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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, Gastroenteritis ≥3 episodes of vomiting or diarrhea in preceding 24 hours Duration of illness less than 96 hours Age 6 months Clinical suspicion of acute intestinal infectious process Weight ≥ 8 kg Clinical dehydration score < 5 Capillary refill < 2 seconds Absence of bulging fontanelle Absence of bilious vomiting Known gastrointestinal diseases (ie. inflammatory bowel disease, celiac) or any other underlying disease process that might place the child at an increased risk of treatment failure Age < 6 months Weight < 8 kg If premature, corrected gestational age < 30 weeks Presence of hematochezia Responsible physician judges the child requires immediate intravenous rehydration English language is so limited that consent and/or follow-up is not possible Non-Ontario resident [Canadian Institute for Health Information (CIHI) follow-up data will not be available]
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-18.0, Atypical Hemolytic-Uremic Syndrome Patient's parent/legal guardian must have been willing and able to give written informed consent and the patient must have been willing to give written informed assent (if applicable as determined by the central IRB/IEC). 2. Pediatric patients with aHUS: Patients could have been newly diagnosed, or with previously diagnosed disease, or post-kidney transplant with the disease. 3. Patients one month to 18 years and body weight ≥ 5kg. 4. Platelet count at screening and baseline visit must have been below lower limit of normal (<LLN). If screening visit and baseline visit are combined into one day, an additional platelet count value obtained at least 24 hours before screening/baseline sample must also be <LLN. 5. Exhibited signs or symptoms of hemolysis at start of current aHUS event (i.e., lactate dehydrogenase (LDH) ≥1.5 x Upper Limit of Normal [ULN] and hemoglobin ≤LLN), fragmented RBC with a negative Coombs test. 6. Serum Creatinine level ≥97 percentile for age at screening (patients requiring dialysis for acute renal failure are also eligible). 7. Patients with aHUS due to complement regulatory protein genetic abnormality or anti-complement factor antibody or those in whom known etiologies of hemolytic uremic syndrome (HUS) have been ruled out as confirmed in the 8. Patients must have been vaccinated against N. meningitidis, pneumococcus and haemophilus (per the vaccine label) at least 14 days prior to study drug initiation or otherwise be protected by prophylactic antibiotics. Patients under age two years were to receive antibiotic prophylaxis throughout the treatment period. 9. Female patients of childbearing potential (female patients who have achieved menarche) must have been practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period. At the time of the last follow-up visit, patients must have agreed to continue to use adequate contraception methods for up to five months following discontinuation of eculizumab treatment. 10. Able and willing to comply with study procedures Any of the following was regarded as a criterion for from the study: 1. Known familial deficiency (ADAMTS-13 <5%). 2. Shiga toxin E.coli-related hemolytic uremic syndrome (STEC-HUS [known Shiga toxin + E.coli]). 3. History of malignancy within five years of screening. 4. Known human immunodeficiency virus (HIV) infection. 5. Identified drug exposure-related HUS. 6. Infection-related HUS. 7. HUS related to bone marrow transplant (BMT). 8. HUS related to vitamin B12 deficiency. 9. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome. 10. Plasma Therapy for >5 weeks prior to enrollment. 11. Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage renal disease [ESRD]). 12. Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within seven days of the screening visit and not treated with antibiotics to which the organism is sensitive. 13. 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. 14. Pregnancy or lactation. 15. History of meningococcal/pneumococcal/gonococcal disease. 16. 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. 17. Patients receiving chronic intravenous immunoglobulin (IVIg) within eight weeks unless for unrelated medical condition (e.g., Hypogammaglobinemia), or chronic Rituximab therapy within 12 weeks of the screening visit. 18. Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors, calcineurin inhibitors (e.g., cyclosporine or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, or [2] patient has confirmed anti-Complement Factor antibodies antibody requiring immunosuppressive therapy or [3] steroids are being used for a condition other than aHUS (example asthma). 19. Participation in any other investigational drug trial or device trial, or procedures beginning four weeks prior to screening and throughout the entire trial 20. Prior use of eculizumab, hypersensitivity to eculizumab, to murine proteins or to one of the excipients
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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, Healthy Volunteers MAIN STUDY Age greater than or equal to 18 years No known active medical conditions Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide) ALT or AST more than 1.5 times the upper limit of normal Positive urine pregnancy test Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures Body weight less than 50 kg Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on oral glucose tolerance testing) Glycosuria PILOT STUDY Age 6-12 years at enrollment
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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): 18.0-85.0, Traveler's Diarrhea Signed informed consent Men or women between 18 and 85 years of age History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours) Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency) Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control Residency in any country with high incidence rate of TD within the past 6 months Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment) Known or suspected infection with non-bacterial pathogen Presence of diarrhoea of >72 hours duration Presence of grossly bloody stool Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin) History of inflammatory bowel disease or celiac disease
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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 Acute Leukemias of Ambiguous Lineage Acute Myeloid Leukemia/Transient Myeloproliferative Disorder Acute Undifferentiated Leukemia Aggressive NK-cell Leukemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm Childhood Burkitt Lymphoma Childhood Chronic Myelogenous Leukemia Childhood Diffuse Large Cell Lymphoma Childhood Grade III Lymphomatoid Granulomatosis Childhood Immunoblastic Large Cell Lymphoma Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia Intraocular Lymphoma Juvenile Myelomonocytic Leukemia Mast Cell Leukemia Myeloid/NK-cell Acute Leukemia Noncutaneous Extranodal Lymphoma Post-transplant Lymphoproliferative Disorder Primary Central Nervous System Hodgkin Lymphoma Primary Central Nervous System Non-Hodgkin Lymphoma Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Patients must have a body surface area > 0.5 m^2 when enrolling on dose levels 0 or 1 of the every other day schedule; no body surface area (BSA) restrictions apply to patients enrolling on higher dose levels; no BSA restrictions apply to patients enrolling on any dose level of the weekly schedule Diagnosis Part A (both schedules): Patients must have a diagnosis of recurrent or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) Part B (both schedules): Patients must have a diagnosis of recurrent or refractory leukemia Disease status Solid tumors: Patients must have either measurable or evaluable disease Leukemia: Patients must have >= 5% blasts in the bone marrow; active extramedullary disease (except for leptomeningeal disease) may also be present Patient's 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 Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; note: neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy 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 anticancer agents are not eligible [except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy]; patients with leukemia may receive intrathecal therapy Patients must not be receiving enzyme-inducing anticonvulsants Patients receiving insulin or growth hormone therapy are not eligible Patients on medications that may cause corrected QT (QTc) interval prolongation are not eligible Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post transplant are not eligible for this trial Patients must be able to swallow whole tablets; nasogastric or G tube administration is not allowed Patients who have an uncontrolled infection are not eligible
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-999.0, Cholera Diarrhoea Vibrio Infection Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 will be recruited in Kolkata Males or non-pregnant females aged 18 years and above 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) Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 years Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Ongoing serious chronic disease For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day) Diarrhea (3 or more loose/watery 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-diarrhea 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 ≥38ºC warrants deferral of the vaccination pending recovery of the subject Receipt of immunoglobulin or any blood product during the past 3 months
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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, Brain Stem Glioma Cerebral Astrocytoma Childhood Cerebellar Anaplastic Astrocytoma Childhood Cerebral Anaplastic Astrocytoma Childhood Spinal Cord Neoplasm Newly diagnosed high-grade glioma Anaplastic astrocytoma Glioblastomamultiforme Gliosarcoma Primary spinal cord malignant glioma allowed No oligodendroglioma oroligoastrocytoma Patient must have histological verification of diagnosis No M+ disease (defined as evidence of neuraxis dissemination) No positive CSF cytology ECOG performance status (PS) 0-2
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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, Intestinal Disease Feeding Disorder Neonatal Birth gestational age (GA) between 25 and 32 weeks Corrected gestational age less than 34 weeks Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours: 1. Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness 2. Visible enlarged bowel loops with abdominal tenderness 3. Recurrent emesis leading to withhold feeds 4. Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth 5. Visible blood in stools without anal etiology Documented informed consent for participation in the study Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart) NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels) Major congenital malformation Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded) Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2 Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment Intraventricular Haemorrhage grade 3 or 4 Hypernatremia ≥ 150 mmol/L
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-18.0, Shiga Toxin Producing Bacterial Infection Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening (signature of the informed consent). 2. Detection of Shiga toxin (Stx1 and/or Stx2) in stool Laboratory findings compatible with development of at least two out of three following that define Hemolytic Uremic Syndrome (HUS): Hemolytic Anemia: hematocrit < 30% with evidence of hemolysis (as indicated by Lactate Dehydrogenase (LDH) above the upper limit of normal for age or the finding of schistocytes on peripheral smear); Thrombocytopenia: platelet count <150 x 103/uL; Nephropathy: serum creatinine > Upper Limit Normal (ULN) adjusted for age and gender. 2. Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases. 3. Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). 4. History of chronic/recurrent hemolytic anemia or thrombocytopenia
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Irritable Bowel Syndrome Presence of diarrhea predominant irritable bowel syndrome according to ROME Gastrointestinal bleeding More than 5% weight loss in the last 6 months Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-21.0, Brain and Central Nervous System Tumors Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Childhood Solid Tumor, Protocol Specific Diagnosis of refractory or recurrent solid tumors, including lymphoma No CNS tumors or known CNS metastases (Part A, dose escalation) CNS tumors or known CNS metastases allowed (Part B, maximum-tolerated dose or recommended phase II dose) No prior or concurrent CNS hemorrhage on a baseline MRI within the past 14 days All patients must have histologic verification of malignancy at original diagnosis or relapse except for Intrinsic brain stem tumors Optic pathway gliomas Pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG Measurable or evaluable disease Disease for which there is 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): 1.0-999.0, Advanced Cancers Sarcoma Age greater than or equal to 1 years 2. Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors. 3. Radiologic workup must demonstrate that the disease is confined to the abdominal cavity 4. Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit 5. Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist. 6. Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, pregnant or lactating females. 7. Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space.' Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist. 8. Patients must have adequate renal function (serum creatinine </= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years of age) 9. Patients will be eligible if the white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (ANC) is >/=1,500 and platelets are >/= 100,000/mm^3 10. Patients will be eligible if serum total bilirubin and liver enzymes are </=2 times the upper limit of normal 11. Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure 2. Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled 3. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum) 4. Patients who have failed previous intraperitoneal platinum therapy will be ineligible 5. Patients with Retroperitoneal Liposarcoma will be ineligible
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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): 15.0-70.0, Transfusion Related Complications patients who sign the consent, with Glasgow Coma Scale (GCS) score of 15, undergoing surgery which blood loss could be more than 800ml or 20% of the patient's whole blood volume Pregnancy Psychopathy Refuse to sign consent
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-17.0, Chemotherapy Induced Nausea and Vomiting Cycle 1 Is 6 months to 17 years of age at time of study entry Is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of vomiting for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting Is expected to receive ondansetron as part of their antiemetic regimen If female and has begun menses, must has a negative urine pregnancy test prior to randomization. A female who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication If >10 years old, have a Karnofsky score ≥ 60; if ≤ 10 years have a Lansky Play Performance score ≥ 60 Have a predicted life expectancy of ≥ 3 months Optional Cycles 2-6 Participant has, in the opinion of the investigator, completed the preceding cycle of chemotherapy and related study procedures satisfactorily Cycle 1 Has vomited in the 24 hours prior to Treatment Day 1 Is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy Has received or will receive radiation therapy to the abdomen or pelvis within a week prior to Treatment Day 1 or during the course of the study Is pregnant or breast feeding Is allergic to aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist Has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting History of QT prolongation or taking other medicinal products that lead to QT prolongation Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug to the participant Has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam
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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, Cholera aged 12 months and older non-pregnant age less than 12 months pregnant too ill/old to get out of bed
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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): 18.0-84.0, Idiopathic Pulmonary Fibrosis (IPF) Key 1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus for the diagnosis of IPF). 2. Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value. 3. DLco (corrected for hemoglobin) ≥ 30% predicted value. 4. Oxygen saturation > 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen. 5. Residual volume ≤ 120% predicted value. 6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator. 7. Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases). 8. High Resolution Computed Tomography (HRCT) image fulfills the for 'Usual Interstitial Pneumonia (UIP) pattern'. 9. If the HRCT image does not fulfill the for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening is acceptable). If a lung biopsy has been performed, it must fulfill the histopathological for either 'UIP pattern' or 'probable UIP pattern' with the appropriate HRCT correlate. 10. Adequate bone marrow and liver function. 11. Patient has a life expectancy of at least 12 months. Key Findings that are diagnostic of a condition other than UIP on surgical lung biopsy (performed either before or after screening), HRCT imaging, transbronchial lung biopsy, or bronchoalveolar lavage (BAL). 2. Serious local infection or systemic infection within 3 months prior to screening. 3. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening. 4. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy for IPF or administration of such therapeutics within 5 half-lives of the agent prior to initial screening in this study. 5. End-stage fibrotic disease requiring organ transplantation within 6 months NOTE: Other protocol defined Inclusion/
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-21.0, Acute Leukemias of Ambiguous Lineage Bacterial Infection Diarrhea Fungal Infection Musculoskeletal Complications Neutropenia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies Patient must fit 1 of the following 2 categories Chemotherapy patients Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy Relapsed acute lymphoblastic leukemia (ALL) For the purposes of this study, "intensive chemotherapy" is defined as regimens that are predicted by the local investigator to cause neutropenia for > 7 days; examples but are not limited to, treatment with "4-drug induction" (anthracycline, vincristine, asparaginase, and steroid), high dose cytarabine, anthracycline/cytarabine, ifosfamide/etoposide, and clofarabine-containing regimens Stem cell transplantation patients Planned to receive at least 1 myeloablative autologous or allogeneic HSCT For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT Patients with an allergy to quinolones Patients with chronic active arthritis Patients with a known pathologic prolongation of the corrected QT (QTc) Females who are pregnant or breast feeding Patients being treated with antibacterial agents, other than any of the following Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis Topical antibiotics Central venous catheter antibiotic lock therapy Note: prophylactic antifungal therapy is NOT an criterion
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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, Sickle Cell Disease Sickle cell patients will be enrolled and will be selected based on: 1. Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements. 2. Hb levels: > 6 gr/dl <10 gr/dl; 3. Age: > 18 years; 4. Body Mass Index ≥20 and ≤30 kg/m2; 5. Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator; 6. Female subjects of reproductive potential must have a negative serum pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating; 7. Adequate venous access and can receive intravenous infusions; 8. Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history". 1. In medical opinion of investigator, the patient is not an appropriate candidate; 2. Patient is infected; 3. The patient is Febrile; 4. Patient has Acute chest syndrome or documented Sickle Cell Crisis; 5. Patient with hemoglobin above 10gr/dl or below 6 gm/dl 6. If female, pregnant or lactating; 7. History of clinically significant disease, as determined by the Investigator; 8. History of allergy or major allergic reaction considered to be clinically significant by the Investigator; 9. Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator; 10. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation; 11. Unable to comply with study attendance, protocol procedures or other study requirements; 12. Frequency of ER hospitalizations > 6x/yr for SCD pain events; 13. Patient has Renal or liver dysfunction; 14. Patient has Severe pulmonary hypertension (index > 3 meters per sec based on documented Echocardiograph); 15. Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results; 16. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency; 17. Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination
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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 Infection Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment Completion and review of comprehension test (achieved > 70% accuracy) Signed informed consent document Available for the required follow-up period and scheduled clinic visits Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following study completion Health problems such as, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the volunteer at increased risk of adverse events. Study clinicians, in consultation with the principal investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Medical Monitor as appropriate Clinically significant abnormalities on physical examination Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or illness (including IgA deficiency) Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last study safety visit and currently nursing women Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit Positive blood test for HBsAg, HCV, HIV-1 Clinically significant abnormalities on basic laboratory screening Immunosuppressive illness or IgA deficiency (below the normal limits) Exclusionary skin history/findings that would confound assessment or prevent appropriate local monitoring of adverse events (AEs), or possibly increase the risk of an AE History of chronic skin disease (clinician judgment)
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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): 12.0-75.0, Acute on Chronic Hepatic Failure All consecutive patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease Age <12 or > 75 years Autoimmune disorders HCC Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP) Multi organ failure Grade 4 HE HIV seropositivity / pregnancy Essential Hypertension Patients being taken up for transplant Refusal to participate in the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-60.0, Healthy Volunteers Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests 2. Age of at least 18 years of age on the day of screening and no greater than 60 years at time of administration 3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks) 4. Willing to undergo HIV testing and counseling and receive HIV test results 5. If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) throughout until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time Confirmed HIV-1 or HIV-2 infection 2. Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease 3. Any use of systemic corticosteroids immunosuppressive anticancer medications 4. Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation 5. Any laboratory value outside of reference range other than CRP, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee. 6. Within the 12 months prior to enrollment, the subject self reports excessive daily alcohol use, frequent binge drinking or chronic marijuana abuse (defined as greater than 2 times a week) or any other use of illicit drugs 7. Positive hepatitis B surface antigen, positive hepatitis C antibodies, or active syphilis infection based on clinical evaluation; 8. If female, pregnant, planning a pregnancy during the trial period, or lactating 9. Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug 10. Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study 11. In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons 12. Allergy to eggs 13. A glomerular filtration rate that is less than 60mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Diarrhea Clostridium Difficile non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline pregnant patients allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness
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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): 2.0-999.0, Hemolytic-uremic Syndrome Escherichia Coli Infections All patients with HUS concomitant to the outbreak linked to E. coli O104:H4 Patient not willing to participate or to sign informed consent
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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): 0.167-999.0, Shiga-like Toxin-producing Escherichia Coli Patient must be willing and able to give written informed consent/Assent. 2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients 3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS) Known complement regulatory mutation or family history of complement regulatory mutation 2. Unresolved systemic meningococcal disease 3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
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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): 18.0-72.0, Diarrhea-Predominant Irritable Bowel Syndrome men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS) increased intestinal permeability on Lactulose/Mannitol permeability test able and willing to cooperate with the study *absence of alcohol or NSAIDs ingestion for 2 weeks prior to into study and throughout the study duration current participation in another research protocol or unable to give informed consent women with a positive urine pregnancy test or breastfeeding history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue + hydrogen breath test for bacterial overgrowth + antiendomysial antibody titer use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study known allergy to glutamine abdominal surgery except for removal of gallbladder, uterus, or appendix Abnormal blood urea nitrogen(BUN) and/or creatinine
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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): 2.0-99.0, Argininosuccinic Aciduria Carbamoyl-Phosphate Synthase I Deficiency Citrullinemia Ornithine Carbamoyltransferase Deficiency Hyperargininemia N-Acetylglutamate Synthase Deficiency Patients: Any gender and ethnicity age 2 years and older with a diagnosis of a urea cycle disorder are eligible to enroll in this protocol. Patients need to be medically and nutritionally managed by a local metabolic provider. If necessary, we will obtain written consent from the patient to review medical records from their home physician to confirm eligibility. Healthy Volunteers: Any gender and ethnicity age 2 years and older are eligible to enroll in this protocol. Have access to own personal medical provider <TAB> Less than 2 years of age Inability to travel to NIH because of their medical condition Recent (6 month) history of vaccination or immune modulating drug Severe reactions to eggs and or latex History of severe reactions to previous immunizations (e.g. hives, rash, difficulty breathing) Persons without a personal medical provider Persons with current infections or under care of medical provider for an ongoing medical issue
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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): 0.0-21.0, Adenovirus Anesthesia Anxiety Anxiolysis Autism Autistic Disorder Bacterial Meningitis Bacterial Septicemia Benzodiazepine Bipolar Disorder Bone and Joint Infections Central Nervous System Infections Convulsions Cytomegalovirus Retinitis Early-onset Schizophrenia Spectrum Disorders Epilepsy General Anesthesia Gynecologic Infections Herpes Simplex Virus Infantile Hemangioma Infection Inflammation Inflammatory Conditions Intra-abdominal Infections Lower Respiratory Tract Infections Migraines Pain Pneumonia Schizophrenia Sedation Seizures Skeletal Muscle Spasms Skin and Skin-structure Infections Treatment-resistant Schizophrenia Urinary Tract Infections Withdrawal Sepsis Gram-negative Infection Bradycardia Cardiac Arrest Cardiac Arrhythmia Staphylococcal Infections Nosocomial Pneumonia Neuromuscular Blockade Methicillin Resistant Staphylococcus Aureus Endocarditis Neutropenia Headache Fibrinolytic Bleeding Pulmonary Arterial Hypertension CMV Retinitis Hypertension Chronic Kidney Diseases Hyperaldosteronism Hypokalemia Heart Failure Hemophilia Heavy Menstrual Bleeding Insomnia Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Failure to obtain consent/assent (as indicated) Known pregnancy as determined via interview or testing if available
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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, Hemophilia A Key Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965, NCT01458106 and NCT02502149) Ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable). Key Confirmed positive high-titer inhibitor (≥5.00 BU/mL). NOTE: Other protocol defined Inclusion/
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Atypical Hemolytic-Uremic Syndrome Male or female patients of any age, including minors, who have been diagnosed with aHUS Patients with or without an identified complement pathogenic variant or anti-complement factor antibody Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)] > 5%, if performed Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC])
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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, Vibrio Cholerae Cholera Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection The subject should be able to continue in the study for the next 4 weeks The subject (or parent/guardian) should be willing to provide 3 blood samples 2. For females of reproductive age, non-pregnant (as determined by urine pregnancy test). 3. Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 years. 4. Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician. 2. Ongoing acute illness. 3. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) 4. Immunocompromising condition or on chronic systemic steroid therapy 5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment 6. Intake of any anti-diarrhea medicine in the past week 7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours 8. Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject 9. Previous hypersensitivity to formaldehyde. 10. Receipt of immunoglobulin or any blood product during the past 3 months 11. Receipt of oral cholera vaccine in the past three years 12. Any potential subject currently participating or who will participate within the next six months in another clinical trial 13. Positive screening urine pregnancy test for females greater than 12 years 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): 18.0-999.0, Diarrhea Fever Vomiting Abdominal Pain Patients with culture-positive stool sample with Campylobacter concisus Diarrheic patients ≥ 18 years symptoms of diarrhea defined as three or more watery stools per day or two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever Diarrheic symptoms for a minimum of 24 hours before enrollment Diarrheic symptoms for a maximum of 21 days before enrollment Informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient The patient must be willing and able to participate in the trial Hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics Pregnancy or breastfeeding (if relevant) Culture positive stool sample with a Co-pathogen Treatment with other antibiotics (in any stage 21 days before the first stool sample) Patients with severe liver disease Patients with severe renal impairment (GFR <10 ml / min) Patients with congenital or documented acquired QT prolongation Patients treated with other active drugs that prolong the QT interval such as: antiarrhythmics of classes IA and III, cisapride and terfenadine Patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia Patients with clinically relevant bradycardia, arrhythmia or severe heart failure
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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, Urea Cycle Disorders Confirmed or highly-likely diagnosis of one of the eight UCDs as established for the Longitudinal Study (5101) (See section 4.2 Table 4 for diagnostic for patients with UCD) Enrolled in Longitudinal Study of Urea Cycle Disorders (RDCRN UCDC #5101) UCD patients who have undergone orthotopic liver transplantation Significant chronic medical co-morbidity that might confound the analysis as determined by the site investigators Significant co-morbidities but are not limited to diabetes, liver failure + cirrhosis renal failure cardiac disease chronic inflammatory diseases asthma requiring daily long-term control medications significant respiratory 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): 0.0-65.0, Urea Cycle Disorders All study groups: • Written informed consent given by subjects or his/her parents/legal guardians who are able to understand and follow instructions related to the study Group 1 Healthy Volunteers Age: 18 years Healthy subjects No clinical or laboratory parameter outside normal ranges at screening and judged as clinically relevant by the investigator Group 2 Symptomatic UCD patients with genetically confirmed CPSD, OTCD, ASSD, or ASLD: Age: 0 years Symptomatic subjects with genetically confirmed Carbamylphosphate synthetase I Deficiency [CPSD], Ornithine Transcarbamylase Deficiency [OTCD], Argininosuccinate Synthetase Deficiency [Citrullinaemia type I], Argininosuccinate Lyase Deficiency [ASLD] at least 1 metabolic decompensation with clinical signs of hyperammonemia in medical history or genetically confirmed and prospectively treated siblings of symptomatic patients, even without clinical symptoms Confirmed diagnosis and medical history available (in particular number and severity of metabolic crises) Group 3 Asymptomatic carriers of UCD mutations Age: 0 Acute illness, including vomiting, fever or other sign of infection Participation in other invasive clinical trials within 30 days prior to Liver or renal disease Acute seizures Coma Bleeding disorder Blood ammonia > 100 µmol/l for patients with a urea cycle disorder and blood ammonia > normal for healthy probands and asymptomatic carriers Metabolic acidosis Pregnancy or lactation Body weight < 8kg
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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): 17.0-80.0, Small Bowel Crohn's Disease patients with known SBCD or newly diagnosed SBCD those patients for whom complete CE examination (in which the capsule reached the cecum within the CE test time) was achieved were retained for study incomplete CE examination infectious enterocolitis symptoms related to perianal penetrating disease gastrointestinal cancer ulcerative colitis indeterminate colitis history of extensive small bowel resection known CD of the upper gastrointestinal tract or colon intake of non-steroidal anti-inflammatory drugs (NSAIDs) (more than two tablets per week) pregnancy
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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, Hemolytic Uremic Syndrome Hemorrhagic Colitis Intestinal Infectious Disease Intestinal Infection Due to E. Coli Proven EHEC O104:H4-infection Presence of bloody diarrhoea + at least one of the following serological platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) > 300 IU/l, leukocytosis ( > 12x10³/ μl ) and elevated CRP (> 5mg/l), hemoglobin < 13.8 g/dL for male patients or < 12.1 g/dL for female patients, respectively or decrease in haptoglobin Bloody diarrhoea due to others reasons than EHEC O104:H4 infection Thrombocytopenia < 100x10³/ μl HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for 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): 14.0-99.0, Transfusion Related Complications Height of usual place of residence less than 2,500 metres above sea level Perioperative hemoglobin level possibly less than 10g/dL Emergency operation ASA classification V or VI Serious blood system diseases Dysfunction of hemoglobin Hypervolemic hemodilution Tumor metastasis Psychopathy Refuse to sign 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): 1.083-21.0, Childhood Solid Neoplasm Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Neuroblastoma Patients must have had histologic verification of malignancy at original diagnosis or relapse; all patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) are eligible except for patients with primary or metastatic central nervous system (CNS) tumors or patients with primary cutaneous ALCL Patients must have either measurable or evaluable disease Patient?s 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 Karnofsky >= 60% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: 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 Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy Myelosuppressive chemotherapy Solid tumors: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) ALCL Patients with ALCL who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy 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 during treatment and for 3 months after stopping treatment Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial Patients chronically receiving medications known to be metabolized by cytochrome P 450, family 3, subfamily A, polypeptide 4 (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 who have an uncontrolled infection are not eligible Patients who have received a prior solid organ transplantation are not eligible
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Acute Watery Diarrhea Dysentery/Febrile Diarrhea Active duty military or military beneficiary, 18 years-old or older. 2. Presence of acute diarrhea (3 or more stools in 24 hours or 2 or more stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) and <96 hours duration. 3. Eligible for ambulatory management. 4. Able to comply with follow-up procedures. 5. Will remain in country for at least 7 days Allergy to rifamycins, quinolones, macrolides, or loperamide (not including mild gastrointestinal upset). 2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, or doxycycline). 3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, and warfarin). 4. History of seizures (relative contraindication to quinolones) 5. Positive pregnancy test at presentation (contraindicated with fluoroquinolone therapy). All female subjects will be administered a urine pregnancy test prior to enrollment. 6. Presence of symptoms >96 hours prior to initiating treatment. 7. Use of >4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Acute Coronary Syndrome Patients admitted in the coronary care unit (CCU) of the Department of Clinical and Experimental Medicine at the Federico 2nd University Hospital Patient with indication to angiographic study even if not immediately Patients referred to CCU with the diagnosis of acute myocardial infraction (AMI), type STEMI, or based on pre-admission assessment of troponin I (TpI) and myocardial band creatin kinase (CK-MB Diagnosis of performed according to standard Patients who could not undergo angiographic 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): 0.0-65.0, Dysentery Lab-confirmed Shigella or ETEC Individuals or patients without diarrheal disease n/a
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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): 18.0-45.0, Escherichia Coli Infection Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment Completion and review of comprehension test (achieved > 70% accuracy) Signed informed consent document Available for the required follow-up period and scheduled clinic visits Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following study completion Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the subjects at increased risk of adverse events. Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate Clinically significant abnormalities on physical examination Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including IgA deficiency (defined by serum IgA below the detectable limit) Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last study safety visit and currently nursing women Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit Positive blood test for HBsAg, HCV, HIV-1 Clinically significant abnormalities on basic laboratory screening Exclusionary skin history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of an AE History of chronic skin disease (clinician judgment) History of atopy such as active eczema
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1
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Stage III Chronic Lymphocytic Leukemia Testicular Lymphoma Waldenström Macroglobulinemia Subjects must have a histologically confirmed hematologic malignancy that has relapsed or proven refractory (in any time frame) to one or more prior therapies, limited to the following subtypes Non-Hodgkin lymphoma (NHL), including cutaneous lymphoma Hodgkin lymphoma (HL) Chronic lymphocytic leukemia (CLL) Chronic myeloid leukemia (CML) Multiple myeloma Patients must have progressed through standard curative treatment options in the case of NHL and HL or not be candidates for curative therapy Patients must have measurable disease, and must meet justifying a need to initiate therapy, for measurable disease and for initiating therapy for purposes of this study are defined as follows NHL/HL: measurable disease by radiographic (>= 1 cm by computed tomography); or any degree of bone marrow involvement with lymphoma by morphologic analysis; or measurable skin involvement according to cutaneous lymphoma response criteria; for initiating therapy aggressive histology (diffuse large B cell lymphoma, nodal T cell lymphomas, Hodgkin lymphoma) or presence of any of the following: systemic symptoms, bulk >= 5 cm, >= 3 nodal sites, marrow compromise remaining within limits of adequate function as defined below, splenomegaly >= 16 cm, disease-related effusion, risk of local compressive symptoms, or circulating lymphoma cells CLL: measurable disease requires B lymphocytes equal or greater than 5,000/μL, or lymphadenopathy (>= 1 cm by computed tomography), or bone marrow involvement of any degree; in addition, patients must have one of the following: Rai stage III (hemoglobin < 11gm/dL) or IV (platelets < 100,000/uL) disease, progressive splenomegaly, hepatomegaly or lymphadenopathy, weight loss > 10% over the preceding 6 month period, grade 2 or 3 fatigue, fevers > 100.5 or night sweats without evidence for infection, progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months Patients may not be receiving any other investigational agents or have received other investigational agents for at least 3 weeks Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant and lactating women are excluded from this study New York Heart Association (NYHA) classification III or IV heart disease Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases Known seizure disorder Known human immunodeficiency virus (HIV) or chronic hepatitis (B or C) infection Patients unwilling or unable for any reason (personal, medical, or psychiatric) to comply with the protocol Patients with known hypersensitivity to fludarabine or a history of purine analog associated autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
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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): 0.167-17.0, Hemolytic-Uremic Syndrome Children Parents Psychological Adjustment children and youth from 2 months to 17 years who had suffered from haemolytic uraemic syndrome willingness and ability to participate in the study freely signed informed consent missing written informed consent children who do not fulfil the age criterion
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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, Immune Thrombocytopenic Purpura Clinical diagnoses of idiopathic thrombocytopenic purpura Hormone and immune suppression, splenectomy is invalid patients had a bad tolerance to rapamycin platelet counts < 10*10E9/L during the treatment of rapamycin
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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): 16.0-95.0, Appendicitis all patients undergoing appendectomy for suspected appendicitis preexisting liver 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): 15.0-999.0, Advanced Malignant Solid Neoplasm C-KIT Tyrosine Kinase Protein Overexpression Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Gastrointestinal Stromal Tumor Metastatic Malignant Solid Neoplasm Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Unresectable Melanoma Unresectable Solid Neoplasm For dose escalation study, patients must have histological confirmation of solid tumors that is metastatic or unresectable. For expansion cohorts, patients must have metastatic or unresectable gastrointestinal stromal tumor (GIST), melanoma, or uncategorized tumors with tumor biopsies that are positive for c-KIT mutations by polymerase chain reaction (PCR) or immunohistochemistry (IHC). For patients enrolled in the melanoma expansion cohort, only select KIT mutations will be eligible. Patients with mutations in exon 13 V654X, 14 T6701, 17 D816X and all exon 18 mutations will not be eligible for enrollment Patients who have completed previous therapies 4-weeks prior to (or within 5 drug half lives) enrollment on study. Radiation therapy wash out period will be 2 weeks. This includes an exception of patients with metastatic GIST tumors who are taking maintenance imatinib mesylate therapy. These patients are allowed to remain on imatinib mesylate therapy up to enrollment in this study Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%) Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL Total bilirubin < or = 2.0 mg/dL. (Does NOT apply to patients with Gilbert's syndrome) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal (patients with liver involvement will be allowed < or = 5.0 X institutional upper normal limit) Serum creatinine < 2.0 mg/dL Patients MUST have recovered from all treatment related toxicities to grade 1 National Center Institute (NCI) Common Terminology for Adverse Events (CTCAE) (version [v] 4.0) in severity Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus or autoimmune vasculitis [e.g., Wegener's granulomatosis] are excluded from this study History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab) Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses) Patients who do not agree to practice appropriate birth control methods while on therapy Pregnant women are excluded from this study. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician
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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 Medullary Thyroid Cancer Patients with medullary thyroid cancer Men and women from all ethnic and racial groups Diarrhea ( >=3 loose bowel movements per day) Duration of diarrhea of at least 1 week Patients with MEN 2b (since these patients may have megacolon) Patients taking any clay products History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up Patients who cannot comply with medications Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications Pregnancy or lactation Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.083-21.0, Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Childhood Burkitt Lymphoma Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Childhood Nasal Type Extranodal NK/T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Post-transplant Lymphoproliferative Disorder Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Hairy Cell Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Patients with relapsed or refractory solid tumors or lymphoma, excluding central nervous system (CNS) tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse; (patients with primary CNS tumors, known CNS metastases, or a prior history of CNS metastases are not eligible) Patients must have either measurable or evaluable disease Patient's 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 Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: 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 Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines At least 3 half-lives of the antibody after the last dose of a monoclonal antibody 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 chronic systemic corticosteroids are not eligible Patients who are currently receiving another investigation drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial Patients who have known human immunodeficiency virus (HIV), viral hepatitis, or an uncontrolled infection are not eligible Patients with primary CNS tumors are excluded Patients with prior history of or known metastatic CNS disease involvement are excluded; (Note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated) Patients who have had or are planning to have the following invasive procedures are not eligible Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Atypical Hemolytic Uremic Syndrome (aHUS) All patients with diagnosis of aHUS who have been receiving eculizumab by personal importation (specific below do not apply) Or, 2. Patients with current clinical manifestations of aHUS who meet the following 1. Patient with diagnosis of aHUS with or without an identified complement regulatory protein genetic abnormality or anti-complement factor antibody and for whom other known etiologies of hemolytic uremic syndrome (HUS) have been ruled out as confirmed in the Patient (and legal guardian if patient is not an adult) willing and able to give written informed consent and assent (or verbal assent if patient is unable to read or write) 3. Patient at least 1 month of age and body weight ≥5 kg 4. Platelet count at screening < lower limit of normal (LLN) 5. Signs or symptoms of hemolysis (i.e., lactate dehydrogenase (LDH) ≥ 1.5x upper limit of normal (ULN) and Hemoglobin ≤ LLN) at start of current aHUS event 6. Serum Creatinine (SrCr) level ≥ ULN at screening (patient requiring dialysis for acute renal failure also eligible) 7. Female patient of childbearing potential practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the Follow-up Period. At the time of the last follow-up visit, patient must agree to continue to use adequate contraception methods for up to 5 months following discontinuation of eculizumab treatment 8. Able and willing to comply with study procedures Shiga-toxin producing E. coli-HUS (STEC-HUS; shiga-toxin and/or STEC positive) History of malignancy within 5 years of screening Known human immunodeficiency virus (HIV) infection Identified drug exposure-related HUS Infection-related HUS HUS related to bone marrow transplant (BMT) HUS related to vitamin B12 deficiency Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage renal disease (ESRD)) Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive 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 Pregnancy or lactation Unresolved systemic meningococcal disease Any medical or psychological condition that, in the opinion of the investigator, could increase patient's risk by participating in the study or confound the outcome of the study Patients receiving chronic intravenous immunoglobulin (IVIG) within 8 weeks unless for unrelated medical condition (e.g., hypogammaglobulinemia) or chronic rituximab therapy within 12 weeks of the screening visit Patients receiving other immunosuppressive therapies such as steroids, calcineurin inhibitors (mTOR), (e.g., cyclosporine or tacrolimus) are excluded unless: [1] part of an established post-transplant anti-rejection regimen, or [2] patient has confirmed anti-Complement Factor Antibodies requiring immunosuppressive therapy or [3] steroids are used for a condition other than aHUS (e.g., asthma) Prior eculizumab use, hypersensitivity to eculizumab, to murine proteins or to one of the excipients in any other investigational intervention trial except this study
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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): 0.0-21.0, Diffuse Large B Cell Lymphoma Post Transplant Lymphoproliferative Disorder Primary Mediastinal (Thymic) Large B-cell Lymphoma Patient with newly diagnosed, histologically confirmed, Group B or C diffuse large B-cell lymphoma; or primary mediastinal B-cell lymphoma. Patients with Group B/C post transplant lymphoproliferative disorder are eligible for the study regardless of whether disease is newly diagnosed. (Murphy staging will be used for group classification.) Patient who has received previous chemotherapy or radiation therapy in the previous 3 months, except for empiric initial intrathecal administration at diagnosis. Rituximab or steroid administration is not an criterion Patient who has received any prior anthracyclines Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <28%) NOT due to mediastinal mass Patient with severe renal disease (i.e. creatinine greater than 3 times normal for age; creatinine clearance less than 50 ml/min/1.73m2) Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L) Patient with a Karnofsky performance score <50% or Lansky score <50% HIV-positive patients will be excluded unless antiretroviral therapy can be safely withheld during chemotherapy administration, based on clinical determination of infectious disease team evaluation Female patient who is pregnant or breastfeeding Patient with reproductive potential not willing to use an acceptable method of birth control (i.e. hormonal contraception, intrauterine device, condom or diaphragm with spermicide, or abstinence) for the duration of the study and one year post completion of therapy Patient with primary central nervous system (CNS) lymphoma (lymphoma limited to the craniospinal axis without systemic involvement)
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 20.0-65.0, Major Depressive Disorder Aged 20-65 years. 2. Subjects must be able to understand and willing to sign informed consent. 3. Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study. 4. Laboratory data: red blood cell count(RBC),white blood cell count(WBC), platelets, hematocrit, hemoglobin, prothrombin time(PT), partial thromboplastin time (aPTT),aspartate transaminase(AST),alanine aminotransferase(ALT), Lactate dehydrogenase(LDH), total bilirubin, blood urea nitrogen(BUN),serum creatinine, free thyroxine (FT4), thyroid-stimulating hormone (TSH) level,sodium, potassium, calcium, glucose, are all within the normal range. 5. No significantly abnormal findings on physical examination, ECG and vital sign With any clinically significant neurological, gastrointestinal, renal, hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator. 2. A positive drug screen. 3. Any mental disorder diagnosed by board-certificated psychiatrist through detailed diagnostic interview. 4. Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS. 5. The intensity of suicidal ideation in the past 6 months is no less than 4 defined by the C-SSRS. 6. Have received any prescribed medicine, investigational drug or any non prescribed medicine (including herbal remedies) with 14 days prior to enroll this study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-85.0, Pruritus Patients w/ histologically confirmed mycosis fungoides stage IB to IVA eligible to receive oral vorinostat Patients w/ stage IB to IV reporting pruritus Patients age 18-85 years, of any race, sex, and ethnicity Life expectancy > 24 weeks Patient must have performance status of ≤2 on the ECOG Performance Scale Patients w/ a min. of 3 weeks since their last systemic treatment Women who are not pregnant, lactating, or of childbearing potential Female patients w/ reproductive potential must use an adequate contraceptive method during treatment and for three months after completing treatment Male patient w/ reproductive potential, agrees to use an adequate method of contraception for the duration of the study and for 30 days beyond the duration of study Patients, or legal representative must to be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study Patients w/ a recent cardiac history, such as a myocardial infarct within the last year, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities Patients w/ a history of liver damage (2.5 x normal ALT, AST), leukopenia, or thrombocytopenia Women who are pregnant or nursing a child Patients w/ severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen Patients who have received and histone deacetylase inhibitor within the last 6 months Patients receiving valproic acid will be excluded unless there has been a wash-out period of 30 or more days Patients who will have received systemic therapy, radiation therapy or phototherapy within 3 weeks prior to initial dosing with study drugs or who has not recovered from adverse events due to agents administered more than 3 weeks earlier QTc prolongation greater than 500ms Patient w/ a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse
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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, Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Recurrent Age 18-65 2. Relapsed/refractory disease after receiving one line of standard chemoimmunotherapy (R-CHOP, GA-CHOP, R-CHOP like) 3. Diffuse Large B-cell Lymphoma at relapse. Patient has to be re-biopsied prior to study entry. If this is harmful for the patient, the patient can be enrolled if archivial tumor sample and block from first diagnosis are available. 4. No prior Bortezomib therapy 5. Measurable and/or evaluable disease 6. Any Ann Arbor stage and IPI group at relapse 7. Performance status < 2 according to ECOG scale unless due to lymphoma 8. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma) 9. Adequate hematological counts: ANC > 1.5 x 109/L, Hgb > 9 g/dl (transfusion independent), Platelet count > 75 x 109/L (transfusion independent), with the exception of cytopenia due to lymphoma bone marrow involvement 10. HIV negativity, HCV negativity, HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/ with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory) 11. Normal liver function (ALP, AST, ALT, GGT, conjugated bilirubin total < 2 x ULN) if not related to lymphoma 12. Normal kidney function (creatinine clearance > 45 ml/min) 13. Cardiac ejection fraction > 50% (MUGA scan or echocardiography) 14. Normal lung function 15. Absence of active opportunistic infections 16. Non peripheral neuropathy or active neurological non neoplastic disease of CNS 17. Non major surgical intervention prior 3 months to randomization if not due to lymphoma and/or no other disease life-threatening that can compromise chemotherapy treatment 18. Disease free of prior malignancies other than lymphoma for > 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast 19. Life expectancy > 6 months 20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 21. Written informed consent 22. Women must be postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months) surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy) abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth control measures for at least 12 months after terminating treatment. 23. Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening 24. Men must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug Diagnosis of Lymphoblastic Lymphoma, Burkitt Lymphoma, Non Hodgkin Lymphoma CD20 negative, Mantle Cell Lymphoma, Follicular Lymphoma g I-II-IIIa-IIIb, Primary Mediastinal Lymphoma 2. Age > 65 years 3. Patients ineligible to high-dose chemotherapy 4. Performance status > 2 according to ECOG scale if not due to lymphoma 5. Patient has known or suspected hypersensitivity or intolerance to Rituximab 6. Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 7. CNS disease (meningeal and/or brain involvement by lymphoma) 8. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances 9. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug 10. Uncontrolled or severe cardiovascular disease including myocardial infarction within six months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 11. Cardiac ejection fraction < 50% (MUGA scan or echocardiography) 12. Creatinine clearance < 45 ml/min 13. Presence of major neurological disorders 14. HIV positivity, HCV positivity, HBV positivity with the exception of patients with HBcAb +, HbsAg -, HBs Ab+/ with HBV-DNA negative 15. Active opportunistic infection 16. Major surgical intervention prior 3 months to randomization if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment 17. Prior malignancies other than lymphoma in the last 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast 18. Life expectancy < 6 months 19. Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent. 20. If female, the patient is pregnant or breast-feeding
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-80.0, Hypoparathyroidism Primary Hypoparathyroidism low levels of intact PTH during hypocalcemia at diagnosis Subjects receiving calcium and vitamin D supplementation at least 1 year prior to the beginning of the study Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study Subjects who provide written informed consent to participate in the study Age: 18-80, inclusive Calcium (albumin corrected) serum values below 7.0 mg/dL or above 10.0 mg/dL Any known diseases affecting the absorption from the gastrointestinal tract Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) Chronic diarrhea Subjects with neuropsychiatric disease Subjects with impaired renal function (glomerular filtration rate, ≤40 mL/min) Subjects with other severe chronic disease requiring long-term therapy Impaired liver function (Liver enzymes> x3 upper limit of normal) Subjects with history or presence of kidney stones Recurrent urinary tract infections
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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 A participant is considered eligible for participation in the trial if the following are satisfied on admission (Day 1, before randomization) to the hospital: 1. Participant is a male between 18 and 65 years of age inclusive 2. Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission) 3. Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline) 4. Dipstick test/Dark-field examination positive for Vibrio cholera 5. Written informed consent is provided 6. Participant is willing and able to comply with all trial requirements A participant who meets any of the following on admission (before randomization) to the hospital will not qualify for the study 1. Evidence or history of any clinically significant illness as per the Investigator's discretion. 2. Known case of HIV or Hepatitis B 3. History of cancer 4. Known renal disease 5. Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years 6. History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission 7. Concomitant infection requiring antimicrobial therapy 8. Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation 9. Clinically significant abnormal laboratory test results as determined by the investigator 10. Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device 11. History of seizure (including febrile seizure) or loss of consciousness; 12. History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis 13. For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee 14. Prior enrolment in this 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): 0.5-65.0, Malaria, Falciparum (COHORT STUDY) 1. Age 6 months to 65 years, inclusive 2. Resident of Kenieroba with no plans to relocate away from Kenieroba for 1 year 3. Willingness to participate in the study as evidenced by informed consent (if <18 years, the informed consent of parent or guardian of the child, and assent from children 14 to 17 years old) (COHORT STUDY) 1. Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease) 2. 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 the participant (e.g., severe malnutrition) 3. Pregnancy for venous blood collections (March 2013, October 2013, March 2014) (ADULT BLOOD STUDY) 1. Age 18 to 65 years, inclusive 2. Hb level greater than or equal to 8.5 g/dL 3. Willingness to participate in the study as evidenced by informed consent (ADULT BLOOD STUDY) 1. Pregnancy 2. Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease) 3. 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 the participant (e.g., severe malnutrition) (PARASITIZED BLOOD STUDY): 1. Age 2 to 17 years, inclusive 2. Hb level greater than or equal to 8.5 g/dL 3. Previous enrollment in cohort study on protocol #08-I-N120 4. Uncomplicated malaria* 5. P. falciparum density greater than or equal to 10,000/microliters 6. Known hemoglobin type HbAA or HbAS 7. Not enrolled in this protocol s cohort study 8. Willingness to participate in the study as evidenced by informed consent and assent from children 14-17 years old) Uncomplicated malaria: axillary temperature >37.5 degrees Celcius or history of fever in the past few days and no of SM (see next paragraph) and no other etiologies of febrile illness (e.g., respiratory tract infection) on clinical examination. Severe P. falciparum malaria: parasitemia of any density and any one of the following: coma (Blantyre coma score less than or equal to 2), convulsions (witnessed by investigator), severe prostration, severe anemia (hemoglobin less than or equal to 6 g/dl), respiratory distress, hypoglycemia (serum glucose less than or equal to less than or equal to 40 mg/dl), jaundice/icterus, shock (systolic blood pressure less than or equal to 70 mmHg, rapid pulse, cool extremities), cessation of eating and drinking, repetitive vomiting (PARASITIZED BLOOD STUDY): 1. Pregnancy 2. Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease) 3. Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary risks to study participants (e.g., severe malnutrition, acquired or inherited immunodeficiency)
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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): 1.0-14.0, Japanese Encephalitis Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal Asexual Plasmodium falciparum parasites in blood Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes Pregnant or breastfeeding females Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex
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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): 5.0-17.0, Chronic Abdominal Pain Chronic Diarrhea have been referred to the pediatric gastroenterology service at the Kingston University Hospital Network for abdominal pain or chronic diarrhea be between 5 to 17 years of age overt signs and symptoms of an inflammatory gastrointestinal disease in the referral letter (will triaged with high priority within 14 working days evidence of GI bleeding, extraintestinal manifestations of inflammatory bowel disease, significant weight loss or laboratory abnormalities
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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 Man or woman, aged 18 to 65 years, inclusive Based on the Roman III diagnostic for diagnosis of IBS-D subjects, recurrent abdominal pain or discomfort (hard to describe the discomfort of pain), monthly attack within the past 3months at least 3 days. With two or more of the following three kinds of symptoms: At least a portion of the time abdominal pain or defecate increase when discomfort. At least a portion of the time abdominal pain or the row of loose stools when discomfort. At least a portion of the time abdominal pain or discomfort improved after defecation. Symptoms for at least 6 months before diagnosis Screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week Voluntarily signed the informed consent form The absorption of any known adverse History of gastrointestinal surgery ( not including appendectomy) History of organic gastrointestinal diseases: IBS, cancer etc History of chronic diseases: anemia (hemoglobin<90g/L), pulmonary tuberculosis, diabetes or cardiovascular, liver, kidney, brain, and hematopoietic system and other serious diseases and psychiatric patients, AST(aspartate aminotransferase), ALT (alanine aminotransferase)> 1.5 times, BUN (blood urea nitrogen)> 1.2 times, Cr > 1.0 times normal The disease of lactose intolerance, gallstones, endometriosis, easily confused with IBS symptoms of Progressive weight loss Concomitant medication is unable to stop but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology Concomitant medication use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as parasympathetic inhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc Other researchers think not suitable for the list
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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): 18.0-100.0, Celiac Disease Celiac Sprue Gluten Enteropathy Gluten-Sensitive Enteropathy 1.1.1 Patients must be greater than or equal to 18-years-old. 2.1.1.2 All patients must have a pathologically confirmed diagnosis of refractory celiac disease(RCD) defined by internationally accepted of persistent and recurrent symptoms(diarrhea, weight loss, and abdominal pain) associated with intestinal damage, characterized by partial to total villous atrophy with intraepithelial lymphocytes defined by > 25 intraepithelial lymphocytes per 100 epithelial cells. 2.1.1.3 Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months 2.1.1.4 Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology 2.1.1.5 Patients must have a life expectancy of > 3 months 2.1.1.6 Patients must have a creatinine of less than 2.0 mg/dL or if the patient has an elevated creatinine measured creatinine clearance (Ccr) must be > 60 mL/min/1.73m(2) 2.1.1.7 Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN) 2.1.1.8 Patients must have a total bilirubin of less than 2.5 x ULN 2.1.1.9 Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration 2.1.1.10 Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible 2.1.1.11 Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study 2.1.1.12 Patients must be able to understand and sign an informed consent 1.2.1 Patients enrolled in another therapeutic study 2.1.2.2 Patients with a history of venous thrombosis 2.1.2.3 Patients with antibodies to Hu-Mik-Beta-1 2.1.2.4 A contraindication to monoclonal antibody therapy including adverse events related to prior monoclonal antibody therapy. Patients who have received prior antibody therapy will have permanent medical records reviewed by the study investigator. 2.1.2.5 Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection 2.1.2.6 History of malignancy (active or within the previous 5 years) 2.1.2.7 Patients with HIV infection (antibody positive) with positive confirmatory molecular tests 2.1.2.8 Patients who have chronic hepatitis B or chronic hepatitis C 2.1.2.9 Pregnant or breastfeeding women. Women who not using an acceptable method of contraception. Acceptability of various methods of contraception will be determined by the investigator. Postmenopausal or surgically sterile women who have documentation of postmenopausal status or surgical sterility availability prior to enrollment. 2.1.2.10 Patients with significant co-morbidities including uncontrolled hypertension (diastolic B/P > 115 mm/Hg), unstable angina, congestive heart failure (> N.Y.H.A. Class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months or uncontrolled atrial or ventricular cardiac arrhythmias. 2.1.2.11 Abnormal screening/baseline tests exceeding the limits outlined below Total white blood cell count (WBC) <300/mm(3) Platelet count <85,000/mm(3) INR greater than or equal to 1.5 Serum creatinine level > 1.5 mg/dL Serum alanine transaminase, aspartate transaminase or creatinine kinase > 2 x the upper limits of normal 2.1.2.12 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up 2.1.2.13 at the discretion of the PI or delegate if participation in the study is deemed too risky (e.g., clinically significant pleural or pericardial effusion or ascites) 2.1.2.14 Inability to give informed consent 2.1.2.15 History of diverticulitis
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.25-5.0, Acute Diarrhea children of both sexes aged between 3 and 60 months, with acute watery diarrhea lasting more than 12 hours but less than 72 hours, requiring hospitalization. Children with clinical signs of mild to moderate dehydration (prolonged capillary refill time, abnormal skin turgor and 3-9% percentage loss of body weight) clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit were excluded. Other were use of antibiotics or probiotics 1 month before admission, severe malnutrition and chronic underlying disease including immunocompromised conditions
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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, Non-small Cell Lung Cancer The cohort consists of approximately 250 patients. As a rule of thumb 5-10 events per variable are needed to avoid overfitting a model. To model 6 clinical variables + 9 biomarker variables 75-150 events are needed. Assuming a two-year survival of 40%, the calculated (constant) hazard rate is 0.46 per year. With an rate of 50 patients per year, and a follow-up time varying between 0.5 and 4 year, at the time of analysis (November/December 2013) it is expected that there will be 138 events available for analysis
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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): 1.0-18.0, Clostridium Difficile Infections Clostridium Difficile infection Age < 1 year Age > 18 years
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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, Upper Gastrointestinal Bleeding Blood Urea Nitrogen < 18.2 mg/dl 2. Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women 3. Systolic blood pressure ≥ 110 mm Hg 4. Heart rate < 100 beats/min Inability to obtain informed consent 2. Pregnancy 3. History of liver disease 4. History of heart failure 5. Syncope that is temporally related to ongoing bleeding 6. Melena 7. Contraindication to proton pump inhibitor use 8. Other conditions that necessitate inpatient evaluation. 9. Inpatients with new onset of GI bleeding
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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): 1.0-30.0, Hepatoblastoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Liver Cancer Recurrent Childhood Rhabdomyosarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Neuroblastoma Recurrent Osteosarcoma Rhabdomyosarcoma Patients with any of the following tumors who have relapsed or refractory disease are eligible Osteosarcoma Ewing?s sarcoma / peripheral primitive neuroectodermal tumor (PNET) Rhabdomyosarcoma Neuroblastoma (measurable or evaluable disease) Hepatoblastoma Patients must have had histologic verification of malignancy at original diagnosis or relapse Patients must have radiographically measurable disease (with the exception of neuroblastoma) Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm) Note: the following do not qualify as measurable disease Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy; study drug may also potentially be secreted in milk and therefore breastfeeding women are excluded Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim) Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Anti-graft-versus-host disease (GVHD) or agents to prevent organ rejection post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial Patients who have an uncontrolled infection are not eligible Patients who have received prior treatment with imetelstat are not eligible Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible Patients with prior allogeneic transplants are not eligible
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-75.0, Refractory Ascites Hepatic Hydrothorax Hepatic Encephalopathy Cirrhosis Cirrhosis (any etiology) Refractory ascites or hepatic hydrothorax and plan for TIPS placement Well-documented overt hepatic encephalopathy, either persistent or at the time of screening Any contraindication for TIPS placement Except for coagulopathy and thrombocytopenia (decided on an individual basis) Uncontrolled depression/anxiety disorder or use of antipsychotic drugs Active use of alcohol or illicit drugs History of dementia TIPS planned for another indication Active alcoholic liver 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): 1.0-999.0, Cholera Healthy subjects > 1 year of age and above Living in high risk area for cholera Provision of Informed consent for participating in the study by participant /parent or guardian as well as verbal assent for children 11-17 years Pregnant women Aged less than 1 year History of taking 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): 0.0-999.0, Hemophilia A Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F 2. Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records. 3. Negative assays for FVIII inhibitor at (<0.6BU Nijmegen assay), i.e. at the end of study "GreenGene™ F_P3" for patients entering into this extension study immediately after finishing the previous phase III study. 4. Normal liver and kidney function 5. Platelet count ≥ 100,000㎕ 6. Normal prothrombin time or International Normalized Ratio (INR) < 1.5 7. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen 8. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay 9. Absolute CD4 lymphocyte cell count ≥ 200㎕ 10. Signed the written informed consent form or informed consent was obtained from the subject's legal guardian 11. Females must not be lactating or pregnant at screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before the first dose of study drug 12. All females will be considered to be of childbearing potential unless they are appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing) 13. Willing and able to comply with all aspects of the protocol Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay. 2. Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices 3. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg) 4. Hemoglobin < 10 g/dL 5. Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN) 6. Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x the ULN) 7. History of diabetes or other metabolic disease 8. History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates 9. History of pretreatment prior to the administration of FVIII products (e.g., antihistamines) 10. Regular use of antifibrinolytics or medications affecting platelet function 11. Hypersensitivity to hamster or mouse derived proteins 12. Blood transfusions within 30 days of enrollment into the study 13. Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study 14. Unable or unwilling to cooperate with study procedures 15. Females who are pregnant (positive β-hCG test) or breastfeeding
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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, Celiac Disease Iron Deficiency Iron Malabsorption Active outpatients in the Providence Internal Medicine Residency Clinic, Family Medicine Residency Clinics, or Providence Internal Medicine Clinic 2. Demographic Age > 18 years. Diagnostic markers of iron deficiency at last check are defined as MCV<80 fL, Iron Sat<20% or ferritin<30 ng/mL. 3. Patient signs informed consent document and HIPAA authorization for release of personal health information. 4. Ability to understand procedures and comply with them for one year duration of study Any documented significant acute or chronic blood loss, per medical record review or self report (see Appendix B). Significant blood loss includes 1. Acute blood loss requiring iron treatment or transfusions within 1 year prior to the above measure of iron deficiency 2. Chronic blood loss (such as menorrhagia, GI bleeding, hemoptysis, hematuria, chronic nose bleeds, hemolysis, regular blood donations, or major trauma requiring transfusion or iron therapy) 3. Thalassemia or other major hemolytic diseases. 2. Prior diagnosis of celiac disease, or other documented cause of iron malabsorption. 3. Women who are currently pregnant, or who were pregnant with 6 months prior to time of last testing. 4. Those currently or recently on chemotherapy (within the last 6 months) 5. Those with prior gastric resection or bariatric surgery 6. Those with advanced chronic kidney disease (stage 4 or 5) 7. Any other reasons that, in the investigators' opinion, may prevent compliance with 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): 18.0-999.0, Campylobacter Infections Irritable Bowel Syndrome Age ≥ 18 Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample Pregnancy declared by the candidate History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease Coeliac Disease Pancreatitis Gallstone disease (biliary colic, cholecystitis) Diverticulitis Cancer of the gastrointestinal tract Irritable Bowel Syndrome Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
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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): 15.0-65.0, Diarrhea Persons aged 15 years old Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for <3 days) to participating health care settings For whom the study physicians recommend antimicrobial treatment Is pregnant Requires hospitalization Has signs or symptoms of septicemia Has a primary complaint of another acute illness Has a serious chronic illness Has an allergy to aspirin Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment Previously enrolled in 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): 18.0-45.0, Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive Provide written informed consent before initiation of any study procedures General good health, without (a) significant medical illness, (b) clinically significant physical examination findings, including vitals, as determined by the PI, and (c) screening laboratory values outside the site's normal limits Within 46 days of vaccination, have normal screening laboratories, per Appendix B for white blood cells (WBCs), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) Have normal screening laboratories for urine protein Trace protein is acceptable HgbA1C <6.5% at screening. - Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Agrees to complete all study visits and procedures 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 using an effective method of birth control (e.g., use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents must have a vasectomized partner) within 2 months of vaccination, or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 29 study visit. Male subjects must agree not to father a child for 30 days after the Day 29 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 prior to vaccination 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 - Palpated heart rate <55 or >100 beats/minute at rest on 2 separate days*; or *If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders. --Temperature >/= 38.0 degrees C (100.4 degrees F) Symptoms of an acute self-limited illness, including a temperature >/= 38.0 degrees C (100.4 degrees F), such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT. - Positive hepatitis C, or HIV serology or positive hepatitis B serology not consistent with prior hepatitis B immunization Have a positive urine drug screen for opiates Subjects who are unwilling or unable to cease smoking for the duration of the overnight stay. - History of antimicrobial treatment in the 2 weeks before administration of dmLT Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholera challenges; or previous infection with cholera or diarrheagenic E. coli Abnormal routine bowel habits as defined by fewer than three stools per week or more than two stools per day in the past 6 months History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than three times per week is permitted), or other significant gastrointestinal tract disease
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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): 7.0-17.0, Flatfeet Planovalgus foot deformity Patient normally ambulates without use of assistive devices Patient is between the ages of 7 and 17 at the initial evaluation Hip flexion contractures greater than 15 deg Knee flexion contractures greater than 10 deg Ankle dorsiflexion less than 0 deg. (plantarflexion contracture) Taking medication which effects motor control Inability to follow instructions to perform 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): 0.0-72.0, Ductus Arteriosus Patent Respiratory Distress Syndrome inborn neonates preterm neonates ≤ 31+ 6 days weeks gestation newborns with HsPDA parental written informed consent for participation in the study must be obtained Serum creatinine concentration greater than 1,5 mg/dl (132MMole/L) Urine output less than 1 ml/Kg/h Severe IVH (> grade II according to Volpe classification) Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate) Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals Thrombocyte count of less than 50.000/mm3 Proved Sepsis Severe coagulopathy or liver failure Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0 Known genetic or chromosomal disorders
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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, Central Nervous System Embryonal Tumor With Rhabdoid Features Central Nervous System Embryonal Tumor, Not Otherwise Specified Central Nervous System Ganglioneuroblastoma Embryonal Tumor With Multilayered Rosettes, C19MC-Altered Pineoblastoma Primary Central Nervous System Neoplasm Recurrent Childhood Central Nervous System Embryonal Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Medulloblastoma Recurrent Neuroblastoma Recurrent Rhabdomyosarcoma Refractory Malignant Solid Neoplasm Refractory Medulloblastoma Refractory Neuroblastoma Refractory Rhabdomyosarcoma Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) Part A: Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors Part B: Patients with relapsed or refractory neuroblastoma Part C: Patients with relapsed or refractory medulloblastoma or CNS embryonal tumors formally classified as PNET (pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes, medulloepithelioma, CNS embryonal tumor with rhabdoid features [INI1 intact] and CNS embryonal tumor, not otherwise specified) Part D: Patients with relapsed or refractory rhabdomyosarcoma Part A: Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment if enrolling on dose levels 1-5; patients must have a body surface area >= 0.46 m^2 at the time of study enrollment if enrolling on dose level 0 Parts B, C, and D: Phase 2 Expansion: Patients must have a body surface area of > 0.49 m^2 at the time of study enrollment at the recommended phase 2 dose of AZD-1775 Part A: Patients must have either measurable or evaluable disease Part B: Patients must have either measurable disease or must be evaluable for MIBG response without evidence of Response Evaluation in Solid Tumors (RECIST) measurable lesions; patients with neuroblastoma in bone marrow only are not eligible Part C: Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) Pregnant or breast-feeding women may not be entered on this study as there is yet no available information regarding human fetal or teratogenic toxicities; 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 double barrier contraceptive method for the entire duration of protocol therapy and for 3 months (males) and 1 month (females) after study drug discontinuation Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant as an antiemetic is prohibited due to early drug interaction data demonstrating increased exposure to AZD1775 (MK-1775); caution should be exercised with concomitant administration of AZD1755 (MK-1775) and agents that are sensitive substrates of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), 2C9 and 2C19, or substrates of this enzyme with narrow therapeutic ranges, as well as agents that are inhibitors or substrates of permeability glycoprotein (P-gp) Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial Patients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollment Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial Patients who have an uncontrolled infection are not eligible
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-999.0, Soil-transmitted Helminthiasis Schistosomiasis Strongyloidiasis Shigellosis Intestinal Salmonellosis Campylobacteriosis Aeromonas Spp. Infections Giardiasis Amoebiasis Dientamoebiasis Cryptosporidium Spp. Infections Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence). 2. Individuals with written informed consent provided Individuals in need of immediate intensive or surgical care. 2. Individuals who are unable or unwilling to give written informed consent. 3. Individuals who do not meet the for being a case or control (e.g. people with acute diarrhoea). 4. Individuals with clinical jaundice (assessed by direct observation of the conjunctivae). 5. Individuals who are unable, in the study physician's opinion, to comply with the study requirements. 6. Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials
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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 Hemangioendothelioma (KHE) Kasabach-Merritt Syndrome Tufted Angioma Diagnosis: All patients must have one of the following vascular anomalies as determined by clinical, radiologic and histologic (when possible). Biopsy strongly recommended (but not required) with suggested immunostains: CD34, PROX-1 or D240, Glut-1 and MIB-1. 1. Kaposiform Hemangioendotheliomas 2. Tufted angioma High Risk Stratification: In addition to the above diagnosis, all of the following need to be met: a. Kasabach Merritt Syndrome defined at a platelet counts less than 50,000 K/µl and/or fibrinogen level < 100 mg/dl at the time of diagnosis Age: Patients must be 0 years of age at the time of study entry. Enrollment includes patients of both genders and all ethnic groups Organ function requirements: 1. Adequate liver function defined as: 1. Total bilirubin ≤ 1.5 x ULN for age, and 2. SGPT (ALT) ≤ 5 x ULN for age, and 3. Serum albumin >/= 2 g/dL. 4. Fasting LDL cholesterol of <160 mg/dL 5. Fasting triglyceride <400 mg/dl 2. Adequate Bone Marrow Function defined as: 1. Peripheral absolute neutrophil count (ANC) >/= 1000/uL 2. Hemoglobin >/= 8.0 g/dL (may receive RBC transfusions) 3. No Platelet requirement 3. Adequate Renal Function Defined as: 1. A serum creatinine based on age as follows: Age (Years) Maximum Serum Creatinine (mg/dL) 0.8 6 to ≤10 1.0 11 to ≤15 1.2 >15 1.5 2. Urine protein to creatinine ratio (UPC) < 0.3 g/l Performance Status: Karnofsky >/= 50 (≥16 years of age) and Lansky >/= 50 for patients <16 years of age Prior therapy 1. Patients who have undergone surgical resection or interventional radiology procedures for disease control are eligible if they meet all after surgery/procedure 2. Surgery: At least 2 weeks since undergoing any major surgery 3. Radiation: > 6 months from involved field radiation 4. Prior vincristine therapy is permitted. Patients may also have received up to 2 doses of vincristine prior to randomization Concurrent severe and/or uncontrolled medical disease that 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) Patients who require medications that are strong inhibitors/inducers CYP3A4 enzyme activity, including anticonvulsants, (Appendix II) to control concurrent medical conditions are not eligible. Patients who discontinue use of prohibited medications with a one week washout prior to start of study treatment are eligible 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 Females 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. Females of childbearing potential will be given a pregnancy test within 7 days prior to administration of study treatment 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 Patients who currently have an uncontrolled infection, defined as receiving intravenous antibiotics
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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): 5.0-55.0, Secretory Diarrhea Approximately 170 adult (male and female) patients must be enrolled to ensure that 96 patients (48 active and 48 placebo) are evaluable in Part A. In Part B, approximately 156 pediatric patients will be enrolled to ensure that 120 pediatric patients (60 active and 60 placebo) are evaluable for the analysis of 24 hour stool output, the primary outcome measure. PART A ***Inclusion Criteria*** A patient will be considered eligible for participation in the study if the following are satisfied on admission (Day 1) to the Dhaka Hospital of icddr,b Adults aged 18 years to 55 years Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces Clinical signs and symptoms of severe dehydration (>10% loss of body weight based on rehydration weight) Stool RDT and/or stool DF microscopy demonstrating presence of V. cholerae Must have a purging rate greater than/equal to 20 mL/kg (5 mL/kg/h) during the initial 4 to 6-hour screening/observation period, and signs of clinical dehydration must be corrected Written informed consent for participation in the study (see Section 6.1.2 for details of the consent process) Negative urine pregnancy test for all female patients *** A patient with any of the following at screening for study enrollment will not qualify for the study Received antidiarrheal medication (eg, loperamide, diphenoxylate) within 7 days before screening Abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate Use of drugs metabolized predominantly via CYP2C9 within 7 days before screening (see Section 5.7) Concomitant infection requiring antimicrobial therapy other than the study drug that may interfere with the evaluation of either the efficacy or safety of the study drug Patients unwilling or unable to take part in this study or refusing to sign informed consent (patients who participate on the basis of proxy consent will be re-consented at the end of the screening/observation period; those refusing consent at that time will be excluded from further study participation) Patients previously enrolled in this or any other investigational study within the past 30 days PART B ***Inclusion Criteria*** A patient will be considered eligible for participation in the study if the following are satisfied on admission (Day 1) to the Clinical Research Ward (CRW) of Dhaka Hospital Pediatric population aged ≥ 5 years to < 18 years of age Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces
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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): 30.0-60.0, Constipation Males or females aged 30-60 years Abnormal blood lipids level Have aperiodic or occasional gastrointestinal symptom (gastrointestinal tympanites, abnormal borborygmus, heavy feeling after meal, celiodynia, abdominal pain) Slow power of intestinal tract or irregular intestinal moving (abnormal feces solidity, decreased feces quantity, e.g. defecate every 2-3 days or defecate less than 3 times a week) Diagnosed as chronic constipation Receiving treatment for gastrointestinal symptoms Lactose Intolerance In use of analgesic such as aspirin or Panadol, etc Have had laxatives or other substance that will enhance digestion within 2 weeks before the study begins Have had dairy products or other food containing probiotics within 10 days before the study begins Have diarrhea currently
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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, Organophosphate Poisoning Male (females usually wear national dresses considered to provide adequate protection (43) Age min. 18 years (implies being a legal worker) Grows crops in knee and abdomen height in given data collection period Willing to spend 1.5-3 hours working with organophosphates under normal working conditions Involved in farming minimum two years (implies being active) Usually sprays at least once in two weeks with organophosphates on average (implies being active) Uses a hand pressured backpack sprayer placed at home (necessary to complete non-intervention) Works with crops in 5-10 katha land (sufficient to apply organophosphates for given time) Has a mobile/landline number (necessary for easy contact) Has a helper during work with organophosphates (organophosphate exposure reduced)
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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, Diabetes Mellitus Type 1 UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV & HIV by PCR test before enrollment in the study and positivity for any of these parameters means of this patient from the study
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Diffuse Large B Cell Non-Hodgkin Lymphoma Patients 18 years or older who have undergone an autologous HCT for the treatment of DLBCL and are in a complete remission (CR), partial remission (PR) or have stable disease (SD) at the day 28 post-transplant reassessment Karnofsky Score of ≥ 70% (appendix II) Able to start the protocol therapy (1st dose of rituximab) between day 28-75 post-transplant Adequate organ function defined as Hematologic: platelets ≥ 50,000 x 109/L; ANC ≥ 1000 x 109/L unsupported by G-CSF or GM-CSF for 3 days Renal: creatinine < 1.5 mg/dl or glomerular filtration rate > 50 ml/min Hepatic: Alanine transaminase (ALT, SGPT) and aspartate aminotransferase (SGOT, AST) < 3 x upper limit of institutional normal and total bilirubin < 3.0 mg/dl (if total bilirubin is ≥ 3.0 patient is eligible if direct bilirubin is within normal limits) Pulmonary: clinically no evidence of pulmonary disease Cardiac: no symptoms of uncontrolled cardiac disease If post-transplant consolidation radiation therapy is given, the patient must be at least 14 days between last radiation treatment and 1st dose of rituximab Pregnant or lactating Studies to evaluate the potential for embryo toxicity and teratogenicity have not been performed for INCB7839. Until additional information is available, women of childbearing potential should use appropriate precautions to avoid becoming pregnant. Rituximab is Pregnancy Category C: There are no adequate and well-controlled studies of rituximab in pregnant women. Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study treatment start Recent venous thrombosis within 4 weeks prior to study enrollment. Patients at high risk for thrombotic events due to inherited risk factors (i.e. factor V Leiden) or DVT/PE in the past 12 months should be on secondary prophylaxis with anti-coagulant therapy (i.e. warfarin or low molecular weight heparin) prior to enrollment Active uncontrolled infection Active CNS disease Previous severe or life-threatening allergic reaction with rituximab or known allergy to the compounds found in INCB7839 Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome) Unwilling or unable to swallow tablets BID Serologic or clinical evidence of current active hepatitis B or C infection, defined as elevated levels of Hep B antigen or Hep C antibody (unless active infection is ruled out by nucleic acid tests) Known HIV infection
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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): 2.0-17.0, Egg Allergy Egg allergic children Uncontrolled asthma the day of immunization severe asthma treated by oral steroids or high dose of inhaled steroids urticaria on the day of immunization antihistamines taken in the previous 3 to 7 days of immunization acute disease on the day of immunization (fever,irritability, vomiting, diarrhea, pallor, cyanosis, diaphoresis, lethargy) immunosuppressed patients or health worker who should be in contact with immunosuppressed patients
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-60.0, Abdominal Pain emergency department's patients undergoing CT evaluation for acute abdominal pain and tenderness (acute is defined as onset of current episode within 7 days of emergency department presentation) neurological disorders altered mental status history of intra-abdominal surgery in the past 30 days BMI higher than 35 immunocompromised patients abdominal trauma in the past 30 days CT is ordered for the following indications isolated vomiting fever without source staging of malignancy
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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): 0.635-999.0, Uncomplicated Neonatal Hyperbilirubinemia Newborns with gestational age >33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis) Liver disease
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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, Gastric Cancer Gastric Metaplasia Gastric Dysplasia presenting for upper endoscopy for gastric indications gastric indications upper abdominal pain dyspepsia abnormal gastric imaging iron deficiency anemia gastric ulcer management of GI blood loss without active bleeding reflux weight loss Subjects who are incarcerated, younger than 18, or unable to give informed consent will be excluded Patients who have evidence of active gastrointestinal bleeding will be excluded Patients taking anti-thrombotic agents including clopidogrel, ticlopidine, coumadin, heparin, enoxaparin, and direct II or Xa inhibitors Patients with INR >1.5, platelet count <75,000
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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): 6.0-18.0, Abdominal Pain Rectal Bloodloss Diarrhea Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Irritable Bowel Syndrome Eligible patients are those aged between 6 and 18 years with at least one of the following Persistent diarrhea (at least 4 wks) Recurrent abdominal pain with diarrhea (at least 2 episodes in 6 months) Rectal bloodloss Peri-anal disease OR at least two of the following Involuntary weight loss First degree family member with IBD Anemia (HB < -2 SD for age and gender) Increased marker of inflammation (ESR >20 mm/hour or CRP >10 mg/L) Extra-intestinal symptoms (erythema nodosum, arthritis, uveitis, thromboembolism, aphtous ulcera) We did not define any
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-18.0, Hemolytic Uremic Syndrome of Childhood Pediatric patient (1 month-18 years old) Affected by STEC-HUS defined by Thrombocytopenia (<150 000/mm3) Mechanic hemolytic anemia (Hemoglobin < 10g/dL, haptoglobin <LLN, lactate dehydrogenase (LDH) >upper limit of normal (ULN) and/or bilirubin > ULN, presence of schizocytes) ARF defined by an estimated Schwartz 2009 creatinin clearance <75ml/min/1,73m² With prodromal diarrhea and/or presence of an enterohemorrhagic strain of Escherichia Coli and/or identification of the Stx 1 or 2 genes in the stool sample or rectal swab Written consent of the 2 parents Female patients of childbearing potential must be practicing an effective, reliable and medically acceptable contraceptive regimen during the entire duration of the study and 5 months after the end of the participation Neonatal HUS Malignancy Known HIV infection Pregnancy or lactation Identified drug exposure-related HUS Infection-related HUS Known systemic lupus erythematosus or antiphospholipid antibody positivity or syndrome Patient already enrolled in a drug trial Patient with ongoing meningococcal infection Patient affected by aHUS or family history of aHUS
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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, Clostridium Difficile Infection Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli
|
0
|
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): 0.083-13.0, Acute Gastroenteritis Diarrhea Dehydration acute gastroenteritis immunodeficiency malnutrition
|
1
|
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): 17.0-75.0, Chronic Myeloid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia Donor Donors must be eligible and approved for a hematopoietic stem cell graft according to institutional (related donor) or NMDP (volunteer unrelated donor) Donors must be ≥ 17 years old and ≤ 75 years old Donors must be agreeable to receive G-CSF for CD34 cell mobilization and undergo apheresis for the second donation of peripheral blood mononuclear cells (PBMC) Donor must have adequate peripheral venous catheter access for apheresis or must agree to placement of a central catheter The following laboratory tests/evaluations will be performed for all donors registered in the study. Additional evaluations/studies may also be performed by the site as dictated by the donor's clinical situation or standard practice for monitoring normal donors History and physical examination Automated complete blood count (WBC, red blood cells [RBC], hematocrit, hemoglobin) with differential and platelet counts Serum chemistries panel including electrolytes, glucose, blood urea nitrogen (BUN), alanine aminotransferase (ALT), creatinine, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH) and albumin. Electrolytes to sodium, potassium, chloride, carbon dioxide, calcium and magnesium Infections disease titers by FDA licensed tests for
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0
|
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, Severe Alcoholic Hepatitis in 'Extremis'- Defined by mDF>54 Severe Alcoholic hepatitis (mDF > 54) 2. Age 18-65 Year 4. Actively consuming alcohol within 6 weeks of entry into the study Failure to obtain informed consent 2. Active infection or sepsis 3. Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease 4. HIV positive 5. Cow milk allergy or severe lactose intolerance 6. Active Gastrointestinal bleeding 7. Acute kidney injury at time of randomization with Creatinine > 1.5 mg/dL 8. Evidence of acute pancreatitis or biliary obstruction 9. Subjects who are pregnant or lactating 10. Significant systemic cardio-pulmonary illness 11. Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization 12. Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week. 13. Any patient who has received any investigational drug or device within 30 days entering into the study
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0
|
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, Urea Cycle Disorders Enrollment in UCDC RDCRN Contact Registry Patient reported diagnosis of one of the eight UCDs or UCD diagnosis highly likely/pending Cases of hyperammonemia caused by an organic acidemia, lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects and primary liver disease Individuals with rare and unrelated serious comorbidities, e.g., Down syndrome, intraventricular hemorrhage in the newborn period, and extreme low birth weight (<1,500 grams) Inability to provide informed consent and complete surveys
|
0
|
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, Surgery Blood Loss Patient scheduled for non cardiac and non emergency surgery Cardiac surgery Emergency surgery
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0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-18.0, Haemolytic and Uremic Syndrome Patient aged from 6 months to 18 years old, residing in France, with a D+HUS according to the definition used by the National Institute for Public Health Surveillance (InVS) Renal impairment with a serum creatinine > 60μmol/l in children less than 2 years old and > 75μmol/l over 2 years old AND hemolytic anemia defined by hemoglobin < 10g/dl associated with schizocytes ≥ 2% Collection of free and informed consent of the holders of parental authority Age < 6 months and > 18 years Administration of antibiotics in the 15 days preceding the diagnosis of D+HUS Personal or family history of atypical HUS More than 15 days between the onset of diarrhea and the diagnosis of D+HUS Hypersensitivity to azithromycin, erythromycin, or any macrolide patient treated with dihydroergotamine, ergotamine or cisapride Severe hepatic impairment No affiliation to a social security scheme (beneficiary or legal) Pregnancy Breastfeeding
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2
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