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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation ≥ 18 years of age Patients of African, European, and Hispanic descent History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF ECG that was recorded within 1 month of randomization showing AF Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year A history of prior AF ablation Have already been tried on 2 or more AADs in the past for AF Creatinine clearance <40 ml/min Left ventricular ejection fraction < 50% Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Hypobetalipoproteinemia For index cases without family screening: o Patient with HBL: fasting LDL-C ≤ 50 mg/dl For familial affected cases Relative with HBL: fasting LDL-C ≤ 80 mg/dl and/or Apo B ≤ 50 mg/dl and at least one related family case suffering from HBL. All subjects, including familial non-affected cases, must give written consent (dated and signed) to participate at the constitution of biobank (including DNA samples and urine samples) Use of lipid-lowering drugs (statins, fibrates, ezetimibe, bile-acid sequestering resin) or nutraceuticals known to affect lipids (red yeast rice, margarine and dairy with plant sterol) Patient screened within an extreme metabolic disturbance (emergency situations, sepsis, hospitalization in intensive care unit) Patients with hyperthyroidism, severe liver failure, end stage chronic kidney disease, serious pancreatic failure, anemia related to thalassemia or sickle cell disease, strict vegan diet or malnutrition Refusal of the patient or his legal representative to participate in the study"
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Neonatal Hyperbilirubinemia Written or thumb print informed consent from the mother during pregnancy Neonates who are born to mothers who followed antenatal care at SMRU antenatal clinics Neonates who are born in a SMRU clinic OR neonates who are born outside SMRU but visit a SMRU clinic within 48 hours after birth OR neonates who are born outside SMRU and present with neonatal jaundice at any moment in the first 8 days No written or thumb print informed consent from the mother during pregnancy Neonates who are born to mothers who did not follow antenatal care Neonates < 28 weeks gestation Neonate born outside SMRU and present > 48 hours after delivery without jaundice
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-4.0, Diarrhea Helminthiasis Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection (including number of people served) Refusal to participate
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-0.033, Tuberculosis Maternal: 1. The infant's mother must be aged 18 years or older at screening. 2. The infant's mother must be able and willing to comply with the study protocol, available and willing to allow her child to complete all the study assessments and must have signed an Informed Consent form that has been approved by all relevant Ethics Committee/s. 3. The infant's mother must not have any symptoms or signs of active TB as indicated by history of cough for more than two weeks, fever, weight loss, breathlessness, chest pain, blood in sputum, night sweats and loss of appetite 4. The infant's mother should not be planning to relocate from the research site area and should be reachable by phone during the whole study period i.e. for the 12 months on-study period as well as the 24 month structured medical surveillance period. 5. For HIV-unexposed group: The infant's mother must test negative for HIV-1 (ELISA 4th generation) within the period from 2 weeks prior to the infant's birth to vaccination of the infant with the investigational product. For the HIV-exposed group: The infant's mother must test positive for HIV-1 (ELISA 4th generation) within the period from 2 weeks prior to the infant's birth to vaccination of the infant with the investigational product. The infant's mother must have enrolled for standard antiretroviral therapy (ART) at least 3 months before the participating infant's birth and must have a viral load at screening below 1000 copies/ml. The use of ART, including combination antiretroviral therapy (cART) and preventive mother to child transmission (PMTCT) must be documented. CD4+ T cell count and HIV viral load must be documented. 6. The infant's mother must test negative for Hepatitis B and syphilis serology at screening. 7. The infant's mother should have no history or evidence of diabetes mellitus. 8. No participation of the infant's mother in a clinical trial within 3 months prior to the birth of the participating infant. In addition, if breast-feeding, no participation in another clinical trial during the 12 months of the current study. 9. The infant's mother must have no known history of immunodeficiency, except for HIV. Infant: 1. Healthy male or female newborn infants aged 0 to 12 days. 2. Infants must have a birth weight of 2500 g and an Apgar score of > 7 at 5 minutes or earlier. 3. No eczema or other significant skin lesion or infection at the intended injection site. 4. No routine BCG vaccination administered (as per vaccination record) 5. Infants must receive Oral Polio Vaccine as part of the routine South African Expanded Programme on Immunisation (EPI) Childhood Immunisation schedule, and must adhere to the subsequent EPI schedule for the entire study period, except for the BCG vaccination at birth. 6. No participation of the infant in another clinical trial before study vaccination and during the 12 months of the current study Maternal: 1. Known presence of any person in the household of the mother and newborn infant, or any recent visitor to the household with recently diagnosed, active tuberculosis disease (within last 3 months). 2. Treatment of the mother with blood products in the 6 months prior to or during the birth of the participating infant. 3. For the HIV-unexposed group: Positive test for HIV-1 either during the current pregnancy or at screening. For the HIV-exposed group: Negative test for HIV-1 either during the current pregnancy or at screening. 4. Presence of signs or symptoms of any reported acute infectious disease at the time of screening. 5. Any reported or suspected substance abuse. Infant: 1. History or evidence of any systemic disease on physical examination or any acute, chronic or intercurrent illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. Note: Neonatal jaundice not considered clinically significant by the investigator is not an exclusion. 2. Fever within the period post birth and prior to dosing. For the purposes of this protocol, fever in the infant will be defined as an axillary body temperature > 38.0°C measured by digital thermometer on at least 2 occasions not less than 6 hours apart. 3. Hypothermia within the period post birth and prior to dosing. For the purposes of this protocol, hypothermia in the infant will be defined as an axillary body temperature < 36.0°C measured by digital thermometer on at least 2 occasions not less than 6 hours apart. 4. Clinically suspected newborn sepsis. 5. Any malignant condition. 6. Any severe congenital malformation. 7. Concomitant treatment with medication that may significantly affect immune function (e.g. systemic corticoids, immunosuppressive drugs) before study vaccination. Antibiotics given before study vaccination would further constitute exclusion. 8. Treatment of the infant with blood products
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-80.0, Stroke An individual is eligible for if all of the following apply: 1. Is 18-80 years old 2. Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the middle cerebral artery (MCA) distribution without a midline shift as detected by magnetic resonance imaging (MRI) as a diffusion-weighted image (DWI) abnormality 3. Has a National Institutes of Health Stroke Scale (NIHSS) score of 8-15 (R) and 8-18 (L) at the time of enrollment with no more than a 4 point increase (worsening of score) from the baseline score compared to 24 hours prior to infusion 4. Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dl, and white blood cell count (wbc) >2,500/uL. 5. Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the study. 6. Is able to provide consent to study or consent is obtained from the subject's legally authorized representative 7. Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention so that, in the opinion of the investigator, they will not become pregnant during the course of the study 8. Is a good candidate for the trial, in the opinion of the investigator 9. Agrees to participate in follow up visits 10. Has an ABO/Rh matched umbilical cord blood unit with a minimum of 0.5 x 10^7 total nucleated cells (TNCC)/kg based on the pre-cryopreservation TNCC An individual is ineligible to participate if any of the following apply. Medical Conditions: 1. Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale >1 before stroke or has a pre-existing cognitive deficit 2. Has clinically significant and/or symptomatic hemorrhage associated with stroke 3. Has new intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion 4. Has hypotension as defined as the need for IV pressor support of systolic blood pressure <90 5. Has isolated brain stem stroke 6. Has pure lacunar stroke 7. Requires mechanical ventilation 8. Requires a craniotomy 9. Has a serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales 10. Has an active systemic infection or is HIV positive 11. Has had an active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma 12. Has known coagulopathy such as Factor V Leyden, AntiPhospholipid Syndrome (APC), Protein C, Protein S deficiency, sickle cell, anticardiolipin antibody, or phospholipid syndrome 13. Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety 14. Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse 15. Pregnant as documented by urine or blood test Concomitant or Prior Therapies: 1. Subjects currently receiving immunosuppressant drugs 2. History of prior transfusion reaction 3. Currently on dialysis 4. Recipient of bone marrow or organ transplant 5. Renal insufficiency with serum creatinine >2.0 mg/dL 6. Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >5x the upper limit of normal). Patients with Gilberts syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level. 7. Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy 8. Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening Other: 1. Pregnant or lactating women 2. Unable to be evaluated for follow up visits
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-21.0, Unspecified Childhood Solid Tumor, Excluding CNS Neuroblastoma Diagnosis: Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of CSF or serum tumor markers including alpha-fetaprotein or beta-HCG Performance Level: Karnofsky >/= 50% for patients > 16 years of age and Lansky >/= 50 for patients </=16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Adequate Bone Marrow Function Defined as: a. For patients with solid tumors Peripheral absolute neutrophil count (ANC) >/= 1000/microLiter Platelet count >/= 100,000/microLiter (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) Hemoglobin >/= 8.0 g/dL (may receive RBC transfusions) Creatinine clearance or radioisotope GFR >/= 70ml/min/1.73 m2 Bilirubin (sum of conjugated + unconjugated) </= 1.5 x upper limit of normal (ULN) for age, and SGPT (ALT) </= 5.0 x ULN for age (≤ 225 U/L). For the purpose of this study, the ULN for SGPT is 45 U/L Pregnant or breast-feeding women will not be entered on this study Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anticancer agents, digoxin, cyclosporine, tacrolimus or sirolimus, use of daily benzodiazepines are not eligible Patients who have an uncontrolled infection are not eligible
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.673-999.0, Transcutaneous Bilirubinometry Parental informed consent 2. Male and female newborns with a GA ≥ 35 wks 3. Enrollment at age > 6 hrs until neonatal discharge 4. Pre-phototherapy Infants requiring respiratory assistance (such as mechanical ventilation) 2. Severe or life-threatening congenital anomalies 3. Hematomas at the point of measurement on both ears 4. Neonates undergone blood transfusion
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 45.0-75.0, Diabetes Mellitus, Adult-Onset Diabetes Complications Carcinoma, Pancreatic Ductal Pancreatic Neoplasm Age between 45 and 75 years Diagnosis of diabetes mellitus made within the two years preceding the date of observation (new onset diabetes) Adherence to the study documented the voluntary signing of an informed consent Availability to follow a telephone follow-up Remote medical history (> 2 years) positive for diabetes mellitus Previous history of malignancy Pregnancy Renal Failure Documented diabetic microangiopathy Sepsis
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-39.0, Polycystic Ovary Syndrome Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL) Cushing's syndrome Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal Antidiabetic and antiobesity drugs
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-70.0, Alcoholic Hepatitis Alcoholic hepatitis Jaundice < 3 months Bilirubin > 5 mg/dl PTI (INR) Increased: >1.4 Leucocytosis >> 11,000/micro L. AST< 300 IU/l ; AST/ALT >2 2. Hepatic Encephalopathy 3. Men and women age > 18 years and above 4. DF>32 5. MELD≥21 6. Actively consuming alcohol within 6 weeks of entry into the study 7. Patient with controlled upper GI bleed, resolved sepsis and acute kidney injury can be enrolled 8. Voluntary informed consent Failure to obtain informed consent 2. Jaundice more than 3 months 3. AST>500 IU/L, ALT>300 IU/L 4. Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease 5. HIV positive 6. Cow milk allergy or severe lactose intolerance 7. Active Gastrointestinal bleeding 8. Acute kidney injury at time of randomization with Creatinine> 1.5 mg/dL 9. Evidence of acute pancreatitis or biliary obstruction 10. Subjects who are pregnant or lactating 11. Significant systemic cardio-pulmonary illness (what if on ventilator for HE or respiratory failure) These are terminally ill patients, hence be excluded 12. Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization 13. Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week. 14. Any patient who has received any investigational drug or device within 30 days entering into the study. 15. Patient who withdraw consent
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 19.0-74.0, Bacterial Enteritis The patient provides written, informed consent before the clinical trial is initiated The patient has distinctive symptoms and findings of bacterial enteritis The patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter, pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis The patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (IMPs) to 4 weeks after administration of IMPs The patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment The patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy The patient has a severe hepatic dysfunction The patient has a severe cardiac dysfunction The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the patient is treated with a drug reported to prolong QTc interval The patient has a moderate or severe renal dysfunction Women with confirmed or suspected pregnancy or breast-feeding women Patients judged to be ineligible by the investigator for any other reasons
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 4.0-10.0, Allergy to Peanut Challenge CHILD study participants will be eligible for challenge if they 1. Have completed their 5-year-old CHILD Study visit 2. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (>0.35 kU/L) to peanut at their 1-, 3 and/or 5-year-old CHILD study visit 3. Are not eating peanut. Children who eat less than 8-10 g of peanut per month or who eat only foods that 'may contain' traces of peanut will still be eligible for inclusion. Challenge CHILD study participants will be ineligible for challenge if 1. They have never had a positive skin prick test or allergen-specific IgE level to peanut 2. They are eating 8-10 g of peanut at least once per month, despite having had a positive skin prick test or allergen-specific IgE level to peanut 3. Their family has declined to participate 4. They have a peanut skin prick test wheal size >8mm and/or a peanut-specific IgE >15 kU/L and a history suggestive of an IgE-mediated allergic reaction to peanut. 5. They have a history of anaphylaxis to peanut or a challenge-proven diagnosis of peanut allergy within the past 1-2 years. 6. They have uncontrolled asthma or any other contraindication to performing a DBPC food challenge on the day of challenge. These children may be rescheduled if their asthma control improves. Blood Draw CHILD study participants will be eligible for blood draw if they 1. Have completed their 5-year-old CHILD Study visit 2. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (>0.35 kU/L) to peanut at their 1-, 3 and/or 5-year-old CHILD study visit Blood Draw CHILD study participants will be ineligible for blood draw if 1. They have never had a positive skin prick test or allergen-specific IgE level to peanut 2. Their family has declined to participate Immunological analyses of the blood samples are underway now that the 2 sites participating in this portion of the study (University of Manitoba and University of British Columbia) have completed their challenges. Challenges were halted in the spring
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Gastroenteritis Infectious Colitis The specimen is from a patient suspected of having C. difficile associated disease (CDAD) The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site The specimen is preserved The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.25-17.0, Complicated Urinary Tract Infections Must be ≥3 calendar months to <18 years of age. Patients aged ≥3 calendar months to <1 year must have been born at term (defined as gestational age ≥37 weeks). 2. Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from patient (if age appropriate according to local regulations) 3. If female and has reached menarche, or has reached Tanner stage 3 development (even if not having reached menarche) (refer to Appendix E for further details on Tanner staging), the patient is authorised to participate in this clinical study if the following are met: At screening: (i) (a) Patient reports sexual abstinence for the prior 3 months or reports use of at least 1 of the acceptable methods of contraception, including an intrauterine device (with copper banded coil), levonorgestrel intrauterine system (eg, Mirena®), or regular medroxyprogesterone injections (Depo-Provera®); or (b) Patient agrees to initiate sexual abstinence from the time of screening until 7 days after end of treatment with study drug; and (ii) Patient is advised to avoid conception from the time of screening until 7 days after receipt of study drug and agrees not to attempt pregnancy from the time of screening until 7 days after end of treatment with study drug; and (iii) Patient is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and (iv) Patient has a negative serum β-human chorionic gonadotropin (β-hCG) test just prior to study entry. Since serum tests may miss an early pregnancy, relevant menstrual history and sexual history, including methods of contraception, should be considered. Note: if the result of the serum β-hCG test cannot be obtained prior to dosing of investigational product, a patient may be enrolled on the basis of a negative urine pregnancy test, though a serum β-hCG test result must still be obtained. 4. Patient has a clinically suspected and/or bacteriologically documented cUTI or acute pyelonephritis judged by the Investigator to be serious and requires the patient to be hospitalised for treatment with intravenous (IV) therapy 5. Patient has pyuria: Cohorts 1 to 3 as determined by a midstream clean catch or clean urethral catheterisation urine specimen with ≥10 white blood cells (WBCs) per high power field on standard examination of urine sediment or ≥10 WBCs/mm3 in unspun urine Cohort 4a and 4b as determined by a midstream clean catch or clean urethral catheterisation urine specimen or urine specimen obtained using urine collection pads(or supra-pubic collection if standard procedure in the assigned sites) ≥5 WBCs per high-power field on standard examination of urine sediment or ≥5 WBCs/mm3 in unspun urine 6. Patient has a positive urine culture: 1 midstream clean catch or clean urethral catheterisation urine specimen taken within 48 hours of randomisation containing ≥105 colony-forming units (CFU)/mL of a recognised uropathogen known to be susceptible to the IV study therapy (CAZ-AVI and cefepime) Note: If patients meet all of entry except for positive urine culture as outlined above, the patients may be enrolled before urine culture results are available if the results are likely (based on urinalysis and clinical findings) to be positive and study drugs are considered appropriate empiric therapy. If a patient urine culture is negative after 24 or 48 hours of treatment but the patient is improving, the Investigator can keep the patient on treatment. If the urine culture is negative and the patient is not improving, study treatment will be stopped, and the patient will be followed for the rest of the study including undergoing all safety assessments until late follow up (LFU). 7. Demonstrates either acute pyelonephritis or complicated lower UTI as defined by the following 1. Qualifying patients must have at least 1 of the following signs/symptoms (signs/symptoms must have onset or have worsened within 7 days of enrolment) in addition to pyuria: Dysuria (including perceived dysuria as referred by parent/caregiver) Urgency Frequency Abdominal pain Fever defined as oral temperature >38.5°C (or equivalent by other methods) with or without patient symptoms of rigor, chills, warmth Nausea Vomiting Irritability Loss of appetite Flank pain 2. Or patients considered to have complicated UTI as indicated by 2 of the previous qualifying signs/symptoms in (a) plus at least 1 complicating factor from the following: Recurrent UTI (2 or more within 12 months period) Obstructive uropathy that is scheduled to be surgically relieved during IV study therapy and before the EOT Functional or anatomical abnormality of the urogenital tract, including anatomic malformations or neurogenic bladder Vesicoureteral reflux Use of intermittent bladder catheterisation or presence of an indwelling bladder catheter for >48 hours prior to the diagnosis of cUTI Urogenital procedure (eg, cystoscopy or urogenital surgery) within the 7 days prior to study entry Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous enrolment or randomisation in the present study 3. Participation in another clinical study with an investigational product (IP) during the last 30 days before the first dose of IV study drug or have previously participated in the current study or in another study of CAZ-AVI (in which an active agent was received) 4. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillins or other β-lactam antibiotics 5. Concurrent infection, including, but not limited to, central nervous system infection requiring systemic antibiotics in addition to the IV study drug therapy at the time of randomisation 6. Receipt of more than 24 hours of any systemic antibiotics after culture and before study drug therapy 7. Receipt of systemic antibiotics within 24 hours before obtaining the study qualifying pre-treatment baseline urine sample and before study drug therapy 8. The child is suspected or documented to have an infection caused by organisms resistant to the prophylactic antibiotics 9. A permanent indwelling bladder catheter or instrumentation including nephrostomy or current urinary catheter that will not be removed or anticipation of urinary catheter placement that will not be removed during the course of IV study drug therapy administration 10. Patient has suspected or known complete obstruction of any portion of the urinary tract, perinephric abscess, or ileal loops 11. Patient has had trauma to the pelvis or urinary tract 12. Patient has undergone renal transplantation 13. Patient has a condition or history of any illness that, in the opinion of the Investigator, would make the patient unsuitable for the study (eg, may confound the results of the study or pose additional risk in administering the study therapy to the patient) 14. Patient is considered unlikely to survive the 6 to 8 week study period or have a rapidly progressive illness, including septic shock that is associated with a high risk of mortality 15. At the time of randomisation, patient is known to have a cUTI caused by pathogens resistant to the antimicrobials planned to be used in the study 16. Presence of any of the following clinically significant laboratory abnormalities: 1. Haematocrit <25% or haemoglobin <8 g/dL (<80 g/L, <4.9 mmol/L) 2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×the age-specific upper limit of normal (ULN), or total bilirubin >2×ULN (except known Gilbert's disease) For a) to b): unless if these values are acute and directly related to the infectious process being treated. 17. Creatinine clearance <30 mL/min/1.73 m2 calculated using the child's measured height (length) and serum creatinine within the updated "bedside" Schwartz formula (Schwartz et al 2009): CrCl (mL/min/1.73m2)=0.413×height (length) (cm)/serum creatinine (mg/dL) 18. History of seizures, excluding well-documented febrile seizure of childhood 19. If female, currently pregnant or breast feeding
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Diarrhea Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal. 2. At least 3 unformed stools recorded within the 24 hours immediately preceding randomization. 3. At least 1 of the following signs and symptoms of enteric infection abdominal pain or cramps nausea vomiting fecal urgency excessive gas/flatulence tenesmus 4. Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study Pregnant, breast feeding, or planning a pregnancy. 2. Immediately prior to randomization, acute diarrhea for >72 hours. 3. Presence of fever (≥100 degrees fahrenheit [°F] or ≥37.8 degrees celsius [°C]), or hematochezia (blood in stool), or clinical findings suggesting moderate or severe dehydration. 4. Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system. 5. Administration of any of the following any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization 6. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-40.0, Cholera Subject willing to provide written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative. 2. Individuals aged 1 years. 3. An individual who can be followed up during the study period and is capable of complying with the study requirements Known history of hypersensitivity reactions to other preventive vaccines. 2. Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic drugs or other immunosuppressants. 3. Severe chronic diseases, based on the judgment of the investigator. 4. 38℃ or higher body temperature measured prior to investigational product dosing. 5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation. 6. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhoea within 1 week prior to study initiation. 7. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation. 8. Other vaccination within 1 week prior to study initiation or planned vaccination during the study, except for tetanus toxoid vaccine. 9. Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation. 10. Pregnant or lactating women, women of reproductive age planning pregnancy and/or lactation before the end of the study period. 11. An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator 12. History of cholera vaccinations or history of cholera. 13. History of alcohol or substance abuse 14. Participant planning to move from the study area before the end of study period
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 9.0-999.0, Hyperhidrosis Male or female ≥ 9 years of age Primary, axillary hyperhidrosis of at least 6 months duration Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically Prior surgical procedure for hyperhidrosis Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational) Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1 Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months Other treatment with glycopyrrolate within 4 weeks prior to Baseline Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis History of Sjögren's syndrome or Sicca syndrome
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 9.0-999.0, Hyperhidrosis Male or female ≥ 9 years of age Primary, axillary hyperhidrosis of at least 6 months duration Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically Prior surgical procedure for hyperhidrosis Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational) Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1 Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months Other treatment with glycopyrrolate within 4 weeks prior to Baseline Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis History of Sjögren's syndrome or Sicca syndrome
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-45.0, Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive. 2. Provide written informed consent before initiation of any study procedures. 3. Are in general good health As defined by being without significant medical illness clinically significant physical examination findings, including vitals, as determined by the PI, and ---screening laboratory values outside the site's normal limits. 4. Within 46 days of vaccination, have normal screening laboratories. -Screening labs white blood cells (WBCs) , hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST). 5. Have normal screening laboratories for urine protein. Trace protein is acceptable. 6. Hemoglobin (Hgb) A1C < 6.5 percent at screening. 7. Agrees to complete all study visits and procedures and to provide a screening stool sample. 8. Female subjects must be of non-childbearing potential or if of childbearing potential, must be using an effective method of birth control or must be abstinent. -Non-childbearing potential is defined as surgically sterile or postmenopausal for > one year. --Effective methods of birth control the use of hormonal or barrier birth control such as implants, injectable contraceptives, combined oral contraceptives, intrauterine devices [IUDs], cervical sponges, diaphragms, or condoms with spermicidal agents within 2 months of vaccination. Female subjects must be using an effective method of birth control or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 43 study visit. ---A woman is eligible if she is monogamous with a vasectomized male. 9. Male subjects must agree not to father a child for 30 days after the last dose of the vaccine. 10. Agrees not to participate in another clinical trial during the study period. 11. Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine. 12. Potential subjects must be willing to adhere to the following prohibitions and restrictions on exercise during the course of the study to be eligible for participation Strenuous exercise (e.g., long distance running > 5km/day, weight lifting, or any physical activity to which the subject is not accustomed) is to be avoided for at least 72 hours prior to each study drug administration (and the Follow-up visit) Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test on vaccination days. 2. Abnormal vital signs, defined as: -Hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days. --Palpated heart rate < 55 or > 100 beats/minute at rest on 2 separate days. ---If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders. ----Oral Temperature >= 38.0 Degrees Celsius (100.4 Degrees Fahrenheit). 3. Symptoms of an acute self-limited illness, including an oral temperature >= 38.0 Degrees Celsius (100.4 Degrees Fahrenheit), such as an upper respiratory infection or gastroenteritis within 7 days of administration of Double Mutant Heat-Labile Toxin (dmLT). 4. Positive hepatitis C, or Human Immunodeficiency Virus (HIV) serology or positive hepatitis B serology not consistent with prior hepatitis B immunization. 5. Have a positive urine drug screen for opiates. 6. History of antimicrobial treatment in the 2 weeks before any administration of dmLT. 7. Received previous experimental E. coli, Labile Toxin (LT), or cholera vaccines or live E. coli or Vibrio cholera challenges; or previous known infections with cholera or diarrheagenic E. coli. 8. Abnormal routine bowel habits as defined by fewer than three stools per week or more than two stools per day in the past 6 months. 9. History of chronic gastrointestinal illness. -This includes severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than three times per week is permitted), or other significant gastrointestinal tract disease. 10. Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy. 11. History of major gastrointestinal surgery, excluding uncomplicated appendectomy or cholecystectomy. 12. Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (> 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. 13. Long-term use is defined as longer than 14 days. Nasal and topical steroids are allowed. -Long-term use is defined as longer than 14 days. Nasal and topical steroids are allowed. 14. Have a diagnosis of schizophrenia or other major psychiatric diagnosis. 15. Are receiving impermissible psychiatric drugs. -The following psychiatric drugs are not permitted: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate, or lithium citrate. --Subjects who are receiving a single antidepressant drug and are stable for at least 3 months before enrollment without de-compensating symptoms are allowed to be enrolled in the study. 16. History of receiving Immunoglobulin (Ig) or other blood product within the 3 months before enrollment in this study. 17. Subjects who have traveled to an ETEC-endemic area within the past 3 years or have been raised in a cholera or ETEC endemic area. -Defined as Africa, Middle East, South Asia, or Central or South America. 18. Subjects who plan to travel to an ETEC-endemic area during the long-term safety follow-up period (6 months after last vaccination) of the study. -Defined as Africa, Middle East, South Asia, or Central or South America. 19. Received any licensed vaccine prior to enrollment in this study or plans to receive any licensed vaccine after any study vaccination. -Inactivated vaccines may not have been received within 2 weeks of enrollment or within 2 weeks after any study vaccination. Live vaccines may not have been received within 4 weeks of enrollment, while on study, or within 4 weeks of final study visit. 20. An acute or chronic medical condition that, in the opinion of the investigator, would render administration of dmLT unsafe or would interfere with the evaluation of responses. -This includes, but is not limited to: known or suspected immunodeficiency, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, history of diabetes, cancer (other than a healed skin lesion), heart disease (in the hospital for a heart attack, history of irregular heart beat or have had postural hypotension in the past year, unconsciousness (other than a single brief concussion), seizures (other than with fever when subject was a child <5 years old), asthma requiring treatment with inhaler or medication in the prior 2 years, autoimmune disease or eating disorder, and transplant recipients. 21. Have received experimental products within 30 days prior to study entry or plan to receive experimental products at any time during the study. 22. History of alcohol or drug abuse in the last 5 years. 23. Plans to travel outside of the USA in the time between study vaccination and 4 weeks following the final vaccination. 24. Any condition that would, in the opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 25. Use of prescription or over-the-counter (OTC) anti-inflammatory medications 48 hours prior to receiving the investigational product. -This includes medications that contain naproxen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs. 26. Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation. 27. Known allergies to study compound or components of the study vaccine. 28. Special populations, e.g., non-English speakers, children, illiterate or non-writing individuals, vulnerable populations
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-45.0, Escherichia Coli Diarrhea Adults 1. Healthy male or female adults 18-45 years old, inclusive 2. General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination 3. Properly informed about the study, able to understand it and sign or thumb print the informed consent form 4. Available for the entire period of the study and reachable by study staff throughout the entire follow-up period 5. Females of childbearing potential who are willing to take a urine pregnancy test at screening and before the second vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable. 6. Informed Consent (signature or thumb print provided, with witness signature) Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol. 2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment 3. Screening positive with hepatitis B antigen and/or hepatitis C antibodies 4. Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product 5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician 6. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement) 7. Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine 8. Prior receipt of a blood transfusion or blood products, including immunoglobulins 9. Evidence of current illicit drug use or drug dependence 10. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug 11. Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives 12. Receipt of antimicrobial drugs for any reason within 14 days before vaccination 13. History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea) 14. Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination. 15. Acute disease at the time of enrollment or 3 days prior to enrollment 16. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Children, Toddlers and Infants 1. Healthy male or female infants/toddlers/children ages Part B: >24 and ≤59 months old at the time of enrollment Part C: ≥12 and <24 months old at the time of enrollment Part D: ≥6 and <12 months at the time of enrollment 2. General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination 3. Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form 4. Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period 5. Informed Consent (signature or thumb of parent, with signature of witness, provided) Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol. 2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment 3. Screening positive with hepatitis B antigen and/or hepatitis C antibodies 4. Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product 5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician 6. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement) 7. Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine 8. Prior receipt of a blood transfusion or blood products, including immunoglobulins 9. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug 10. Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives 11. Receipt of antimicrobial drugs for any reason within 14 days before vaccination 12. History of diarrhea during the 7 days before vaccination (see Protocol definition of diarrhea)) 13. Culture positive for ETEC, Shigella, V. cholerae, Salmonella or Rotavirus (the latter for all children <5 years of age) within 7 days of vaccination 14. Acute disease at the time of enrollment or 3 days prior to enrollment 15. Known or suspected impairment of immunological function based on medical history and physical examination 16. Participant's parents/guardians not able, available or willing to accept active weekly follow-up by the study staff 17. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study 18. Any medical condition in the child/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent 19. Medically significant malnutrition, defined as moderate malnutrition (wt-for-ht z-score between -3.0 and -2.0) and severe malnutrition (wt-for-ht z-score <-3.0 or edema)
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-999.0, Atypical Hemolytic Uremic Syndrome Children and adults under eculizumab treatment for aHUS (initial episode or relapse) defined by at least two of the following: thrombocytopenia (platelet count < 150 G/L), mechanical hemolytical anaemia (Hb < 10 g:dl, LDH > upper limit of normal, undetectable haptoglobin, presence of schizocytes on blood smear), acute kidney injury (serum creatinine and/or proteinuria/creatininuria > upper limit of normal for age or an increase > 15% compared to baseline levels ) 2. Patients not requiring dialysis. 3. Adults: HUS remission and normal or stabilized renal function under eculizumab treatment since at least 6 months (3 months in patients with MCP mutations) 4. Children: age > 3 years at eculizumab withdrawal; HUS remission and normal renal function under eculizumab treatment since at least 3 months in children with isolated MCP mutation, at least 6 months in children with complement mutation other than MCP Patients on dialysis. 2. Women treated with eculizumab starting or planning a pregnancy. Pregnancy including the post-partum period is high-risk periods for the occurrence of aHUS. 3. Patients who did not give informed consent. 4. Patients under protection of a judicial authority Patients can be enrolled in the study within ten weeks after Eculizumab stop
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.712-0.808, Jaundice Neonatal All maternal-fetal dyads must comply with all of the following at randomization Term delivery between 37 -42 weeks of gestation (estimated by ultrasound) Signed parental consent Singleton delivery Nonsmoking mothers Mothers willing to return for follow up visits Declaration of breastfeeding for at least six months The following maternal fetal dyads will be excluded 1. Preterm delivery < 37 weeks of gestation (estimated by ultrasound). 2. Isoimmune hemolytic disease. 3. Sepsis. 4. Maternal Gilbert syndrome. 5. Birth asphyxia. 6. Serious maternal hemorrhage during delivery. 7. Major congenital abnormalities. 8. Need for early cord clamping (tight nuchal cord, need for resuscitation). 9. Participation in another trial
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 8.0-18.0, Headaches will consist of children aged eight to 18 years who present to the pediatric ED with a chief complaint of headaches, regardless of the type, with a moderate or severe pain score. Pain was considered at least moderate if superior or equal to 36 mm on the VAS as demonstrated by Hirschfeld et. Al. This level have been chosen because it has been recognized that adequate sensitivity in analgesia trials for acute pain can only be obtained if patients experience at least moderate pain before administration of any treatment Allergy or any contra-indication to opioids and-or ibuprofen 2. Previous participation in study to preserve the statistic independence of each participant 3. Caregiver unable to provide consent (language barrier or lack of caregiver presence) 4. Circumstance which, in the opinion of the investigator, would adversely affect their participation in the trial such as a medical or psychiatric condition or a language barrier (neither French or English) 5. Nasopharyngeal anomalies, blockage or traumatized preventing nasal administration 6. Suspicion of life-threatening illness such as acute intracranial haemorrhage, meningitis, encephalopathy, or intracranial cerebral vascular occlusion 7. Signs of intracranial pressure or suspicion of intracerebral process such as mass or tumors (altered mental status, focal neurological deficit, etc.) 8. Any head injury with possible associate intracranial injury in the past 14 daysRecent or acute head injury 9. Current opioid use or opioid antagonist use 10. Intoxication
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 2.0-65.0, Accute Falciparum Malaria Subject AL Resistance Monitoring Study Resident of Kenieroba Age 2 to 17 years Uncomplicated falciparum malaria, confirmed by the presence of asexual P. falciparum parasites on blood film Asexual P. falciparum count between 2,000 and 200,000/ microliters (inclusive) at screening Tympanic or axillary temperature greater than or equal to 37.5 (Infinite)C or history of fever in the previous 24 hours Written informed consent from the child s parent or guardian, and assent from children aged 14-17 years Subject Parasite Clearance Substudy Enrolled in the AL Resistance Monitoring Study Asexual P. falciparum count greater than or equal to 10,000/ microliters at screening Hb level greater than or equal to 7 g/dL Subject Blood Collection Study Subject AL Efficacy Study Signs of severe malaria, defined as one or more of the following Blantyre Coma Scale less than or equal to 3/5 in children Witnessed convulsions Severe prostration Shock (poor perfusion, cool peripheries) Hb <5 g/dL Jaundice Respiratory distress (labored breathing, nasal flaring, intercostal retraction)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Irritable Bowel Syndrome good constitution for shigyakusan weak constitution for shigyakusan
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Gastroenteritis acutely admitted more than three Loose stool, or lest than three Loose stools and vomiting within the last three weeks age under 18 years
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-999.0, Lymphoma Lymphoma, Non-Hodgkin Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Prior to Cell Procurement Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form for procurement Ages 3 to 17 years of age for pediatric subjects (weight must be ≥10kg), and for adults ages ≥18 years of age Diagnosis of recurrent HL or NHL in subjects who have failed >2 prior treatment regimens. Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Karnofsky or Lansky score of >60% (Karnofsky for ≥16 years old and Lansky for <16 years old) Evidence of adequate organ function as defined by Hemoglobin ≥ 8.0 g/dL (transfusion independent for 2 weeks prior to enrollment) Total bilirubin ≤ 1.5 × ULN, unless attributed to Gilbert's Syndrome AST ≤ 3 × ULN Serum creatinine ≤ 1.5 × ULN For subjects <18 years old use the following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 ≤0.8 ≤0.8 6 to <10 ≤1.0 ≤1.0 10 to <13 ≤1.2 ≤1.2 13 to <16 ≤1.5 ≤1.4 ≥16 and <18 ≤1.7 ≤1.4 Negative serum pregnancy test in females within 72 hours prior to procurement or documentation that the subject is post-menopausal or premenarchal. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year. • Postmenopausal status must be confirmed with documentation of absence of menses for >1 year Prior to Cell Procurement Pregnant or lactating Tumor in a location where enlargement could cause airway obstruction Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy. Subjects are required to have negative HIV antibody or negative HIV viral load, negative HTLV1 and 2 antibody, negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded". Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. Prior to Lymphodepletion Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to lymphodepletion); Note: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Prior to administration of lymphodepletion Absolute neutrophil count (ANC) is > 1.0 × 109/L Platelet count > 75 × 109/L For Grade 4 neutropenia, Grade ≥3 febrile neutropenia, or Grade 4 thrombocytopenia, hold bendamustine until toxicity resolve to Grade ≤2 For WOCBP negative serum pregnancy test within 72 hours prior to lymphodepletion. Imaging results from within 7 days (30 days in subjects with cutaneous T cell lymphoma) prior to lymphodepletion. Subjects who have received bridging chemotherapy must have imaging performed at least 3 weeks after most recent therapy (imaging does not need to be repeated if it is within 7 days prior to lymphodepletion). Karnofsky or Lansky score of >60% (Karnofsky for pediatric subjects ≥16 years old and Lansky for <16 years old). Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year Prior to Lymphodepletion Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion. Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion. Received chemotherapy within the previous 3 weeks prior to lymphodepletion. Subject has rapidly progressive disease, per treating oncologist's discretion. Subject is not a good candidate for CAR T cell therapy, per treating oncologist's discretion. Pregnant or lactating. Tumor in a location where enlargement could cause airway obstruction. Current use of systemic corticosteroids at doses equivalent of ≥10mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. For pediatric subjects, physiologic replacement hydrocortisone at doses 6-12 mg/m2/day is allowed. Equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day. Inhaled steroids are allowed. Subjects on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2 Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy. Subjects are required to have negative HIV antibody or negative HIV viral load, negative HTLV1 and 2 antibody, negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen are excluded. Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core Antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible if the subject has initiated an anti-HBV prophylaxis regimen prior to lymphodepletion. Prior to Infusion of Cells Evidence of adequate organ function as defined by Total bilirubin ≤1.5 × ULN, unless attributed to Gilbert's Syndrome AST ≤3 × ULN Serum creatinine ≤1.5 × ULN Pulse oximetry of >90% on room air For subjects <18 years old use following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 ≤0.8 ≤0.8 6 to <10 ≤1.0 ≤1.0 10 to <13 ≤1.2 ≤1.2 13 to <16 ≤1.5 ≤1.4 ≥16 and <18 ≤1.7 ≤1.4 Karnofsky or Lansky score of >60% (Karnofsky for ≥16 years old and Lansky for <16 years old) Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-75.0, Chronic Liver Failure Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above Patients tolerating enteral nutrition Patients with no overt sepsis no fever, sterile blood and urine cultures, procalcitonin <2 Active ongoing GI bleed Allergy to soya oil, eggs, peanuts or other ingredients of intralipid Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism Renal failure (S.creatinine > 2.5mg%) Pregnancy Patients with shock requiring vasopressor support Patients on anticoagulants Refusal to participate in the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, NUT Midline Carcinoma (NMC) Triple Negative Breast Cancer (TNBC) Non-small Cell Lung Cancer (NSCLC) Castration-resistant Prostate Cancer (CRPC) Males and females ≥18 years of age for NSCLC, TNBC, and CRPC Males and females ≥16 years of age for NMC Diagnosis of one of the following advanced solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the participant: NMC;TNBC; NSCLC; or CRPC Have at least 1 measurable lesion per Response Evaluation in Solid Tumors (RECIST) 1.1. CRPC participants may be enrolled with objective evidence of disease as per Prostate Cancer Working Group (PCWG2) Life expectancy ≥3 months Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 Have an interval of ≥3 weeks (or ≥2 weeks for NMC participants) since chemotherapy (≥6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy or surgical intervention resection, or ≥3 half-lives for monoclonal antibodies, or ≥5 half-lives for other non-cytotoxic agents (whichever is longer) CRPC participants must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue, antagonist or orchiectomy providing serum testosterone is <50 ng/dL (<1.7 nmol/L) Participants receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before start of study therapy Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start) Has inability to swallow oral medications or presence of a gastrointestinal disorder (e.g. malabsorption) deemed to jeopardize intestinal absorption of birabresib Has persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia). Stable sensory neuropathy ≤ grade 2 National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 is accepted Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases. Treated and stable CNS metastases are allowed History of prior or concomitant malignancies within 3 years of study start Have other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start Known human immunodeficiency virus (HIV) and/or active Hepatitis B or C infections Have one of the following cardiac-related conditions: Congestive heart failure or angina pectoris (except if medically controlled); myocardial infarction (within 1 year of study start); uncontrolled hypertension; or uncontrolled arrhythmias Other concomitant anticancer treatment Participation in another clinical trial or treatment with any investigational drug (excluding anticancer treatments) within 30 days of study start
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-12.0, Gastroenteritis The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office The participant has mild-to-moderate dehydration The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office The participant has severe dehydration or severe malnutrition The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit The participant needs intravenous (IV) fluid replacement The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-10.0, Nausea Vomiting Children, both sexes, aged 1-10 years Diagnosis of acute gastroenteritis (duration less than 24 hours they had at least one episode of vomiting (no bile, no blood) in the previous four hours, with mild-state of dehydration moderate) Children under 12 months of age and older than 10 years concomitant presence of chronic diseases malnutrition (z score for lower 3 standard deviations weight / height) severe dehydration malformations of the gastrointestinal tract malignancy neurological diseases metabolic diseases eosinophilic esophagitis or other gastrointestinal diseases history of functional dyspepsia or cyclic vomiting
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.442-1.0, Cholestasis Jaundice, Obstructive Greater than 14 days old and less than 1 year of age Greater than 1 kg Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL Currently standard therapy with soy-based Intralipid Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week Be expected to require intravenous nutrition for at least an additional 21 days Have a congenitally lethal condition Have clinically severe bleeding or clinical liver failure not able to be managed with routine measures Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-999.0, Anaplastic Large Cell Lymphoma, ALK-Positive CD30-Positive Neoplastic Cells Present Systemic Anaplastic Large Cell Lymphoma Treatment-naive systemic ALK-positive ALCL patients Histologically confirmed diagnosis of cluster of differentiation (CD)30-positive ALCL with documented ALK-positive status Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and dimensional measurable disease of at least 1.5 cm as documented by radiographic technique (spiral computed tomography [CT] preferred) Eastern Cooperative Oncology Group (ECOG) performance status =< 3 Absolute neutrophil count (ANC) >= 1500/ul Platelet count >= 75,000/ul (unless documented bone marrow involvement with lymphoma) Hemoglobin (Hgb) >= 8 gr/dL Serum creatinine =< 1.5 x mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome or documented hepatic involvement with lymphoma who may be included if bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN Aspartate transaminase (AST) =< 3 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULN Known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate) Known prior history of interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention) Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ceritinib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome) or inability to swallow up to five ceritinib capsules daily History of pancreatitis or history of increased amylase or lipase that was due to pancreatitis Other severe, acute, or chronic medical condition including uncontrolled diabetes mellitus or psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase risk associated with study participation or may interfere with the interpretation of study results Major surgery (e.g. intra-abdominal, intra-thoracic or intra-pelvic) within 4 weeks prior to starting study treatment or lack of recovery from side effects of such procedure; video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can receive study treatment >= 1 week after these procedures History of another primary malignancy that has not been in remission for at least 3 years (the following malignancies are exempt from the 3 year limit: non-melanoma skin cancer, fully-excised melanoma in situ [stage 0], curatively treated, localized prostate cancer, and cervical carcinoma in situ in biopsy or a squamous intraepithelial lesion on Papanicolau [PAP] smear) Known cerebral/meningeal disease Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: * Unstable angina * Myocardial infarction * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication * Ventricular arrhythmias, or supraventricular/nodal arrhythmias not controlled with medications; other cardiac arrhythmias not controlled with medications * Left ventricular ejection fraction < 20% corrected QT (QTcF) > 470 ms using Fridericia's correction on the screening electrocardiogram (ECG) * Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening Any active grade 3 or higher (per the National Cancer Institute [NCI] Common Terminology for Adverse Events [CTCAE], version 4.03) viral, bacterial, or fungal) infection within two weeks prior to the first dose of study treatment
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 14.0-80.0, Schistosomiasis (SCREENING): 1. Male or non-pregnant female subjects 2. Age 14-80 years (per participant self-report) 3. Resident of Tienegubougou, Bougoudiana or surrounding villages 5. Consent to a blood draw to screen for filarial infection and a urine exam to screen for schistosomiasis 6. Must be willing to have blood samples stored (SCREENING): 1. Known to be pregnant (by history) 2. Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant 3. History of hypersensitivity reaction to PZQ. 4. Weight less than 20 kg (INTERVENTIONAL STUDY): 1. S. haematobium infection documented at screening and within 14 days prior to the baseline visit 2. The subject agrees to storage of samples for study (INTERVENTIONAL STUDY): 1. Pregnancy (by urine beta-HCG) 2. Chronic kidney or liver disease 3. Hgb <10 mg/dL 4. PZQ treatment since the screening visit 5. Concomitant Schistosoma mansoni, Wuchereria bancrofti (Wb) or Onchocerca volvulus infection 6. Use of immunosuppressive therapies, including steroids, within the past month 7. Any condition that in the investigator s opinion places the subject at undue risk by participating in the study. OF AND WOMEN: Pregnant women will be excluded from this study since it involves administration of medications contraindicated in pregnancy. Children less than 14 years old will be excluded because of the amount of blood required for the immunologic studies. The age of consent in Mali is 18 years of age, so children aged 14 to 17 years will sign an assent form in addition to the consent form to be signed by a parent or tutor. However, married women between the ages of 14 and 17 will sign consent as adults in view of the laws governing emancipation of women in Mali. Subjects who do not participate in this study will receive PZQ as part of the national schistosomiasis control program. Participation of Women: -Pregnancy: The effects of praziquantel on the developing human fetus are unknown (pregnancy category B). For this reason, females of childbearing-age must have a negative pregnancy test result prior to receiving praziquantel. Since the half-life of praziquantel is short (3-4 hours), contraceptive measures will not be required post-treatment. -Breast feeding: Praziquantel is known to be present in breast milk for up to 3 days following a single dose and is not approved for use in children under the age of 4 years. Consequently, women will be asked to suspend breastfeeding after treatment with PZQ for 3 days. Formula will be provided for breastfed children affected by their mother s participation during this time to ensure adequate nutrition. Depending on the age of the child, formula may be given. A pediatric nurse will be present during this time to provide assistance and counsel to the mothers
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-65.0, Amoebic Dysentery Giardiasis Provide written informed consent prior to initiation of any study procedures. 2. Able to understand and comply with planned study procedures and be available for all study visits. 3. Male or non-pregnant non-lactating females 18-65 years of age, inclusive. Females of reproductive potential currently using effective contraceptive methods are eligible. 4. Amebiasis or giardiasis identified by rapid Enzyme Immunoassay (EIA) and positive antigen detection EIA of stool if a subject is infected with both E. histolytica and Giardia, they will be enrolled in the E. histolytica study arm. Once the Entamoeba study arm is fully enrolled, any subsequent dual infected subjects will be enrolled in the Giardia arm. If a subject is infected with both Giardia and Cryptosporidium, they will not be enrolled. 5. Has diarrhea (defined as three or more loose stools) in the past 24 hrs, but is assessed to be clinically stable and in otherwise good health as determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions that would affect the assessment of and safety of subjects. Existing medical diagnoses or conditions (except those in the Subject ) must be deemed as stable chronic medical conditions. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months (90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months (180 days). Any change due to change of health care provider, insurance company, or that is done for financial reasons, as long as in the same class of medication, will not be considered a violation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a violation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety. Topical, nasal, and inhaled medications, vitamins, and contraceptives are permitted. 6. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges. 7. Laboratory tests (blood urea nitrogen, creatinine, aspartate transaminase (AST), alanine transaminase (ALT), white blood cells, platelets, and hemoglobin) are all within protocol-defined ranges. Subjects will be eligible for enrollment with the following laboratory values: blood urea nitrogen less than or equal to 30 mg/dL, creatinine less than or equal to 133 umol/L, AST or ALT less than or equal to 70.0 U/L, white cell count between 3.5 and 13.0 inclusive (10^9/L), platelets between 131 and 550 (10^9/L), hemoglobin between 11.0 and 18.0 gm/dL inclusive. 8. Urinalysis with no greater than trace protein. If a high protein is confirmed to be due to menstruation, it should be repeated. 9. Women of reproductive potential must have a negative urine pregnancy test within 72 hours of starting study medications Female subjects who are surgically sterile via tubal sterilization, bilateral oophorectomy or hysterectomy who have been postmenopausal for greater than 1 year are not considered to be of reproductive potential. 10. Female subjects participating in sexual activity that could lead to pregnancy must be using and continue to use highly effective contraception for a total of 4 months after enrollment Highly effective methods of contraception are defined as having low failure rates (i.e. less than 1 percent per year) when used consistently and correctly and may but are not limited to, abstinence from intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, diaphragm with spermicide, intrauterine devices, and licensed hormonal methods. Females on effective forms of birth control will continue while on the study and for the follow-up period of 4 months total. The method and compliance of birth control used will be confirmed and documented at all study visits Known intolerance of auranofin or gold compounds. 2. Pregnant or breastfeeding women or women of reproductive potential not using effective contraception or who plan to become pregnant or breastfeed at any given time during the study or within 3 months of study completion. 3. Use of metronidazole within the past 7 days. 4. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 5. Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days. 6. History of alcohol or drug abuse within the last five years
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-18.0, Urea Cycle Disorders Aim 1 (UCD patients) Age 18 and under Diagnosed with the following Neonatal-type urea cycle disorders CPSD, OTCD, ASD or ALD, as defined as follows Diagnosis of CPS I deficiency, defined as decreased (less than 20 % of control) CPS I enzyme activity in liver, and/or an identified pathogenic mutation, and/or hyperammonemia and first-degree relative meets at least one of the for CPS I deficiency Diagnosis of OTC deficiency, defined as the identification of a pathogenic mutation, and/or less than 20% of control of OTC activity in the liver, and/or elevated urinary orotate (greater than 20 uM/mM) in a random urine sample or after allopurinol challenge test, and/or hyperammonemia and first degree relative meets at least one of the for OTC deficiency Diagnosis of AS deficiency (Citrullinemia), defined as a greater than or equal to 10-fold elevation of citrulline in plasma, and/or decreased (less than 20% of control) AS enzyme activity in cultured skin fibroblasts or other appropriate tissue, and/or identification of a pathogenic mutation in the AS gene, and/or hyperammonemia and first degree relative meets at least one of the for AS Deficiency Diagnosis of AL deficiency (Argininosuccinic Aciduria, ASA), defined as the presence of argininosuccinic acid in the blood or urine, and/or decreased (less than 20% of control) AL enzyme activity in cultured skin fibroblasts or other appropriate tissue, and/or identification of a pathogenic mutation in the AL gene, and/or hyperammonemia and first degree relative meets at least one of the for AL Deficiency Willing to participate in at least 1 neurocognitive assessment and 1 quality of life assessment Permit access to medical records and medical providers Aim 1 Rare and unrelated comorbidities (e.g., Down's syndrome, intraventricular hemorrhage in the newborn period, and extreme prematurity)
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-4.917, Malaria Age between 6 and 59 months Weight ≥ 5 Kg Slide-confirmed infection with Plasmodium falciparum only (no mixed infections) Asexual parasite density between 2000 and 200000/µl of blood Measured axillary temperature ≥ 37.5°C Ability to swallow oral medication High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.) Informed consent from a parent or caretaker aged at least 18 years • General danger signs according to the WHO definition (Appendix 5.1.1) Signs of severe/complicated malaria according to the WHO definition (Appendix 5.1.2) Severe anaemia (haemoglobin < 5 g/dL) Known history of hypersensitivity to any of the study drugs Severe acute malnutrition (as defined by a weight-for-height below -3 Z-score and/or symmetrical oedemas involving at least the feet) Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration) Having received already a full course of the treatment (or one of the treatments) under study in the previous 28 days (as indicated by the parent/caretaker). Note that previous incomplete anti-malarial intake of treatments under study, or previous intake of anti-malarials not under study, are not but details of any such intake should be recorded carefully History of hypersensitivity reactions or contra-indications to any medicines being tested
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-45.0, Cholera Age: 1-45 Years. 2. Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years. 3. Participation in the study at least for next 6 months 4. Considered healthy as per medical judgment of the investigator Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months 2. History of taking oral cholera vaccine and history of confirmed cholera. 3. History of taking any other live or killed enteric vaccine in the last 8 weeks. 4. History of anaphylaxis or serious vaccine reaction. 5. Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing. 7.Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months. 8.Currently on antimicrobial therapy. 9.Severe malnutrition or chornic disease based on the jugement of the investigator. 10.Stool sample at screening positive for V. cholerae. 11.Pregnant women or plans to become pregnant during the study period
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 7.0-17.0, Cerebral Palsy 17 years old diagnosis of hemiplegic or diplegic Cerebral Palsy GMFCS Level I-II able to follow testing and motor imagery instructions able to actively participate in a minimum of 45 minutes (min) of physical activity show evidence of independent dorsiflexion of both ankles able to commit to attendance of sessions two to three times weekly for six weeks orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months inability to put BTX-A on hold during trial severe spasticity (may be a contraindication for neuroimaging procedures) seizure disorder (if not fully controlled by medication for 12 months) not prepared or unable to discontinue any formal lower limb therapy intervention or physical activity program during the trial involved in another intervention study standard MRI contraindications (e.g., magnetic implants, inability to lay still, claustrophobia etc.)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Osteochondritis Dissecans Diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or MRI Non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-50.0, Healthy Volunteer Male or female between 18 and 50 years of age, inclusive. 2. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the PI. 3. Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination. 4. Willingness to participate after informed consent obtained. 5. Availability for the study duration, including all planned follow-up visits. 6. Negative pregnancy test with understanding to not become pregnant during the study or within three months following last scheduled study visit Presence of a significant medical condition which in the opinion of the investigator precludes participation in the study. 2. Significant abnormalities in screening hematology or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor. 3. Evidence of confirmed infection with HIV, Hepatitis B, or Hepatitis C. 4. Evidence of Immunoglobulin A (IgA) deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay). 5. Evidence of current excessive alcohol consumption or drug dependence (a targeted drug screen may be used to evaluate at the clinician's discretion). 6. Evidence of impaired immune function. 7. Recent vaccination or receipt of an investigational product (within 30 days before receipt of challenge). 8. Any other which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study. 9. History of microbiologically confirmed ETEC or cholera infection in last 3 years. 10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years. 11. Symptoms consistent with Travelers' Diarrhea concurrent with travel or planned travel to countries where ETEC infection is endemic. 12. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to dosing. 13. Any prior experimental infection with ETEC strain B7A. 14. Abnormal stool pattern. 15. Regular use of laxatives, antacids, or other agents to lower stomach acidity. 16. Use of any medication known to affect the immune function. 17. Known allergy to two of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and amoxicillin
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Surgical Site Infection Wound Infection Postoperative Pain Local Anesthetics Patients who are planned to a elective gastrointestinal surgery Biliary-pancreatic open procedures: biliodigestive Derivation, Pancreatoduodenectomy, Pancreato-jejunostomy (Puestow procedure, Frey) Open upper gastrointestinal procedures: total gastrectomy, subtotal gastrectomy (distal gastrectomy with Billroth I reconstruction or Billroth II or Roux-Y), Gastro-jejunum anastomosis, Open gastro-jejunal Roux Y bypass, intestinal resection, intestinal reconnection, intestinal Fistulectomy Open colorectal procedures: Right or Left Hemicolectomy, total colectomy, low anterior resection, abdominal-perineal resection Patients who decide signing the informed consent after explained the study Patients with postoperative follow-up of at least 30 days, in whom the wound and / or local complications will be evaluated Patients operated laparoscopically Patients operated at another hospital Patients with clean surgical wounds Patients in whom an epidural or subarachnoid block is used Patients who are unable to sign the informed consent Patients with less than 50 kg Patients wiht history of: Malignant hyperthermia, cardiac disease (Heart failure, history of myocardial infarction, arrhythmias), Epilepsy, Allergic to amides Patients with incomplete follow-up (less than 30 days) Pregnant patients
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-45.0, Cholera Age: 1years to less than 5 years for the younger children group; 5 less than18 years for older children and adolescent group and 18 years (inclusive) for the adult group. 2. Sex: Male, Female, Transgender. 3. Consent: Informed consent from study participants and guardian in case of children along with assent in children 11-17 years (inclusive) of age. 4. Apparently healthy Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months 2. History of taking oral cholera vaccine. 3. History of taking any other live or killed enteric vaccine in the last 8 weeks. 4. History of anaphylaxis or serious vaccine reaction. 5. Currently use of any immunosuppressive or immune-modifying drugs. 6. Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months. 7. Currently on antimicrobial therapy (taking antibiotics within 24 hours during screening and vaccination). 8. Severe malnutrition defined as wt-for-ht z-score <-3.0 with or without oedema. 9. For married females pregnancy or plans to become pregnant during the study period (as determined by verbal screening) will be excluded. In addition, pregnancy test will be done by pregnancy strip test before each day of vaccination (Day 0 and day 14) for married female. 10. Culture positive V. cholerae, ETEC, Salmonella and Shigella in stool
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-999.0, Zika Virus Disease (Disorder) Dengue Chikungunya Febrile Rash Cohort Subjects with fever and/or rash will be included if they are 1 year of age or older, and meet one of the following (1 or 2): 1. Meeting the WHO/PAHO case definition, as defined as (a and b and c): 1. One or both of the following primary signs Rash Elevated body temperature (> 37.2 °C) AND 2. One or more of the following symptoms (not explained by other medical conditions) Arthralgia Myalgia Non-purulent conjunctivitis or conjunctival hyperemia Headache Malaise AND 3. Onset of illness in the last 7 days 2. Modified case definition (a and b): 1. Any two of the following Rash Elevated body temperature (> 37.2 °C)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Cto, Acef Score Among the 2952 patients with STEMI successful treatment by PCI, 395 patients (13.4%) had a non-IRA CTO lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). Due to unavailability of ejection fraction or renal function before CTO-PCI, ACEF score could not be calculated in 5 patients. The remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged CTO-PCI attempt(ranging 7-28 days) and was successful in 221 of them. Due to low possibility of PCI success or patients refused to perform PCI, 98 patients did not undergo the PCI attempt. The patients were then divided into successful CTO-PCI group (221 patients) and failed/ non-attempted CTO-PCI group (156 patients). -
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 65.0-105.0, Beta-lactamase Extended Spectrum, E. Coli, Elderly, Mortality, Risk Factor All patients with positive blood culture E. coli BLSE will be included in the study. Bacteremia E. coli BLSE will be defined as the identification of one or more blood cultures positive for E. coli BLSE in patients with clinical of systemic inflammatory response, at least two of the following 4 temperature> 38 ° C or < 36 ° C heart rate> 90 beat / min respiratory rate > 20 c / min or PaCO2 < 32 mmHg WBC > 12,000 / microL or < 4000 / microL or 10% immature forms For each patient included, only the first episode of bacteremia will be included in the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Escherichia Coli Infections Patients infected with ESBL producing E. coli Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Migraine Near Death Experience Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience Topic agreeing to participate in the study Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study Other than obtained Participation Agreement
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Sepsis With Escherichia Coli All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli Patients without sepsis with E. coli
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-999.0, Cholera Diarrhea for cholera cases Seeks treatment for acute non-bloody diarrhea (defined as 3 or more loose, watery or liquid stools in a 24-hour period with an onset of 3 days or fewer prior to presentation) at a participating study site Diarrhea episode is diagnosed as cholera, confirmed by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (i.e. ≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant during the vaccination campaign) for cholera cases < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign for non-cholera diarrhea cases Seeks treatment for acute non-bloody diarrhea (as defined above) at a participating study site Culture negative cholera by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant at the time of the campaign) for non-cholera diarrhea cases < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign for all controls
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-45.0, Diarrhea, Infantile Provide written informed consent before initiation of any study procedures Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history Within 15 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), C-reactive protein (CRP) Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 80 percent) Capable of understanding, consenting and complying with the entire study protocol Female subjects must be of non-childbearing potential, (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents, or must have a vasectomized partner) within 2 months of infection and must agree to continue such precautions during the study and for 30 days after the Day 56 study visit. Male subjects must agree not to father a child for 90 days after the Day 28 study visit. A woman is eligible if she is monogamous with a vasectomized male Agrees not to participate in another clinical trial during the study period Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility Abnormal Vital signs, defined as Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or (heart rate <55 at rest on 2 separate days) Respiratory rate >17 Temperature >/= 38.0 C (100.4 F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of inoculum Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies History of antimicrobial treatment in the 2 weeks before bacterial inoculum Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli Abnormal bowel habits as defined by fewer than 3 stools per week or more than 2 stools per day in the past 6 months History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than 3 times per week is permitted), lactose intolerance, or other significant gastrointestinal tract disease
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Escherichia Coli Bloodstream Infection Isolation of E. coli from 1 or more set of aseptically inoculated blood culture bottle collected in one of the study centres Age ≥ 18 year-old Receiving vasopressors before the onset of the bacteraemia Patient previously included in the study Patient's opposition
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Hemolytic Uremic Syndrome Patients with a clinical diagnosis of typical or atypical HUS in acute phase Patient with positive serological screening test for infection with the HIV Patients with a history of cancer Patients who have undergone organ transplantation or bone marrow Patient with a vivid picture of autoimmune thrombotic thrombocytopenic purpura
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-65.0, Gastritis, Atrophic Gastric Cancer Aged between 18 and 65 years No apparent abnormality in the routine blood test, urinalysis, routine stool & fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG) The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome Voluntary participation Having given written informed consent Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma) Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis) Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases Pregnancy, or planning pregnancy during the trial or within three month period thereafter Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.538-999.0, Neonatal Hyperbilirubinemia Cases Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting one or more of the following Two consecutive SBR measures above the exchange transfusion threshold of the phototherapy charts for gestational age SBR levels rising > 8.5 µmol/L per hour One or more neurological signs compatible with ABE in the absence of other known neurological condition and in the presence of confirmed NH Controls Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting all of the following At least one SBR between the moderate and the severe threshold of the phototherapy charts for gestational age No SBR above the severe threshold at any time point No reported abnormal neurological signs (i.e. convulsions, abnormal cry or tone) Each case who has been discharged alive from the SCBU will be matched to one control from the same clinic, sex, gestational age, season of birth and hospitalized within the same month and the clinical and neurodevelopment of both children will be conducted once Stillborn Twins Liveborn < 28 weeks gestation Major congenital malformation Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU without SBR done or with all SBR below the moderate threshold of the phototherapy charts for gestational age
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 15.0-999.0, Anorexia Nervosa Appetite Disorders Patients with severe AN admitted to the specialized nutrition unit at Center for Eating disorders at Odense University Hospital are included Patients admitted only for short-term water-electrolyte correction, are excluded
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-64.0, Influenza Patients who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately. As for adolescent patients, informed consent/assent of voluntary participation should be obtained in accordance with local requirements 2. Male or female patients aged ≥ 12 to ≤ 64 years at the time of signing the informed consent/assent form. 3. Patients with a diagnosis of influenza virus infection confirmed by all of the following: 1. Fever ≥ 38ºC (axillary) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken 2. At least one of the following general systemic symptoms associated with influenza are present with a severity of moderate or greater Headache Feverishness or chills Muscle or joint pain Fatigue 3. At least one of the following respiratory symptoms associated with influenza are present with a severity of moderate or greater Cough Sore throat Nasal congestion 4. The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either: 1. Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature) 2. Time when the patient experiences at least one general or respiratory symptom 5. Women of childbearing potential who agree to use a highly effective method of contraception for 3 months after the first dose of study drug Patients with severe influenza virus infection requiring inpatient treatment. 2. Patients aged ≥ 20 years with known allergy to oseltamivir (Tamiflu®). 3. Patients with any of the following risk factors 1. Women who are pregnant or within 2 weeks post-partum 2. Residents of long-term care facilities (eg, welfare facilities for the elderly, nursing homes) 3. Chronic respiratory diseases including bronchial asthma 4. Neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (eg, cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) 5. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms) 6. American Indians and Alaskan natives 7. Blood disorders (such as sickle cell disease) 8. Endocrine disorders (including diabetes mellitus) 9. Kidney disorders 10. Liver disorders 11. Metabolic disorders 12. Compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus [HIV] infection) 13. Morbid obesity (body mass index [BMI] ≥ 40) 4. Patients unable to swallow tablets or capsules. 5. Patients who have previously received Baloxavir Marboxil. 6. Patients weighing < 40 kg 7. Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations. 8. Women who are breastfeeding or have a positive pregnancy test in the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test in the predose examinations: 1. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women 2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation 9. Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the predose examinations. 10. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, or amantadine within 30 days prior to the predose examinations. 11. Patients who have received an investigational monoclonal antibody for a viral disease in the last year. 12. Patients with severe underlying diseases. 13. Patients with known creatinine clearance ≤ 60 mL/min. 14. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 8.0-20.0, Sickle Cell Anemia Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or analysis of either hemoglobin or DNA) Patient's written informed consent from those ≥18 years of age must be obtained before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 18 years of age Detectable baseline of background or episodic pain measured by daily e-diary over 1 to 2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm without analgesic use over a period of at least 7 days and/or, At least one episode of pain requiring analgesic use during a period of up to 14 days History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with no other, non-sickle cell identifiable cause that requires analgesia and interferes with the patient's normal daily routine History of known hypersensitivity to canakinumab Ongoing or treatment with the past 3 months with red blood cell transfusion therapy, or have evidence of iron overload requiring chelation therapy Transcranial Doppler ultrasound in the past year or at screening in patients with an accessible transtemporal window, demonstrating velocity in middle or anterior cerebral or internal carotid artery ≥200 cm/sec Administration of any other blood products within 3 weeks of screening visit. Other protocol-defined inclusion/
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-80.0, Obesity Male or female, age > 18 years and legal age of consent. 2. If female, the subject is either post-menopausal or surgically sterilized, or has a negative urine pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study. 3. Obesity, defined as BMI ≥ 25 kg/m2 4. Stable weight (weight change no more than 5% within 3 months) 5. If subject has been treated with medications that might cause weight change (such as corticosteroid, antidepressant, antipsychotics, oral contraceptive pills) prior to admission, he/she must have taken the medication regularly at a steady dose for at least 8 weeks up. 6. The subject has provided written informed consent prior to admission to the study A subject will be excluded from the study for any of the following reasons: 1. Pregnancy or lactation 2. Diagnosed with diabetes mellitus 3. Weight change ≥ 5 % within 3 months prior to admission to the study 4. Has taken any weight loss medications within 3 months prior to admission to the study 5. Immunocompromised status, including a debilitated state or malignancy 6. Active liver, renal, thyroid diseases 7. Frequent alcoholic consumption more than twice a week; with beer > 360 mL, alcohol > 45 mL, wine > 150 mL for female, or beer > 720 mL, whisky > 90 mL, wine > 300 mL for male each time 8. Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation 9. Lack of ability or willingness to give informed consent 10. Taken any medications than might cause weight loss or weight gain such as corticosteroid, antidepressant, antipsychotics, oral contraceptive pills < 8 weeks or change the dose of these medication with 8 week prior to admission 11. Enrolled in any other clinical study within 3 months before enrolment
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-60.0, Lymphoma, Large B-Cell, Diffuse NCCN-IPI>1 Known IPI, cell of origin and DHL at time of diagnosis Negative pregnancy test Men must agree not to father a child during the therapy to 8 cycles R-CHOP/like, total of 8 x Rituximab CR, CRu Transformed lymphoma Secondary malignancy HIV positive Evidence of CNS involvement Cardiac dysfunction (systolic ejection fraction <50%) Creatinine > 2.0 mg/dl
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-100.0, Respiratory Tract Infections Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, or fatigue Subject provides written informed consent/assent/parental permission Willing and able to provide NPS specimen Subject is unable to provide consent/assent/parental permission Children whose legal guardian is not available to give permission Unable/unwilling to provide NPS specimen Non-English speaking
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-80.0, Lymphoma, Extranodal NK-T-Cell newly diagnosed NK/T-cell lymphoma treated using an anthracycline-containing regimen minimal follow-up at 6 months after the completion of first-line treatment complete medical history and clinicopathological data secondary malignant disease serious infection or inflammation (e.g., HIV) primary central nervous system lymphoma hepatic or renal dysfunction
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-80.0, Lymphoma, T-Cell, Peripheral newly diagnosed PTCL treated using an anthracycline-containing regimen minimal follow-up at 6 months after the completion of first-line treatment complete medical history and clinicopathological data secondary malignant disease serious infection or inflammation (e.g., HIV) primary central nervous system lymphoma hepatic or renal dysfunction
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-17.0, Gastroenteritis Children aged more than 6 months and weight ≥ 8kg At least 4 non-bilious, non-bloody vomiting in the preceding 24 hours The last vomiting occured less than 2 hours ago No other diagnostic more likely than gastroenteritis suspected by the nurse at triage Severe dehydration (based on poor capillary refill or hypotension) Underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia) Bilious or bloody vomiting Bloody stool A history of abdominal surgery Allergy to ondansetron Long QT syndrome or major cardiac condition Previous enrolment in the study Girl at risk of pregnancy (pubertal girl) Inability to obtain parental informed consent (language barrier, absence, etc.)
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma Pre-ASCT At least 18 years of age Histologically confirmed diagnosis of CD19 positive diffuse large B-cell lymphoma (DLBCL) or transformed large cell lymphoma from low grade lymphoma Chemo-sensitive (defined by complete remission (CR) or partial remission (PR) to most recent chemo regimen) based on pre-transplant positron emission tomography (PET) within 2 months of autologous transplant Patients with bulky disease are eligible for study provided that the patient not undergo radiation therapy until 30 days after the end of blinatumomab administration Available representative tissue (from fresh or formalin fixed paraffin embedded tissue) from the most recent biopsy or archival tumor tissue for Clonotype evaluation for minimal residual disease (MRD) testing. Pre-ASCT Chemo-resistant (defined by stable disease (SD) or progressive disease (PD) to most recent chemo regimen) Pregnant or breastfeeding Active central nervous system (CNS) involvement of Non-Hodgkin's Lymphoma (NHL) Clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis Prior stem cell transplant Concurrent hematologic or non-hematologic malignancy requiring treatment HIV seropositive, or active Hepatitis A, B, or C infection Uncontrolled congestive heart failure (CHF) or other comorbid systemic illnesses or severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. to Begin Consolidation Therapy A participant must meet all of the following on Day +42 visit in order to continue on the study to begin consolidation therapy with blinatumomab Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky ≥ 60 %
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 2.0-80.0, Sickle Cell Disease Patients with any type of sickle cell disease who are at high risk for disease-related morbidity or mortality, defined by having severe end-organ damage (A, B, or C) or potentially modifiable complication(s) not ameliorated by hydroxyurea (D): A. Stroke defined as a clinically significant neurologic event that is accompanied by an infarct or hemorrhage on cerebral MRI or cerebral arteriopathy requiring chronic transfusion therapy; OR B. Tricuspid regurgitant jet velocity (TRV) of greater than or equal to 2.5 m/s at baseline (without vaso-occlusive crisis) and/or pulmonary hypertension; OR C. Sickle hepatopathy defined as either ferritin >1000 mcg/L and platelet count < 250,000/uL (without vaso-occlusive crisis) OR direct bilirubin > 0.4 mg/dL and platelet count <250,000/uL (without vaso-occlusive crisis) D. Any one of the below complications Complication-Vaso-occlusive crises; Eligible for HSCT-Recurrent vaso-occlusive pain crises (at least 2 per year for the last 2 years) despite hydroxyurea Complication-Acute chest syndrome; Eligible for HSCT-any ACS while on hydroxyurea. Non-disease specific: A. Age greater than or equal to 18 years B. Haploidentical relative donor available C. Ability to comprehend and willing to sign an informed consent D. Negative serum beta-HCG E. Ejection fraction greater than or equal to 35% F. Glomerular filtration rate >60 mL/min/1.73m^2 by cystatin C-based or iothalamate-based or other equivalent GFR testing G. Adjusted DLCO greater than or equal to 35% (any of the following would the subject from participating) 1. Available 6/6 HLA-matched sibling donor 2. ECOG performance status of 3 or more (See Appendix A) 3. Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to starting the conditioning regimen. 4. Patients with fever or suspected minor infection should await resolution of symptoms before starting the conditioning regimen. 5. Major anticipated illness or organ failure incompatible with survival from PBSC transplant 6. Pregnant or breast-feeding 7. Donor specific anti-HLA antibodies (DSAs) greater than or equal to 2000 Mean Fluorescence Intensity (MFI) 8. Patients seronegative for EBV who have EBV seropositive donors Haploidentical relative donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood for research. Related donors will be evaluated in accordance with existing Standard NIH Policies and Procedures for determination of and suitability for clinical donation. Note that participation in this study is offered to all related donors, but is not required for a do le that not all related donors will enroll onto this study -DONOR: None
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 20.0-999.0, Gynecologic Cancer Chemotherapy Gynecologic cancer patients under chemotherapy aged 20 and above Patients who had been enrolled for other investigational drug trials within the data collection period of this study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-80.0, Diffuse Parenchymal Lung Disease Clinical diagnosis of PM/DM-ILD,RA-ILD,IPAF,IPF Combined with pulmonary infection,pulmonary tuberculosis,carsinoma
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-99.0, Neoplasms, Nerve Tissue Neurofibromatosis 1 Heredodegenerative Disorders, Nervous System Peripheral Nervous System Diseases Age: greater than or equal to 3 years of age, BSA greater than or equal to 0.55 m^2, and able to swallow intact capsules Diagnosis: must have either a clinical diagnosis of NF1 or a germline NF1 mutation, or in patients without the NF1 syndrome, demonstrate an NF1 mutation in the GIST verified in a CLIA certified laboratory. In patients without the NF1 syndrome, confirmation of the NF1 mutation in the GIST is required for enrollment a) For a clinical diagnosis of NF1 patients must have at least two of the diagnostic for NF1 listed below Six or more cafe-au-lait macules (greater or equal to 0.5cm in prepubertal subjects or greater than or equal to 1.5 cm in post pubertal subjects) Freckling in axilla or groin A neurofibroma or plexiform neurofibroma Optic glioma Two or more Lisch nodules A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex) A first-degree relative with NF1 Patients with evidence of another malignancy or benign tumor requiring chemotherapy or radiation therapy are excluded; however, those patients with a plexiform neurofibroma requiring treatment will be eligible as selumetinib has documented activity in plexiform neurofibromas Patients with a diagnosis of NF1 and GIST who do not meet other may enroll on the NF1 Natural History Study, and will be followed on this study. Should they require therapy for GIST based on evidence of progression, they may then enroll on study Patients who are receiving any other investigational agents Prior therapy with selumetinib or another specific MEK inhibitor is not permitted History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or other agents used in study Previous MEK, RAS, or RAF inhibitor use Patients who anticipate the need for surgical intervention within the first three cycles (3 months), as surgical intervention during the period of DLT evaluation may affect analysis of adherence and/or make the subject inevaluable Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Patients with the following cardiac conditions are excluded Uncontrolled hypertension (Adults: blood pressure [BP] of greater than or equal to 150/95 despite medical support/management. Participants 18 years of age and younger should have a blood pressure less than or equal to 95th percentile for age, height and gender. Preexisting hypertension in adults should be controlled (either with pharmacological or nonpharmacological methods) at the time of enrollment.)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-45.0, HELLP Syndrome Patients with class (II) (12) HELLP syndrome scheduled for elective caesarian section: Diagnosis of HELLP syndrome was based on the clinical diagnosis of preeclampsia and the following laboratory abnormalities (13): 1. Hemolysis: characteristic peripheral blood smear, serum lactic dehydrogenase (LDH) ≥ 600 U/ l, total bilirubin ≥ 1.2 mg /dl, decreased hemoglobin and hematocrit. 2. Elevated liver enzymes, defined as aspartate aminotransferase (AST). ≥ 70 U/ l, alanin aminotransferase (ALT) ≥ 50 U/ l and lactate dehydrogenase (LDH) ≥ 600 U/ l. 3. Low platelet count: class 2 HELLP having a platelet nadir between > 50000 and 100000 mm-3 Emergency cases 2. Placenta praevia 3. Cardiovascular or cerebrovascular disease. 4. Morbid obesity with a BMI ≥40 5. Gestational age <36 or >41 weeks 6. Platelet counts less than 50000 mm-3; class 1 HELLP and class 3 HELLP having platelet count more than 100 000 mm-3
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-18.0, Type 1 Diabetes Mellitus Diabetic Ketoacidosis New onset T1D and known T1D DKA (mild, moderate and severe DKA eligible) 17 years of age Toilet trained Boys and girls All ethnicities Initial presentation to Children's Hospital Colorado (CHCO) Main ED Non-T1D etiology History of chronic kidney disease (eGFR <60ml/min/1.73m2) or dialysis dependent History of tubulopathy (e.g. Fanconi syndrome) Currently menstruating Patient visiting Colorado with plan to establish diabetes care outside of Colorado On ACE-inhibitors or angiotensin II-receptor blockers (ARB) On sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma Key 1. Histologically confirmed non-germinal center diffuse large B cell lymphoma (DLBCL), by immunohistochemistry using the Hans algorithm, 1. CD10 and BCL6-, 2. CD10-, BCL6+, but MUM1+ 2. Men and women ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4. Measurable disease is defined as at least 1 lymph node >1.5 cm in longest diameter and measurable in 2 perpendicular dimensions. 5. All participants must provide fresh tumor biopsy or recent tumor tissue samples (within 2 years of study entry [informed consent form signed]). 6. Received at least one prior therapy for DLBCL that includes anthracycline based chemotherapy. 7. Participant not eligible for or refuses intensive chemotherapy and hematopoietic stem cell transplant. 8. Documented failure to achieve at least partial response (PR) with, or documented disease progression after response to, the most recent treatment regimen. 9. Neutrophils ≥ 1 x 109/L independent of growth factor support within 7 days of study entry. 10. Platelets ≥ 75 x 109/L, independent of growth factor support or transfusion within 7 days of study entry 11. Creatinine clearance of ≥ 30 mL/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR]. 12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN. 13. Bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome), then up to 5xULN allowed. 14. Independent of erythropoietin (EPO) support or transfusion within 7 days of first dose of study drug. 15. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. 16. Participants may be enrolled who relapse after autologous stem cell transplant if they are at least 6 months after transplant, participants should have no active infections (ie, fungal or viral). 17. Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Highly effective forms of birth control can be defined as abstinence, hysterectomy, bilateral oophorectomy with no menstrual bleeding for up to 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptive, etc. Males must have undergone sterilization-vasectomy, or utilize a barrier method where the female partner utilizes the effective forms of birth control noted above. 18. Life expectancy of > 3 months. 19. Able to provide written informed consent and can understand and comply with the requirements of the study. Key Current or history of central nervous system (CNS) lymphoma. 2. Prior exposure to a BTK inhibitor. 3. Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, or antibody based therapies or Chinese anti-cancer herbal therapies within 4 weeks of the start of study drug. 4. Major surgery within 4 weeks of screening. 5. Toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, absolute neutrophil count (ANC) and platelets. For ANC and platelets, please follow #9 [neutrophils] and #10 [platelets]). 6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent. 7. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or history of myocardial infarction within 6 months of screening. Left Ventricular Ejection Fraction (LVEF) is lower than 50% measured by echocardiography (ECHO) (AHA,2016). 8. QTcF (Fredericia's correction) > 450 msecs or other significant ECG abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block. 9. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. 10. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy. 11. Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction [PCR]). 12. Pregnant or lactating women. 13. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, or put the study at risk. 14. On medications which are strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or CYP3A inducers NOTE: Other protocol defined Inclusion/
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 10.0-18.0, Obesity, Childhood obesity, according to the IOTF criteria waist circumference ≥ 90th percentile diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year) specific causes of endocrine or genetic obesity type 1 diabetes previous kidney diseases
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-999.0, Sepsis Suspected source of infection Presence of any of the following organ dysfunction Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg Creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours OR Bilirubin> 2mg/dl Platelet count<100,000 Lactate> 2 mmol/dl (or above the reference value) Coagulopathy (RNI> 1.5 or APTT>60 sec) PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90 End of life care Previous sepsis episode in the same hospital admission
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 6.0-16.0, Helicobacter Pylori Infection Children who are investigated by a standard esophagogastroduodenoscopy (EGD) for gastrointestinal symptoms those suggesting of an organic disease such as chronic abdominal pain, unexplained nausea and/or vomiting, severe regurgitation, gastrointestinal bleeding, unexplained weight loss, or chronic diarrhea and who are found to be H. pylori positive in gastric biopsies are included in the study Patients who were treated for H. pylori infection previously, or who used an antimicrobial agent, bismuth, a non-steroid anti-inflammatory drug, or any form of gastric acid suppressor during the eight weeks prior to EGD, or who had history of major gastrointestinal surgery, chronic renal or hepatic disease and who were known to have drug allergy were excluded from the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-0.077, Neonatal Jaundice Indication for phototherapy with single light Gestational age > 33 weeks Birth weight > 1800 grams Should be treatable in a cradle Haemolytic disease Indication for double/triple phototherapy or exchange transfusion
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Jaundice, Neonatal For patient level record (de-identified), diagnosed by the facility for having infant jaundice The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.423-0.615, Necrotising Enterocolitis Abdominal distension Visible bowels loops Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of >50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis) Temperature instability (defined as ≥ 2 consecutive measurements) Frank bloody stools Cardiovascular instability (hypotension; defined as MAP < 30mmHg, tachycardia >160/' or bradycardia < 80/') Recurrent apnea Increase of abdominal girth > 2cm (allowing inter-observer variability of 1 cm) within 12 h Abdominal wall erythemia And/or at least 2 of the below laboratory findings5 Thrombocytopenia < 50 x103/uL • < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound) Congenital abnormalities No parental consent
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 5.0-18.0, Achondroplasia Parent(s) or guardian(s) consent to < 18 years old ACH, documented and confirmed by genetic testing At least a 6-month period of pretreatment growth assessment in Study 111-901 before study entry If sexually active, willing to use a highly effective method of contraception Ambulatory and able to stand without assistance Hypochondroplasia or short stature condition other than ACH Have any of the following Hypothyroidism or hyperthyroidism Insulin-requiring diabetes mellitus Autoimmune inflammatory disease Inflammatory bowel disease Autonomic neuropathy History of any of the following Renal insufficiency defined as serum creatinine > 2 mg/dL Chronic anemia
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 12.0-999.0, Thrombotic Microangiopathies Atypical Hemolytic Uremic Syndrome Competent to provide informed consent, or if a minor, have at least one parent or legal guardian to provide informed consent with written assent from the subject Are at least 12 years old at screening (Visit 1) Have a clinically diagnosis of primary atypical hemolytic uremic syndrome (aHUS), with activity greater than 5% in plasma Plasma therapy-resistant aHUS patients must have a screening platelet count less than 150,000/uL, evidence of microangiopathic hemolysis, and serum creatinine greater than upper limit of normal Plasma therapy-responsive aHUS patients must have documented history of requiring plasma therapy to prevent aHUS exacerbation and received plasma therapy at least once every 2 weeks at an unchanged frequency for at least 8 weeks before first dose of OMS721 Have STEC-HUS, a direct positive Coombs test, history of hematopoietic stem cell transplant, and/or HUS from an identified drug History of vitamin B12 deficiency-related HUS, systemic lupus erythematosus, and/or antiphospholipid syndrome Active cancer or history of cancer (except non-melanoma skin cancers) within 5 years of screening Have been on hemodialysis or peritoneal dialysis for greater than or equal to 12 weeks Have an active systemic bacterial or fungal infection requiring systemic antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed) Baseline resting heart rate less than 45 beats per minute or greater than 115 beats per minute Baseline QTcF greater than 470 milliseconds Have malignant hypertension (diastolic blood pressure [BP] greater than 120 mm Hg with bilateral hemorrhages or "cotton-wool" exudates on funduscopic examination) Have a poor prognosis with a life expectancy of less than three months in the opinion of the Investigator Are pregnant or lactating
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-60.0, Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules) Healthy adults aged 16-60 years old as established by medical history and clinical examination The subjects' guardians are able to understand and sign the informed consent Subjects who can and will comply with the requirements of the protocol Hemoglobin: 110-150g/L (female), 120-160g/L (male) Leukocyte count: 4.0-10.0×109 /L Lymphocyte count: 0.8-4.5×109 /L Platelet count: 100-300×109/L Alanine aminotransferase: (ALT)0-40U/L Serum creatinine: 44-106μmol/L Subjects with temperature ≤37.0°C on axillary setting Pregnant or lactating women Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine Have serious side effects to vaccine, such as allergies, hives, breathing difficulties, angioneurotic oedema or abdominal pain abdominal pain or diarrhea asthma, in the past two years, unsteady and require emergency treatment, hospitalization, intubation, oral administration or intravenous corticosteroids Diabetes (type I or II), not including gestational diabetes Thyroid disease Serious angioneurotic edema in the past three years, or in need of treatment in the past 2 years Hypertension, over 145/95 mmHg Blood coagulation disorder (such as the lack of clotting factors, clotting hemorrhagic disease, abnormal platelet) or apparent bruises or blood coagulation disorder
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 20.0-40.0, Pre-Eclampsia, Severe HELLP Syndrome Microangiopathy Gestational age more than 20 weeks Age from18 to 40 years old Fulfilled for the diagnosis of severe preeclampsia Fulfilled for the diagnosis of HELLP syndrome. Diagnostic for severe preeclampsia(one of the following) Blood pressure of 160 mm Hg systolic or higher or 110 mm Hg diastolic or higher on two occasions at least 6 hours apart while the patient is on bed rest (unless antihypertensive therapy is intiated befor this time) New onest Cerebral or visual disturbances Pulmonary edema or cyanosis Sever persistant epigastric or right upper-quadrant pain unresponsive to medication and not accounted for by alternative diagnosis, or both Impaired liver function as indicated by abnormally elevated blood concentration of liver enzymes (to twic normal concentration) Thrombocytopenia (platlet count less than 100, 000 per microliter. Diagnostic for HELLP syndrome any non included
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Thrombotic Microangiopathies Patients be scheduled to undergo HSCT; 2. Not received decitabine 6 month ago; 3. Without severe organ damage; 4. ECOG 0-2; 5. Informed consent were obtained Be sensitive to NAC; 2. Bronchial asthma； 3. Peptic ulcer； 4. Severe organ damage； 5. Pregnancy and breastfeeding women；
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-0.077, Necrotizing Enterocolitis All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year . I. Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy) surgical problems other than NEC ,NEC beyond neonatal period. -
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 14.0-60.0, Giant Cell Tumor of Bone Giant cell tumor of bone patients confirmed by clinical, medical imaging and Pathology (1) less than 14 patients; 2) pregnant patients; 3) A patient who receives other medications during treatment
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-17.0, Chronic Diarrhea -all patient from 1 month up to 17 years (1month-17 year) admitted gastroenterology unit at Assuit University Children Hospital 2. Diarrhea 14 days or more ( ≥14 day) age less than 1 month (≤1 month) 2. diarrhea less than 14 days (≤14 day) 3. chronic diarrhea due to malignancy & chemotherapy
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-18.0, Diarrhea The parents and the child who give consent The children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics Children who are born mature, for the children who are younger than 1 year of age The parents and child who do not give consent Children who have primary and secondary immunosuppressive states Children who had abdominal/gastrointestinal tract surgery in the past Children who had used probiotics/prebiotics in the last one month period Children who had used antibiotics in the last one month period Children who has accompanying gastrointestinal symptoms Children who are using anti-acid treatment at the time of involvement
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-18.0, Hemolytic-Uremic Syndrome Age <18.0 years; 2. STEC infection [positive culture OR antigen OR polymerase chain reaction test for Stx/gene]; 3. Day of illness 1-10: Children who develop HUS will do so by day #14 of illness;8 restricting enrolment to the first 10 days will ensure all participants are at risk of HUS Evidence of evolving HUS: A) Hematocrit <30% OR B) Platelet count <150 x 109/L; 2. Responsible physician desires patient admission (therefore unable to randomize); 3. Unable to contact family within 48 hours of positive stool test; 4. Patient with history of atypical HUS; 5. Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 6.0-18.0, Obesity, Childhood Insulin Resistance Zinc Deficiency Inositol both sexes between 6 and 18 years of age obese, according to the IOTF (Cole TJ et al., 2000) pubertal stage ≥ 3 according to the Tanner stage (Tanner et al., 1961) HOMA-IR > 2,5 or insulin > 15 µU/ml Serum Zinc level in the range of normality or under the normal levels Adverse reactions to the product or component of the product (allergies…) Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-Biedl syndrome…), endocrinological obesity (Cushing syndrome, hypothyroidism) Chronic diseases, hepatic or gastroenterological diseases Medical treatment for chronic diseases Supplementation with inositol-like products or supplements containing Zinc and Inositol
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Nosocomial Pneumonia Ventilator Associated Pneumonia Escherichia Coli Infections Escherichia Coli Pneumonia Escherichia Coli; Diarrhea, Enteroaggregative Mechanical Ventilation Complication adult, admitted to the intensive care unit under invasive mechanical ventilation presence of Escherichia coli in lower respiratory tract specimen
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-999.0, Rotavirus Infections Environmental Enteric Dysfunction Enteric Infections Mother residing in an intervention or control compound of a previous sanitation trial (NCT02362932) for at least 6 months prior to recruitment and not intending to switch study compound over the next 9 months 2. Mother being pregnant and having gestational age between 3 and 9 months or being puerperal (up to 40 days postpartum) 3. Mother planning to use the prenatal care, delivery and vaccination services provided by the Ministry of Health of Mozambique 4. Mother able to understand and complete the informed consent process and allow your newborn to participate in the study 5. Mother at least 16 years of age 6. Infant eligible to receive rotavirus vaccination Infant whose medical team considers that they cannot be part of the study 2. Infant with complications associated with gestation, childbirth or postpartum, including congenital malformations 3. Infant with any medical, psychiatric or social condition, occupational reason, or other responsibility on the part of the pregnant woman, which, in the opinion of the investigator, is a contraindication to protocol compliance or impedes the participant's ability to give informed consent 4. Infant who has already received the rotavirus vaccine
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Anemia pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l vitamin B12 deficiency anemia folic acid deficiency anemia hemoglobinopathy multiples liver disease kidney disease
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-70.0, Peptic Ulcer Disease Patient should be diagnosed as gastric or duodenal ulcer under endoscope; the diameter of ulcers range from 0.3 to 1.0 cm; no indicator of bleeding or perforation. 2. Patient should be diagnosed as syndrome of spleen qi deficiency, that is, meet 2 main symptoms of spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of spleen deficiency, 1 main symptoms of qi deficiency and tongue symptoms as follow Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or at afternoon Main symptoms of qi deficiency: a) fatigue and weak; b) tired mind and taciturnity Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, or polysialia; b) abdominal pain, as a result either patients like warm or press; pain remits after meal or occurs when work; c) nausea and vomiting; d) tightness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur 3. Age is between 18 to 70 years 4. Sign the informed consent Patients who have complex peptic ulcer (i.e. have gastric and duodenal ulcer meanwhile) 2. Patients who have history of ulcer complications (e.g. bleeding or perforation) 3. Patients who have indicators of ulcer complications, including bleeding (Forrest stage I, IIa and IIb) or perforation (area of ulcer is more than 1 cm). 4. Patients whose ulcer have healed, that is, the ulcer is at healing stage or scarring stage according to the diagnosis in Consensus View of Integrated Chinese and Western Medicine on Diagnosis and Treatment of Peptic Ulcer (2011, Tianjin) 5. Patients who took proton-pump inhibitor more than 3 days within 15 days, or took non-steroid anti-inflammatory drugs for a long term 6. Female patients who are pregnant or breast-feeding, or prepare to pregnant for pregnancy within 2 years 7. Patients who are allergic to sample or sample composition 8. Patients who are allergic to sample or sample composition 9. Patients who have impaired liver function, including one of following condition: a) total bilirubin > 35 μmol/L; b) alanine transaminase >2 upper limit of normal (ULN); or c) aspartate aminotransferase >2 ULN 10. Patients who have impaired kidney function, that is, serum creatinine >2 ULN 11. Patients who have obviously abnormal electrocardiogram 12. Patients who have stool occult blood, that is, positive result in immunoassay or iron elemental test, and the results continue to be positive after 3 days of vegetarian diet. 13. Patients who undertaken drugs that could damage stomach and intestine, or experienced side effects of dyspepsia for undertaking non-steroidal anti-inflammatory drugs, theophylline, oral antibiotic or potassium supplements within 3 months 14. Patients who are receiving any agents or other intervention for treating his/her gastrointestinal disorder 15. Patients with any malignant tumor 16. Patients who have severe mental disorders so that could not control his/her action and coordinate the treatment in this trial. 17. Patients who are unwilling to provider personal information and enter this trial 18. Patients who cannot understand and sign informed consent
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-18.0, Ascites age from 1month to 18 year infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous ) infants and children with peritonitis age <1month surgical conditions as ruptured viscous or located abscess
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.25-5.0, Diarrhea Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h Age over 3 months and under 5 years Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week Exclusive breastfeeding Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy) Immunodeficiencies Malnutrition (weight / height / length less than P3 according to WHO standards) Severe dehydration Impossibility of follow-up Known hypersensitivity to gelatin or xyloglucan Absence of informed consent Caregivers / parents who can not understand or comply with all the instructions and requirements of the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-18.0, Diarrhea Bloody Be aged 6 months 99 years of age 2. Have ≥3 episodes of diarrhea within the preceding 24 hours and have blood identified in the stool (by physician, nurse or parent) Previously enrolled in the study 2. Unavailable for Day 14 follow-up 3. Currently (most recent complete blood count) known to be neutropenic (Neutrophils <1000), or at high-risk of being neutropenic (receiving chemotherapy) at present 4. Blood work performed prior to enrollment 5. Known to be STEC positive (stool culture, PCT, or toxin) 6. Pre-existing diagnosis of IBD (Crohn's disease, Ulcerative Colitis) 7. Language barrier that prevents the ability to obtain informed consent and assent (when appropriate)
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Diarrhea We will samples from participants with self-reported or clinical provider documented diarrhea defined as one or more loose or watery stools per day as defined by a or b below Cases of acute diarrhea (i.e., diarrhea which is currently active or was experienced up to one day prior to sampling or still active during sampling) will be included Cases of persistent diarrhea (i.e., diarrhea which is chronic or chronic-intermittently, i.e., once a week or more, experienced for at least 2 to 4 weeks prior to sampling), will be included. In the case of chronic diarrhea, diarrhea does not have to be active on the day of, or immediately prior to (i.e., one day) sampling. 2. Current enrollment in an active NIH protocol or enrollment in 12-NR-0195. 3. Able to provide 50ml stool sample within 2-3 hours. 4. Children will only be enrolled if they are currently enrolled in an active NIH protocol or enrolled in 12-NR-0195 This protocol will outpatients who are clinically unstable patients. Clinically unstable patient is defined as someone requiring emergent care or hospitalization. 2. Antibiotic use, which can affect intestinal flora, is not exclusionary but will be controlled for via post-hoc analysis. 3. NINR employees, subordinates/relatives/ or co-workers. 4. Any NIH employee who is a subordinates/relatives/or co-workers of study investigator
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 11.0-17.0, Clavicle Fracture Adolescent 17 years old with fractures of the middle third of the clavicle Displaced 100% the width of the clavicle or shortened 1 centimeter Operative and non-operative treated clavicles will be eligible for enrollment Open clavicle fractures Ipsilateral shoulder injuries Fractures involving the lateral ligaments or the sternoclavicular joint Bilateral clavicle fractures Pathologic fractures Refractures Fractures with neurovascular compromise Displaced fractures with impending skin compromise If there has been more than 21 days between injury and enrollment Patients with cognitive disabilities that inhibit the completion of the questionnaires
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0
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