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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): 8.0-17.0, Abdominal Pain Ages 8 years Evaluated in Abdominal Pain Clinic at Children's Mercy Hospital or the Gastroenterology Clinic at Children's Mercy South for abdominal pain of at least 8 weeks duration and fulfilling symptom-based for FD, IBS, or FD/IBS Previous abdominal surgery Chronic disease requiring regular medical care (e.g. gastrointestinal diseases, diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer) Non-English speaking NOTE: Control subjects will meet all patient inclusion/ except for #2. Control subjects will be excluded for history of abdominal pain, nausea, vomiting, diarrhea, constipation, or bloating
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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 Healthy adults age 18 to 45 years old who are willing to participate, complete training on ETEC and diarrhea and procedures of the protocol, pass the test documenting knowledge of the study, and give informed consent age<18 or >45 years 2. Chronic illness, chemical dependency, or significant medical illness as determined by the investigator. 3. immunosuppressive condition or IgA (Immunoglobulin A) deficiency 4. HIV antibody positive 5. hepatitis B surface antigen positive 6. hepatitis C antibody positive 7. travel to ETEC endemic area within 2 years 8. vaccination or other exposure to ETEC, cholera, or heat labile toxin (LT) toxin within 3 years 9. pregnancy as defined by + serum or urine human chorionic gonadotropin (HCG) on the day before immunization 10. inability to pass the written examination 11. use of antibiotic, H2 blocking agent or proton pump inhibitor within 7 days of challenge 12. regular use of laxatives antacids or other agents to lower stomach acidity 13. significant abnormality in screening lav hematology and chemistry tests as determined by the investigator. 14. significant abnormality on EKG for those 40 to 50 years old as determined by the investigator. 15. allergy to quinolones, penicillin's and Bactrim. 16. abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day)
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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, Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction suspected exposure to tick-borne relapsing fever after returning from field exercise in a tick-borne relapsing fever infected area having a tick bite or staying in field in close proximity to a subject with tick bite sign known sensitivity to tetracycline or doxycycline febrile illness on recruitment
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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): 17.0-999.0, Thrombotic Thrombocytopenic Purpura Patients will be included in the trial based on the following Patients must have TTP with platelet count < 100,000/mL and microangiopathic hemolytic anemia which is defined as presence of at 3-10 fragmented red blood cells (schistocytes) per high power filed on the peripheral blood smear Either gender, age 17 or older Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment TTP not related to underlying cancer, treatment of cancer or transplantation New onset TTP, or previously diagnosed TTP with an unmaintained remission for >12 months LDH >2X upper limit of normal Prothrombin time (PT), partial thromboplastin time (PTT) normal Direct antiglobulin test (DAT) negative Subject has provided written informed consent Patients will be excluded from the trial based on the following A diagnosis of AIDS. Patients with HIV infection with absolute CD4 counts >200/ul and no active, significant opportunistic infection are eligible Patients with a known hepatitis C infection (HCV) and/or with hepatitis B Patients receiving pheresis more than once a day Recent (within 1 year) bone marrow or hematopoietic stem cell transplant Patient is on calcineurin inhibitors, or is unable to come off them Acute or chronic disseminated intravascular coagulation (DIC), defined by D-dimers >8mg/ml and fibrinogen < 100 mg (0.1g)/dl A diagnosis of metastatic or non-metastatic malignancy other than basal cell carcinoma Malignant hypertension (systolic blood pressure [BP] > 200 mm Hg or a diastolic BP > 130 mm Hg) Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment). resumes 3 days after delivery
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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): 19.0-80.0, Gastroenteritis Subjects were included if they had mild-to-moderate diarrhea, with mildly sunken eyes and a clinical assessment of dehydration of less than 5%, a serum sodium concentration between 130-150 mEq/L, adequate general health and nutrition, a BUN/creatinine ratio of >20 and with a normal pulse rate for age and degree of fever and adequate skin turgor Patients were excluded if they had hyperthermia (>39.0º C), serum sodium >150 mEq/L or <130 mEq/L, white cell count >15,000, bloody diarrhea (dysentery), abnormal cardiovascular or renal function or an underlying metabolic or nutritional disorder and most importantly, if the clinical assessment of dehydration was >7% that suggested a need for intravenous fluids
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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): 0.5-7.0, Fever Age 6 months years of age at time of the fever Initial temperature of 38.0C (100.4F) or more Ability to cooperate with serial temporal artery temperature measurements Ability to take medications by mouth Willingness of the child's guardian/sponsor to give informed consent Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen, aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of presentation Patients >=3 years of age that have received narcotics in the previous 24 hours Children with weight >60 kg. Treatment of children with weights >60 kg will result in greater than recommended adult doses of the medications History of adverse reaction to any study medication ingredient History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or thrombocytopenia Presence of moderate or severe dehydration in the trial on 3 previous occasions Medical judgment that the severity of the underlying illness prohibits 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): 18.0-999.0, Clostridium Infections Diarrhea Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort Subject has a positive Clostridium difficile stool toxin assay at screening Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization
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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, Diarrhea Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day Gross blood, pus in the stools Fever >39ºC Other episode of acute watery diarrhoea within the last 30 days History of chronic diarrhoea or motor diarrhoea
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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): 0.0-6.0, Hyperbilirubinemia Erythroblastosis, Fetal All newborns with a gestational age equal or higher than 32 weeks, with a Rh (D) positive blood type, children of sensitized Rh (D) negative mothers, regardless if they were submitted or not to an intra-uterus transfusion Newborns in serious condition, hydropic, hemodynamically instable or with indication for exchange transfusion at birth. The indications for exchange transfusion at birth are: presence of bilirubin in the umbilical cord higher or equal to 4mg%; hydrops, cardiac insufficiency secondary to severe 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): 1.0-999.0, Diarrhea Cholera Vibrio Infections All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area individuals who are too weak to get out of bed to receive the vaccine pregnant women (identified through verbal screening); and those less than 1 year of 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): 0.0-17.0, Nutritional and Metabolic Diseases <18 years of age Patient with newly diagnosed hematological malignancies presenting with hyperuricemia Uric acid > 7.5 mg/dL in patients ≥ 13 years old Uric acid > 6.5mg/dL in patients <13 years old Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following At least one lymph node or mass >5 cm in diameter LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period Low birth weight infant (<2500g) or gestational age <37 weeks Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period Known history of severe allergic reaction and/or severe asthma Known history or family history of glucose-6-phosphate dehydrogenase deficiency Known history of hemolysis and methemoglobinemia Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN Uncontrollable infections (including viral infections) Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. 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): 0.0-70.0, Lymphoma Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age <70. 6. Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen -
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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, Clostridium Enterocolitis Pseudomembranous Colitis Patient must be > 18 years of age Clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces Disease has been treated, and the symptoms failed to respond to treatment with metronidazole or vancomycin, or symptoms promptly relapsed after completing a course of therapy with either of these drugs Able to take oral medication Patients with other recognized causes of diarrhea or colitis Women of child bearing age who are pregnant, breast feeding, or not using birth control Patients taking coumadin, phenytoin, celecoxib, or losartan Patients with renal insufficiency (BUN or creatinine >2 times baseline) Serious systemic disorder incompatible with 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, Enterocolitis Pseudomembranous Colitis Antibiotic-associated Colitis Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus
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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, Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort 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): 16.0-999.0, Gastroenteritis Caregiver of a child aged 3 months to 4 years of age, presenting to the emergency department with a diagnosis of gastroenteritis, which may be manifested by vomiting, diarrhea, or both Age > 16 years Ability to speak and read English Do not live in the metropolitan Toronto area Previously enrolled in this trial
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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, Polyarteritis Nodosa Parent or guardian willing to provide informed consent, if applicable Diagnosis of vasculitis Diagnosis of PAN, meeting at least 1 major criterion and 1 minor criterion OR 2 major of the following adapted American College of Rheumatology (ACR) that fall under the diagnosis of PAN and that are not explained by other causes: MAJOR 1. Arteriographic abnormality 2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy 3. Mononeuropathy or polyneuropathy MINOR 1. Weight loss of more than 4 kg (8.8 lbs) 2. Livedo reticularis, cutaneous ulcerations, or skin nodules 3. Testicular pain or tenderness 4. Myalgias 5. Diastolic blood pressure greater than 90 mm Hg 6. Elevated blood urea nitrogen (BUN) or serum creatinine levels 7. Ischemic abdominal pain Microscopic polyangiitis Granulomatosis with polyangiitis(Wegener's) Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) Takayasu's arteritis Giant cell arteritis Cogan's syndrome Behcet's disease Sarcoidosis Kawasaki disease Cryoglobulinemic vasculitis
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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, Accelerated Phase Chronic Myelogenous Leukemia Blastic Phase Chronic Myelogenous Leukemia Childhood Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Meningeal Chronic Myelogenous Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Relapsing Chronic Myelogenous Leukemia Unspecified Childhood Solid Tumor, Protocol Specific Histologically confirmed diagnosis of 1 of the following Malignant extracranial solid tumor Recurrent or refractory disease Known bone marrow metastases* allowed Imatinib mesylate-resistant Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), defined as M3 bone marrow in a patient who previously received imatinib mesylate-containing treatment regimen Imatinib mesylate-resistant Ph+ chronic myelogenous leukemia (CML), as defined by any of the following Increasing WBC or platelet count while on imatinib mesylate therapy Lack of any cytogenetic response after an adequate duration of imatinib mesylate therapy, as defined by 1 of the following Failed to achieve a complete hematologic response after completion of 3 months of imatinib mesylate treatment Failed to achieve a partial or complete cytogenetic response (i.e., ≤ 35% Ph+ cells) after 6 months of imatinib mesylate 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): 20.0-74.0, Cancer Patients with histologically or cytologically confirmed solid tumors. 2. Patients who have progressed on or following standard therapy and with no other treatment options. 3. Patients aged 20-74 when they give informed consent. 4. Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 5. Patients who can stay at the hospital from the start of the study drug treatment to 2 weeks of the first cycle. 6. Patients having adequate function of major organs (bone marrow, liver, kidney and lungs): (1) Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4) Aspartate aminotransferase [AST] 2.5 times the upper limits of normal (ULN) in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (5) Alanine aminotransferase [ALT] 2.5 times ULN in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (6) Total bilirubin 1.5 times ULN in institute (7) Serum creatinine 1.5 times ULN in institute (8) Pulse oximeter oxygen saturation 90% 7. Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by the prior therapy or could influence the safety evaluation of the study drug. The withdrawal periods required from the completion of the prior therapy to the start of the study drug therapy are as follows: 1. Chemotherapy (excluding oral 5-FU and molecular target drugs), surgical therapy, other study drugs: 4 weeks 2. Nitrosourea agents, mitomycin C: 6 weeks 3. Radiotherapy, endocrinotherapy, immunotherapy, oral 5-FU, molecular target drugs, blood transfusion, blood products, G-CSF and other hematopoietic factors: 2 weeks 8. Patients who give written informed consent. 9. Patients with an expected survival of longer than 3 months from the start of the study drug therapy Patients with systemic infection with a fever (38°C). 2. Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage. 3. Patients with brain metastasis with clinical symptoms. 4. Patients with serious complications: (1) Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension) (2) Patients with myocardial infarction within 6 months prior to study entry (3) Patients with a complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and pulmonary fibrosis (5) Patients with a bleeding tendency 5. Women who are pregnant or breastfeeding, or premenopausal women of childbearing potential. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Premenopausal women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test, or have not agreed to use adequate measures of contraception. 6. Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception. 7. Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus surface antigen (HBsAg). 8. Patients who need continuous systemic steroid therapy during the study period. 9. Patients who need continuous use of phenytoin, carbamazepine, rifampicin and/or barbiturate which induces cytochrome P450 (CYP3A4), a drug-metabolizing enzyme, during the study period. 10. Patients who have received extensive radiation therapy (30% or more of bone marrow). 11. Patients who refused to receive a supportive therapy of blood transfusion by suppressing bone marrow. 12. Patients who are participating in other clinical studies. 13. Patients whom the investigator or subinvestigator has judged inappropriate for 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): 0.25-3.0, Diarrhea, Malnutrition Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for > 2 weeks or height-for-age Z-score (HAZ) less than -1, which is the median of HAZ scores in children at HIAS. 2. Be an inpatient and willing to stay for 7 nights at HIAS. 3. Child's parent or guardian must sign informed consent Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect) 2. Children who participated in the "community study" or any other study within the past two years (Reason: The children in the "community study" will have received glutamine.) 3. Children with suspected other illnesses as indicated by fever >102 degrees F at time of screening off antipyretics. 4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella 5. Severe malnutrition defined as HAZ <-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): 0.0-999.0, Genetics The study population will the members of the 330 Framingham Study families and 1888 random individuals. The Original Cohort will also be included
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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): 0.0-21.0, Brain and Central Nervous System Tumors Neurofibromatosis Type 1 Histologically confirmed* low-grade glioma, including 1 of the following subtypes Astrocytoma variants Fibrillary, protoplasmic, or mixed Pilocytic astrocytoma, including pilomyxoid variants Pleomorphic xanthoastrocytoma Infantile desmoplastic astrocytoma Ganglioglioma Oligodendroglial tumors Mixed glioma, including oligoastrocytoma NOTE: *Biopsy not required for patients who have visual pathway tumors involving the optic nerves and/or optic radiations (i.e., not isolated to the hypothalamus/chiasm) Biopsy proven focal low-grade gliomas of the brainstem with measurable disease allowed
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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): 18.0-40.0, Escherichia Coli Infections Sign an Institutional Review Board-approved consent prior to any study-related activities Initiate screening 21± 7 days prior to admission or enrollment Must accomplish all laboratory and diagnostic examinations at 21± 7 days prior to admission or enrollment Be at least 18 years of age but not older than 40 years of age at the time of enrollment Be otherwise healthy with a stable address and telephone where the volunteer can be contacted Be able to read and write English Possess a social security number in order to receive compensation Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the morning of the challenge and use effective birth control during the entire study period. Methods of effective birth control complete abstinence, the use of a licensed hormonal method, intrauterine device, barrier method plus spermicide, or having sexual relations exclusively with a vasectomized partner. Appropriate barrier methods condoms, cervical sponge, and diaphragm. Females who are not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any female with tubal ligation or who is postmenopausal. For purposes of this study, postmenopausal status will be defined as absence of menses for at least 1 year Be seronegative for antibodies to dispersin Have normal laboratory screening values including a white blood cell (WBC) count, hemoglobin, hematocrit, platelets, blood urea nitrogen, glucose, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), quantitative immunoglobulins, T cell subsets (CD4 and CD8), urinalysis Has acute or chronic medical illness (i.e., renal or hepatic disease, hypertension, diabetes mellitus, coronary artery disease, malnutrition, obesity (body mass index >30 kg/m2), HIV, corticosteroid use, cancer or receiving chemotherapy, chronic debilitating illness, syphilis) Has used antibiotics within 7 days of challenge Has used medications or drugs, including over-the-counter medications such as decongestants, antacids (calcium carbonate or aluminum-based antacids, H2 blockers), anti-diarrheal medications (such as bismuth subsalicylate or loperamide), antihistamines within 7 days of challenge Has a history of chronic gastrointestinal illness, intra-abdominal surgery, chronic functional dyspepsia, chronic gastroesophageal reflux, documented peptic ulcer disease, gastrointestinal hemorrhage, gallbladder disease, inflammatory bowel disease (Crohn's and ulcerative colitis), diverticulitis, irritable bowel syndrome or frequent diarrhea Has a history any of the following psychiatric illness(es) Depression not controlled with current drug therapy or involving institutionalization Schizophrenia or psychosis Suicide attempt Has a history of or current alcohol or illicit drug abuse Is unable to remain as an inpatient in the University Clinical Research Unit for up to 8 days
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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, Infection E Coli Infections Klebsiella Infections Proteus Infections All patients with E. coli, Klebsiella species, and Proteus species infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as Isolation of the organism two or more days after admission for hospitalization OR History of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR Previous isolation of an antibiotic resistant organism 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): 0.083-3.0, Diarrhea Dehydration Males Age 1 month up to 36 months Passage of 3 or more liquid stools in a 24-hour period, every day, and at least one in 12 hours prior to admission Diarrhea for < 7days (168 hours) severe systemic illness requiring intensive care management; systemic infection will be suspected if there is a general appearance of non-wellbeing with one or more of the following symptoms: shrill cry and irritability, temperature instability, hypotension, hypoglycemia, altered sensorium, lethargy or refusal of feeds, abdominal distension chronic illness like Tuberculosis, Nephrotic syndrome, malignancy etc or any surgical disorder severe malnutrition (weight for age <65% of NCHS median gross blood in stool refusal of 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): 5.0-75.0, Hepatitis B Diagnosis of acute hepatitis B Bilirubin > 5 mg/dl at presentation Patients with co-infection, a history of hepatotoxic drug intake or alcohol use >20g/day, or any evidence of chronic liver disease in the past, at presentation or during follow-up
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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, Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Thromboembolism Vaginal Cancer Vulvar Cancer Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed gynecologic malignancy Age 18 years or older at the time of signing the consent Gynecologic Oncology Group (GOG) performance status of ≤ 2 Life expectancy of > 3 months Patient's weight must be ≥ 50 kg Adequate organ function within 28 days of study entry defined as Hemoglobin ≥ 9.0 g/dL Platelet ≥ 100,000 x 109/L Blood urea nitrogen (BUN) ≤ 30 mg/dL Serum creatinine ≤ 1.5 mg/dL Current treatment with anticoagulants Thromboembolism within the previous 6 months Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g., active ulcers), history of stroke within past 3 years, or severe and currently uncontrolled high blood pressure Bacterial endocarditis Known hypersensitivity to fondaparinux sodium
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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, Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Histologically confirmed diffuse or mediastinal large B-cell lymphoma*, meeting the following Advanced or metastatic disease, Incurable by standard therapies, Relapsed or refractory disease [Note: *Patients with diffuse large B-cell lymphoma whose disease has transformed from an earlier diagnosis of low grade lymphoma (i.e., an indolent histology) are eligible] Bidimensionally measurable disease** by CT scan, MRI, or physical exam, with >= 1 disease site meeting 1 of the following Lymph nodes >= 1.5 cm x 1.5 cm by spiral CT scan, Non-nodal regions >= 1 cm x 1 cm by MRI, CT scan, or physical exam [Note: **Bone lesions are not considered bidimensionally measurable disease] Received 1-2 prior chemotherapy regimens that included doxorubicin hydrochloride; Prior stem cell transplantation and high-dose chemotherapy is considered one regimen; One prior non-chemotherapy regimen in the form of radiation allowed; Measurable disease must be outside the previously irradiated area No sole site of disease in a previously irradiated area unless progressive disease or new lesions are documented; Low-dose palliative radiotherapy may be allowed No known brain metastases Life expectancy >= 12 weeks ECOG performance status 0-1 Absolute granulocyte count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 AST and ALT =< 2.5 times upper limit of normal (ULN)
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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): 13.0-25.0, Schizophrenia Prodrome /written informed consent (for individuals under 18 written informed consent of at least one of the parents is required), 2. /age between 13 and 25 years, 3. /ARMS as classified by the PACE (Yung et al., 1998) PACE for ARMS one or more of following characteristics which must have occurred within the last 12 months Frank psychotic symptoms < 1 week (Transient psychosis group) Attenuated psychotic symptoms > 1 week, > 2 times per week Decline in global function (drop in GAF of > 30%) plus family history of psychosis or individual has schizotypal personality disorder To operationalize PACE duration and severity ratings of psychotic symptoms will be performed using the Positive and Negative Syndromes of Schizophrenia Scale (PANSS) (Kay et al., 1987) applying following cut-off scores, following Morrison et al (2002): Ad 1) Transient psychosis is defined with the presence of symptoms that score 4 or more on hallucinations, 4 or more on delusions, or 5 or more on conceptual disorganizations, last less than one week and resolve without antipsychotic medication. Ad 2) Attenuated psychotic symptoms are defined by the presence of symptoms that score 3 on delusions, 2-3 on hallucinations, 3-4 on suspiciousness or 3-4 on conceptual disorganization /Acute suicidal behaviour, aggressive behaviour (PANSS hostility, suicidality = 7), 2. /Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC), 3. /Alcohol abuse if considered as major problem, 4. /Epilepsy, 5. /Mental Retardation (IQ<80), 6. /Pregnancy and lactation, 7. /Structural changes in MRI or CT scan (e.g., tumours), expect for enlargement of ventricles or sulci, 8. /Previous history of antipsychotic drug (>1 week) or mood stabilizer treatment, 9. /Laboratory values more than 10% outside the normal range for transaminases, CRP or bleeding parameters, 10. /Individuals with organic brain syndrome, 11. /Individuals who are taking anticoagulants, 12. /Individuals who are taking omega 3 supplements, currently or within 8 weeks of being included in the trial, 13. /Individuals who have other, severe, intercurrent illness which in the opinion of the investigator may put them at risk or influence the results of the trial or affect ability to take part in the 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): 16.0-999.0, Enterobacteriaceae Infections Bacteremia Pneumonia Skin Diseases Urinary Tract Infections All patients with infections (i.e. bacteremia, pneumonia, abdomen infections, skin infections, and urinary tract infections) caused by ESBL-producing Enterobacteriaceae Children < 16 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): 18.0-90.0, Lymphoma, Non-Hodgkin Lymphoma, B-Cell Small Lymphocytic Lymphoma Follicular Cell Lymphoma (grades I and II) Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia Marginal Zone Lymphoma MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation Adequate bone marrow function, renal function, and hepatic function as outlined in details below ECOG performance status of 0, 1, or 2 Able to read, understand, and sign an IRB approved informed consent Known HIV positive status Known CNS involvement Prior therapy for lymphoma antibiotic treatment for MALT-Type NHL
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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, Clostridium Difficile Age ≥ 18 years In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay Patients able to take oral medications Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or colestipol. [Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study] Patients willing to abstain from alcohol during the 10-day treatment duration and for two days following treatment Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy) Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. [Patients that have taken up to 2 doses of metronidazole or vancomycin can be included in the study] Females of child bearing age who are either pregnant, breast-feeding or not using birth control. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up) Patients taking phenytoin, celecoxib, and/or losartan. [Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter] Patients with severe renal or hepatic impairment Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation) Serious systemic disorders incompatible with the study History of hypersensitivity to metronidazole
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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 Diarrhea Vibrio Infections Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years All subjects must satisfy the following at study entry Male or female adult residents aged 18-40 years or children aged 1 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) For females of reproductive age, they must not be pregnant (as determined by verbal screening) Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator Ongoing serious chronic disease Immunocompromising condition or therapy Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months intake of any anti-diarrhoeal medicine in the past week abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours acute disease one week prior to enrollment, with or without fever. Temperature > or = 38 degrees C (oral) or axillary temperature > or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject receipt of antibiotics in past 14 days receipt of live or killed enteric vaccine in last month
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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, Restless Legs Syndrome Patients with a diagnosis of RLS Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg Normal blood pressure pre-study Light smokers only (<20/day) History of postural hypotension or faints Secondary RLS Patients who suffer from a primary sleep disorder other than RLS Patients diagnosed with movement disorders Patients with unstable medical conditions Patients with personal or family history of adverse reactions or hypersensitivity to the study drug Patients with abnormal laboratory values Patients with hepatitis or HIV Patients who abuse alcohol or drugs Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
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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): 1.5-999.0, Acute Diarrhea All patients having acute diarrhea i.e. 3 or more stools per day or stool weight exceeding 200 grams lasting less than 15 days Patients having the following diagnosis as they might have high calprotectin levels not only because of the diarrhea per se but may also be because of the underlying pathology itself Inflammatory bowel disease (Crohn's disease, ulcerative disease) Gastrointestinal malignancy (colorectal cancer, gastric cancer etc) Cirrhosis of liver Chronic pancreatitis Currently on non steroidal anti inflammatory therapy Younger than 1 year of age
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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): 10.0-999.0, Inflammatory Bowel Diseases Patient will be 10 years and older Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohn's Disease) Positive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal α-1 antitrypsin) Unexplained anemia Recurrent fever Weight loss (at least 10% of normal body weight in adults) Hypoalbuminaemia (<3.5 g/dL) Gastro-intestinal bleeding Chronic perianal disease (fistula, fissure) Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the are not otherwise met Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting) Definite stricture seen on SBFT Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule Patient has a pacemaker or other implanted electro-medical device Patient has known history of small bowel Crohn's disease Patient on treatment for active IBD Patient with suspected celiac disease that has not been excluded Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment Patient is pregnant
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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 Male or female between 18 and 45 years of age General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%) Willing to participate after informed consent obtained Available for all planned follow-up visits Negative serum pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for female volunteers of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female volunteers unable to bear children must have this documented (e.g., tubal ligation or hysterectomy) Presence of a significant medical condition, (e.g. psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study Immunosuppressive illness or IgA deficiency (below the normal limits) Positive serology results for HIV, HBsAg, or HCV antibodies Significant abnormalities in screening lab hematology, serum chemistry, urinalysis or EKG (EKG in volunteers ≥ 40 years), as determined by PI Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to two of three) Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis History of diarrhea in the 2 weeks prior to planned inpatient phase Regular use of laxatives, antacids, or other agents to lower stomach acidity (regular defined as at least weekly) Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to dosing
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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): 0.154-0.385, Diarrhea Access to telephone at home or in the immediate neighborhood. 2. Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days). 3. Parent's permission to participate in the study is available. 4. No plans to travel over the next 4 months Gestational age <37 weeks. 2. Any major physical congenital malformation. 3. Living in a household or has contact with an individual who is immunosuppressed. 4. Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness. 5. Is required to take daily medications other than vitamins or herbal "tonics". 6. Evidence of cardiovascular disease as indicated by any of the following Central cyanosis Cyanotic or apnoeic spells Features of congestive heart failure Significant heart murmur detected on physical examination 7. Evidence of gastrointestinal disease indicated by following Diarrhea in the previous 7 days Blood in the stools any time since birth 8. Evidence of neurological disease, as indicated by History of seizures any time since birth History of unconsciousness Focal deficit on physical examination 9. Evidence of liver or other reticuloendothelial disease, as indicated by any of the following
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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): 15.0-75.0, Crohn's Disease Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study Subject is considered by the investigator, for any reason, to be an unsuitable candidate for 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): 40.0-75.0, Diabetes Mellitus Hypertension Men or women of any racial background Age >= 40 years and <= 75 years SBP>= 130 mmHg and < 140 mmHg or DBP >= 85 mmHg and < 90 mmHg, average of screening and randomisation visits (in absence of any antihypertensive medication) FG >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication) Waist circumference >= 102 cm in men and >= 88 cm in women SBP >= 140 mmHg or DBP >= 90 mmHg Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, ßBs, ACEIs, ARBs, CAs, and any other antihypertensive medication Any medical condition preventing adherence to lifestyle measures included in the protocol Hepatic disease as AST (SGOT) or ALT (SGPT) values equal or greater than two times the upper limit of normal Chronic renal dysfunction as serum creatinine > 2.0 mg/dl Any gastrointestinal disorder interfering with drug absorption Known allergy or contraindications to ACEIs or ARBs Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods Malignancy within the last 5 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): 0.0-76.0, Leukemia Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (> 6 months) hypereosinophilia (1,500/mm^3); and (3) signs or symptoms of organ involvement. 2. Age less than 76 years old. 3. Patient is not pregnant. 4. Zubrod performance status < 3. 5. Life expectancy is not severely limited by concomitant illness. 6. Serum creatinine < 2 mg/dL. 7. Serum bilirubin < 2 times upper limit of normal (2 mg/dL). 8. Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L). 9. Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis. 2. Presence of an active infection. 3. HIV positive. 4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities). 5. Recent history of parasite infection. 6. Recent history of allergic reaction
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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): 10.0-65.0, Crohn's Disease Patients ages 10-65 years, inclusive Patient suffers from either diarrhea for more than 6 weeks and less than 3 years and/or abdominal pain for more than 6 weeks and less than 3 years and/or extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis Patient suffers from at least one of the symptoms / lab abnormalities listed below Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment Unexplained anemia (less than normal limits) within 3 months prior to enrollment Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment Positive ASCA within 3 months of enrollment Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the are not otherwise met Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting Definite long stricture seen on radiological exam Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract Known history of small bowel Crohn's Disease Current treatment for active IBD Positive Anti-tTG or anti-endomysial antibody Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment Patient is pregnant
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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, Influenza Subjects must have Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms Chills/sweats Cough Dyspnea (labored, difficult breathing) Fatigue Headache Myalgia (deep muscle aches) Nasal congestion Runny nose Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in 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): 0.0-999.0, Leukemia Lymphoma Patients receiving allogeneic hematopoietic transplants from an unrelated donor or one antigen mismatched related donors. 2. Patients with AML, ALL, Hodgkin's disease, MDS (including CMML), CML in late chronic or accelerated phase or in blast crisis, and lymphoma in first or later relapses. 3. Patients must have bilirubin < 1.5 mg/dL, DLCO > 50% predicted, LVEF > 45% and performance status 0 or 1. 4. Candidates must have a creatinine level < 1.5 mg/dL or a calculated creatinine clearance > 60 ml/min HIV seropositivity 2. Uncontrolled infection 3. Pregnancy 4. Candidates should not have received chemotherapy other than hydroxyurea or Gleevec for at least 3 weeks prior to treatment. Maintenance therapy with oral chemotherapy is acceptable. Treatment day is defined as transplant day +8, which is the date of first dose of pentostatin. 5. Diagnosis of myelofibrosis
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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): 18.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of stage I, II, or III multiple myeloma requiring therapy No prior systemic therapy for multiple myeloma Patients who have received steroids or radiotherapy for cord compression or spinal cord disease are eligible for this study Patients who have received 1 prior course of antimyeloma therapy may be enrolled at the investigator's discretion provided disease progression is not noted Karnofsky performance status 60-100% Platelet count ≥ 75,000 cells/mm^3 (< 75,000 cells/mm^3 secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support) ANC ≥ 1,000 cells/mm^3 Hemoglobin ≥ 8.0 g/dL (< 8 g/dL secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support) Creatinine clearance > 20 mL/min AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence of liver metastases) Pregnant or lactating Active, serious infections uncontrolled by antibiotics Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol Any of the following conditions History of uncontrolled New York Heart Association class II-IV heart disease or clinical evidence of congestive heart failure Myocardial infarction within the past 6 months Uncontrolled angina Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or active conduction system abnormalities Peripheral neuropathy ≥ grade 2 PRIOR
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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, Colon Cancer Patients (men or women) that are >18 years of age undergoing colonoscopy for a variety of indications (bleeding, diarrhea, weight loss, anemia, abdominal pain, etc) concurrent hospitalization visible rectal bleeding known diagnosis of inflammatory bowel disease hematuria menstruation at the time of obtaining a stool specimen and performing the tests inability to prepare the 3 different IFOBT or 3 different FOBT kits
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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, Irritable Bowel Syndrome Female from 18 to 65 years of age, inclusive Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Negative serum and urine pregnancy tests Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization Serious underlying diseases, including psychiatric disorders Current history of conditions affecting bowel transit Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome Presence of a medical condition which could interfere with the interpretation of study data Significant use of nicotine or caffeine
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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): 8.0-17.0, Functional Gastrointestinal Disorders Age 8 to 17 years Diagnosis of functional abdominal pain or irritable bowel syndrome made by a pediatric gastroenterologist according to Rome II Mean daily intensity of pain of 25 mm in the week prior to the initiation of the study, based on the Word-Graphic Rating Scale continuous score Following evaluation in the six months prior to the study: normal EKG and laboratory tests including complete blood count, erythrocyte sedimentation rate, albumin, serum amylase, lipase, liver enzymes, urine analysis, stool examination for occult blood and ova and parasites. Urinary culture will be obtained if the symptoms or urinalysis suggest the possibility of a urinary infection Normal lactose breath test or history of lack of resolution of symptoms on a lactose-free diet Consenting parents Patient assent not met Evidence of organic gastrointestinal disease, hepatic disorders, urinary or cardiac disease, seizures, blood dyscrasias, glaucoma History of allergic reaction to amitriptyline Patients receiving barbiturates, cimetidine, neuroleptics, monoamine oxidase inhibitors, sympathomimetic agents or quinidine Children below the 5th percentile for weight or height Hemoccult positive stools
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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, Gallbladder Cancer Liver Cancer Bile Duct Cancer Clinical diagnosis of malignant biliary obstruction Radiologic or histologic evidence of MBO Percutaneous biliary drainage procedure planned or Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned KPS >50% Age 18 years or greater Able to speak and read English Able to comprehend and execute informed consent Prior intervention for MBO not exclusionary Unable to complete questionnaire due to performance status Proxy completion is not accepted Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
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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): 19.0-90.0, Colorectal Adenoma Colorectal Carcinoma Mass suspicious for carcinoma, clinical diagnosis of adenocarcinoma of the colon (to be histologically confirmed upon study entry) or an adenoma that is not removable by endoscopy. 2. Patient must be undergoing colo-rectal resection 3. age > 18yrs 4. Karnofsky performance status(KPS) > 60. 5. Signed and dated informed consent. 6. Complete history and physical examination within 30 days of study entry. 7. Laboratory evaluations within 30 days of study entry to Complete Blood Count(CBC) with differential and platelets, Blood Urea Nitrogen(BUN), creatinine, bilirubin, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase(SGPT), lactate dehydrogenase(LDH), alkaline phosphatase, total protein, albumin and carcinoembryonic antigen(CEA). 8. Chest x-ray within 30 days of study entry. 9. The subject has no other serious medical illness, other than that treated by this study, which would limit the ability of the patient to receive protocol therapy, or psychiatric condition which would prevent informed consent. Absolute severe infection ;White Blood Cell Count(WBC) > 2 times normal, fever, sepsis) 2. immunosuppression (steroids, transplant patient) 3. emergent operation(perforation, obstruction). 4. Patients with serum bilirubin or creatinine levels greater than two times the normal upper limit would be excluded. 5. Pregnant or lactating women or subjects of child bearing age who do not practice effective means of birth control 6. Sulfonamide allergy 7. Recurrent or previous history of known ischemic heart disease or thrombotic events as well as any angioplasty or cardiac by-pass procedures in the previous 12 months. Relative Medications taken by the patient that are listed in section 9.0 of this protocol would be reviewed by the enlisting physician prior to entry into the study. Warfarin, aspirin and methotrexate would be stopped prior to protocol entry as these are stopped prior to any surgery. The most common of the listed medications would be ACE inhibitors and furosemide. The dose, schedule and indications of the medications would be reviewed with the patient and a decision regarding entry into the study would be made by the enlisting physician. Other less common medications will be similarly reviewed, however most had little or no clinical side effects despite potential biochemical interactions. 2. Medications known to be COX inhibitors would have to be stopped prior to entry into the study. This would any aspirin,nonsteroidal antiinflammatory drugs(NSAID) (ibuprofen, naproxen, rofecoxib, celecoxib, Mobic, etc) or over the counter cold medication that might contain these substances. A list of common over-the-counter medications that might contain such substances will be reviewed with the patient and if there are any questions after the study has begun, instructions to call before taking any medications will be given
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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, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Unspecified Childhood Solid Tumor, Protocol Specific Histologically confirmed solid tumor Relapsed or refractory disease No central nervous system (CNS) tumor or lymphoma Histological confirmation may have been made at original diagnosis or at relapse Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Measurable or evaluable disease Patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) must have tissue blocks or slides available Study chair must be notified if tissue blocks or slides are not available Karnofsky performance status (PS) ≥ 50% (patients > 10 years of age) and Lansky (PS) ≥ 50% (patients ≤ 10 years of age) Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
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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): 16.0-64.0, Ulcerative Colitis Severe refractory UC patients who meets the following Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding Steroid resistant or dependent OR Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study Mild or fulminant type Renal failure patients, hepatic failure patients Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry Patients who received LCAP or GCAP within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before 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): 18.0-45.0, Escherichia Coli Infections Male or female age 18-45, inclusive Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, vital signs, screening laboratories, and medication history Capable of understanding, consenting and complying with the entire study protocol including the inpatient period Female subjects must be of non-childbearing potential, or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (e.g., oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit Male subjects must agree not to father a child during the study and for 90 days after the Day 0 study visit Provide voluntary written informed consent and attained at least 70% on an examination about the study on the first attempt Have normal screening laboratories for serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT), creatinine, sodium, potassium, total white blood count (WBC), hemoglobin, neutrophils, lymphocytes, platelets, urine protein, urine glucose and urine red blood cells (RBC) Women who are pregnant or lactating or have a positive serum pregnancy test at screening or upon admission to inpatient facility Subjects who are immunocompromised or immunodeficient, or have had a prior malignancy (exception: a history of basal cell or squamous cell carcinoma in remission without treatment for more than 5 years prior to study entry) History of clinically significant chronic illness or other condition requiring chronic medication therapy History of malabsorption or maldigestion disorder (e.g., celiac sprue), major gastrointestinal (GI) surgery, or any other chronic GI disorders that would interfere with the study or the investigational product Any current or past use of immunosuppressive medications including inhaled steroids (e.g., for asthma) within 6 months of screening Recent (e.g., within 5 years) history of travel to a cholera or Enterotoxigenic Escherichia coli (ETEC) endemic area, raised in a cholera or ETEC endemic area or a history of raising a child from an endemic area for cholera or ETEC. Individuals who may work with Vibrio (V) cholerae or ETEC in the laboratory are also excluded Vaccination against or infection with cholera or E. coli, or participation in a clinical trial using cholera or ETEC vaccine or organisms at any time History of drug or alcohol abuse any time in the last 6 months Presence of HIV antibody, hepatitis C antibody, or positive hepatitis B surface antigen Clinically abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes; for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions
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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): 13.0-70.0, Lymphoma Myeloma Leukemia Patients who have undergone an autologous stem cell transplant for the following diseases Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Age 13 years old Able to give informed consent Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal ECOG Performance Status less than or equal to 1 (at planned time of transplantation) Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have > grade 2 toxicity in any organ system) Patients who have insufficient engraftment parameters according to the following WBC < 2,500 /mm3 and platelets < 50,000/mm3 Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion Intrinsic impaired organ function (as stated above) Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance Uncontrolled, life-threatening infections at the time of infusion Concurrent treatment with corticosteroids and/or other immuno-suppressive 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): 0.0-100.0, Malaria (Cohort Study) Resident of Kandal, Ekapheap, and Sangkumthmey villages (Thmar Da commune), and no plans to leave the Thmar Da commune for the next 5 years. Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian, and willingness to come to commune health posts if he/she develops fever or other symptoms of malaria. Individuals of all ages will be enrolled (Cohort Study) Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease). Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS). (P. vivax Collection Study) P. vivax malaria (mono-infection). Willingness to participate in the study as evidenced by informed consent of subjects or his/her parent or guardian. Age greater than or equal to 2. Hematocrit greater than or equal to 25% (P. vivax Collection Study) Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease). Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS). Pregnancy. Prior use of antimalarials during the past 2 months. (Cord and Peripheral Blood Collection Study) Healthy male or female adults greater than or equal to 18 years old or healthy pregnant female adults greater than or equal to 18 years old. Willingness to participate in the study as evidenced by informed consent (Cord and Peripheral Blood Collection Study) Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease). Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS). (Collection of peripheral blood for identifying and isolating memory B cells) Healthy male or non pregnant female adults greater than or equal to 18 years old. Previous enrollment on the P. vivax collection study. Willingness to participate in the study as evidenced by written informed consent (Collection of peripheral blood for identifying and isolating memory B cells) For the follow-up blood draw (250 mL), symptomatic parasitemia with any species of Plasmodium. For the follow-up blood draw (250 mL), hemoglobin level <9 g/dL. For the follow-up blood draw (250 mL), weight <45 kg. Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric illness). Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS)
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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, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness
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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): 0.5-5.0, Incidence of Acute Diarrhea Incidence of Abdominal Pain Children 6 months to 5 years of age Presented with passage of 3 or more loose or watery stools Caretakers are willing to let their child to participate in the study Failure to produce consent Children with severe malnutrition or having chronic illness
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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): 0.0-30.0, Neonatal Jaundice Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life Rh incompatibility Those given exchange transfusion/ phototherapy within 24 h of age Major gross congenital anomaly Anticipated to require neonatal intensive care or required neonatal intensive care for more than 24 h Systemic sepsis
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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, Diarrhea Have 3 or greater liquid stools in the past 24 hours Provide written informed consent from at least one parent in the case of children under 18 years of age Provide written informed consent for those participants above 18 years of age Provide assent in the case of children 10 years of age or greater Previously enrolled in the study Parents are unwilling or unable to provide written informed consent Report using antibiotics in the last 30 days Adolescent (<18 years old) parent of a child already enrolled in the study
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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, Acute Hepatitis A Acute Hepatitis B Acute Hepatitis C Acute Hepatitis E Acute EBV Hepatitis Acute CMV Hepatitis Diagnosis of acute viral hepatitis (<1 month) as manifested by a combination of the following symptoms: jaundice, dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, aversion to smoking and right upper abdominal discomfort, pain or feeling of pressure Serum ALT level > 2.5 times the upper limit of normal Albumin level >3.5 gm/dl Negative anti-HCV antibody Males and females >= 18 years of age Subject has given written informed consent. If patient is between 18 and 21 years parents/legal guardian have/has also signed the informed consent form The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications Subjects < 18 years of age Pregnant or breastfeeding women Suspected hypersensitivity to silymarin or multivitamins Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy) Chronic liver disease as cirrhosis Subjects with positive anti-HCV antibody Simultaneous elevation of bilirubin > 10 mg/dl along with an ALT level between 100 and 150 U/L Platelets count <150,000 Subjects with morbid obesity i.e. a Body Mass Index (BMI) > 40 Subjects with severe illness, e.g., multisystem failure, cancer or poorly controlled diabetes i.e. known diabetic with Hemoglobin A1C (HbA1C)>7%
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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, Vibrio Cholerae Male or female adults aged 18-40 years and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection). 2. For females of reproductive age, they must not be pregnant (as determined by verbal screening). 3. Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 years. 4. Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator Ongoing serious chronic disease 2. Immunocompromising condition or therapy 3. Diarrhea (3 or more loose/more watery stools within a 24-hour period) 6 weeks prior to enrollment 4. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months 5. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months 6. Intake of any anti-diarrhea medicine in the past week 7. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours 8. Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC warrants deferral of the vaccination pending recovery of the subject 9. Receipt of antibiotics in past 14 days 10. Receipt of live or killed enteric vaccine in past 4 weeks 11. Receipt of killed oral cholera 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): 12.0-17.0, Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease Depression for youths with IBD for Step 1 of Screening Process Age 12 to 17 inclusive English-speaking Capable of completing CDI Meeting diagnostic for IBD Absence of mental retardation by history Having at least one appointment at the GI clinic. for Classification of IBD: 1. Presence of appropriate history: abdominal pain, chronic diarrhea, bloody diarrhea (with or without extraintestinal symptoms) or, less commonly, a) primary extraintestinal symptoms, b) growth retardation, c) perirectal abscess, or d) acute abdomen. 2. Evidence of colitis, ileitis or granulomatous esophagitis, gastritis or duodenitis by biopsy and/or small bowel strictures or fistulas by X-ray or multiple small intestinal ulcerations by capsule endoscopy. For youths with IBD for Intervention Phase of the Comparison Study 1. CDI or CDI-P > 10 at Step 1 2. Childhood Depression Rating Scale-revised (CDRS-R) > 34 at Step 2 3. Presence of at least one biological parent History or current episode of bipolar disorder, eating disorder, or psychotic disorder by Diagnostic and Statistical Manual (DSM)-IV criteria. 2. Recent suicide attempt (within 1 month of study entry) or depression severity requiring acute psychiatric hospitalization within 3 months of study entry. 3. Antidepressant medications within one month of assessment. 4. Substance abuse by history within 1 month of study entry. 5. Current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual. If currently receiving other psychotherapy modalities, willingness to suspend treatment for 12-week acute treatment phase of study. Physically Healthy Comparison Children Age 12 to 17 inclusive English-speaking Capable of completing CDI Absence of mental retardation by history self-report of a cold, flu or other infection within the past two weeks self-reported use of any antibiotics within the past 2 weeks score of 6 or more on the blood draw screening questionnaire Screening process for youths with IBD: Participants will be recruited from the clinic through a 2-step screening of all consecutive pediatric patients seen in the IBD clinic or while medically hospitalized for an IBD flare-up at Children's Hospital of Pittsburgh, who have confirmed IBD and who meet the other as determined by medical staff in IBD clinic (Tables 5 and 6). The medical diagnosis of IBD will be determined by a GI physician using below and will be confirmed in the medical record. Step 1: administration of the CDI and CDI-P during the medical visit. Those subjects whose CDI and/or CDI-P score of > 10 will be invited by phone to participate in Step 2: a face to face interview. Step 2 assessment will be conducted within one week of Step 1 so that both CDI score and IBD severity ratings are still valid from the Step 1 screen. All subjects meeting for Step 2 will be invited to participate in the completion of neuropsychiatric questionnaires, blood draw, pupil measurements, and brain functional magnetic resonance imaging. All subjects meeting after Step 2 will be invited to participate in the treatment phase of the study. Normal controls (N=15) will be recruited from the Department of Pediatrics during outpatient clinical office 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): 18.0-70.0, Healthy, no Evidence of Disease Non-smokers and non-users of abuse drugs as confirmed by urine cotinine (Accutest NicoMeter Urine Professional strip or equivalent test) and drug screen at visit 1 Free of acute, unstable, chronic or recurring medical conditions based on history, physical examination, laboratory tests; the laboratory tests to be performed will be: blood serum chemistry screen to comprehensive metabolic panel (glucose, creatinine, urea nitrogen [blood urea nitrogen (BUN)], sodium, potassium, chloride, calcium, total bilirubin, protein, albumin, globulin, cholesterol and the enzymes alkaline phosphatase, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]) and lipid panel (total, low density lipoprotein [LDL] and high density lipoprotein [HDL] cholesterol and triglycerides); complete blood count including differential and platelet count; prothrombin time; and routine urinalysis; values for laboratory tests must be within the ranges below grade 2 of Common Toxicity (CTC) and/or as specified below Hemoglobin > 10 g/dL Absolute granulocyte count > 1500/ìL Creatinine < 2.0 mg/dl Albumin > 3.0 g/dl Bilirubin < 1.8 mg/dl AST < 110 U/l ALT < 110 U/l Alkaline phosphatase < 300 U/l Subjects with serious drug allergies or other serious intolerance or allergies will be excluded; those with mild seasonal allergies will be accepted Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions Subjects with a serious acute or chronic illness (diabetes, arthritis, asthma, etc.) or requiring chronic drug therapy, who continuously take supplements or have taken an investigational drug within the past three months Subjects who have evidence of an active malignancy or have received chemotherapy, and/or antiestrogen therapy Subjects who have a life expectancy of < 12 months Subjects who have regularly taken over the past 21 days any concomitant medications, herbal products, dietary supplements or vitamins; women taking oral contraceptives will be accepted; women who are pregnant (positive urine human chorionic gonadotropin [hCG] at visit 2) or lactating will be 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): 18.0-34.0, Vaginal Delivery having first child (nulliparous) term pregnancy (> 37 weeks) vertex presentation singleton gestation ability to provide informed consent request for analgesia for labor pain birth of second or more child (multiparous) preterm pregnancy (< 37 weeks) presentation other than vertex (ie. breech, transverse) diabetic admit temperature > 99.5 active drug/alcohol dependence active genital herpes infection allergy to anesthetics used
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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): 13.0-45.0, Obesity Stress Irritable Bowel Syndrome Women Abdominal Pain To be included, patients must meet all of the following Have a history of abdominal pain for greater than 6 months Males ages 13-45 years old or females ages 13-45 years old who have had their menses for at least 2 years Provide written informed consent, prior to entering the study or undergoing any study procedures Patients with any of the following will be excluded Have a history of an organic GI disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection) cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology Are currently taking medications for GI symptoms daily such as 5-HT3 antagonists/5-HT4 agonists, prokinetic drugs, laxatives (but not fiber supplements), anti-diarrheals or antispasmodics Are currently taking other medications daily that would alter serotonin (e.g., serotonin specific reuptake inhibitors [SSRI]), catecholamines (e.g., tricycle antidepressants but not inhaled beta-agonist for mild-moderate asthma), cortisol (excluding inhaled corticosteroids) Work during the late evening and night (as cortisol levels may be altered) Severe co-morbid pain or psychiatric conditions (e.g., fibromyalgia, bipolar or psychotic disorder) Take greater than 300 mg of caffeine containing beverages or food (e.g. chocolate) in the afternoon-evening or greater than 2 servings of alcohol containing beverages everyday (decaffeinated coffee is acceptable) Are unable to give informed consent Are unable to physically use the touch screen for the purpose of the study Are visually impaired or currently institutionalized
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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): 0.583-30.0, Adult Rhabdomyosarcoma Adult Synovial Sarcoma Childhood Hepatoblastoma Childhood Synovial Sarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Adrenocortical Carcinoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Liver Cancer Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Neuroblastoma Recurrent Osteosarcoma Recurrent Retinoblastoma Recurrent Wilms Tumor and Other Childhood Kidney Tumors Histologically confirmed malignant solid tumor, including the following Osteosarcoma Ewing sarcoma/peripheral primitive neuroectodermal tumor Rhabdomyosarcoma Neuroblastoma Wilms tumor Synovial sarcoma Hepatoblastoma Adrenocortical carcinoma Retinoblastoma
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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): 12.0-17.0, Atypical Hemolytic Uremic Syndrome Male or female patients between ages from 12 and up to 18 years of age weighing ≥ 40 kg who have been diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS). 2. Patients must be receiving PT for aHUS and must be observed to receive ≥ 1 PT treatment every two weeks and no more than 3 PT treatments/week (at an unchanged frequency) for at least 8 weeks before the first dose of IP. 3. Platelet Count Pre-PT Baseline Set-Point (collected in the hours before the Qualifying PT Episode) is within 75% of the average of the pre-PT platelet counts collected at Screening and during the Observation Period. 4. Known complement regulatory protein genetic abnormality. 5. Lactate dehydrogenase (LDH) level at screening or at the onset of the current aHUS episode was ≥ ULN. If LDH is normal at screening, other markers indicative of ongoing hemolysis such as haptoglobin, schistocytes should be evaluated and discussed with Sponsor. 6. Creatinine level ≥ ULN for age. 7. Female patients of childbearing potential must be practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period and for up to 5 months following eculizumab treatment discontinuation. 8. Patient's parents/legal guardian must be willing and able to give written informed consent and patient must be willing to give written informed assent (if applicable as determined by the IRB/IEC). 9. Able and willing to comply with study procedures TTP, (defined as activity <5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory. 2. Malignancy within 5 years of screening. 3. Typical HUS (Shiga toxin +). 4. Known HIV infection. 5. Identified drug exposure-related HUS. 6. Infection-related HUS. 7. HUS related to bone marrow transplant. 8. HUS related to vitamin B12 deficiency. 9. Patients with a confirmed diagnosis of sepsis. 10. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease. 11. Pregnancy or lactation. 12. Unresolved meningococcal disease. 13. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome. 14. Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 15. Patients who have received previous treatment with eculizumab. 16. Patients receiving IVIg within 8 weeks or Rituximab therapy within 12 weeks of the screening visit. 17. Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, [2] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and [3] dose of such medications have been unchanged for at least 4 weeks prior to the screening period and throughout the Obeservation Period or [4] patient is experiencing an acute aHUS relapse immediately after transplant. 18. Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period or a washout period of at least 2 weeks from the last dose of ESA therapy. 19. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial. 20. Hypersensitivity to eculizumab, to murine proteins, or to one of the excipients. 21. Patients between the ages from 12 and up to 18 years weighing < 40 kg
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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): 12.0-17.0, Atypical Hemolytic Uremic Syndrome Male or female patients from 12 and up to 18 years weighing ≥ 40 kg who have been diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS). 2. Decrease in platelet count despite at least 4 plasma therapy (PT) treatments in the 1 week immediately prior to screening. 1. Screening platelet count , < 150 x10^9/L and at least 25% lower than the average remission platelet count or 2. If remission counts not available, platelet count at onset of the current aHUS episode must be ≤75x10^9/L and platelet count at screening must be ≤ 100 x 10^9/L despite PT treatment administration of at least 4 PT treatments in the 1 week immediately prior to screening 3. Known complement regulatory protein genetic abnormality 4. Lactate dehydrogenase (LDH) level ≥ ULN unless the patient has been receiving plasma exchange and LDH at the onset of the current aHUS episode was at least the ULN. If LDH is normal at screening, other markers indicative of ongoing hemolysis such as haptoglobin, schistocytes should be evaluated and discussed with Sponsor 5. Creatinine level ≥ ULN for age 6. Female patients of childbearing potential must be practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period and for up to 5 months following of eculizumab treatment discontinuation. 7. Patient's parents/legal guardian must be willing and able to give written informed consent and patient must be willing to give written informed assent. 8. Able and willing to comply with study procedures TTP, (defined as activity <5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory 2. Malignancy within 5 years of screening. 3. Typical HUS (Shiga toxin +). 4. Known HIV infection. 5. Identified drug exposure-related HUS. 6. Infection-related HUS. 7. HUS related to bone marrow transplant 8. HUS related to vitamin B12 deficiency 9. Renal function status requiring chronic dialysis 10. Patients with a confirmed diagnosis of sepsis 11. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease. 12. Pregnancy or lactation. 13. Unresolved meningococcal disease. 14. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome. 15. Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 16. Patients who have received previous treatment with eculizumab 17. Patients receiving IVIG within 8 weeks or Rituximab therapy within 12 weeks of screening. 18. Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, [2] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and [3] dose of such medications have been unchanged for at least 4 weeks prior to the screening period or [4] patient is experiencing an acute aHUS relapse immediately after transplant 19. Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period or a washout period of at least 2 weeks from the last dose of ESA therapy. 20. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial. 21. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients 22. Patients between ages from 12 and up to 18 years weighing < 40 kg
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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, Gallstone Pancreatitis All adults are included between the age of 18 and 100 with mild to moderate gallstone pancreatitis A subject is classified as having gallstone pancreatitis if they had the following: 1. upper abdominal pain, nausea, vomiting and epigastric tenderness; 2. absence of ethanol abuse; 3. elevated amylase level to at least twice the upper limit of normal and elevated lipase level to at lease three times the upper limit of normal; and 4. imaging confirmation of gallstones The classification of mild to moderate pancreatitis is defined by the presence of the following: 1. three or fewer Ranson's on admission: age > 55 years, glucose > 200 mg/dL , LDH> 350 mg/dL, AST > 250 units/L, and WBC>16 K/mm3; 2. clinical stability with admission to a non-monitored ward bed; 3. absence of acute cholangitis: defined as a temperature >38.6°C, right upper quadrant pain and tenderness, and significant hyperbilirubinemia; and 4. low suspicion for a retained common bile duct (CBD) stone (total bilirubin <4 mg/dl on admission) Severe pancreatitis (as defined by the presence of more than three Ranson's on admission) Suspected concomitant acute cholangitis High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg/dl on admission or ultrasound demonstration of CBD stone) Patient refusal to participate Severe preexisting medical comorbidities contraindicating cholecystectomy (as determined by the primary physicians) Pregnancy Prior gastric bypass surgery (making ERC difficult ) Admission to a monitored unit. The need for admission to a monitored bed is determined by the admitting surgeon and is guided primarily by a need for aggressive fluid administration as demonstrated by severe volume depletion (e.g., admission tachycardia >110 beats/minute, blood urea nitrogen > 15 mg/dl) or evidence of cholangitis
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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): 6.0-999.0, Hemophilia A Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively) Subjects with previous exposure to FVIII replacement therapy If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200/µL within 6 months of study entry Diagnosed with any bleeding disorder in addition to hemophilia A Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory) Subject has no history of exposure to FVIII products (previously untreated patient [PUP]) Subject is currently utilizing primary FVIII prophylaxis Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation Subjects with a known hypersensitivity to hamster protein Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >5 x upper limit of normal [ULN], bilirubin >2 mg/dL or serum creatinine >1.25 x ULN) Prothrombin Time >1.5 x ULN
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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, Travelers' Diarrhea passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted is > 18 years of age has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness has acute diarrhea less than 1 week's duration willingness to provide a diarrhea stool sample willingness to keep a daily diary for 5 days signed informed consent fever or bloody diarrhea has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline) is pregnant now, likely to become pregnant, or breast-feeding has duration of diarrhea of greater than 1 weeks is allergic to Rifampin or Rifaximin has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder is more than moderately dehydrated
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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, E Coli Infections patients with E. coli infections at UPMC not meeting entry
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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): 16.0-999.0, Cryptococcal Meningitis HIV Infections Step 1 CM documented either by a positive CSF cryptococcal culture, a positive CSF India ink preparation, or a positive CSF cryptococcal antigen latex agglutination test within 7 days prior to entry. More information on this criterion can be found in the protocol CSF collection for quantitative cryptococcal culture within 72 hours prior to study entry or planned to be performed at study entry HIV-1 infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by or within 10 days after study entry by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, by HIV-1 antigen, or by plasma HIV-1 RNA viral load. More information on this criterion can be found in the protocol Ability to take oral medications. NOTE: Administration of fluconazole tablets via nasogastric tube is permitted For patients with a co-morbid complication of HIV, including opportunistic infections, reasonable certainty that the site investigator will be able to perform CSF sampling and manage expected study drug toxicities. More information on this criterion can be found in the protocol For female participants of reproductive potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months [i.e., who have had menses within the preceding 24 months, or have not undergone surgical sterilization, for example, a hysterectomy, or bilateral oophorectomy or salpingotomy]) a negative serum or urine pregnancy test result must be obtained within 2 days prior to study entry All participants must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) If participating in sexual activity that could lead to pregnancy, female study participants must agree to the simultaneous use of two forms of contraception (listed in protocol) during sexual activity, and male study participants must agree to use a condom during such sexual activity. This requirement continues while the study participant is on study treatment and for 6 weeks after fluconazole has been discontinued. More information on this criterion can be found in the protocol Study participants who are not of reproductive potential (defined as women who have been post-menopausal for at least 24 consecutive months, women who have undergone surgical sterilization [e.g., hysterectomy, or bilateral oophorectomy or salpingectomy], or men who have documented azoospermia) are eligible without the requirement to use contraceptives. More information on this criterion can be found in the protocol Step 1 Expected survival of 2 weeks or less, in the opinion of the site investigator and, if available, the primary care provider For patients with a comorbid complication of HIV, anticipated difficulty, in the opinion of the site investigator, in judging response to study treatment as a result of the comorbid complication or the drugs used to treat it Breastfeeding A prior episode of CM, either as indicated by patient or as noted in patient medical records Use of certain drugs within specified time periods. More information on this criterion can be found in the study protocol For candidates who are currently taking nevirapine, the inability to discontinue nevirapine and replace it with a drug that does not have fluconazole drug interactions at or by study entry in the event they are randomized to a high-dose fluconazole treatment arm. More information on this criterion can be found in the study protocol Known allergy, sensitivity to, or intolerance of fluconazole or other imidazole or triazole compounds or to ampho B or other components of the standard of care ampho B based regimen History of clinically significant cardiac disease, in the opinion of the site investigator, including symptoms of ischemia, coronary artery disease, congestive heart failure, or arrhythmia ECG with QTc interval greater than 450 msec within 7 days prior to study entry. More information on this criterion can be found in the study protocol
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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, May-Hemalin Fechtner Syndrome (Disorder) Epstein Syndrome (Disorder) MYH9 Related Disorders Thrombocytopenia with large/giant platelets (macrothrombocytopenia=MT) 2. and at least one of the following chronicity of the MT or MT at least found at 2 successive examinations Leukocyte inclusions in polymorphonuclear neutrophils Juvenile sensorineural hearing loss Nephritis Presenile cataracts Familial cases with bleeding disorder associated at least with one of the following symptoms: thrombocytopenia, nephritis, cataracts, deafness, leukocyte inclusions in polymorphonuclear neutrophils 3. Patient who has given his consent 4. Patient who has a social insurance - Other proven constitutional macrothrombocytopenia
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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): 2.0-25.0, Childhood Central Nervous System Choriocarcinoma Childhood Central Nervous System Embryonal Tumor Childhood Central Nervous System Germ Cell Tumor Childhood Central Nervous System Germinoma Childhood Central Nervous System Mixed Germ Cell Tumor Childhood Central Nervous System Teratoma Childhood Central Nervous System Yolk Sac Tumor Metastatic Childhood Soft Tissue Sarcoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Central Nervous System Embryonal Tumor Recurrent Childhood Soft Tissue Sarcoma Recurrent Childhood Visual Pathway Glioma Unspecified Childhood Solid Tumor, Protocol Specific Diagnosis of 1 of the following: NOTE: Histologic confirmation not required for intrinsic brain stem cell tumor, optic pathway gliomas, pineal tumors and elevations of cerebrospinal fluid, and serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin Histologically confirmed relapsed or refractory solid tumors at original diagnosis including CNS tumors* (Part 1 and Part 2a) Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week Histologically confirmed soft tissue sarcoma, desmoplastic small round cell tumor, or extraosseus Ewing sarcoma at original diagnosis including the following (Part 2b) Tumor in the head, neck, or extremity or fixed within the abdomen or pelvis that it is not sensitive to motion artifact No isolated pulmonary metastases Disease with no known curative therapy or no therapy proven to prolong survival with acceptable quality of life Measurable or evaluable disease (Part 1 and Part 2a) Measurable tumor that is ≥ 2 cm in its longest diameter (Part 2b) Patients must be
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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): 0.5-2.0, Diarrhea Sex: male 2. Age: 6 months 3. Better nourished (weight for age > 60 NCHS median) 4. H/o. diarrhea of less than 48 hours 5. Written informed consent from either parents/guardian (thumb impression for those who are not literate) for children 6. Negative test results for dark field microscopy of Vibrio cholerae and ELISA test for rotavirus in initial stool samples Systemic infection requiring antibiotic treatment 2. Severe malnutrition (W/A < 60%) 3. Unwilling to comply with study procedures 4. Currently participating or have participated in another clinical trial within the last 4 weeks at screening 5. Clinically significant abnormalities from medical history, physical examination, vital signs, haematology, clinical chemistry results, or other laboratory abnormalities 6. Clinically suggestive of invasive diarrhea
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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): 1.0-21.0, Relapsed Acute Myelogenous Leukemia Age: patients must be ≥ 1 and ≤ 21 years of age at the of study entry Diagnosis Patients must have a diagnosis of first or second relapse or refractory acute myelogenous leukemia (AML) according to WHO classification with ≥ 5% blasts in the bone marrow, with or without extramedullary disease Patients may have CNS 1 or CNS 2 disease but not CNS 3 Performance Level: Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ≤ 16 years of age Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patient has not received more than 2 previous induction attempts. (Frontline therapy is included in this count) Patients must have adequate venous access At least 1 year must have elapsed since hematopoietic stem cell transplant (HSCT) and patients must not have active GVHD Patients with Down Syndrome Prior treatment with Clofarabine Previous history of veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin > 1.4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy Patients who have a history of cirrhosis of the liver or who are positive for hepatitis B core antibody (anti-HBc) or have a positive test for hepatitis C antibody (anti-HCV) Patient has received TBI If it has been less than 1 year since the patient had a HSCT Infection Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) Positive blood culture within 48 hours of study registration Patient required supplemental oxygen or vasopressors within 48 hours of study (Oxygen after anesthesia for procedures is ok)
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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, Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Malignant Solid Neoplasm Recurrent Neuroblastoma Refractory Anaplastic Large Cell Lymphoma Refractory Malignant Solid Neoplasm Refractory Neuroblastoma Patients receiving the formulated capsules must have a body surface area (BSA) >= 0.63 m^2 at the time of study enrollment Patients must have had histologic verification of malignancy at original diagnosis or relapse * Phase 1 (Part A1) Patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (excluding patients with primary or metastatic central nervous system [CNS] tumors or patients with primary cutaneous ALCL) * Phase 1 (Part A2) Patients with confirmed ALK fusion proteins, ALK mutations, ALK amplification (defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm) or MET proto-oncogene, receptor tyrosine kinase (MET) mutation or amplification; testing to confirm the presence of ALK fusion proteins, ALK mutations, ALK amplification or evidence of MET mutation or amplification for purposes must be performed as a Clinical Laboratory Improvement Act (CLIA)-certified assay; ALK immunohistochemistry can be used as a surrogate for fluorescent in situ hybridization (FISH) for patients with inflammatory myofibroblastic tumors (IMT) or ALCL ** Note: Evidence for MET mutation or amplification is defined as Positive for c-Met amplification by FISH; or Positive for known c-Met kinase domain activating mutations including V1110L, H1112L, H1112Y, H1124D, M1149T, T1191I, V1206L, L1213V, V1238I, M1268T, P1009S, T1010I, R988C, V941L, but excluding Y1248C, Y1248H, Y1248D, and Y1253D; or Chromosomal translocations that lead to altered transcriptional regulation of c-Met and/or hepatocyte growth factor (HGF) including metastatic alveolar soft part sarcoma, clear cell sarcoma, rhabdomyosarcoma, or translocation associated renal cell carcinoma) Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method 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 anti-cancer agents, with the exception of hydroxyurea for patients with ALCL, are not eligible As Crizotinib is an inhibitor of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to, ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed Patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, tipranavir, ritonavir, and St. John's wort are not eligible; the topical use of these medications (if applicable) is allowed Patients with known interstitial fibrosis or interstitial lung disease are not eligible Patients with a known history of myocardial infarction or cerebrovascular accident are not eligible Patients with central nervous system (CNS) tumors or known CNS metastases are not eligible; patients with a history of CNS metastases that have been surgically resected are eligible only if the baseline evaluation shows no evidence of current CNS metastases; patients with any evidence of CNS metastases on baseline evaluation are not eligible, regardless of whether the lesions have been previously treated and/or appear stable
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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): 0.0-31.0, Kaposiform Hemangioendotheliomas Tufted Angioma Capillary Venous Lymphatic Malformation Venous Lymphatic Malformation Microcystic Lymphatic Malformation Mucocutaneous Lymphangiomatosis and Thrombocytopenia Capillary Lymphatic Arterial Venous Malformations PTEN Overgrowth Syndrome With Vascular Anomaly Lymphangiectasia Syndromes will be strictly limited to children and young adults with vascular anomalies with complications that require systemic therapy for control. Diagnosis: All patients must have one of the following vascular anomalies as determined by clinical, radiographic and histologic (when possible) Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon Kaposiform Hemangioendotheliomas without Kasabach-Merritt Phenomenon Tufted Angioma with Kasabach-Merritt Phenomenon Tufted Angioma without Kasabach-Merritt Phenomenon Capillary Lymphatico-Venous Malformation (CLVM) Venous Lymphatic Malformation (VLM) Microcystic Lymphatic Malformation (MLM) Multifocal Lymphangiomatosis and Thrombocytopenia (MLT)/Cutaneovisceral Angiomatosis and Thrombocytopenia (CAT) Capillary Lymphatic Arterial Venous Malformations (CLAVM) Dental braces or prosthesis only if it interferes with radiologic analysis of vascular anomaly Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration) Chronic treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Patients with the diagnosis of a vascular tumor (KHE, TA) can be on a weaning dose of steroids Patients who require medications that inhibit/induce CYP3A4 enzyme activity to control concurrent medical conditions Known history of HIV seropositivity or known immunodeficiency. Testing is not required unless a condition is suspected Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sirolimus (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A gastric tube or nasogastric tube is allowed Women who are pregnant or breast feeding Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter. Abstinence is an acceptable method of birth control. Women of childbearing potential will be given a pregnancy test within 7 days prior to administration of sirolimus and must have a negative urine or serum pregnancy test Patients who have received prior treatment with an mTOR inhibitor Patients unwilling or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring 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): 15.0-80.0, Gall Bladder Stone in Cirrhotics patients with liver cirrhosis with symptomatic gall bladder stone patients above 80 years old patients with history of upper laparotomy patients with common bile duct stones and pregnant females
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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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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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): 0.25-3.0, Diarrhea Children 3-36 months old seen in the pediatrician offices presenting acute diarrhea lasting less than 48 h are considered eligible for the study Diarrhea lasting more than 48 h Malnutrition as judged by a body weight/height ratio below the 5th percentile Clinical signs of severe dehydration Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia) Immunodeficiency Underlying severe chronic disease Malnutrition Cystic fibrosis Food allergy or other chronic gastrointestinal diseases Use of pre/probiotics in the previous 3 weeks
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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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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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, FEVER The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department- both boys and girls of all ages. A patient might be measured several times 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): 1.0-45.0, Healthy Age: 12-23 months for younger children group, 2-5 years for the toddler group and 18-45 years for the adult group. 2. Sex: Either 3. Consent: Written informed consent from study participants and parents in case of children. 4. Compliance to study procedures: e.g. available for follow-up visits and agrees to specimen collection. 5. Apparently healthy: as determined by medical history, physical examination findings, and clinical judgment of the study physician Chronic disease: history or evidence of chronic illness. 2. Gastrointestinal symptoms such as abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours or abdominal pain lasting for more than 2 weeks in the past 6 months 3. Intake of any anti-diarrheal medicine or antimicrobial therapy the past week. 4. Acute disease one week prior to enrollment, with or without fever ≥38ºC . 5. Receiving of cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks. 6. Diarrhea within 6 week period at screening
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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): 3.0-21.0, Adrenocortical Carcinoma Gastrointestinal Carcinoid Tumor Kidney Cancer Neuroblastoma Retinoblastoma Sarcoma Histologically confirmed diagnosis of 1 of the following Neuroblastoma Rhabdomyosarcoma Wilms tumor Retinoblastoma Adrenocortical carcinoma Carcinoid tumor Relapsed or refractory disease Measurable or evaluable disease No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
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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, Diabetic Foot Ulcers Foot Wounds The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart Subjects 18 years of age or older. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the investigator, will not interfere with the study assessments Willing to make all required study visits Able to follow instructions and perform the dressing changes at home, or, have a caregiver who can perform the dressing changes according to the protocol Willing to use the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase A history of Type I or Type II Diabetes Mellitus requiring insulin or oral hypoglycemic medications to normalize blood glucose levels. A foot wound which is Superficial, involving the full skin thickness but not underlying tissues and is 0.5 cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided) Chronic, defined as open for 30 days On a neuropathic foot, defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area Adequately perfused, defined as TcPO2 > 40 mmHg; or toe pressure > 40 mmHg, or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels) Target wound does not require debridement, or is covered with dry eschar Uncontrolled bleeding disorder Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia) Any of the following Target wound tunneling per probing and visual assessment Osteomyelitis of the target foot or wound probes to bone Target wound is on the heel Target wound is over a Charcot deformity which cannot be offloaded
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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, HIV Infections Raltegravir cohort patients: From the Danish HIV Cohort Study (DHCS) we included all HIV-1 positive patients, who 1. started raltegravir after 1 January 2006 and before 1 July 2009, 2. had been treated with HAART previously 3. had at least two VL tests done prior to initiation of raltegravir treatment, 4. had virological failure prior to start of raltegravir and 5. did not participate in randomized clinical trials on raltegravir. Virological failure was defined as VL > 500 copies/ml in the two latest VL tests prior to raltegravir initiation while on HAART treatment Control cohort patients: From DHCS we identified a control cohort of HIV infected patients who started HAART for the first time after 1 January 2006 and before 1 July 2009. From this population we extracted two control patients for each raltegravir patient, each matched by gender, race (Caucasian, Black and other), route of HIV infection (homosexual, heterosexual, injection drug user (IDU) and other) and age (intervals of < 20 years, 20 to 30 years, 30 to 40 years, > 50 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): 12.0-999.0, Clostridium Difficile Patients older than 12 months of age Having diarrhea Inadequate volume of sample to perform all three diagnostic tests (less than 3mL Formed stools
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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, Intraabdominal Infections Hospitalized males or females 3 months to 17 years of age Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following Gross peritoneal inflammation with purulent exudate within the abdominal cavity Intra-abdominal abscess Macroscopic intestinal perforation with diffuse peritonitis OR Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain) Presumed spontaneous bacterial peritonitis All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination Infections originating from the female genital tract Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled Congenital or documented acquired QT prolongation Receiving concomitant treatment with QT prolonging drugs History of tendon disease/disorder related to quinolone treatment Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel 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): 18.0-75.0, Irritable Bowel Syndrome Adult male or female, aged ≥18 and ≤75 years old Subject/ legal representative is able to understand and sign informed consent form Have abdominal pain severity defined as weekly average of "worst abdominal pain in past 24 hours" score of ≥ 3.0 on a 0 to 10 point scale during the second week of the Baseline phase Have IBS-D according to Rome III and ≥25% of stools on the BSS rated as 6 or 7 during the Baseline phase Not pregnant, lactating, or breastfeeding If a female of childbearing potential, the subject must agree to remain abstinent or practice two medically acceptable forms of contraception during the screening, baseline, treatment, and withdrawal periods. Acceptable forms of contraception oral contraception, intrauterine devices, implantable devices, and barrier methods. If a barrier method is chosen, a double barrier is required Discontinue all medications used to treat IBS symptoms (prescription and non-prescription) and prescription analgesics at least two (2) weeks prior to the start of the baseline period until after the final study visit. (Final study visit occurs two (2) weeks after the last dose of study medication.) Acetaminophen may be used as a rescue medication as long as it is carefully documented on the Case Report Form (CRF). Fiber supplements are permitted if they are taken at the same frequency and amount throughout the study and were taken during the four (4) weeks prior to the Baseline phase. This must be documented in the source document file and the CRF Willing and able to comply with all study-related procedures, including not incorporating significant changes in diet Positive for fecal ova and parasites (O&P) or Clostridium difficile (ELISA) or other bacterial pathogens (standard stool culture) during the Screening phase Taking medication for the treatment of IBS during the baseline phase (other than acetaminophen) Taking any treatment for IBS including any of the following classes of medications within 2 weeks prior to baseline visit (Visit 2), or at any point during the study Antispasmodic or anticholinergic agents Combination products including atropine, hyoscyamine, phenobarbital, and/or scopolamine Antidepressants (such as monoamine oxidase inhibitors [MAOI], selective serotonin reuptake inhibitors [SSRIs], and tricyclic antidepressants), to but not limited to the following Combination products including pheniramine, phenyltoloxamine, or pyrilamine Laxatives Opioids/narcotic analgesics Phenothiazines antipsychotics and anti-emetics
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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, Childhood Atypical Teratoid/Rhabdoid Tumor Childhood Central Nervous System Choriocarcinoma Childhood Central Nervous System Germinoma Childhood Central Nervous System Mixed Germ Cell Tumor Childhood Central Nervous System Teratoma Childhood Central Nervous System Yolk Sac Tumor Childhood Choroid Plexus Tumor Childhood Craniopharyngioma Childhood Ependymoblastoma Childhood Grade I Meningioma Childhood Grade II Meningioma Childhood Grade III Meningioma Childhood Infratentorial Ependymoma Childhood Medulloepithelioma Childhood Mixed Glioma Childhood Oligodendroglioma Childhood Supratentorial Ependymoma Gonadotroph Adenoma Pituitary Basophilic Adenoma Pituitary Chromophobe Adenoma Pituitary Eosinophilic Adenoma Prolactin Secreting Adenoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Central Nervous System Embryonal Tumor Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Ependymoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Medulloblastoma Recurrent Childhood Pineoblastoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Childhood Spinal Cord Neoplasm Recurrent Childhood Subependymal Giant Cell Astrocytoma Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor Recurrent Childhood Visual Pathway and Hypothalamic Glioma Recurrent Childhood Visual Pathway Glioma Recurrent Pituitary Tumor Recurrent/Refractory Childhood Hodgkin Lymphoma T-cell Childhood Acute Lymphoblastic Leukemia T-cell Large Granular Lymphocyte Leukemia TSH Secreting Adenoma Unspecified Childhood Solid Tumor, Protocol Specific Histologically confirmed malignancy (at diagnosis or relapse) Biopsy not required for intrinsic brain stem tumors or optic pathway gliomas No B-cell precursor acute lymphoblastic lymphoma (ALL) or acute myeloid leukemia No T-cell leukemia with CNS3 disease Measurable or evaluable disease Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Neurologic deficits in patients with CNS tumors must have been relatively stable for 1 week No active CNS leukemia Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age) Patients who are unable to walk because of paralysis,but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the PS
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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): 60.0-80.0, Lymphoma Diffuse Large B-cell Lymphoma Ages Eligible for Study: Between 60 and 80 years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No For patients registered at the time of initial diagnosis Patient with histologically proven CD20+ diffuse large B cel (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable previous untreated with chemo or radiotherapy For patients registered after response evaluation to first line treatment with R-CHOP Patient with histologically proven CD20+ diffuse large B cell (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimens and up to 8 cycles of R-CHOP21 Previously untreated with Radiotherapy For all patients aged from 60 to 80 years at time of registration Ann Arbor stages II-IV at time of initial diagnosis aaIPI> 1 at time of initial diagnosis Any other histological type of Lymphoma, Burkitt included Any history of treated or non treated small B-cell lymphoma Central nervous system or meningeal involvement by lymphoma Contraindication to any drug contained in the chemotherapy regimen Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV Uncontrolled hypertension Uncontrolled diabetes mellitus as defined by the investigator Active systemic infection requiring treatment previously known HIV positive serology Active hepatitis B or C Prior history of malignancies other than lymphoma within 3 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): 18.0-60.0, Irritable Bowel Syndrome Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool history of weight loss or rectal bleeding history of psychiatric illness (severe depression, mania and schizophrenia) history of active infection recent antibiotic therapy or anti-inflammatory medication
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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): 0.083-0.583, Hydronephrosis Urinary Tract Infection Infants with AHN (one to seven months of age) confirmed postnatally with renal-bladder ultrasound and/or a dilated ureter ≥ 7mm 2. SFU grade III and IV AHN (high grade hydronephrosis) 3. Patients without grades II to V VUR determined by voiding cystogram (includes UPJO-like and primary megaureter (hydroureteronephrosis) only); 4. Parent or legal guardian able to give free and informed consent Infants with grades II to V VUR 2. Infants with posterior urethral valves or Prune-Belly syndrome 3. Duplication anomalies (ureteroceles, ectopic ureters) 4. Other conditions that may require chronic use of antibiotics 5. Previous renal failure 6. Allergy to trimethoprim 7. Co-enrollment in another intervention 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): 18.0-45.0, Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive 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 45 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), aspartate aminotransferase (AST), prothrombin time (PT), partial thromboplastin time (PTT), International Normalized Ratio (INR), C-reactive protein (CRP), and fibrinogen as defined in Appendix B Have normal screening laboratories for urine protein and urine glucose Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Capable of understanding, consenting and complying with the entire study protocol including the inpatient period 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 vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit. Male subjects must agree not to father a child for 90 days after the Day 0 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 Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine 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 administration of dmLT Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies Have a positive urine drug screen Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay History of antimicrobial treatment in the 2 weeks before ingestion of dmLT 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): 1.0-21.0, Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Unspecified Childhood Solid Tumor, Protocol Specific Histologically confirmed diagnosis of one of the following Relapsed or refractory extracranial solid tumor Relapsed or refractory leukemia At least 25% blasts in the bone marrow (M3) with the exception of patients with acute myeloid leukemia (AML), who must have > 20% blasts in the bone marrow Relapsed or refractory myeloproliferative neoplasm (MPN) At original diagnosis or relapse Current diagnostic for MPNs polycythemia vera, essential thrombocythemia, juvenile myelomonocytic leukemia, myelofibrosis, and atypical chronic myeloid leukemia Relapsed or refractory leukemia or MPN that have confirmed JAK mutations and/or positive TSLPR surface staining Testing for JAK mutations and/or confirmed positive flow cytometry surface staining for the thymic stromal lymphopoietin receptor (TSLPR; encoded by CRLF2); for part C will be contingent upon patients demonstrating overexpression of CRLF2 by flow cytometric methods measured at either JHU or U. Washington flow laboratories (therefore, pre-enrollment samples need to be sent to one of these laboratories after discussion with Dr. Loh) or if the patient has a CLIA lab documented alteration in JAK1 or JAK2, SH2B3, IL7RA, or another gene that would predict sensitivity to JAK inhibition Measurable or evaluable disease (for patients with solid tumors)
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