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Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Compliance, Patient stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month Life expectancy <1 year Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-60.0, OSA fractional exhaled nitric oxide and Hs-CRP were measured next morning of PSG, CPAP for moderate to severe OSA patient was advised with measurement of FeNO and Hs-CRP after 3months of CPAP 1. were ≥ 18 years old, 2. non-smokers and 3. excluded from any inflammatory disorders (allergy, bronchial asthma, gastro-esophageal reflux disease, cardiovascular diseases, and cerebrovascular diseases) or use of any regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors), 4. or had upper or lower respiratory tract infection 2 weeks prior to sampling. 5. Control healthy subjects were also free from any sleep disorders symptoms. Cases were recruited from Sleep-disordered breathing unit out Patient Clinic in pulmonary medicine department Mansoura University Egypt smokers 2. inflammatory disorders 3. cardiovascular disease, 4. on regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors) - | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease on Dialysis Peritoneal Dialysis Hemodialysis Adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous China Q study and who enrolled in SURinD study with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks Will and able to provide the informed consent form (ICF) Patients have stopped dialysis due to kidney function recovery or kidney transplantation Patients refuse to provide consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Self-Care Self Efficacy Perceived Social Support Peritoneal Dialysis Patients who were receive peritoneal dialysis at Akdeniz University Hospital Patients who receiving peritoneal dialysis treatment for at least one months Patients who were over 18 years of age Patients who had orientation of individual, place and time Patients who were literate Patients who has Internet at home Patients who has computer or mobile phone Patients who no barriers to written or verbal communication Patients who agree to participate in the study Diagnosis of psychiatric illness Malignancy diagnosed Visually and hearing impaired | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-90.0, Hemorrhagic Stroke Meet the diagnostic of acute intracerebral hemorrhage； 2. CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml; 3. The time from onset to confirmed diagnosis by CT scan is within 4 hours; 4. Enrolled and receive treatment within 12 hours from onset; 5. Age ≥18 years old; 6. Obtain approval from the patient or family members The time from onset to confirmed diagnosis by CT scan is over 4 hours; 2. CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one); 3. The volume of hematoma is above 80ml; 4. Glasgow Coma Scale (GCS) is ≤ 5 points; 5. The time from onset to confirmed diagnosis is over 12 hours; 6. Have a surgical treatment planning within 24 hours; 7. Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons; 8. Patients with disabilities before onset (modified mRS score > 2); 9. Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system; 10. Patients who have participated in other clinical trials within the past 1 month; 11. Pregnant or nursing women; 12. Allergic constitution (allergic to more than two kinds of food or medications) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-59.0, Malaria Falciparum Malaria Vivax Malaria Above 6 months old to 59 years old Mono-infection with P. falciparum or P. vivax, with parasitemia of: P. falciparum: 1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C Ability to swallow medication Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old Informed assent from any minor participant aged 12 years; and Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years old Severe malnutrition Mixed Plasmodium species detected by microscopy Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] <110 mm) Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS) Regular medication, which may interfere with antimalarial pharmacokinetics History of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment Positive pregnancy test or breastfeeding; and Unable to or unwilling to take pregnancy test or to use contraception for women or child-bearing age and who are sexually active | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-999.0, Cystic Fibrosis Key Subjects From Study VX16-809-122 Part B (Study 122) Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B Subjects Not From Study 122 Subjects will be 1 to less than 2 years of age Homozygous for the F508del mutation (F/F) Key Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject Solid organ or hematological transplantation Other protocol defined Inclusion/ | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Colonization Clostridium Difficile Diarrhea Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below) Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are) Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection Any patients with contra-indications to probiotics or vancomycin Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of <200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome) Structural heart disease (e.g. atrial septal defect, ventricular septal defect) Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis) Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin Prior or current hearing loss Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of <15ml/min, or absence of a current estimated creatinine clearance | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Septic Shock Sepsis Hypovolemia Male or female at least 18 years of age 2. Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection or an elevated procalcitonin. 3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market. 4. Patient is on two or more pressor drugs at the following minimal doses: Levophed =20 mcg/minute, epinephrine 10 mcg/minute, dopamine 20 mcg/kg/minute, phenylephrine 180mcg/minute, vasopressin 4 units/hour, at full dose required to maintain a mean blood pressure of 65 mmHg or Patient is on Levophed or its equivalent at 55 mcg/min with conversion factors for other vasopressors to Levophed being 5.6 x Vasopressin ( in units/hour), 0.5 x dopamine( in mcg/kg/minute) epinephrine ( in mcg/minute) 0.1 x phenylephrine ( in mcg/minute) at full dose to maintain a mean blood pressure of 65 mmHg. (Predicted mortality >80%) 5. Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%) 6. Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline) 7. Sepsis diagnosis Patients with a ventricular assist device 2. Acute coronary syndrome 3. Pregnant 4. Bronchospasm 5. Mesenteric ischemia 6. Emergency surgery 7. History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis 8. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19 9. Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000) 10. Absolute neutrophil count of < 1000 mm3 11. Current participation or participation in another experimental or device study within the last 30 days before the start of this study 12. Patients with a known allergy to soybeans or eggs | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Diagnosed of C. difficile infection 2. Age older than 18 years old Failing to meet the 2. If the positive microbiological results were not associated with clinical features of gastrointestinal infection. 3. Patients with incomplete data | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, Coronavirus Disease 2019 Novel Coronavirus Pneumonia Adult male or female patients aged 18-85 years old; 2. The newly diagnosed COVID-19 patients who meet the diagnostic set forth in the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)", issued by the National Health Commission of the People's Republic of China on 8 February 2020; 3. Patients whose blood oxygen saturation is not less than 90%. 4. Patients who agree to participate in the study and voluntarily comply with the relevant requirements of the study Patients with other diseases that may affect, in the opinion of study researchers, the implementation of the study or the observation of the efficacy data; 2. Patients with severe Coronavirus Disease 2019 (COVID-19), that is based on "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)" with respect to the for clinical severity classification; 3. Female patients with known pregnancy and in lactation at screening; 4. Patients with previous allergies to T89 or Radix Salvia Miltiorrhizae, Radix Notoginseng and Borneol; 5. Any other condition that, in the opinion of the investigator, may affect the conduct of the study, reduce compliance or increase the risk of patients | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Spondyloarthritis Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria Participants have a history of back pain ≥3 months with age at onset <45 years Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs Have a history of prior therapy for axSpa for at least 12 weeks prior to screening Have total ankylosis of the spine Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year Have an ongoing or serious infection within the last 12 weeks Have a compromised immune system Have any other serious and/or uncontrolled diseases Have either a current diagnosis or a recent history of malignant disease Have had major surgery within 8 weeks of baseline, or will require surgery during the study Are pregnant or breastfeeding | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Influenza, Human Respiratory Syncytial Virus Infections The subject may be of any age and either sex Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza and/or RSV at the time of the study visit. The subject must exhibit two (2) or more of the following signs and symptoms for stuffy or runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing), wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms must not have begun more than four (4) days prior to study enrollment The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects 18 years and older must report having a fever, but a quantitative reported measurement is not necessary for inclusion The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit The subject is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™) The subject is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis) The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy The subject has previously participated in this research study | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, COVID-19 Recombinant Human Interferon α1β Age ≥ 18 years; 2. Clinically diagnosed patients with new type of coronavirus pneumonia, including: in accordance with the for suspected cases, have one of the following etiology evidence: ① Real-time fluorescence RT-PCR of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid; ② Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronavirus 3. The time interval between the onset of symptoms and random enrollment is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough, diarrhea or other related symptoms can be used Any situation where the programme cannot be carried out safely; 2. Patients who have used interferon or remedesivir; 3. No clinical manifestations and chest imaging findings 4. Known allergy or hypersensitivity to interferon (including asthma); 5. Disabled in patients with uncontrolled autoimmune diseases; 6. Patients with severe heart disease, decompensated liver disease, renal insufficiency (CrCL <50ml / min), and those with abnormal bone marrow function are prohibited; 7. Epilepsy and impaired central nervous system function; 8. Pregnancy: Positive pregnancy test for women of childbearing age; 9. Breastfeeding women have not stopped breastfeeding; 10. The patient may be transferred to a non-participating hospital within 72 hours | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Chronic Kidney Diseases Cardiovascular Risk Factor Partner, Domestic Patients with either stable rheumatoid arthritis OR stable stage 3 or 4 chronic kidney disease with at least 2 uncontrolled cardiovascular risk factors AND a partner who is also willing to take part in the study Stable rheumatoid arthritis (RA). Rheumatoid arthritis as diagnosed by a rheumatologist. Stable meaning that there was no escalation of disease modifying antirheumatic drugs OR escalation in steroid dose/frequency within the previous 6 months. Patients on a stable dose of chronic steroids are eligible for inclusion Stable chronic kidney disease (CKD). CKD can be of any cause. Stable meaning that there was no significant change in renal function over a period of 3 months Stage of CKD is based on the 2012 KDIGO guidelines:19 Stage 3 CKD: GFR 30-59ml/min/1.73m2 Stage 4 CKD: GFR of 15-29ml/min/1.73m2. GFR will be calculated based on CKD-EPI equation At least 2 of the 5 following uncontrolled cardiovascular risk factors Hypertension (BP ≥130/80mmHg) Active smokers BMI ≥30kg/m2 Dyslipidemia (LDL ≥1.4mmol/L in very high risk, ≥1.8mmol/L with high risk, LDL Both the patient and the partner must freely sign informed consent Known unstable angina, symptomatic severe aortic stenosis, pregnant patients, severe cognitive impairment, physical impairment leading to inability to exercise, currently enrolled in another lifestyle program, currently awaiting organ transplant, previous renal transplant, patients with End Stage Renal Disease (Stage 5 CKD) or those expected to commence dialysis within the next 6 months, acute pulmonary embolus or pulmonary infarction | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-99.0, Peritoneal Dialysis Complication age > 18 years ability to give informed consent peritoneal dialysis (PD) treatment PD vintage of more than 3 months absence of signs of active acute systemic or localized infections at least four weeks apart from the trial pregnancy | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 65.0-110.0, Clostridioides Difficile Infection Clostridium Difficile Infection Clostridium Difficile Diarrhea Clostridia Difficile Colitis Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged > 65 years 4. Admitted in the hospital 5. Presence of diarrhea* 6. Stool positive for C. difficile tcdB and TcdB 7. 1st episode of C. difficile infection, non-severe or severe uncomplicated 8. Within 48 hours of receiving standard therapy (oral vancomycin at UVA) At enrollment, presence of any of the following Hypotension or shock Megacolon or moderate to severe ileus Acute abdomen Admission to intensive care unit 2. Inability to tolerate oral or enteral medication 3. Presence of other known infectious etiology of diarrhea 4. Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea 5. Enrollment in another investigational drug trial 6. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant). 7. On probiotics and not willing to discontinue. 8. Cirrhosis or in participants with ALT > 3X normal 9. End stage renal disease, on dialysis, or creatinine clearance or estimated GFR of <30mL/min even after adequate hydration 10. Life expectancy of < 6 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Patients must have histologically or cytologically confirmed clinically detected, node involved Stage IIIB/C/D melanoma by American Joint Committee on Cancer (AJCC) version 8 and surgically resectable disease. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at multidisciplinary tumor conference attended by melanoma medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement that would preclude complete resection or necessitate the use of adjuvant radiation. Only cases where a complete surgical resection with tumor free margins can safely be achieved are defined as resectable BRAF mutation-positive melanoma (V600E or V600K) based on report from a Clinical Laboratory Improvement Act (CLIA) certified laboratory Patients must have measurable disease, defined by Response Evaluation in Solid Tumors (RECIST) 1.1 Patients who have been previously treated in the adjuvant setting with ipilimumab or interferon alpha or investigational vaccines for melanoma will be eligible for treatment after a 28 day wash-out period Patients who have previously received anti PD-1 in the adjuvant setting will be allowed if it has been six months or longer since previous drug exposure Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Women of childbearing potential, defined as all women physiologically capable of becoming pregnant will be required to use highly effective methods of contraception during dosing and for 150-days after stopping treatment with spartalizumab. Highly effective contraception methods Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug within 28 days Evidence of metastatic melanoma or patients with only in-transit metastases without involved nodes Prior BRAF or MEK inhibitor use Prior anti PD-1 or anti PD-L1 inhibitor use in last 6 months Prior malignancy active within the previous 2 years except for patient's prior diagnosis of melanoma and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast with local control measures (surgery, radiation) Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease Any positive test result for hepatitis B or C and human immunodeficiency virus (HIV) virus indicating acute or chronic infection Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome History of severe hypersensitivity reaction to any monoclonal antibody | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, COVID19 Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device. 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation 12. Patients receiving anti-hcv treatment 13. Permanent blindness in one eye 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery 16-The competent physician considered it inappropriate to participate in the study ------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------- ---------------------------------------------------------- Safety and promising features of isotretinoin in tne era of COVID 2019 according Principal Investigator Protocol: 1. This medication have the feature of Aerosolized Drug Delivery to increase its efficacy beside Oral administration, Which makes it distinct from other medication in which should dose be only given orally. A study demonstrated that treating with 13 cis retinoic acid aerosolized via inhalation rout did not cause any damage in lung cells. 2. Repeated high doses of 13 cis retinoic by inhalation resulted in moderate loss of body weight, but microscopic investigation of ten tissues including lung and oesophagus did not detect any significant aerosol-induced damage. The results suggest that administration of isotretinoin via powder aerosol inhalation is probably superior to its application via the oral route in terms of achieving efficacious drug concentrations in the lung. 3. Inhaled isotretinoin might provide sufficient drug to the target cells for efficacy while avoiding systemic toxicity. 4. A study demonstrated that 13 cis retinoic is used in treating Emphysema (emphysema is a lung condition that causes shortness of breath) 5. RA has been reported to induce formation of new alveoli and returns elastic recoil in the lung to approximately normal values in animal models of emphysema. 6. Strong expectation of complete COVID -19 blockade from cell entry and infection depending on strong ethics, researches and references. 7. Availability of our compounds. 8. Ease of application. 9. Expectation of COVID -19 treating by isotretinoin via more than one distinct mechanism. 10. Expectation of High induction of anti inflammatory T cells and significant inhibition of IL-6 at low concentrations of isotretinoin. 11. Controlling Accompanying cytokine storm. 12. No interactions with Egyptian protocol drugs were found. 13. (13 cis -Retinoic acid ) can be given in the form of aerosol to avoid these systemic side effects. A clinical trial conducted on 148 subject from 5 university hospitals to evaluate the possibility of retinoids in the treatment of emphysema. The patients, were randomized to receive 13-cis retinoic acid (1 mg/kg/day, daily or ATRA at either low dose (1 mg/kg/day for 4 days/wk) or high dose (2 mg/kg/day for 4 days/wk), placebo for six months, followed by a three-month crossover phase. then, they were observed for an additional nine months before the final evaluation. In the trial, retinoids(13 cis retinoic acid ) were proven to be safe as the drug-related AEs were generally mild[188]. A study reported that the application of aerosolized RA system led to a rise of RA levels in lung, but not plasma. or liver. In lung concentration and levels of retinol, retinyl palmitate and retinyl stearate also showed to be unchanged [189] A study on rabbits demonstrated that 13 cis retinoic acid can be given in the form of aerosol without serious side effects In this study repeated elevated doses of 13 cis retinoic acid by inhalation caused moderate loss of body weight, but microscopic examination of ten tissues including oesophagus and lung did not found any significant inhalation-induced injury or damage therefore aerosolized 13 cis retinoic acid might provide sufficient therapy to the target cells in lung for efficacy while avoiding systemic toxicity © 2000 Cancer Research Campaign[190] | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Enterococcal Bacteremia Hospitalized patient ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization bacterial isolate(s) is/are available for further characterization Repeat blood culture(s) within 7 days from the first positive culture Cultures obtained from patients not admitted to the hospital Isolate(s) not available for further studies | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-65.0, Migraine, Hemicrania age >18 yrs diagnosis of MOH and CM (1) written informed consent co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses seizures use of opioids | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 17.0-999.0, Dysphagia, Esophageal Dysphagia, Oral Phase Dysphagia Comes and Goes Thyroiditis Thyroid Cancer Thyroid Neoplasms Thyroid Goiter Thyroid Nodule (Benign) Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma) Patients with total thyroidectomy (TT) indication Patients over 17 year-old Patients without thyroid disease Patients with thyroid disorder, but prepared for surgery other than TT Healthy volunteers Patients below 17 y/o | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-17.0, Cystic Fibrosis and Non CF Bronchiectasis ages less than 18 years Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations) Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis Vitamin D deficient or insufficient CF and non CF bronchiectasis patients if they had sufficient Vitamin D level chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases reported taking vitamin-D supplements or steroid therapy in the last 6 weeks | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Chronic Kidney Diseases Aged 18 years or older Willing and able to undertake the interview process Able to give informed consent Age < 18 years Does not provide written informed consent Any neurological/psychiatric diagnoses Lack of fluency in English Individuals who have commenced RRT within three months of the study start date Transplant patients being seen in clinic more than once every fortnight | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 75.0-999.0, Elderly Infection Frailty Frail Elderly Syndrome Infection, Bacterial Patients presenting at the emergency department and later on admitted to the geriatric department Patient age 75 years or older Patients with geriatric profile according to KATZ scale, G8 screening test or CIRS score Patient receiving antibiotic treatment (amoxicillin-clavulanate, piperacillin-tazobactam) Intravenous access available for blood sampling. For measurement of the peak concentration an intravenous access other than the drug infusion line is required Admission to other units than the geriatric department incl. the ICU Absence of informed consent Known hypersensitivity to beta-lactam antibiotics Patients who received oral amoxicillin-clavulanate prior to admission will not be included in the iv. amoxicillin-clavulanate group | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Weakness of the Lower Limbs For patients Step 1: Patient hospitalized in the Physical Medicine and Rehabilitation department of the Rennes University Hospital following a stay in intensive care or in a Continuing Care Unit, in particular following a COVID-19 infection, and with muscle weakness of the lower limbs with an MRC motor testing on the main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion of ICU Weakness) Steps 2 and 3: Patient hospitalized in one of the ICU of the Rennes University Hospital and presenting post-resuscitation muscle weakness in the lower limbs with MRC motor testing on the main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion of ICU Weakness) Steps 4 and 5: Patient hospitalized in one of the ICU or in the Physical Medicine and Rehabilitation service of the Rennes University Hospital and presenting post-resuscitation muscle weakness in the lower limbs with an MRC motor testing on the main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion of ICU-Weakness) For nursing staff: Step 2: Person with one of the following professions: nursing assistant, nurse, doctor, physiotherapist, and practicing for more than a month in one of the ICU of the Rennes University Hospital . For everyone Person of full age Affiliation to a social security insurance Free, informed and written consent signed For patients History of central neurological event with clinical repercussions Gait disturbances preexisting in ICU hospitalization and limiting the gait perimeter (declaration by the patient) or requiring the use of technical assistance Uncontrolled epilepsy (last crisis occurring less than 6 months old) Persons of full age subject to legal protection (safeguard of justice, curators, guardians), persons deprived of their liberty Pregnant or lactating woman. For caregivers Non-French fluent people Adults over the age of legal protection (safeguard of justice, curators, guardians), persons deprived of their liberty | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-99.0, COVID-19 FDG PET/CT Inflammation Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized during the time period from day 6 to day 14 of the onset of symptoms, and if their initial (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they were initially referred to the critical care unit, and in case of a pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-120.0, Corona Virus Infection Stroke Stroke survivors with COVID19 Non-stroke individuals with COVID19 Stroke survivors still in inpatient hospital care | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, COVID-19 Group with hydroxychloroquine treatment (HC +) LED/SG diagnosed Treatment with Hydroxy-Chloroquine in the 3 months before and during the outbreak at COVID 19, at least in December 2019. Patients may have treatment with Azathioprine or Methotrexate in combination with Hydroxy-Chloroquine COVID19 diagnostic questionnaire and available serology result. Group without hydroxychloroquine treatment (HC-) No Hydroxy-Chloroquine intake for more than 12 months --> HC without an immunosuppressant Viral hepatitis C cured for more than 12 months or primitive bile cholangitis (CBP) whose diagnosis is based on international criteria Non-significant liver fibrosis assessed either by historical histology or by fibroscan with non-significant liver fibrosis Metavir F3 (at last available examination) No Hydroxy-Chloroquine, Azathioprine or Methotrexate or other immunosuppressants have been taken for more than 12 months Anti-CD20 or Cyclophosphamide taken during the six months prior to the completion of the COVID 19 serology Refusal of a blood test for antibodies to COVID-19 Protected adults Pregnant or breastfeeding women Lack of health insurance coverage | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-65.0, Blood Glucose, Low who had both upper extremities good capillary saturation blood glucose monitoring requests for OGTT who were fasting for 8-12 hours before giving blood who had requests for 75 gr sugar loading who volunteered to participate in the study who refused to participate in the study whose capillary blood glucose could not be looked at after sugar loading | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, SARS-CoV-2 Infection Anti-SARS-CoV-2 Infection Between ≥18 and 80 years of age, inclusive Ability to provide informed consent Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Sepsis Septic Shock Septic patients in accordance with the definition of sepsis and septic shock published in 2016 (JAMA) and whose use is recommended by the European Society of Intensive Care Medicine Initial aggression dated less than 4 days before admission to intensive care (selection of "community" patients). The onset of aggression will be defined by the onset of clinical signs of infection Patients hospitalized for less than 48 hours before admission to intensive care (selection of patients without malnutrition and immunosuppression acquired in hospital) * Patients under invasive mechanical ventilation with a foreseeable ventilation duration> 2 days ** Exclusive enteral nutrition Affiliation to a social security scheme Consent signed by the patient, relative or legal representative or under emergency procedure Non Pregnancy in progress Morbid obesity (BMI> 40) State of immunosuppression defined by at least one of these continuous administration of steroids at any dose for more than one month before hospitalization, steroids at high doses (> 0.5 mg / kg / day of methylprednisolone or equivalent), radiotherapy or chemotherapy in the previous year, proven humoral or cellular deficiency Institution of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high dose corticosteroid therapy (> 0.5 mg / kg / day) | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 50.0-65.0, Diabetic Polyneuropathy Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes. 2-The age of the patients ranged from 35 to 55 years. 3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness 4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis History of diabetic ulcer and amputation . 2. Osteoporosis. 3. Fractures of lower limbs. 4. Gross musculoskeletal problems eg:burn. 5. Significant Scar tissue or calluses on the feet. 6. Peripheral vascular diseases (PVD) or Microcirculation problems. 7. Balance disturbance rather than diabetic peripheral neuropathy as ear problems, labrynthinitis, stroke or cerebellar problems. 8. Visual disturbance. 9. Autonomic neuropathy. 10. Advanced Osteoarthritis of lower limbs. 11. Nerve root compression (Radicuolopathy) affecting lower limbs. 12. Patients with implanted devices for pain control such as deep brain | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-90.0, Covid 19 Male or non-pregnant female patients at least 18 years old 2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection, either Confirmed cases: prospective participants who test positive to a validated specific SARS-CoV-2 nucleic acid test or has the virus identified by electron microscopy or viral culture, as per local trust policy ≤ 7 days before randomisation Probable/Suspected case: prospective participants who may have been in contact with a confirmed case of COVID-19, AND have mild to severe COVID-19 clinical symptoms AND radio-graphic evidence* of pulmonary infiltrates consistent with COVID-19 disease 3. Moderate to severe COVID-19 requiring hospitalisation defined as: a) Clinical status category 3-5 (inclusive) on the 7-point clinical status category scale as proposed by the World Health Organisation (WHO) master protocol: I. Category 3: hospitalized, no oxygen therapy II. Category 4: hospitalized, oxygen by mask or nasal prongs III. Category 5: hospitalized, non-invasive ventilation or high-flow oxygen *where routinely available, no tests will be requested for research purpose Therapy Use of the following concomitant medications is prohibited at Screening Visit and throughout the duration of the trial: 1. Use of Oseltamivir for more than 48 hrs prior to the first treatment dose 2. Use of antiviral drugs (e.g. nucleoside analogue reverse-transcriptase inhibitors, protease inhibitors, etc.) 3. History of long-term or concurrent use of mycophenolate mofetil, methotrexate exceeding 17.5 mg weekly 4. Chloroquine or hydroxychloroquine 5. Any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad as well as uricosuric drugs such as probenecid 6. Treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib 7. Any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogues 8. Use of rosuvastatin at daily doses higher than 10 mg Medical History of Concomitant Disease Allergic or hypersensitivity to the IMU-838, Oseltamivir, or any of the ingredients Pregnant or breastfeeding or with intention to become pregnant during the study Participants who cannot take trial medication orally at presentation Undergoing active chemotherapy or radiotherapy If the attending clinician believes that there is a specific contra-indication to the IONIC intervention Patient has a medical or concomitant disease history preventing them from participating Critical patients whose expected survival time < 48-72 hours Evidence of pancytopenia or immunosuppression | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-65.0, Transthoracic Echocardiography Hemodialysis End-stage renal disease patients on a regular dialysis program Being on dialysis at least 6 months >18 years old Ischemic heart disease Left ventricular systolic dysfunction with an ejection fraction (EF) of less than 55 % Valvulopathy Left bundle branch block Atrial fibrilation Previous renal transplantation Chronic obstructive pulmonary disease Interstitial lung diseases Connective tissue disorders Chronic thromboembolic disease | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-65.0, Irritable Bowel Syndrome aged 18-65 years at the time of screening normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms IBS-SSS score of ≥175 at the end of 7-day screening period individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months individuals with any known food allergy or insulin-dependent diabetes known history of celiac disease, inflammatory bowel disease or microscopic colitis prior small bowel or colonic surgery or cholecystectomy pregnant patients antibiotics in the past 3 months those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 (STEP 0) Patient must be newly diagnosed with B-ALL or is suspected to have ALL Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin Step 1 therapy while awaiting central laboratory confirmation NOTE: Bone marrow and/or peripheral blood specimen must be submitted to the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, given that adequate circulating blasts are present (> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to Step 1 without waiting for central confirmation Patients who started any kind of TKI prior to study registration are allowed to proceed on the study if they received no more than 14 days of TKI STEP 1 The diagnosis of Philadelphia chromosome positive (Ph+) ALL has been determined locally, and bone marrow and/or peripheral blood was sent for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center Total bilirubin =< 3 mg/dL (unless related to Gilbert's syndrome in which case total bilirubin must be =< 5 mg/dL) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X the institutional upper limit of normal (ULN) Estimated creatinine clearance > 45 mg/min (based on Cockcroft-Gault equation) (STEP 0) Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of hydroxyurea or steroids of any kind with the aim to reduce disease burden prior to study registration are eligible Patient must not have unstable epilepsy that requires treatment STEP 1 Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment, and until at least six months after the last dose of study treatment Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies can be included Patients must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol STEP 2 Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, Inflammatory Bowel Diseases patients with inflammatory bowel disease between 18 to 55 years presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Pulmonary Embolism COVID Male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. 2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 14 days prior to randomization. 3. Acute intermediate-risk pulmonary embolism defined as Presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) AND Presence of clot burden with at least one lobar artery involved AND Abnormal right ventricular (RV) function by echocardiography, AND Elevated troponin-I or troponin-T as defined by local lab reference ranges. 4. Subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. In the Investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned TNK bolus versus placebo Anticipated transfer to another hospital (which is not a study site) within 72 hours 2. Allergy or contraindications to TNK 3. Contraindications to systemic anticoagulation 4. Active bleeding 5. Known significant bleeding risk (although recent exposure to aspirin or any other antiplatelet therapy is not an criterion). While there is no specific hemoglobin cut-off value for enrollment, Investigators will gauge the severity / stability of the Hgb and patients deemed inappropriate. 6. Major GI or GU bleed within the past 3 weeks 7. History of hemorrhagic stroke 8. History of acute ischemic stroke in the last 90 days 9. High-risk (massive) acute PE (PE associated with hypotension (systolic BP < 90 mmHg for > 15 min). 10. PE associated with syncope and any degree of head trauma 11. PE meeting for intermediate-risk PE and thus for enrollment, but with clinical evidence of deterioration such that the Investigator deems the patient not appropriate for enrollment. 12. Administration of thrombolytic agent within the previous 7 days 13. Pulmonary thrombectomy within the previous 30 days 14. Uncontrolled hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at randomization 15. Severe ARDS (P/F ratio < 100) 16. Platelet count lower than 80,000/mm3 17. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR >1.7 18. Arterial puncture at a non-compressible site within the past 5 days 19. Prior brain surgery 20. Severe trauma in the prior 2 weeks 21. Major surgery in the prior 2 weeks 22. Brain malignancy / metastases, brain tumor in past 5 years 23. Brain AVM or ruptured aneurysm at any time 24. Acute myocardial infarction or history of myocardial infarction within the past 3 weeks or cardiac arrest during hospitalization 25. Cardiac tamponade 26. Lumbar puncture with in past 7 days 27. Known abdominal or thoracic aneurysm 28. Acute or chronic renal failure requiring dialysis 29. Chronic liver failure (acutely elevated liver function tests not an criterion) 30. Bacterial endocarditis at time of study entry 31. Seizure during pre-hospital course or during hospitalization for COVID-19 32. Currently on ECMO 33. Pregnancy, lactation or parturition within the previous 30 days 34. Patients, in whom, in the opinion of the Investigator, are critically ill from concomitant comorbid cardiopulmonary disease, and unlikely to benefit. 35. Any other condition that the Investigator felt would place the patient at increased risk if the investigational therapy were initiated 36. Previous enrollment in this study | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Melanoma Stage III Melanoma Stage IV Inoperable Disease Histologically or cytologically confirmed metastatic melanoma. This includes American Joint Committee on Cancer (AJCC) stage IV or advanced/inoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally/regionally advanced/inoperable disease or distant metastases Measurable disease, according to version 1.1 Must be free of active brain metastasis by contrast-enhanced CT/MRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study Must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) and later experienced disease progression Must not have received systemic therapy or radiotherapy (including SRS) within the preceding 3 weeks. Patients must have recovered from adverse events from previous therapy by the time registration Must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery, and must be free of significant detectable infection prior to registration Patients who have received prior anti-CTLA4 monoclonal antibody therapy (ipilimumab or tremelimumab) are eligible Patients who have previously experienced prior high-grade (grade 3 or 4 by CTCAE criteria) immune related adverse events with immune checkpoint inhibitors must be discussed with the study PI and cleared prior to enrollment on this study in order to ensure patient safety Patients with BRAF V600 mutant melanoma must have previously received BRAF targeted therapy for metastatic melanoma and later experienced disease progression. Patients who refuse or decline to receive BRAF targeted therapy or were intolerant of BRAF targeted therapy are eligible Life expectancy of greater than 3 months in the opinion of the investigator Patients who have had systemic therapy for melanoma or radiotherapy within 3 weeks prior to registering on the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. Patients with a history of endocrinopathies (e.g. hypothyroidism) are eligible if they are stable on hormone replacement therapy. Patients with a history of adrenal insufficiency are not eligible Patients may not be receiving any other investigational agents Patients with active brain metastasis are excluded Patients with clinically significant cardiovascular or cerebrovascular disease Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements Patients who have other current malignancies are not eligible. Patients with other malignancies are eligible if they have been continuously disease free for > 2 years prior to the time of registration. Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible. Patients with prior history of basal or squamous skin cancer are eligible. Patients who have had multiple primary melanomas are eligible Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids or steroid inhalers. If a patient had been taking steroids, at least 2 weeks must have passed since the last dose | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Thoracic Spine Neoplasm Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.) All diagnoses are eligible Vertebral body site to be treated located from T2 to T12 Signed informed consent Requires open spinal procedure or a percutaneous procedure without the use of image guidance Unable to tolerate general anesthesia and prone position Unable to undergo MRI scan of the spine | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-80.0, Covid19 Adult SARI patients with 2019-ncov infection confirmed by PCR Absolute value of lymphocytes < 0. 6x 109/L Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor) COPD or end-stage lung disease requires home oxygen therapy Expected survival time not exceeding 48 hours Participated in other clinical intervention trials within the last 3 months Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation Received radiotherapy and chemotherapy for malignant tumor within 6 months | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, Non-Alcoholic Fatty Liver Disease Patients posted for Upper GI endoscopy for other indications 2. 18 yrs of age with NAFLD and 3. BMI ≤ 35 or 4. Body Mass Index (BMI) is ≤30 to 34.9 kg/m2 with at least one treated or untreated comorbid condition (hypertension, dyslipidaemia, cardiovascular disease, glucose intolerance, sleep apnoea, NASH). 5. Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program). 6. Failed to life style therapy HIV, HBsAg or HCV positive 2. Prior bariatric surgery 3. Change in weight of ≤5 % within 3 months 4. Malignancy within 5 years 5. Recent major surgery; history of seizure disorder 6. Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication 7. Pregnancy or lactation 8. Significant uncontrolled cardiopulmonary diseases 9. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening 10. Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled. 11. Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening. 12. Uncontrolled DM with HbA1c greater than 9%. 13. Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents) 14. Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids 15. Recent history (within 2 years prior to the screening visit) of significant alcohol use 16. Significant change in diet or level of physical activity within 1 month prior to enrolment 17. Use of very-low calorie (< 1,000/day) liquid weight diet within 6 months | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Infection Adult patients at least 18 years of age Receiving Wake Forest Baptist Health OPAT services Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg Pre-existing leukopenia: WBC < 4,000 x 103 cells/µL | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.083-5.0, Diarrhea, Infantile (Inclusion Criteria) Patients under 5years old who Presented with acute diarrhea and clinical evidence of significant (Moderate and severe) dehydration and sepsis based on blood picture ,high grade fever and CRP Patients under 5 years old with dehydration and non septic condition Patients under 5years old have cardiomyopathy previously diagnosed. ( Patients receiving oral rehydration solution only chronic medical conditions, bronchopulmonary dysplasia and renal and liver diseases Children with acute blood loss were also excluded | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-15.0, Vancomycin age: 0-15 years admitted to ICU or PHO unit suspected or confirmed Gram positive infection planned to start on intravenous intermittent or continuous infusion vancomycin treatment informed consent signed by parents or legal representatives not previously enrolled in this trial extracorporeal treatment at or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling) n or p RIFLE category failure at (Day 0) (see section 8.1.2. screening) Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation patient death is deemed imminent and inevitable | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridioides Difficile Infection Adults aged 18 and over No history of C. difficile infection Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms Known active pregnancy Other known active gastrointestinal infectious process Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease) Vulnerable adults Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 BRCA-Mutated Malignant Neoplasm BRCA-Mutated Metastatic Breast Carcinoma BRCA-Mutated Ovarian Carcinoma Metastatic Breast Carcinoma Metastatic Fallopian Tube Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Ovarian Carcinoma Metastatic Pancreatic Carcinoma Metastatic Primary Peritoneal Carcinoma Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Fallopian Tube Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage III Primary Peritoneal Cancer AJCC v8 Stage IIIA Fallopian Tube Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Primary Peritoneal Cancer AJCC v8 Stage IIIA1 Fallopian Tube Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Fallopian Tube Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Fallopian Tube Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Primary Peritoneal Cancer AJCC v8 Stage IIIC Fallopian Tube Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Primary Peritoneal Cancer AJCC v8 Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Primary Peritoneal Cancer AJCC v8 Stage IVA Fallopian Tube Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Primary Peritoneal Cancer AJCC v8 Stage IVB Fallopian Tube Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Primary Peritoneal Cancer AJCC v8 Unresectable Breast Carcinoma Unresectable Fallopian Tube Carcinoma Unresectable Malignant Solid Neoplasm Unresectable Ovarian Carcinoma Unresectable Pancreatic Carcinoma Unresectable Primary Peritoneal Carcinoma Participant must have breast, pancreas, ovary, fallopian tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing such as University of Washington (UW) OncoPlex assay or equivalent, and who have experienced progression or been intolerant to standard therapies for their disease Breast cancer patients with or without HER2+, estrogen receptor (ER)+, and/or progesterone receptor (PR)+ disease, as determined by pathological report, are allowed Participant must be able and willing to undergo pre-treatment and on-treatment biopsy Participant must have life expectancy of 4 months or greater Tumor must be measurable according to Response Evaluation in Solid Tumors (RECIST)1.1 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 Participant must be >= 18 years of age Patient must be able to tolerate oral medication Absolute neutrophil count >= 1,500/uL Platelets >= 100,000/uL Participant must not be simultaneously enrolled in any interventional clinical trial Participant must not have had major surgery =< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects Prior treatment with both PARP inhibitor and immune checkpoint inhibitor blockade either sequentially or together including inhibitors of PD1, PD-L1 or CTLA4 is not allowed. Patients may have had either PARP inhibitor or Immune checkpoint inhibitor previously but not within 3 months of starting treatment Participant must not have received investigational therapy =< 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy Participant must not have had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy Participant must not have a known hypersensitivity to niraparib and dostarlimab (TSR-042) components or excipients Participant must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridioides Difficile Infection Adults aged 18 and over Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea Known pregnancy Prior diagnosis of C. difficile infection within 2 months of this diagnosis Other known active gastrointestinal infectious process Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions Vulnerable adults Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-3.0, Diarrhea, Infantile Age: 6 months months, 2. Duration of diarrhea ≤48 hours, 3. Some dehydration (judged clinically according to the "Dhaka method"), 4. Written informed consent by either parent/guardian Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema) 2. Patients with diarrhea due to cholera. 3. Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.) 4. Bloody diarrhea 5. Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.) 6. Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated 7. Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridioides Difficile Infection Adults aged 18 and over Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea Known active pregnancy Prior diagnosis of C. difficile infection within 2 months of this diagnosis Other known active gastrointestinal infectious process Vulnerable adults Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Knee Extension Students enrolled in second year of physiotherapy training in Rouen's physiotherapy Institute, taking part to neurodynamic technique course unit (CU 7) Ability to perform daily physiotherapy techniques, assessed by an accredited doctor from regional health agency and a medical examination during the first year of scholarship (occupational medicine service of Rouen's University hospital) French commonly spoken and red Aged 18 or older Registered to the national care & health system (Social security number) Willingness to take part to the study Person denied of freedom by judicial or administrative decision Person requiring a guardian, guardianship or curators History of psychological disease/illness or sensorial disease preventing from understanding the recruitment conditions | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, Acute Respiratory Distress Syndrome Intensive Care Unit The study included patients who required invasive mechanical ventilation but was not initially diagnosed with ARDS 9, had a LIPS (Lung Injury Prediction Score) of > 7, and have been staying in the ICU for more than 24 hours pregnancy intracranial hypertension (suspected or confirmed by measurement with external ventricular drainage catheter) severe chronic obstructive pulmonary disease or type II respiratory failure confirmed bronchopleural fistula documented barotrauma history of pneumonectomy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 20.0-999.0, CKD age over 20 years old CKD group:CKD stage 3-5 including dialysis patients Healthy group: without any medical history cancer acute infection unable to protrude the tongue stably risk of temporomandibular joint dislocation | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Covid19 Anosmia Fever Cough Shortness of Breath Sore Throat Nausea Vomiting Headache Muscle Weakness Pain, Muscle Pain, Chest Pain, Joint Pain, Abdominal Pain Irritable Mood Confusion Covid-19 positive by polymerase chain reaction (PCR) testing Participant must be able to evaluate their symptoms and report them in the symptoms diary Patients must be able to take their oral temperature daily with an electronic thermometer provided to them with study materials Males and females, at least 18 years of age, capable and willing to provide informed consent Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study Patient must have received a diagnosis of COVID-19 infection within the last 48 hours and have one or more symptoms Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization) Patient must be able and willing to comply with the requirements of this study protocol Patient currently hospitalized or under immediate consideration for hospitalization Patient currently in shock or with hemodynamic instability Patient undergoing chemotherapy for cancer Patient is unable to take oral temperature using an electronic thermometer Patient who received at least one dose of the COVID-19 vaccine Female patient who is pregnant or breast-feeding or is considering becoming pregnant during the study People taking anticoagulant/antiplatelet medications, those with bleeding disorders, and people two weeks before or after surgery Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study Regular consumption of natural products containing more than 150 mg of hesperidin or regular consumption of more than 1 glass of orange juice per day Known allergy to any of the medicinal and non-medicinal ingredient: hesperidin, microcrystalline cellulose, magnesium stearate | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridioides Difficile Infection Age more than or equal to 18 years Both genders Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B • No apply | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Thyroid Gland Anaplastic Carcinoma Male or female subjects ≥ 18 years of age. 2. Willingness to participate in the study by signing an informed consent form approved by the ethics committee of the KVMT named after N.I. Pirogov St. Petersburg State University. 3. ECOG status 0 or 1 or 2. The ECOG assessment must be completed within 7 days prior to the distribution date. 4. Measurable disease according to 1.1, as defined by the investigator. 5. Patients with a histologically confirmed disease (according to the pathologist's report) that meets one of the following (according to 2010 WHO classification): BRAF positive anaplastic thyroid cancer, determined by immunohistochemistry for the presence of the BRAF V600E mutation in tumor tissue, genetic/molecular testing of the tumor, or by liquid biopsy of circulating DNA to determine the presence of the BRAF V600E mutation (if the histological examination is not possible). The primary tumor may or may not be resectable, but the risk of aerodigestive compression or bleeding should be excluded. 6. Weight over 30 kg. 7. Ability to swallow tablets/capsules or gastrostomy. 8. The absence of metastases in the brain. 9. Normal organ and bone marrow function as defined below (obtained = <30 days prior to study entry) Hemoglobin ≥ 9.0 g / dL Absolute neutrophil count (ANC)> 1500 per mm Platelet count ≥ 100,000 per mm Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN) if liver metastases are absent, in which case it should be ≤ 2X ULN. This does not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, which is predominantly unconjugated in the absence of hemolysis or liver pathology); however, they will only be admitted after consulting their doctor Aspartate transaminase (AST) (SGOT) / alanine aminotransferase (ALT) (SGPT) ≤ 2.5x the institutional upper limit of normal, unless liver metastases are present, in which case it should be ≤ 5x ULN Measured creatinine clearance (CL)> 40 ml/min or Estimated creatinine clearance> 40 ml/min using the Cockcroft-Gault formula (Cockcroft and Gault, 1976) or 24-hour urine collection to determine creatinine clearance Albumin> = 2.5 mg / dL (received = <30 days prior to registration) International normalized ratio (INR) or prothrombin time (PT) = <1.5 X ULN if the subject is not receiving anticoagulant therapy while PT or partial thromboplastin time (PTT) is within the therapeutic range of the intended use of anticoagulants Concurrent participation in another clinical trial unless it is an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial. 2. Taking any type of low molecular weight kinase inhibitor (including the investigational kinase inhibitor) for 2 weeks or 5 half-lives of the agent, whichever is greater. 3. Receiving any type of anticancer drugs (including investigational) or systemic chemotherapy within 2 weeks before starting treatment. 4. The presence of distant metastases (for example, to the brain, lungs). 5. Subject has an uncontrolled, serious underlying medical condition or recent illness, including but not limited to the following conditions: A) Cardiovascular diseases Congestive heart failure, grade 3 or 4 as defined by the New York Heart Association, unstable angina, and severe cardiac arrhythmias Uncontrolled hypertension, defined as sustained blood pressure> 150 mm Hg. Systolic or diastolic> 100 mmHg Stroke, including transient ischemic attack (TIA), myocardial infarction, other ischemic event or thromboembolic events such as deep vein thrombosis (DVT) and pulmonary embolism) within 6 months prior to inclusion. Subjects with a later diagnosis of DVT are eligible if they are stable, asymptomatic, and have received LMWH for at least 6 weeks prior to study treatment. B) Gastrointestinal disorders (eg malabsorption syndrome or gastric outlet obstruction), including those associated with a high risk of perforation or fistula formation Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreas or bile ducts, or obstruction of the gastric outlet Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months prior to inclusion. Note: Complete healing of the intra-abdominal abscess must be confirmed before starting treatment. C) Clinically significant vomiting or hemoptysis> 0.5 teaspoons (> 2.5 ml) of red blood or another significant bleeding in history within 3 months prior to treatment. D) Interstitial lung lesions or known manifestations of the endobronchial disease. F) Lesions invading the main pulmonary blood vessels. F) Other clinically significant disorders such as An active infection requiring systemic treatment, infection with human immunodeficiency virus or disease associated with acquired immunodeficiency syndrome, or chronic infection with hepatitis B or C Serious non-healing wound / ulcer / bone fracture Moderate or severe liver failure (Child-Pugh B or C) The need for hemodialysis or peritoneal dialysis | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 30.0-70.0, Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage All patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well. 2. Patient who had a follow up Glasgow coma scale <9 after resuscitation (as this can lead to biasness; requires surgery) 2. Contraindication to tranexamic acid, 3. Hemorrhagic stroke secondary to trauma, 4. Hemorrhage was caused by coagulopathy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.167-999.0, Atypical Hemolytic Uremic Syndrome aHUS Written informed consent to study participation. 2. Male and female patients aged 2 months and older with documented atypical hemolytic uremic syndrome (aHUS)diagnosis. 3. By the time of in the study, Elizaria® should be prescribed as a pathogenetic therapy for aHUS Intolerance to eculizumab, or other components of the drug | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 20.0-80.0, Inguinal Hernia all patients with confirmed groin hernia of both sexes none | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Covid19 COVID-19 patients who are admitted to the CWZ with COVID-19, with a laboratory confirmed SARS-CoV-2 infection within the previous 96 hours Respiratory failure requiring supplemental oxygen, defined as requiring supplemental oxygen to sustain an arterial PO2 ≥70mmHg (measured by arterial blood gas) or an oxygen saturation of ≥94% (measured using a pulse oximeter) At least 18 years old Able to safely swallow the study medication or possibility of safely administering this through a nasogastric tube Use of prophylactic heparin or LWMH according to hospital protocols, or use of therapeutic dosages if there is a medical indication for this Informed consent signed by patient Use of oral anticoagulation drugs; patients may be included when they have been switched to LMWH Patients on vitamin K antagonists with a supra-therapeutic anticoagulation at admission who require vitamin K supplementation to correct this, or were administered vitamin K for this reason within the preceding 5 days Patients already using vitamin K supplements at admission Participation in another intervention study Direct admission to an intensive care unit (ICU) for invasive ventilation at presentation Confirmed active pulmonary embolism or deep venous thrombosis prior to Known allergy to any of the components of the study medication or placebo Patients who are hemodialysis dependent at admission Pregnancy at the time of Diagnosed malignancy at the time of | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Stroke Cerebrovascular Diseases Cerebral Infarction Cerebral Hemorrhage Transient Ischemic Attack Subarachnoid Hemorrhage Patients were included in the registry if they were hospitalized with a primary diagnose of： cerebral infarction (I63) nontraumatic intracerebral hemorrhage (I61) nontraumatic subarachnoid hemorrhage (I60) transient cerebral ischemic attack and related syndromes (G45) intracranial and intraspinal phlebitis and thrombophlebitis (G08) vascular dementia (F01) other aneurysms (I72) Patients diagnosed with other diseases | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridioides Difficile Infection More than or equal to 3 diarrheal stools/day in 24 hours prior to randomization and in the judgment of the investigator that C difficile is the likely causative agent for the diarrhea. 2. Stool positive for C. difficile GDH plus Toxin A and/or B 3. Participants with a primary episode or first recurrence of CDI are eligible 4. In the judgement of the investigator, the expectation that the participant will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study 5. Participants may be either inpatient or outpatient | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Covid19 Obesity Overweight Pneumonia, Viral Patients over 18 years of age. 2. Diagnosis of severe pneumonia secondary to COVID-19 infection and acute respiratory distress syndrome, defined by upper and lower respiratory symptoms plus positive C-reactive protein test for COVID-19. 3. Patient admission to the Clinical del Country and Clinica de la Colina intermediate care units. 4. Oxygen therapy by high-flow system (high-flow cannula) requirement. 5. Anthropometric data availability upon admission to our facilities Patients with a survival expectancy of less than 12 months according to the Charlson scale categorization or patients with oncological pathology. 2. Patients under 18 years of age. 3. Pregnant women. 4. Patients with cardiogenic pulmonary edema. 5. History of chronic liver disease or cirrhosis Child Pugh C. 6. Patients with contraindications to high-flow cannula therapy initiation. 7. Patients with respiratory, hemodynamic and neurological indications that contraindicate HFNC initiation | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Health Care Associated Infection Nosocomial Infection Age older than 18 years New episode of Clostridioides difficile infection, based on IDSA criteria None | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 12.0-17.0, Clostridioides Difficile Infection Has signed informed consent by parents or legally authorized representatives and assent by the child according to local requirements (e.g., Protected Health Information [PHI]) prior to initiation of any study-mandated procedure Is aged 12 to <18 years Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs (5, 6 or 7 on the Bristol Stool Chart, see Appendix 5)) in the 24 h prior to randomization Has tested positive for toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must have been produced within 72 hours prior to randomization Has a negative stool test for other pathogens than C. difficile, or a positive test that in the investigator's judgement is not associated with clinically significant signs and symptoms of GI infection, within 48 hours of randomization. Example pathogens may be norovirus, enteroviruses (coxsackie and ECHO), enteric adenoviruses, Salmonella, Shigella, Yersinia and Campylobacter) Has contraceptive measures in place as follows (see Appendix 4 for details): Male subject: Agrees to use a highly effective contraceptive method as detailed in Appendix 4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment OR Agrees to adhere to abstinence, Refrains from donating sperm during the treatment period and for at least 30 days after the last dose of study treatment. Female subject: Is not pregnant or breastfeeding and must have a documented negative pregnancy test at screening, complies with one of the following three conditions: Not a woman of childbearing potential (WOCBP) as defined in Appendix 4, A WOCBP who agrees to follow the guidance in Appendix 4 on highly effective contraceptive methods during the treatment period and for at least 30 days after the last dose of study treatment, A WOCBP adhering to abstinence Has had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole) Has prior or current use or application of ridinilazole any time in the past, a (investigational) vaccine against C. difficile any time in the past, anti-toxin antibodies including bezlotoxumab within the past 6 months, intravenous immunoglobulin (IVIG) within the past 3 months, fecal microbiota replacement therapy within the past 3 months, or any investigational medicinal product for treatment of CDI within the past 3 months Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus Has had major GI surgery (e.g. significant bowel resection, but not including appendectomy) within the past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study Has current or planned (for within the study period up to Day 40) cancer treatment (including chemotherapy, radiotherapy, biologic treatment (e.g. monoclonal antibodies), immune-oncological treatments) that generally is associated with or currently is causing vomiting and/or severe nausea that cannot be managed with antiemetics and is limiting the ability to take oral medications Has been involved in a clinical trial and received an investigational medicinal product for an indication other than CDI within the past month or five half-lives (whichever is longer) Has a known history of bone marrow or hematopoietic stem cell transplantation Is unable to tolerate oral medications Has a known history of hypersensitivity or allergic reaction to vancomycin or any excipient of vancomycin or ridinilazole Is, in the Investigator's judgment, inappropriate for participation in the study including for example those subjects with any other (medical) condition that would make the subject unsuitable for in the study, who are not likely to complete the whole study for whatever reason, e.g., a short life expectancy, or who are unwilling or unable to comply with protocol requirements, for example complete the full course of study treatment, attend study clinic visits, provide stool samples, ingest capsules, tolerate blood draws | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-89.0, Covid19 Sepsis Adults Emergency Department Adult patients [18-89 years of age] Present to the Emergency Department With symptoms suggestive of COVID-19 or respiratory infection Whose assessment includes CBC-Diff and RT-PCR testing Pregnancy Prisoners <18 years of age >89 years of age Previously evaluated in this study No RT-PCR testing Sample age >2 hours from time of draw Instrument flags, including vote outs and review flags for the MDW parameter Samples stored in refrigerated temperatures | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Local Anesthetic Complication Local Anesthetic Drug Adverse Reaction Scheduled for unilateral primary TKA with CACB TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness) Contraindication to spinal anesthesia or adductor canal-based analgesia History of muscle wasting or related disease History of autoimmune disorders that may affect muscles History of neurologic condition affecting the lower extremities Contraindications to MRI | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Incomplete Spinal Cord Injury for subacute upper limb: 1. Aged above 18 2. Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI 3. Injury occurred no more than six months prior to participation in the study 4. Injury level C3 to C7 5. Normal or corrected to normal vision 6. Spasticity equivalent of MAS level 1+ and above for chronic upper limb: 1. Aged above 18 2. Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI 3. Injury occurred more than one year prior to participation in the study 4. Injury level C3 to C7 5. Normal or corrected to normal vision 6. Spasticity equivalent of MAS level 1+ and above 7. Live in Greater Glasgow and Clyde area for subacute lower limb: 1. Aged above 18 2. Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI 3. Injury occurred no more than six months prior to participation in the study 4. Injury level T1 to L1 5. Normal or corrected to normal vision 6. Ability to walk > 10 meters (assisted or unassisted), if ASIA level D 7. Spasticity equivalent of MAS level 1+ and above for chronic lower limb: 1. Aged above 18 2. Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI 3. Injury occurred more than one year prior to participation in the study 4. Injury level T1 to L1 5. Normal or corrected to normal vision 6. Ability to walk > 10 meters (assisted or unassisted), if ASIA level D 7. Spasticity equivalent of MAS level 1+ and above 8. Live in Greater Glasgow and Clyde area for subacute groups: 1. Participation in any other neurofeedback intervention group 2. Inability to understand the task 3. Self-reported neurological disorders e.g. previously confirmed peripheral nerve injury or brain injury 4. General poor health due to secondary consequences of injury 5. Conditions contra-indicative of neurostimulator usage (implanted devices, sensitive skin sores in the upper and lower extremities, pregnancy, severe autonomic dysreflexia) 6. History of epilepsy 7. Inability to sit for 1.5 hours 8. Inability to speak and/or understand English for chronic groups: 1. Participation in any other neurofeedback intervention group 2. Inability to understand the task 3. Self-reported neurological disorders e.g. previously confirmed peripheral nerve injury or brain injury 4. General poor health due to secondary consequences of injury 5. Conditions contra-indicative of neurostimulator usage (implanted devices, sensitive skin sores in the upper and lower extremities, pregnancy, severe autonomic dysreflexia) 6. History of epilepsy 7. Inability to sit for 1.5 hours 8. Inability to speak and/or understand English 9. Live outside Greater Glasgow and Clyde area | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 16.0-999.0, Crohn Disease Eligible participants are all adults (≥16 years old) with active CD (defined as Crohn's Disease Activity Index ≥ 150) who are due to initiate standard adalimumab (TNFα antagonist) induction treatment (160 mg day 0, 80 mg at 2 weeks and then 40 mg every 2 weeks) Inability to provide written consent to participate in the study Pregnant and/or breastfeeding individuals Presence of stoma Presence of short bowel syndrome Previous treatment with an anti-TNFα inhibitor Use of any other biologic therapy or oral small molecule therapy within the last 12 weeks Patients currently receiving oral or intravenous steroids at a dosage >20mg/day prednisolone or >9mg budesonide Introduction of or change in dose of immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 8 weeks Use of oral antibiotics within the past 4 weeks CD with a major fistulising or symptomatic fibrotic stricturing phenotype | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Central Auditory Disease Healthy Subjects selected will be between the ages of 12 and 18 years. All subjects must score within normal limits on measures of threshold sensitivity, speech recognition in quiet, middle ear function and TEOAEs to be included in the study. Group A subjects must be identified as having learning or attention problems in school and show show reduced scores on speech-in-noise tasks. Group B subjects must demonstrate speech-in-noise scores within normal limits. Groups will be matched for sex, age and handedness Subjects will be excluded for history of voice disorders, autism, stuttering, aphasia, multiple sclerosis, traumatic brain injury, severe language disorders and psychiatric disorders. Children who are being treated for hyperactivity disorder will be excluded. Children who are taking medication prescribed for hyperactivity, anxiety or depression may be excluded. Children younger than 12 will be excluded | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Orthostatic Hypotension ENTRY --Disease Characteristics- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Liver Cirrhosis, Biliary ENTRY --Disease Characteristics- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites --Prior/Concurrent Therapy- No concurrent drugs associated with chronic liver disease --Patient Characteristics-- Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30% Renal: No renal disease that could cause liver dysfunction Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-64.0, Portal Hypertension Hepatic Encephalopathy Cirrhosis ENTRY --Disease Characteristics-- Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting --Prior/Concurrent Therapy-- No concurrent therapy for hepatic encephalopathy --Patient Characteristics-- Age: Under 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Chronic Hepatitis c Cirrhosis, Liver Fibrosis, Liver Hepatic Cirrhosis Age at entry at least 18 years Positive for Hepatitis C Previous treatment with any interferon or interferon and ribavirin for at least 3 months Documented non-response to treatment with interferon A liver biopsy demonstrating significant liver scarring No other liver disease No unstable major medical diseases or conditions No major complications of cirrhosis No recent abuse of alcohol or illicit drugs | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-0.083, Hypoxia, Brain Hypoxia-Ischemia, Brain All of the following must be met Gestation age (GA) at birth >= 28 weeks Discharged to home care with parent or other guardian who has legal authority to give informed consent Greater than 10th percentile for GA at birth using the scales according to Lubchenco, Hansman, and Boyd from Pediatrics 1966 volume 37 and Battaglia and Lubchenco in the Journal of Pediatrics 1967 volume 71 Jewelry in pierced body parts can be removed Mothers > 17 years old Recruited within 60 days of EDC (estimated date of conception) Two or more of the following must be met Intrapartum distress as determined by placental abruption, thick meconium staining of amniotic fluid, sustained fetal bradycardia of heart rate < 100 beats/min, or late or absent heart rate variability Profound metabolic or mixed academia as determined by umbilical artery pH < 7.0, base deficit of > 10 mEq/L or pH < 7.1 and base excess greater than 14 mmol/L within 72 hours of birth, Apgar score < 5 at 5 minutes or beyond, or need for positive pressure ventilation resuscitation for > 1 min after birth Neonatal neurological manifestations such as seizures during hospital stay, lethargy, hypotonia or hypertonia, stupor, flaccidity, or decerebration Infants of substance abusing mothers (ISAM) Intrauterine growth retardation (IUGR) Infants requiring extracorporeal membrane oxygenation (ECMO) in the neonatal period Hearing or visual impairment Congenital cyanotic heart disease with cyanosis and requiring PGE infusion. Children with minimum cardiac structural anomalies (e.g., PDA or VSD or peripheral pulmonary stenosis) will not be excluded from the study Congenital abnormalities of the central nervous system such as congenital hydrocephalus Grade IV intraventicular hemorrhage requiring ventriculo-peritoneal shunt (VP shunt) Trisomy 13, 18, or 21, or Fragile X Metabolic encephalopathy from inborn errors of metabolism (e.g. PKU, OTC) Metal or wire mesh implants, pacemaker implants, cochlear implants, orthopedic surgical wires or implants | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Hepatitis C English speaking/reading Serum positive for HCV virus by PCR Elevated alanine transferase (ALT) within 6 months of the Entry Visit, unattributable to causes other than HCV Liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic HCV Laboratory parameters available at the Entry Visit including CBC, differential, and platelet count | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Leukemia B-cell acute lymphoblastic leukemia Disease involving at least 30% of bone marrow or circulating blasts In first relapse with at least 1 of the following high-risk features Age under 1 year at diagnosis Age over 18 years at diagnosis t(9;22) Occurrence of first relapse less than 18 months after diagnosis In second relapse or beyond Refractory disease Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine Concurrent treatment as part of another therapeutic research protocol Pregnancy or nursing mothers Clinically significant pulmonary or cardiac disease Clinically significant autoimmune disease Documented infection that is active and/or not responding to therapy Evidence of HIV infection or known positive HIV serology Lansky performance scale (if <18yo) <60%, Karnofsky performance scale (if >18yo) >60% Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy. ********************************************NOTE******************************************* ******** It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill for vaccination in the future (i.e. should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.*** | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Spinocerebellar Degenerations Adults over 18 with hereditary or sporadic cerebellar degeneration. Sporadic cerebellar degeneration may the cerebellar predominant variant of Multiple System Atrophy (MSA-C). Hereditary ataxia is limited to the SCAs (spinocerebellar ataxias) or those patients with clear autosomal dominant ataxia. Patients must also have evidence for an immune component to their condition such as gluten-sensitivity or antiganglioside antibodies Patients on the gluten-free diet. Those who wish to participate in this trial must be off the diet for a period of 3 months prior to the start of the study. Patients with Friedreich's ataxia. To date, this has not been associated with autoimmune phenomena. We would not expect this population to respond. Patients with other autosomal recessive and mitochondrial forms of ataxia, since autoimmunity has not been studied in this population. Patients with hypercoaguable disorders. This includes conditions like Protein C or S deficiency, underlying malignancy and/or paraproteinemia. Patient with acute renal insufficiency or patients on known nephrotoxic drugs. Patients with selective IgA deficiency Known paraneoplastic cerebellar degeneration. Cerebellar ataxia that is congenital, static and/or symptomatic (due to stroke, tumor, demyelinating or infectious). Women who are pregnant or lactating. Those of child-bearing age will be asked to use effective contraception for the duration of the study. Those patients who do not wish to use a product derived from human serum (for example, Jehovah's Witness) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis C, Chronic Signed written informed consent Age over 18 years old Presence of HCV RNA measured by qualitative PCR Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 3 months (12 weeks) Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin Liver biopsy consistent with cirrhosis or progression to cirrhosis (METAVIR fibrosis score 3 to 4) due to chronic hepatitis C within the last 12 months before treatment starts, and at least 6 months after the end of the prior failed therapy Cirrhosis classified as Child-Pugh "A" (no more than 6 points) Compensated liver disease with prothrombin time prolonged less than 3 seconds over control, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, bleeding varices or a history of detection of stigmata of recent bleeding on existing varices or ascites Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC Hematocrit > 30%, platelet count > 75,000, WBC > 2,500, and absolute neutrophil cell count > 1,500 Use of systemic corticosteroids within 6 months of entry Evidence of drug-induced liver injury Current use of any drug known to have or suspected of having therapeutic activity in hepatitis C, or any immunosuppressive drug (including corticosteroids) Evidence of any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease Alpha-fetoprotein > 200 ng/mL Child-Pugh "B" or "C" cirrhosis (score of 7 or more points), either currently or at any occasion in the past Decompensated liver disease based on a history of hepatic encephalopathy, bleeding varices or a history of detection of stigmata of recent bleeding on existing varices, or ascites HIV infection diagnosed by HIV seropositivity and confirmed by Western blot Concomitant or prior history of malignancy other than curatively treated skin cancer or surgically cured in situ carcinoma of the cervix Active infectious process other than HCV that is not of a self-limited nature | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis C, Chronic Signed written informed consent Age over 18 years old Presence of HCV RNA measured by qualitative PCR Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 12 weeks Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin Liver biopsy consistent with chronic hepatitis C within the last 12 months before treatment starts, and at least 6 months after the end of the prior failed therapy No clinical or histological evidence of cirrhosis (METAVIR fibrosis score 0 to 3) Compensated liver disease with prothrombin time prolonged less than 3 seconds over control, serum albumin stable and within normal limits, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, esophageal varices or ascites Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC Hematocrit > 30%, platelet count > 100 x 109/L, WBC > 3 x 109/L, and polymorphonuclear white cell count > 1.5 x 109/L Use of systemic corticosteroids within 6 months of entry Current use of any drug known to be hepatotoxic, any drug (other than the study drugs) known to have or suspected of having therapeutic activity in hepatitis C or of any immunosuppressive drug (including corticosteroids) Any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease Alpha-fetoprotein > 200 ng/mL Current or past diagnosis of cirrhosis Evidence of portal hypertension either by Doppler ultrasonography or gastrointestinal endoscopy Decompensated liver disease based on a history of hepatic encephalopathy, esophageal varices, or ascites HIV infection diagnosed by HIV seropositivity and confirmed by Western blot Concomitant or prior history of malignancy other than curatively treated skin cancer or surgically cured in situ carcinoma of the cervix Active infectious process other than HCV that is not of a self-limited nature (eg. TB or AIDS) | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Fibrosis Cirrhosis Men or women 18 to 75 years Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) Must meet minimum blood chemistry requirements Cannot have unstable or uncontrolled thyroid disease Cannot have a variety of other diseases (listed in protocol Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection No fibrolamellar HCC No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study Surgery Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques Must have paraffin tissue block or unstained slides from biopsy or surgical specimen No known brain metastases | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatitis C, Chronic HCV infection according to ELISA-2 Detectable HCV RNA PCR as measured within the previous 6 months Poor responders to, inadequate candidates for, or unwilling to use interferon-based therapies Serum ALT >= 1.3 times above normal Persistently elevated serum ALT levels according to two measures in the previous 12 months Evidence of stage II (periportal fibrosis), III (bridging fibrosis), or IV (compensated cirrhosis) in the Batts-Ludwig scoring system according to a liver biopsy performed in the last 2 (stage II and III patients) to 5 (stage IV patients) years. Patients with clinical signs of compensated cirrhosis (portal hypertension, non-bleeding varices) do not require a biopsy Able and willing to follow protocol directions for the duration of the study Able and willing to maintain a consistent lifestyle routine (e.g., diet, exercise, medications, and dietary supplements) and sleep schedule for the duration of the study Able and willing to stop taking dietary supplements outside the study protocol for the duration of the study Able and willing to practice two methods of contraception during the study period, including the 4 week follow-up. This applies to women with childbearing potential and men whose sexual partners have childbearing potential Pregnant or breastfeeding Liver synthetic dysfunction (albumin < 3.2 g/dL, total bilirubin > 3.0 mg/dL, prothrombin time > 1.5 seconds prolonged) History of ascites, variceal bleeding, encephalopathy, jaundice, or extrahepatic biliary obstruction History of uncontrolled diabetes mellitus Known concomitant acute or chronic viral liver infections (e.g., hepatitis A, hepatitis B, Epstein-Barr, or cytomegalovirus) Concomitant autoimmune and inflammatory disease (e.g., rheumatoid arthritis, lupus) Other types of concomitant liver disease HIV-1 coinfection Chronic use of hepatotoxic drugs (e.g., acetaminophen) Interferon-based therapies in the past 6 months | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Histologically confirmed hepatocellular carcinoma Confirmed by needle aspirate, biopsy, or prior surgical resection specimen Clinically confirmed hepatocellular carcinoma defined as follows Cirrhosis or chronic hepatitis B or C virus infection, with 1 or more hypervascular liver masses more than 2 cm Alpha-fetoprotein (AFP) greater than 400 ng/mL OR greater than 3 times normal and doubling in value during the past 3 months Deemed unresectable Prior surgical resection allowed Recurrence after hepatic resection or other procedure allowed Tumor that extends into branches of the portal or hepatic veins allowed No tumor invading the main portal vein (portal trunk) or inferior vena cava No thromboembolic event within the past 12 months No clinically significant cardiovascular disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring parenteral antibiotics No serious non-healing wound/ulcer or bone fracture No variceal bleeding within the past 6 months No malignancy within the past 5 years except localized nonmelanoma skin cancer No ongoing psychiatric or social situation that would preclude study compliance | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Patients must have advanced unresectable hepatocellular carcinoma based on the following Histologically or cytologically confirmed, OR Alpha-fetoprotein > 400 ng if patient is not hepatitis surface antigen positive, OR Alpha-fetoprotein > 4000 ng if patient is hepatitis surface antigen positive NOTE: If available, tissue should be submitted to assess EGFR/pathway expression Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease ECOG performance status of 0, 1 or 2 Leukocytes >= 2,000/uL OR Absolute neutrophil count >= 1,000/uL | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 16.0-70.0, Hepatitis Hepatitis B, Chronic Cirrhosis Documented decompensated chronic hepatitis B defined by all of the following: 1. Clinical history compatible with decompensated chronic hepatitis B related cirrhosis; 2. Child-Turcotte-Pugh score > 7 points Evidence of hepatic cirrhosis or portal hypertension. Other protocol-defined may apply Patient is pregnant or breastfeeding Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV) Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study. Other protocol-defined | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Colorectal Cancer Metastatic Cancer Histologically or cytologically confirmed colorectal cancer Metastatic disease limited to the parenchyma of the liver No evidence of unresectable extrahepatic disease by preoperative radiology Limited extra-hepatic disease and dominant life-limiting liver disease allowed provided extra-hepatic sites are treatable by local ablative measures (e.g., surgical resection or external beam radiotherapy) At least 40% hepatic replacement by tumor by axial CT scan or MRI Unresectable liver metastases, defined by 1 of the following More than 3 sites of disease in the liver Bilobar disease Tumor abutting major vascular or ductal structures Measurable disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Leukemia Diagnosis of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting 1 of the following Chronic phase Ph+ by cytogenetics or fluorescent in situ hybridization (FISH) assay Accelerated phase, meeting any of the following More than 10% but < 30% myeloblasts and promyelocytes in marrow or peripheral blood Any additional clonal cytogenetic abnormalities Increasing splenomegaly Extramedullary tumor WBC, platelet count, or hematocrit perturbations not controlled by therapy with hydroxyurea, interferon, or imatinib mesylate Persistent unexplained fever or bone pain | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 70.0-999.0, Cognitive Decline Cognitive Symptoms Mild vitamin B12 deficiency Low plasma vitamin B12 concentration (100 < B12 < 300 pmol/L) Elevated methylmalonic acid (MMA) concentration (> 0.32 umol/L) Creatinine concentration < 120 umol/L Severe cognitive impairment Anemia Gastrointestinal surgery or diseases Use of vitamin B12 injections or supplements containing > 25 ug vitamin B12 and/or 200 ug folic acid < 90% compliance during a 2 week placebo run in period No written informed consent Participation in other research studies | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-70.0, Hepatocellular Carcinoma Histologically proven hepatocellular carcinoma. 2. HCC underwent curative resection within 6 weeks before registration. 3. Grossly, the resection margin should be > 1 cm. 4. Patients must be younger than 70 year-old. 5. Patients must have a performance status of ECOG score < 2. 6. Patients must have adequate liver reservation and adequate hemogram. 7. Pugh-Child's Score < 7. 8. The serum total bilirubin level are < 2 mg/dl. 9. The prothrombin times are < 3 sec above normal control. 10. The platelet are > 10 x 104 / mm3. 11. The WBC are > 3,000 / mm3. 12. Patient must have serum creatinine < 1.5 mg/dl 13. Cardiac function with NYHA classification < Grade II 14. Known HBV or HCV status. 15. Signed informed consent Patients who have non-curative resection are not eligible. 2. Resected HCCs with histologically positive margins are not eligible. 3. HCCs with radiological evidence of portal vein thrombus are not eligible. 4. Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible. 5. Patients with advanced second primary malignancy are not eligible. 6. Patients with pregnacy or breast-feeding are not eligible. 7. Patients with severe cardiopulmonary diseases are not eligible. 8. Patients with clinically significant psychiatric disorder are not eligible. 9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-85.0, Hepatitis C Hepatitis B Autoimmune Hepatitis Liver Cirrhosis, Biliary Cholangitis, Sclerosing patients who have a liver biopsy as standard of care and are diagnosed with either patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada Hepatitis C Hepatitis B Autoimmune Hepatitis Primary Biliary Cirrhosis Primary Sclerosing Cholangitis | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Esophageal and/or Gastric Varices Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis with a minimum age of 18 years with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to hospital admission who were expected to be hospitalized for at least seven days who agreed to participate in the study. Randomization did not take place if another therapy was medically indicated for any reason Patients were excluded from the study in whom introduction of an endoscope was not possible for technical reasons who had received an alternative endoscopic treatment to eradicate varices during the last three months (sclerotherapy, ligation) who had proven additional fundus bleeding from varices or bleeding from a hypertensive gastropathy who had end stage tumor disease or end stage liver cirrhosis (Child Pugh class C with organ complications, such as hepatonephric syndrome, infected ascites etc.) who were pregnant or breast feeding who had a known pulmonary disease combined with restricted lung function or right ventricular failure who had congenital or acquired coagulopathies of non-hepatic origin who were currently participating or had participated in another study during the past 30 days or had already been included in this study once who were treated with drugs to decrease portal vein pressure (somatostatin, somatostatin analogs, terlipressin, glycylpressin, except β-blockers and nitrates) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Hepatitis C HIV Infections Sera available and appropriate for testing, including serial sera over a period of time (retrospective analysis) 2. HIV serology positive. 3. Unequivocal HCV antibody positive or HCV RNA positive Those without sera available. 2. Those unwilling to give informed consent. 3. Persons with hepatitis B virus infection, as defined by the presence of hepatitis B surface antigen and/or hepatitis B virus DNA positive | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Gastrointestinal Hemorrhage Consecutive patients with a clinical diagnosis of upper gastrointestinal bleeding will be enrolled if they meet all of the following 1. Presence of melena or melena concomitant with PR bleeding; 2. Gastroscopic findings not accountable for the upper GI bleeding including: (i) clean base ulcers /erosions (refer to User Groups below) without high-risk stigmata, fresh or altered blood but can have grade A or B esophagitis concomitantly ; and (ii) meet the of either the User groups or Non-user group as below User Groups Definition: Patients who used any dose of NSAIDs or aspirin via oral or systemic (intramuscular, Per rectal) route within 2 weeks prior to the onset of upper GI bleeding NSAID group: Clean base gastric or duodenal ulcer is required (i.e., patients with normal finding or erosions alone on endoscopy will not be eligible) Aspirin group: Either an ulcer or multiple (>5) erosions found on endoscopy Non-user group Definition : 1. No continuous use of NSAIDs or aspirin for more than 1 week within the past 3 Months and patients who had not been exposed to NSAIDs, aspirin, or unknown drugs ≥ 4 weeks prior to GI bleed; 2. Clean base gastric or duodenal ulcer is required (i.e., patients with normal finding or erosions alone on OGD will not be eligible) 3. Age ³18; 4. Willing to meet the capsule endoscopy procedure requirements, and have provided written informed consent prior to admission to this study. 5. Concomitant clean base GU and DU can be recruited The presence of any of the following will a subject from study enrollment: 1. Hematemesis as the presenting symptom; 2. Gastroscopic findings accountable for the bleeding episode (i.e., presence of blood in the stomach, ulcers showing high-risk bleeding stigmata, bleeding gastroesophageal varices, Mallory-Weiss tear showing bleeding stigmata, portohypertensive gastropathy); 3. Gastroscopic findings are normal. 4. Uncontrolled bleeding requiring emergency surgery or mesenteric angiography; 5. Has cardiac pacemaker or other electromedical implant; 6. Is expected to undergo MRI examination or be in the vicinity of powerful electromagnetic fields between ingesting the capsule and its excretion; 7. Active malignancy or history of a malignancy within 5 years prior to enrollment; 8. Previous gastric surgery; 9. Known or suspected complete or partial stenosis of the small intestine; 10. Established delayed gastric emptying or diabetic gastroparesis; 11. Known inflammatory bowel disease; 12. Use of misoprostol within the 2 weeks prior to admission; 13. Concomitant use of NSAIDs and aspirin; 14. Currently taking anticoagulants or lithium; 15. Has a swallowing disorder that precludes safe ingestion of the capsule; 16. Pregnancy; 17. History of clinically significant substance abuse, drug addiction or a history of chronic ingestion of more than two alcoholic drinks per day; 18. Any mental or physical condition, which precludes compliance with study and/or device instructions; 19. Received any investigational medication within 30 days prior to the treatment period; 20. Currently participating in another clinical study that may affect the results of this study. 21. Ulcer > 2cm 22. clean base ulcer with grade C or D esophagitis | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis C HIV Infections This is not a clinical trial HCV infected and uninfected (controls) Women Minorities Children Individuals who cannot or will not provide informed consent | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatitis C Virus Advanced Fibrosis Cirrhosis *Adult male or female, age 18 to 75 years HCV RNA positive by PCR Previous treatment with at least three months of interferon or interferon / Ribavirin. Patients should have had no interferon for at least 2 months prior to enrollment. 1. Non-responders are identified by failure to clear virus by PCR after a minimum 3-month course of treatment and who have been off treatment for at least 2 months with a positive PCR for HCV prior to entry into the current study, 2) Partial responders have a reduction of 1 long in HCV RNA, but the virus is still detectable, 3) Breakthrough patients have been negative on treatment, but virus appeared while still on treatment, 4) Relapsers are defined as negative PCR at some point during treatment, but virus reoccurred or was detectable by HCV PCR when treatment stopped. Patients should have had a liver biopsy showing at least Stage 3 disease prior to being considered for this study. A baseline liver biopsy is necessary for in the study. Baseline liver biopsies can be performed within six months of entering the study. In patients with cirrhosis and endoscopic evidence of portal hypertension, a biopsy within the last 2 years is acceptable as the baseline biopsy. For patients with established cirrhosis on liver biopsy and no portal hypertension, a biopsy within 12 months can be used as the baseline biopsy if it is available for evaluation by the Pathology core. All these patients will still require liver biopsy at 2 years and 4 years. The decision to biopsy at 2 and 4 years is also a clinical decision and in the presence of clinical progression or coagulopathy, or where there may be a risk from liver biopsy, the Investigator should call the PI, Dr. Afdhal for a waiver of biopsy. Patients with Ishak Stage 3 and 4 require a biopsy within 6 months of randomization Hemoglobin >= 11 g/dl in males and 10 g/dl in females Neutrophil count > 1,500/mm3 Platelets > 50, 000/mm3 Platelet count: For standard dose of PEG-Intron 0.5mcg/kg platelet count must be greater than 70,000. Patients with platelet count 50 000 can start at 0.25mcg/kg for weeks 0 - 4. If platelets fall to less than 30,000, stop treatment. If platelets remain > 50,000 at week 4, PEG-Intron can be increased to 0.5mcg/kg. Patients randomized to Colchicine with platelets 50,000 000 can be started at standard dose 0.6mg bid po with standard dose reduction Prothrombin time <= 3secs prolonged compared to control or an equivalent INR < 1.5 Total bilirubin < 3gm/dL are met) HIV negative HBsAg negative Childs Pugh score of less than or equal to 7 Serum positive for anti-hepatitis C antibodies or HCV RNA Alpha-fetoprotein < 100ng/ml with ultrasound negative for focal mass or HCC. For any patient with an Alpha-fetoprotein >100 ng/ml either a triple phase contrast CT scan or MRI with gadolinium must show no focal mass or evidence of HCC Ultrasound with no evidence of focal mass suggestive of hepatoma (within 6 months of informed consent) Documentation that sexually active female patients of childbearing potential are practicing adequate contraception during the treatment period. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding. Documentation that sexually active male patients are practicing acceptable methods of contraception during the treatment period Written informed consent specific for this protocol has been obtained prior to entry Any cause of liver disease based on patient history and biopsy (where applicable) other than chronic hepatitis C including but not limited to | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Heart Failure Age 18 and older Patient needs treatment for HF Current MI or ACS with ST deviation of 1 mm or greater Renal failure requiring dialysis Undergone hemodialysis within the last month Enrollment (Baseline) Triage® BNP concentration = 100 pg/ml or less Enrolled in any other drug trial or receiving an experimental treatment for HF | 0 |
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