distress, apnea, poor perfusion, cyanosis, bradycardia, fever or hypothermia, feeding intolerance, and neurological signs (as seizures). Routine sepsis evaluations included complete blood count, C-reactive protein, and blood culture malformations prematurity Apgar score less than seven on antibiotics treatment before the start 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): 0.0-0.019, Jaundice, Neonatal gestational age more than 35 weeks(≥35) - all kinds of congenital diseases, infants with pathologic jaundice - | 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): 18.0-45.0, Tissue Perfusion Deliberate Hypotension Sinus Endoscopic Surgery Adult male or female patients 45 years ASA physical status I-II scheduled for FESS operations uncontrolled hypertension cerebrovascular disorders coagulation disorders cardiovascular diseases renal impairment liver impairment history of allergic reaction to any of the study medications | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-30.0, Central Nervous System Neoplasm Infantile Fibrosarcoma Recurrent Acute Leukemia Refractory Acute Leukemia Solid Neoplasm A: Patients must have a histologic diagnosis of infantile fibrosarcoma with an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Act/College of American Pathologists (CLIA/CAP) certified laboratory. Fusions may be identified by fluorescence in situ hybridization (FISH) or molecular techniques (reverse transcriptase-polymerase chain reaction [RT-PCR] using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, an ETV6 rearrangement is sufficient for in Cohort A. Identification of the upstream TRK fusion partner is not required B: Patients must have a histologic diagnosis of any solid tumor other than infantile fibrosarcoma, including central nervous system (CNS) tumors but excluding high grade gliomas. An NTRK1, NTRK2, or NTRK3 fusion must be identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility) unless the patient has a diagnosis of congenital mesoblastic nephroma in which case an ETV6 rearrangement is sufficient for eligibility. Identification of the upstream TRK fusion partner is not required C: Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility). Identification of the upstream TRK fusion partner is not required SOLID (COHORTS A AND B): Patients must have measurable disease. Patients must have disease that cannot be completely resected without a predicted functional, neurologic, or significant cosmetic deficit in the opinion of the investigator (COHORT C): Patients must have >= 5% blasts in the bone marrow. Extramedullary disease is permitted Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. NOTE: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score A AND B: No prior anti-cancer therapy, including radiotherapy, other than surgical resection is permitted Patients who experience recurrence after surgery alone and no other anti-cancer therapy will be eligible If not eligible due to prior anticancer therapy, patients may be eligible for the larotrectinib arm of Pediatric MATCH (APEC1621A) or treatment with commercial larotrectinib off study C: Patients with relapsed leukemia (Cohort C) must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical are met, e.g. blood count the patient is considered to have recovered adequately Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors ) Stem cell infusions (with or without total body irradiation [TBI]) Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD) Autologous stem cell infusion including boost infusion: >= 42 days Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.) Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial BM radiation Radiopharmaceutical therapy (e.g., radiolabeled antibody): >= 42 days after systemically administered radiopharmaceutical therapy Patients must not have received prior exposure to TRK inhibitors (including larotrectinib, LOXO-195, entrectinib, lorlatinib, crizotinib, or lestaurtinib) | 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, Hypoxic-Ischemic Encephalopathy Neonatal Encephalopathy gestational age at birth of 35 weeks or greater absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia designation as "clinically stable" by the attending neonatologist on service respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator designation as "clinically unstable" by the a member of the medical team use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn high frequency oscillator ventilation presence of electrographic seizures use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains in utero opiate exposure | 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, Umbilical Cord (pregnant women) Low risk pregnancy Full-term pregnancy (37 to 42 weeks) Single fetus Cephalic presentation Normal birth Euthocic delivery. (newborns) Live birth Apgar> 7 in the first minute and fifth minutes Early clamping for any reason (indicated by assistant) Instrumental delivery (forceps) Chorioamnionitis Placental abruption Prolapse of umbilical cord Congenital anomaly Labor analgesia | 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): 15.0-50.0, Hypertension, Pregnancy-Induced Hypertension, Essential Hypertension Hypertension; Pre-Eclampsia Hypertension in Pregnancy High risk pregnancy At 12-16 weeks of gestation Aged between 15 to 50 years Living in Matlab bangladesh Have congenital malformation/anomaly in current pregnancy Current pregnancy have chromosomal abnormality e.g. Down syndrome Have chronic debilitating illness Mother is a known case of psychosis Who do not have electricity at their house Do not have smart phone at their house | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Hyperbilirubinemia, Neonatal Jaundice, Neonatal The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward The patient is less than 28 days old (neonate) The patient is deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice The patient's parent or guardian has provided informed consent for their child to participate Parent or guardian is unable or unwilling to provide informed consent The patient is unable to receive a blood draw/heel stick as determined by their clinician | 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): 12.0-17.0, Non-Alcoholic Fatty Liver Disease NAFLD Pediatric NAFLD For clinical referral to screening visit: 1. Age: 12 to <20 years old 2. Diagnosis of Obesity: BMI-percentile ≥95th (using age and sex based Center for Disease Control definitions) or BMI ≥30 kg/m2 3. Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥44 U/L for girls, ≥50 U/L for boys) within 3 months prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 moths of screening 4. History of lifestyle modification to treat obesity or NAFLD To be obtained at screening visit: 1. Confirmation of Obesity 2. Tanner stage 2 3. Normal fasting glucose tolerance (fasting blood glucose <100 mg/dL) 4. If Screening ALT is used as [if > 2x historic ALT value (historical value obtained clinically within 12 months of screening visit), repeated after 4 weeks [unable to randomize until completed]]. If the repeat ALT is more than 50% increased or decreased over the screening ALT, a third ALT should be obtained. If a third ALT is not within 50% of the previous value, then the subject is ineligible but may be screened at a later date. If ALT is not used An ultrasound will be done to diagnose NAFLD if the diagnosis has not previously been made by ultrasound, MRI or biopsy A MRI-derived HFF ≥ 5.5% 5. Willingness to adhere to lifestyle considerations throughout the study ALT > 250U/L at screening 2. History of significant alcohol intake or current use 3. Impaired fasting glucose (>100 mg/dL) 4. Diabetes (type 1 or 2) 5. Current or recent (<6 months prior to enrollment) use of weight loss medication(s) 6. Vitamin E supplementation 7. Previous bariatric surgery 8. Use of metformin 9. Prior use of empagliflozin 10. Lower limb infection/ulceration within 3 months of screening 11. Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible 12. Structural and functional urogenital abnormalities, that predispose for urogenital infections 13. Recent initiation (<3 months prior to enrollment) of anti-hypertensive or lipid medication(s) 14. Major psychiatric disorder 15. Current pregnancy or plans to become pregnant.Females unwilling to be tested for pregnancy. Females will be tested for pregnancy. Females who are sexually active and not protected by an effective method of birth control (e.g. UID or medication or patch) 16. Tobacco use 17. Significant liver dysfunction (levels >5 times the upper limit of normal (ULN)): ALT (ULN = 50 U/L) AST (ULN = 48 U/L) GGT (ULN = 48 U/L) ALP (ULN = 115 U/L) 18. Platelets < 150,000 cells/mm3 19. Total bilirubin 1.3 mg/dL 20. INR 1.3 21. Albumin <3.2 g/dL 22. Gilbert's Syndrome 23. Any known causes of liver disease (except NAFLD and NASH) 24. Significant renal dysfunction (estimated glomerular filtration rate [eGFR] < 90 mL/min/1.73 m2), 25. Diagnosed monogenic obesity 26. History of cancer 27. Untreated thyroid disorder 28. History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) 29. Current or recent (<6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics) | 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, Hyperbilirubinemia, Neonatal Full-term infants (≧37 weeks). 2. Jaundice index greater than 15 mg/dl on the fourth day after birth Hypothyroidism 2. Trisomy 21 3. Maternal blood type A, B and O incompatibility 4. Gastrointestinal disease 5. Glucose-6-Phosphate Dehydrogenase deficiency (G6PD deficiency) 6. Hemangioma 7. Cephalhaematoma or hemorrhages 8. Severe asphyxia (stage III) 9. Fetal chromosomal anomalies 10. Cyanotic congenital heart disease 11. Omphalocele 12. Early onset sepsis 13. Liver failure | 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): 0.0-0.082, Neonatal Sepsis Neonates with suspected sepsis that show non-specific signs and symptoms or focal signs of infection, including temperature instability, hypotension, poor perfusion with pallor and mottled skin, metabolic acidosis, tachycardia or bradycardia, apnoea, respiratory distress, grunting, cyanosis, irritability, lethargy, seizures, feeding intolerance, abdominal distention, jaundice, petechiae, purpura, and bleeding. Later complications of sepsis might respiratory failure, pulmonary hypertension, cardiac failure, shock, renal failure, liver dysfunction, cerebral edema or thrombosis, adrenal hemorrhage or insufficiency, bone marrow dysfunction (neutropenia, thrombocytopenia, anemia), and disseminated intravascular coagulation. 2. Cases with neonatal sepsis diagnosed by isolating the causative agent from a normally sterile body site (blood, CSF, urine, pleural, joint, and peritoneal fluids (Andi L Shaneetal, 2017) Obvious features of dehydration 2. Major congenital malformations. 3. GIT functional or organic obstruction, hematological disorders, hypersplenism, respiratory distress, malignancy and neurological emergency as intra cranial hemorrhage. 4. Hypoxic ischemic encephalopathy. 5. Post-surgical cases which need NICU observation | 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, Anxiety Stress, Psychological Male and female participants aged 18-70 years 2. Females of childbearing potential must use reliable contraception during the study period; acceptable methods of birth control all hormonal methods, IUDs, complete abstinence, effective physical barriers (e.g. condoms), or confirmed vasectomy of partner (if that information is volunteered by the participant) 3. Participants must be in good health status based on medical history and physical examination, including vital signs and clinical laboratory tests 4. Participants must refrain from taking any prescription or over the counter medication within the 14 days prior to the beginning of the study and during the study period 5. Participants must be non-smokers or light/occasional smokers (not more than 10 cigarettes per day) 6. Alcohol consumption should not exceed 3 drinks on any single day and no more than 7 drinks per week in women and no more than 4 drinks on any single day and no more than 14 drinks per week for men 7. BMI of 18.5-30 kg/m2 excluding markedly underweight and obese individuals 8. Participants must be willing to give written informed consent after the nature of the study has been fully explained Participants demonstrating uncontrolled clinically significant physical disease or abnormal laboratory test results within 14 days prior to the start of the study 2. Participants with current or history of alcohol or drug use disorder 3. Participants with any history of significant drug super-sensitivity, anaphylaxis, or anaphylactic reaction 4. Participants taking prescription medication or OTC medication within 14 days prior to 5. Participants who have a history of any significant psychiatric disorder or currently significant psychiatric symptoms 6. Participants with a family history of serious mental illness in first-degree relatives 7. Participants in a situation or having any condition which, in the opinion of the investigator, may interfere with optimal participation in the study 8. Participants testing positive for amphetamine, cannabinoids, cocaine, barbiturates, benzodiazepines, opioids or hallucinogens 9. Use of other non-prescription natural health products with known anti-anxiety effects 10. Known allergy to any of the medicinal and non-medicinal ingredients in any conditions 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): 0.0-21.0, Acute Lymphoblastic Leukemia Age Participants must be < 22 years of age. Diagnosis Participants must have B-ALL with persistent or rising MRD between 0.1 and 4.99% without extramedullary disease following at least two prior induction attempts, relapse or after hematopoietic stem cell transplant Leukemia blasts demonstrating surface expression of CD22 Performance Level Karnofsky or Lansky performance score ≥ 50% (corresponding to ECOG Score of ≥ 2). The Lansky performance score should be used for participants < 16 years and the Karnofsky performance score for participants ≥ 16 years. Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/ prior to entering this study At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab. Patients must have been off blinatumomab infusion for at least 7 days and all drug related toxicity must have resolved to Grade 2 or lower as outlined in the inclusion/ At least 42 days must have elapsed since CAR-T cell therapy Participant has received ≤ 1 prior bone marrow transplant At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for ≥ 2 weeks, if applicable with no evidence of active GVHD At least 2 weeks must have elapsed since local XRT (small port); ≥ 3 months must have elapsed if prior cranial or craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow irradiation was given. Organ Function Requirements Adequate renal function defined as glomerular filtration rate ≥ 60 cc/min/1.73m2 or serum creatinine based on age as follows Age: <6 months; maximum serum creatinine (mg/dL): 0.4 (male, female); Age: 6 months to <1 year; maximum serum creatinine (mg/dL): 0.5 (male, female); Age: 1 to < 2 years; maximum serum creatinine (mg/dL): 0.6 (male, female); Age: 2 to < 6 years; maximum serum creatinine (mg/dL): 0.8 (male, female); Age: 6 to <10 years; maximum serum creatinine (mg/ dL): 1 (male, female); Age: 10 to <13 years; maximum serum creatinine (mg/dL): 1.2 (male, female); Age: 13 to <16 years; maximum serum creatinine (mg/dL): 1.5 (male), 1.4 (female); Age: ≥ 16 years; maximum serum creatinine (mg/dL): 1.7 (male), 1.4 (female) | 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 B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.003, Preterm Infant Body Temperature preterm infant born before 32 weeks of gestation preterm infant included in the study before 12 hours of life preterm infant nursed in an incubator written informed consent from his parents newborn infant with polymalformative syndrome life threatening events or serious heart disease | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Septicemia Electively scheduled for surgical operation that require general anesthesia and expected duration of hospitalization of longer than one day (for patients in Perioperative Evaluation & Management [POEM]) or high clinical suspicion of sepsis by the emergency physician (for patients in emergency center) Ability to give informed consent. If the patient is incapacitated and unable to give informed consent, the next-of-kin or a person who has the power of attorney must be present for informed consent For patients in the emergency center only, two or more of the following SIRS Leukocytes > 12,000/mm^3 or < 4,000/mm^3 or > 10% immature (band) forms, provided that no filgrastim or pegfilgrastim was administered within 30 days and no leukemia Heart rate > 90 beats/minute (min) Respiratory rate > 20 breaths/min or partial pressure of carbon dioxide (CO2) < 32 mmHg Oral temperature > 38 degrees Celsius (C) or < 36 degrees C or axillary temperature > 37 degrees C or < 35 degrees C Inability to give informed consent or a person who has power of attorney for medical decision is not available Being moribund (for patients in emergency center) or cancellation of surgery (for patients in POEM) Active "Do Not Resuscitate" or "Do Not Intubate" order | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Neonatal Jaundice The mothers are at late 2nd or early 3rd trimester of their pregnancy and agreed to enroll as study participants They are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still not be a candidate for enrollment) Pregnant mother with confirmed multiple pregnancy Pregnant mother with medically identified psychological disorder Any known maternal danger sign | 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, Miscarriage Women who have a positive pregnancy test following IVF or frozen-thawed transfer Women with renal failure are excluded due to assay interference with kisspeptin measurement | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.003, Preterm Infant Jaundice, Neonatal Phototherapy preterm infant less than 35 weeks gestation preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie preterm infant placed in an incubator preterm infant with a jaundice requiring treatment according to NICE guidelines preterm infant with a no hemolytic disease preterm infant with informed written consent from the parents preterm infant more than 35 weeks of gestation preterm infant with hemolytic disease preterm infant with Jaundice related to a cholestasis Jaundice requiring 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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 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, Transplanted Kidney Complication Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation Incomplete records on the patients file Acute complications such as liver 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): 18.0-60.0, Overweight and Obesity Male and female participants with the age of ≥18 and ≤ 60 years of age. 2. BMI of ≥25 ≤ 35 kg/m2 3. Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA: Men: > 102 cm (40 inches), Women: >89 cm (35 inches) 4. Triglycerides >150 mg/dL 5. Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg 6. Fasting blood glucose ≥ 100 mg/ dl 7. Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL 8. Ready to give voluntary, written, informed consent to participate in the study Participants meeting any of the following will be excluded from the trial: 1. Current smoker. 2. Inability to walk independently. 3. Presence of unstable, acutely symptomatic, or life-limiting illness. 4. Neurological conditions causing functional or cognitive impairments 5. Unwillingness or inability to be randomized to one of three intervention groups. 6. Bilateral hip replacements. 7. Exposure to any non-registered drug product within 3 months prior to the screening visit. 8. Unable/unwillingness to complete study specific diaries (digital/paper-based) | 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, Nonalcoholic Fatty Liver Metabolic Syndrome Individuals with liver ultrasound imaging Adults The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis | 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, Ventilator Dependency Age >20y/o Vital signs stable MIP <20cmH2O Ventilator FiO2<40%, PEEP <8 Ventilator mode:PSV or SIMV Patient or family refuse | 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): 0.083-6.0, Gestational Diabetes Mellitus Children term infant; 2. Apgar score>=7 at birth； 3. single birth; 4. no obvious birth defects; 5. no other perinatal diseases that seriously affecting growth and development; 6. no congenital or genetic metabolic diseases that affect intelligence development mother with type 1 or type 2 diabetes before pregnancy; 2. the mother had no OGTT diagnosis results and was not diagnosed in strict accordance with the diagnostic of GDM; 3. the mother had suffered from severe acute and chronic infectious diseases; 4. the mother has other pregnancy complications during pregnancy (hypertensionkidney disease,cardiovascular disease,liver disease,thyroid-related disease,cholestasis,severe anemia,etc.); 5. Mother's age>35 years old; 6. the infants developed diseases that severely affected metabolism or normal growth and development during the follow-up | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Pregnancy Related Stress, Psychological Anxiety Perinatal Depression <21 weeks pregnant with medically confirmed viability Speak, read and write in English fluently Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score > 19) Current enrollment in individual or group psychotherapy Current un-managed serious mental illness including bipolar disorder and psychosis History of previous suicide attempt Inappropriate for participation in group therapy format as determined by study director | 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 Jaundice, Neonatal Males or female neonates greater than or equal to 35 weeks gestational age Elevated total serum bilirubin levels meeting PT in the first 7 days of life Neonates, who are mechanically ventilated Neonates requiring continuous positive airway pressure Neonates with a history of apnea, bradycardia Patients with known cyanotic heart disease Patients experiencing temperature instability or desaturation episodes in 24hr prior to enrollment will be excluded Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures | 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): 18.0-45.0, Intrauterine Growth Restriction Intrauterine Growth restriction (32-36 weeks) Vaginal delivery Delivery at 37 weeks Alcohol, tabacco or other drugs consumption during pregnancy Antibiotic use before recruitment (3 months) or during pregnancy until delivery Gestational diabetes Fetuses anormalities | 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 Disease Necrotizing Enterocolitis Chinese infants admitted in the neonatal unit (NNU) Refuse consent for 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): 15.0-999.0, HIV Infections Immune Activation Comorbidities Consenting pregnant woman of Bantu origin of ≥15 years of age, at least 20 weeks of gestation at enrolment and planning to deliver at any of the 4 study sites, Kuwadzana, Rujeko, Glenview or Budiriro. Mothers should be willing to be followed together with their babies from delivery, and willing to provide the required data and biological specimens in follow-up visits for two years Presence of severe maternal mental disorders | 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): 20.0-70.0, Liver Cirrhosis Of either gender aged 20 to 70 years old (inclusive) 2. Diagnosed liver cirrhosis by imaging, irrespective of etiology 3. With MELD score 10 to 20 (inclusive) and Child-Pugh score 7 to 9 Note: MELD = Model For End-Stage Liver Disease 4. Subject with alcoholic cirrhosis should have been alcohol-abstinent for at least 6 months judged by psychiatrist with records for each month and willing to continue up to the completion of study. 5. Subject with cirrhosis caused by hepatitis B virus (HBV) should be with HBV DNA < 2,000 IU/mL before enrollment. Note: HBV = hepatitis B virus, DNA = deoxyribonucleic acid. IU = International unit 6. Subject with cirrhosis caused by hepatitis C virus (HCV) should have successfully completed treatment for HCV with HCV viral load in the blood undetectable for at least 24 weeks since treatment cessation and with ALT within normal range. 7. Provision of signed and dated informed consent form With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds, platelet count ≤ 60,000/mm3. Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time 2. With evidence of active autoimmune disease 3. With a medical record of solid tumor within 5 years prior to screening, or diagnosed with solid tumor and currently receiving cancer treatment 4. With BMI ≤ 15 kg/m2 Note: BMI = body mass index 5. With inadequate hepatic function, as defined by: total bilirubin level > 3.0 mg/dL; AST > 92.5 U/L, ALT > 112.5 U/L; gamma-GT > 212.5 U/L, or ALP > 340 U/L. Note: gamma-GT = gamma glutamyl transpeptidase 6. With inadequate renal function, as defined by serum creatinine > 2.0 mg/dL 7. The subject refuses to adopt highly effective contraceptives from signing informed consent to Final visit if female subject or female spouse/partner of male subject is of childbearing potential Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms of birth control 1. Established use of oral, injected or implanted hormonal methods of contraception 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 3. Barrier methods of contraception: condom OR occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository 8. Female subject with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating 9. Having participated other investigational study within 4 weeks of entering this study 10. Has a known allergy to study intervention or its excipients. If there is suspicion that the subject may have an allergy, the subject should be excluded. 11. With ongoing infection requiring systemic treatment such as HIV, syphilis or acute infectious disease except HBV or HCV Note: HIV = human immunodeficiency virus 12. With drug dependency for the past 1 year of Screening visit 13. With any rare diseases 14. With uncontrolled hypertension (≥180/≥110 mmHg on more than 2 antihypertensive medications) or uncontrolled diabetic mellitus (HbA1c > 9.0%) 15. With liver abscess or moderate to severe (or refractory) ascites 16. With uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing 17. Having received major surgery within past 12 weeks of Screening visit Note: Major surgery means an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity 18. With acute stroke within past 4 weeks of Screening visit and being unclear consciousness 19. With acute myocardial infarction or acute heart failure 20. Has uncontrolled ongoing illness or medical history considered by the investigator not in the condition to enter the trial | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 19.0-57.0, Diet, Healthy adults aged 19-57 years male to female ratio (1:1 ratio) BMI 19-35 kg/m2 Currently living in Amman without significant apparent diseases Able to drink the tested herbal tea twice a day Have chronic diseases such as diabetes, hypertension, cardiovascular or endocrine diseases or disabilities Using medical drugs and/or supplements Below 19 or above 57 years participation in clinical trials within the last 2 months use of lipid-lowering drugs, or diabetic medication Lactating and pregnant women will be also excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.615-3.167, Massage Neonatal Jaundice families being voluntary to participate in the study infants being born between 32 and 37 weeks plus 6 days of gestation infants having a birth weight of ≥1500 g infants having a fifth-minute Apgar score of more than seven infant's bilirubin level is not sufficient to require phototherapy the vital signs of the baby are within normal limits the absence of congenital major malformation of the infants the lack of patent ductus arteriosus requiring treatment no proven sepsis diagnosis neonates with disease disrupting skin integrity (epidermolysis bullosa, ichthyosis, collodion baby) need for phototherapy infants with gastrointestinal obstruction and biliary atresia infants with congenital major deformations | 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): 0.5-17.0, Shock Septic Males or females age >6 months to <18 years 2. Clinician concern for septic shock, operationalized as: 1. a "positive" ED sepsis alert confirmed by a physician OR 2. physician decision to treat for septic shock OR 3. a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation 3. Administration of at least one IV/IO fluid bolus for resuscitation and additional fluid deemed likely to be necessary to treat poor perfusion, or clinician judgment that >1 fluid bolus is highly likely to be required. Poor perfusion is defined as physician's judgement of hypotension or abnormal (either "flash" or "prolonged") capillary refill. 4. Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization 5. Parental/guardian permission (informed consent) if time permits; otherwise, EFIC met Treating physician judges that patient's condition deems it unsafe to administer either NS or BF (since patients will be equally likely to receive NS or BF at time of study enrollment), including: 1. Clinical suspicion for impending brain herniation 2. Known hyperkalemia, defined as non-hemolyzed whole blood or plasma/serum potassium > 6 mEq/L, based on data available at or before patient meets for study enrollment 3. Known hypercalcemia, defined as plasma/serum total calcium >12 mg/dL or whole blood ionized calcium >1.35 mmol/L, based on data available at or before patient meets for study enrollment 4. Known acute fulminant hepatic failure, defined as plasma/serum alanine aminotransferase (ALT) >10,000 U/L or total bilirubin >12.0 mg/dL, based on data available at or before patient meets for study enrollment 5. Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant 6. Known history of severe renal impairment, defined as peritoneal dialysis or hemodialysis 7. Known metabolic/mitochondrial disorder, inborn error of metabolism, or primary mineralocorticoid deficiency as reported by participant, legally authorized representative (LAR) or accompanying caregiver, or as listed in the medical record 8. Other concern for which the treating clinician deems it unsafe to administer either NS or LR 2. Known pregnancy determined by routine history disclosed by patient and/or accompanying acquaintance. 3. Known prisoner 4. Known allergy to a crystalloid fluid 5. Indication of declined consent to participate based on presence of an opt-out bracelet with appropriate messaging embossed into the bracelet, the presence of the patient's name on an opt-out list that will be kept up-to-date and checked prior to randomization, or verbal "opt-out" prior to enrollment | 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): 0.0-14.0, Diabetes Mellitus All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not Older than 14 years of age 2. Airway obstruction 3. Chest infection 4. Complex congenital heart disease 5. Congestive heart failure 6. Central or peripheral neurological disorders 7. Hyper/hypothermia 8. Severe pain | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Healthy Volunteers Normal Body Mass index (BMI) and weight: BMI[= weight kg/(height m)^2] > 19 kg/m^2 and ≤ 24 kg/m^2, the weight is no less than 50 kg for male and 45 kg for female at screening Female subject must either: Be of non-childbearing potential, postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile. Or, if of childbearing potential: agree not to try to become pregnant during the study and for 60 days after the final study drug administration, must have a negative pregnancy at Screening and Day -1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period, and for 60 days after the final study drug administration Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration Female subject must not donate ova starting at Screening and throughout the study period, and for 60 days after the final study drug administration Male subject and female spouse/partners who are of childbearing potential must be using 1 form of highly effective birth control starting at Screening and throughout the study period, and for 90 days after the final study drug administration Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit Female subject who has been pregnant within 6 months prior to screening or breast feeding within 3 months prior to screening Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used Subject has any of the liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] and total bilirubin [TBL]) above the upper limit of normal on Day -1. In such a case, the assessment may be repeated once Subjects who meet any of the following criterion for laboratory tests on Day -1. Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study. In such a case, the assessment may be repeated once Hematology: a deviation of +20% from the upper limit or -20% from the lower limit of the normal range, and clinically significant Blood biochemistry: a deviation from the normal range regarding serum creatinine, serum electrolytes (Na, K, and Cl), or fasting blood glucose; a deviation of +20% from the upper limit or -20% from the lower limit of the normal range regarding laboratory test items other than above, and clinically significant. However, the lower limit of the normal range will not be established for lactate dehydrogenase (LD), creatinine kinase (CK), total cholesterol, triglyceride, urea, serum creatinine, and uric acid, whose deviation from the lower limit is considered not clinically significant Urinalysis: a deviation from the normal range of each urinalysis test item Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, respiratory,pulmonary, neurologic, cerebrovascular, lymphatic, dermatologic, psychiatric, renal, and/or other major disease or malignancy Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week 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): 0.5-18.0, Typhoid Fever Patients with extended drug resistant typhoid fever defined as culture proven typhoid fever caused by Salmonella Typhi or Para typhi resistant to Ampicillin, Chloramphenicol,Co trimoxazole,Quinolones and Ceftriaxone along with two or more of the following condition High grade fever spikes for more than three days Refusal to eat or drink Drowsy or Unconscious Convulsions Dehydration due to diarrhea or vomiting Abdominal distension with or without tenderness Bleeding diathesis like petechial rash, gum bleed, melena Jaundice or alanine transaminase more than twice of the normal range Thrombocytopenia less than fifty thousand Not given informed consent Children who need ventilator or two inotrope support Severe malnutrition/immunocompromised patient | 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 Related Delivery Complication Cesarean Delivery Affecting Fetus Gestational age (GA) 37 weeks or above with cephalic presentation Planned low transverse uterine incision Cervical dilation <= 6cm Station < 0 Preterm GA <37 weeks Planned classical C-section Unable or unwilling to afford abdominal pressure during the delivery of fetal head Advanced cervical dilation >6cm Station >=0 | 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, Spontaneous Bacterial Peritonitis Adult patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L) Age under 18 years Previous history of SBP Previous use of antibiotics within the previous two weeks Previous GIT bleeding within one month Resolving ascites for one month after diuretic therapy Liver malignancy, organic renal disease Human immunodeficiency virus infection Known hypersensitivity to planned drugs Refusal to provide informed consent | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 1.0-14.0, Severe Malaria Children aged between 1 and 14 years Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity detailed below) Informed consent signed Clinical features of severe malaria Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate > upper normal limit for age) Jaundice (visible jaundice) Circulatory collapse or shock: age <12 systolic blood pressure < 70mm Hg; age > 12 systolic blood pressure <80mm Hg with cool extremities or capillary refill time >3 seconds Spontaneous bleeding Multiple generalized convulsions: more than two episodes within 24h Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance Laboratory features and other findings Co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. E.g. immediate transfer needed | 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 Haugesund Hospital, Norway Born with gestational age >36+6 Birth weight ≥ 2500g and <4500g Age 1 <15 days Are having a blood sample performed, as newborn screening or for jaundice assessment Infants needing intensive treatment. This includes Infants in the need for respiratory support Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other Infants that have received phototherapy | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.654-0.808, Hypoglycaemia Neonatal Mothers Favourable for breastfeeding BMI between 19-24 Newborns Late preterm (gestational age: 34-36 weeks) Term neonates (gestational age: 37-42 weeks), with body weight <10th centile (SGA) or> 90 ° centile according to Bertino's neonatal anthropometric evaluation Born from eutocic childbirth Rooming-in Body temperature between 36.5-37.5 ° C 2 Mothers Lack of informed consent Diabetic mother Taking medicines during pregnancy (beta blockers, tolbutamide) Newborns Major congenital malformations Blood sugar <47 mg / dl Body temperature <36.5 ° C or> 37.5 ° C NICU admissions Milk intake in formula Intravenous infusion of 10% glucose solution | 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): 50.0-75.0, Healthy Subject Healthy Normal-overweight (body mass index [BMI] of 18-30 kg/m^2) Women will be postmenopausal, with no menstrual period in 12 months Non-smoking Consume fiber intakes of less than < 20 g/d White blood cell count 3,000-11,000/mm^3 Platelet count 100,000-400,000 mm^3 Hematocrit 33-50% (women); 36-50% (men) Bilirubin 0.2-1.3 mg/dL Aspartate aminotransferase (AST) 0-35 U/L Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer) Weight change greater than 4.5 kg within past year Oral or intravenous (IV) antibiotic use within the past 3 months Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) Smoking or use of cannabis products Known allergy to fish Intention to relocate out of study area within next 4 months | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.082, Phototherapy Side Effects Stable term neonates with jaundice who require management with phototherapy and are fed with full strength formula or breast fed Jaundiced neonates with hypocalcemia Jaundiced neonates needing exchange transfusion Jaundiced neonates suffering from hypothyroidism Jaundiced infants of diabetic mother Jaundiced infants with other illness as severe RDS, perinatal asphyxia,Sever sepsis or hemolytic disease of newborn Jaundiced infants with congenital abnormalities | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Respiratory Any adult or child within each setting, of any age with any clinical condition, as this will reflect clinical practice Patients deemed too unwell to consent to the procedures or requiring emergency treatment will not be approached For the purposes of this feasibility study, families whose first language is not English will be excluded, to save translation and interpretation costs | 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): 0.5-59.0, Malaria Falciparum Malaria Vivax Malaria Above 6 months old to 59 years old Mono-infection with P. falciparum or P. vivax, with parasitemia of: P. falciparum: 1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C Ability to swallow medication Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old Informed assent from any minor participant aged 12 years; and Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years old Severe malnutrition Mixed Plasmodium species detected by microscopy Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] <110 mm) Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS) Regular medication, which may interfere with antimalarial pharmacokinetics History of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment Positive pregnancy test or breastfeeding; and Unable to or unwilling to take pregnancy test or to use contraception for women or child-bearing age and who are sexually active | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Acute Kidney Injury > 18 years Subjects undergoing heart valve replacement surgery Pregnancy Transplant donor or recipient Required preoperative dialysis, with any degree of renal insufficiency (acute or chronic) and patients who had end-stage renal disease (estimated glomerular fltration rate [eGFR] < 15 mL/min /1.73m2 ) Local anesthesia Lack of creatinine | 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 Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on | 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): 18.0-65.0, Pregnancy Related Anemia, Iron Deficiency Anemia of Pregnancy Singleton gestation Gestational age <24 weeks Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by Hb<11.0 Ferritin<30 and/or total iron saturation <20 Sickle cell Disease (NOT sickle cell trait) Evidence of acute anemia requiring transfusion or IV iron therapy Major congenital or chromosomal anomaly Previous use of IV iron in this pregnancy Severe cardiac, renal, or liver disease Autoimmune disease (ie Systemic Lupus Erythematosus (SLE) Allergy or contraindication to either study drug History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products | 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, Diabetes Mellitus, Type 2 Adult patients 21-65 years old diagnosed with Type II diabetes Fasting blood glucose concentration ≥ 126 mg/dL Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL Normal clotting function defined as defined by INR Normal kidney function defined as serum creatinine values up to 1.3 mg/dL Type I diabetic patients Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E > 400 IU Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease Patient with history of coagulation, MI, stroke and embolization Pregnant or breast feeding women Being on hormonal therapy or receiving contraceptive pills Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics Patients on cholestyramine, antibiotics and coumarins Patients on lipid lowering agents Known intestinal malabsorption syndrome, cholestasis or steatorrhea | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 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, Fetal Distress Singleton pregnancy. 2. Pregnant ≥ 37 weeks gestation. 3. Fetus with longitudinal lie and vertex presentation. 4. Healthy fetus with EFW>2500 gm 5. Intact membranes Patients with previous cesarean delivery or uterine surgery. 2. Antepartum hemorrhage. 3. Cephalopelvic disproportion. 4. Category II or III non-stress test. 5. Medical disease as hypertension, cardiac, renal and hepatic disorders 6. Intrauterine fetal death. 7. Fetal growth restriction. 8. Fetuses with major congenital malformations. 9. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors. 10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil | 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, Body Temperature Oxygen Saturation Heart Rate Respiratory Rate Sleep Pattern Neonates with LBW (<2500 grams) Born prematurely (< 37 complete weeks of gestation) less than 35 weeks of gestation on the day of enrollment to trial Malformations or birth disabilities Dependent on oxygen or IV fluid Any disorder that was deemed necessary for by 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): 0.442-0.654, Pre-Term Body Temperature Changes Transition Patient Discharge Length of Stay Clinical weight less than 1.5 kg at birth Clinically stable No cardio or respiratory support Reached 2/3 of his/her enteral feeding IUGR Clinical unstable On cardio or respiratory support Dysmorphic | 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 Jaundice At time of birth, infant is > 35 weeks gestation Presence of jaundice confirmed by measurement of bilirubin (transcutaneous bilirubinometer) Total bilirubinemia rate requiring phototherapy according to National Institute for Health and Clinical Excellence Weight ≥2.500kg Judged in good health by the investigator following the clinical examination and the medical data (absence of perinatal asphyxia, antibiotic treatment, respiratory disorders) Absence of fœto-maternal rhesus incompatibility or Kell Newborn already treated with phototherapy Febrile state with body temperature > 37.8°C Total bilirubinaemia level is equal or excess 100 μmol / L of the indication of phototherapy Patient whose jaundice is due to haemolysis, obstruction functional or anatomical Minor relative Newborn requiring exchange transfusion Newborn with congenital erythropoietic porphyria or a family history of porphyria Patient requiring treatment other than 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): 18.0-40.0, Gestational Diabetes Mellitus Neonatal Hyperbilirubinemia Neonatal Asphyxia People in the study should meet the following Must be a singleton pregnancy Clinical diagnosis of gestational diabetes mellitus according to ACOG Practice Bulletin Pregnant women and neonates were excluded if they met the (not included in if meeting one of following items ) Maternal clinical diseases (hypertension disorders, abnormal liver function, Rhesus negative blood group or other blood system disease) Maternal other pregnancy complications (polyhydramnios, oligohydramnios, placenta praevia, and abruptio placentae) Delivery before 37 weeks or after 42 weeks Neonatal weight was < 2.5 kg or>4.0 kg Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum) Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism | 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 preliminary work up for cholestasis suspected or inconclusive diagnosis of BA. 2. Serum Direct bilirubin > 2 mg/dl,GGT> 100 U/L 3. Male or female infants with a gestational age> 36 weeks 4. Admission weight > 2 kg 5. Age > 14 days days at diagnosis 6. For Kasai operated subjects, Type 3 or 4 anatomy of BA 7. For Kasai operated subjects, cholangiogram (if performed) diagnostic of BA 8. Liver biopsy supporting BA diagnosis Patients having access to liver transplantation for immediate liver failure 2. Prior Kasai patients 3. Major cardiac, renal, central nervous system (CNS) malformations 4. Intracranial hemorrhage 5. History of recent total parenteral nutrition (TPN) use within the last 2 weeks 6. Gl tract obstruction For Kasai-operated subjects: Type 1 or 2 biliary atresia anatomy 7. Current systemic infection 8. WBC > 20,000 cells/uL 9. Platelet count < 20,000 cells/uL or >1 million cells/uL 10. Concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness 11. Elevated serum creatinine > 1 mg/dL 12. Purpura fulminans or unexplained vascular thrombosis | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Pre-Eclampsia Singleton pregnancy Gestational age up to 34 weeks and above Multiple pregnancy Gestational age less than 34 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): 0.0-18.0, Elastography Fibrosis, Liver Pediatrics Chronic Liver Disease Patients younger than 18 years of age with chronic liver disease who underwent a transient elastography Parents / legal guardians and the patients themselves, if applicable, have read, understood and signed the informed consent of the study Patients who do not meet all the for in the study protocol | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Cholangitis, Secondary Biliary Cholangiocarcinoma Obstructive Jaundice Pancreas Cancer COVID-19 SARS-CoV-2 Patients referred for ERCP or EUS during the study period Patients refusing 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): 18.0-999.0, COVID-19 Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR, with at least one associated risk factor. Considered risk factors are Age ≥ 65 years Obesity defined as BMI ≥ 30 Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg DBP >100 mm Hg) according to investigator Treated diabetes (type I or II) History of ischemic cardiovascular disease 2. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature ≥ 37.8 C oral/tympanic, or ≥ 38.2 C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia. 3. Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment. 4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0 Hemoglobin above 9.0 g / dL Absolute Neutrophil Count ≥ 1000 / mm3 Platelets ≥ 100 000 mm3 Creatinine clearance ≥ 50 mL / min by the Cockcroft Gault formula Patients with moderate or severe acute respiratory failure or requiring noninvasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate ≥ 30 breaths/min). 2. Patients treated with immunosuppressors and/or immunomodulators. 3. Engrafted patients (organ and/or hematopoietic stem cells). 4. Patients with uncontrolled auto-immune disease. 5. Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections. 6. Patients with preexisting, severe and not controlled organ failure. 7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients). 8. Pregnant or breast-feeding women. 9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol. 10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer. 11. Hypersensitivity to ABX464 and/or its excipients. 12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Neonatal Jaundice we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Neonatal Jaundice Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections | 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): 18.0-49.0, Hyperbilirubinemia, Neonatal Jaundice, Neonatal • Normal delivery of the mother Mother being primiparous Newborn being >38 GW Having no multiple infants Absence of congenital anomaly (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles) in the newborn No blood incompatibility between mother and father Exclusive breastfeeding of the newborn Non-contraindication of the mother's milk to her infant Absence of the mother's diagnosed psychiatric story Mother's openness to communication and cooperation • Separation of the mother and the infant due to any situation | 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): 0.0-0.558, Bronchopulmonary Dysplasia of Newborn Documented informed consent from parent or guardian, prior to study procedures 2. < 29 weeks gestational age at birth 3. 32-40 weeks postmenstrual age 4. Receiving respiratory support at enrollment If 32-36 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) If > 36-40 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) OR continuous positive airway pressure (CPAP) Note: 3 and 4 define severe BPD for the purposes of this study CPAP is defined as any of the following Nasal cannula > 2 liters per minute (LPM) Nasal continuous positive airway pressure (NCPAP) Nasal intermittent positive pressure ventilation (NIPPV) Noninvasive neurally adjusted ventilatory assist (NAVA) Any other device designed to provide positive pressure through a nasal device (e.g., RAM cannula, etc.) Previous enrollment and dosing in this study, protocol number (NHLBI-2019-SIL), "Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia (BPD)" 2. Previous exposure to sildenafil within 7 days prior to randomization* 3. Previous exposure to vasopressors within 24 hours prior to randomization* 4. Previous exposure to inhaled nitric oxide within 24 hours prior to randomization 5. Evidence of pulmonary hypertension or moderate/large patent ductus arteriosus (PDA) on the most recent echocardiogram performed within 14 days prior to randomization 6. Known major congenital heart defect requiring medical or surgical intervention in the neonatal period 7. Known allergy to sildenafil 8. Known sickle cell disease 9. Aspartate aminotransferase (AST) > 225 U/L < 72 hours prior to randomization 10. Alanine aminotransferase (ALT) > 150 U/L < 72 hours prior to randomization 11. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study Participant will be reassessed prior to dosing to reconfirm criteria | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Healthy Healthy male subjects 18-45 years old, inclusive Body weight ≥50kg and Body Mass Index: 19.0~26.0 kg/m2, inclusive The vital signs (body temperature, systolic and diastolic blood pressure, heart rate and respiration) were in the normal range, and the normal value range of each vital sign was: (1) body temperature (underarm) 36.3 ~ 37.2 ℃; (2) 90mmHg ≤ systolic blood pressure < 140mmHg; (3) 60mmhg ≤ diastolic blood pressure < 90mmHg; (4) 50th / min ≤ heart rate ≤ 90th / min Before the test, a comprehensive physical examination, laboratory examination and other auxiliary examinations were carried out, and the results were normal or abnormal but of no clinical significance. The ECG QTcF < 450 ms Subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners Subjects understand and will comply with the study procedure, participated voluntarily and signed the informed consent Subjects who have a history of clinical significant drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters) Subjects with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders Subjects with concominant diseases that may affect drug absorption, distribution, metabolism, excretion and safety evaluation, or reduce compliance The test results of human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis are positive Subjects who have used over-the-counter drugs, health products, Chinese herbal medicine or traditional Chinese medicine within 2 weeks before screening, or who are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol orally, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours prio to first dose) Subjects who had used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before 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): 0.442-0.615, Infant, Premature, Diseases Birth weight between 750 g-1500 g ≤ 32 weeks gestational age at birth. GA will be determined by an ultrasound scan or the neonatologist's estimate, with consideration to maternal date Subject has been classified as appropriate for GA (AGA) Enteral feeding of human milk must be initiated by 21 days of life for infants with a birthweight of 750-1000 g (birth date is day of life 0) and initiated by 14 days of life for infants with a birthweight of 1.0 5 kg birthweight Mother agrees to feed the infant human milk as the exclusive feeding during the study period. Human milk may be mothers own or donor milk, plus Singleton or twin births only Serious congenital abnormalities or underlying disease that may affect growth and development minute APGAR: 5 4 Steroids used within the past 5 days Grade Ill or IV periventricular/ intraventricular hemorrhage (PVH/IVH) Maternal cocaine, alcohol or opioid abuse during pregnancy or currently or if the mother or infant is currently receiving treatment for HIV infection Infant major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia) Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life Infant has any other condition that, in the opinion of the investigator, compromises the ability to draw inference about the ability of the to support growth | 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, Pharmacokinetics adults (> 18 years) Non smokers Biological parameters within normal range (blood count, urea, creatinine, AST, ALT, GGT, bilirubine) BMI within 18 and 25 Negative urinary and plasma pregnancy test Informed consent participation to another study with incompatible procedure regarding the French law on research Treatment with a drug drug interaction with tacrolimus Cardiac rhythm at rest below 50 bpm Cardiac issue detected on electrocardiogram Cancer or history of cancer Chronic infection or history of chronic infection Diabetes or history of diabetes Hypertension or history of hypertension Pregnancy or lactation Deprived of liberty (curatorship, guardianship or incarcerate) | 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, Anemia of Prematurity Very Low Birth Weight Infant <1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), with mother at least 18 years of age, and parental consent congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be 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): 0.0-0.417, Infant, Premature, Diseases Continuous Positive Airway Pressure Positive-Pressure Respiration Resuscitation Respiratory Distress Syndrome, Newborn Born before 32 weeks gestational age by best obstetric estimate Infants with major congenital anomalies | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Idiopathic Pulmonary Fibrosis Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. Subjects aged between 18 and 45 (both inclusive) years old. 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening. 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG) Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening. 2. Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation. 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique. 4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing. 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 6. Positive results from urine drug screen test. 7. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test. 8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study. 9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. 10. Subjects who plan to receive or have had organ transplants. 11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 12. Subjects who participated in another clinical trial within 3 months prior to initial dosing. 13. Any other condition with in the opinion of the investigator would render the patient unsuitable for in the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.115, Jaundice, Neonatal All the following conditions must be met 1. Term newborns admitted to hospital with "neonatal hyperbilirubinemia" 2. Exclusive breastfeeding or mainly breastfeeding 3. perinatal infection, G-6P-D deficiency, homoimmune hemolysis, polycythemia, scalp hematoma, intracranial hemorrhage, cholestasis, hypoglycemia, hypothyroidism, hypothermia, neonatal asphyxia, fetus Pathological jaundice factors such as delayed stool excretion As long as any one of the following conditions should be excluded 1. During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml. 2. Other pathological jaundice was diagnosed during the follow-up period. 3. Take probiotics during the sampling period. 4. The guardian asked to withdraw from the study halfway | 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): 0.0-0.082, Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN all the full-term HIE and TTN cases admitted to NICU of the University Children Hospital during the period of December 2016 to June 2018 The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Acute Kidney Injury the serum creatinine was increased above reference range at first when patients were included intensive care unit; 2. renal dialysis and plasma exchange were never occured when patients were included in the study; 3. patients who were included in the study stayed at two days in ICU patients who stayed in ICU for less than 24 hours; 2. the serum creatinine was increased above reference range before ICU admission; 3. kidney-related diseases were existed before ICU admission | 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, Maternal Depressive Disorder Complicating Childbirth Preterm Birth Maternal Anxiety Disorder Complicating Childbirth Mother Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby Older than 18 years of age Infant • Gestational age between 26 0/7 and 30 6/7 weeks Mother • Younger than 18 years Infant • Major congenital or chromosomal anomalies | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Premature Behavior, Child Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA) Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine | 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, Pregnancy Early Pregnancy Related Thyroid Dysfunction Pregnant women 2. Previously healthy known thyroid 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): 0.0-0.038, Neonatal Hyperbilirubinemia Neonatal icterus and total serum bilirubin above threshold for phototherapy Gestational age ≥ 33 weeks Birth weight ≥ 1800 gr Postnatal age > 24 hours and < 2 weeks Hemolysis due to isoimmunization Very high or rapidly rising total serum bilirubin | 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): 18.0-45.0, Major Depressive Disorder Subjects who are willing and are able to provide a written informed consent to participate in the study Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial Subjects aged between 18 and 45 (both inclusive) years old Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG) Subjects with serum creatinine, ALT and AST levels ≥1.5 times of the upper limit of normal value at screening Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique Use of any prescription or non-prescription medications within 14 days prior to initial dosing#Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing Positive results from urine drug screen test History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Insomnia Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. Subjects aged between 18 and 45 (both inclusive) years old. 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening. 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG) Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening. 2. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma. 3. Subjects with history of sleep-related illness. 4. Subjects with history of severe involuntary hypoglycemia 5. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique. 6. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing. 7. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 8. Positive results from urine drug screen test. 9. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test. 10. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug. 11. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. 12. Subjects who plan to receive or have had organ transplants. 13. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 14. Subjects who participated in another clinical trial within 3 months prior to initial dosing. 15. Any other condition with in the opinion of the investigator would render the patient unsuitable for in the study | 0 |
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