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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): 18.0-110.0, Fulminant Clostridium Difficile Colitis Adult patients >18 years old 2. Able to provide informed consent, or presence of a legally authorized representative 3. Meets for operative management as below (Table 1). Table 1. for FCDC (criteria A, B and C all need to be met) A. A diagnosis of FCDC as determined by a history consistent with C.Difficile infection and one of the following: 1. A positive toxin assay 2. Endoscopic finding of pseudomembranes 3. CT scan findings of pancolitis B. At least 2 of the following: 1. Worsening abdominal distention or abdominal pain 2. Sepsis: 2 of the following (HR>100bpm, MAP<60mmHg, temperature>38.5C or<36.5C, and fluid requirement >2L) 3. New onset ventilatory requirement 4. Vasopressor requirement 5. Mental status changes 6. Unexplained clinical deterioration 7. Stable elevated leukocytosis or leukopenia, or worsening leukocytosis, defined as >20,000 or <3,000x109/L C. Attending physician of record (ICU or medicine/surgery) is in agreement with an operative approach - Children (<18 years old) 2. Allergy to vancomycin or polyethyleneglycol 3. Colonic perforation or necrosis 4. 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): 18.0-999.0, Infection Age over 18 years Patients in intensive care : Infection treated with ciprofloxacin IV Osteoarticular infected patients : infection treated with oral ofloxacin Written consent to participate in the study Pregnancy Adults subject to legal protection or 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): 18.0-999.0, End Stage Renal Disease Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF) 2. Male or female subjects aged 18 years or older at the time of randomization 3. Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF 4. Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF 5. Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD 6. Subjects who are able to adhere to the study visit schedule and other protocol requirements 7. Subjects who are able to come to HD clinics as required by the protocol 8. Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks 9. Subjects who have normal liver function, as judged by the Investigator 10. Female subjects of childbearing potential must have negative serum or urine pregnancy test at Screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the Investigator, while in the study Subjects who are HIV positive 2. Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload 3. Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study 4. Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening 5. Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy 6. Subjects who are currently using any investigational drug 7. Subjects who are currently enrolled in other clinical studies 8. Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol 9. Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated 10. Subjects who have a malignancy requiring chemotherapy or radiation therapy 11. Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration 12. Subjects who have a life expectancy of < 48 weeks | 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): 18.0-80.0, Inflammatory Bowel Disease Signed informed consent 2. Inflammatory bowel disease diagnosed at least 3 months ago 3. Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor full induction treatment, or intolerance to either of these drugs. 4. Currently active disease, partial Mayo score ≥4 for ulcerative colitis, or CDAI ≥200 for CD. 5. negative HIV , HTLV I/II, negative stool culture, Negative C diff toxin, negative CMV No informed consent 2. Non active inflammatory bowel disease. 3. Active infection in either the donor or the recipient | 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 Disease High-risk patients, as defined by falling within the high-risk category of our validated prognostic instrument and have approximately 50% 18-month mortality English and Spanish-speaking patients will be included (estimated to be 95% of this population) Patients who receive hemodialysis at one of our 16 research dialysis sites during the data collection period Patients must be willing and able to sign the consent form Patients who are lack the capacity to meaningfully participate in medical decisions must have a surrogate who is willing to sign the informed consent Children 18 years of age. Children constitute 2% of the dialysis population, and our preliminary survey of the study sites found no children were active patients. In any case, the renal and other physical factors of children with ESRD are not directly comparable to those of adults Does not belong to the population's high-mortality risk quintile according to our prognostic instrument Severe psychiatric disorders including schizophrenia, bipolar disorder which would interfere with participation in the study (severity determined by psychiatric hospitalization in the past month or actively suicidal) Active substance abuse (active abuse is defined as using alcohol or recreational drugs in the past 30 days in a way that interferes with their ability to function in daily life) Expectation of native kidney recovery History of poor adherence to thrice-weekly hemodialysis (poor adherence defined by missing 4 treatments in the past month) Unable to communicate in English or Spanish Scheduled for living donor kidney transplant, conversion to peritoneal dialysis, or plans to relocate to another hemodialysis unit Current pregnancy or actively planning to become pregnant Currently a prisoner | 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, Advanced Pleural Malignant Mesothelioma HLA-A*0201 Positive Cells Present Recurrent Non-Small Cell Lung Carcinoma Recurrent Pleural Malignant Mesothelioma Stage III Non-Small Cell Lung Cancer AJCC v7 Stage III Pleural Malignant Mesothelioma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7 Stage IV Pleural Malignant Mesothelioma AJCC v7 WT1 Positive FOR (ARMS 1 AND 2): Histopathological documentation of NSCLC or mesothelioma FOR (ARMS 1 AND 2): Patients must be able to give informed consent FOR (ARMS 1 AND 2): Patients must be able to provide blood and tumor samples and undergo the procedures required for this protocol Arm 2 ONLY: Surgically operable NSCLC or mesothelioma FOR ON ARM 1: Patients must express human leukocyte antigen (HLA)-A*0201 FOR ON ARM 1: Evidence of WT1 tumor expression FOR ON ARM 1: Patients must have received at least one line of therapy for NSCLC or mesothelioma or previously documented to have declined therapy FOR ON ARM 1: NSCLC patients with a mutation in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) must have demonstrated progression or intolerance to at least one of the corresponding targeted therapies (for example erlotinib or crizotinib) FOR ON ARM 1: Bi-dimensionally measurable disease by palpation, clinical exam, or radiographic imaging (X-ray, computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound) FOR ON ARM 1: Ninety days must have passed since the last doses of radiation or chemoradiation treatment involving lung tissue or thorax prior to T cell infusion (to avoid confounding pneumonitis) FOR (ARMS 1 AND 2) Eastern Cooperative Oncology Group (ECOG) performance status >= 2 Active autoimmune disease (e.g., systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigators Any condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol Men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative urine pregnancy test within 2 weeks prior to first infusion Pregnant women and nursing mothers will be eligible for screening only to test HLA type by saliva or buccal swab and WT1 expression from previously collected tissue sample Clinically significant and ongoing immune suppression including, but not limited to, systemic immunosuppressive agents such as cyclosporine or corticosteroids, chronic lymphocytic leukemia (CLL), uncontrolled human immunodeficiency virus (HIV) infection, or solid organ transplantation FOR (ARMS 1 AND 2) Exclusions for the leukapheresis procedure (this can be performed at a later time of symptoms resolve) Infection, with or without antibiotic treatment | 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, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery | 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): 18.0-70.0, Tuberculosis for Patients with Hepatic Impairment (Groups 1-3): 1. Subject is able to give voluntary written informed consent before any study related procedure is performed. 2. 18-70 years of age, inclusive. 3. Acceptable laboratory values* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit Chemistry, complete blood count, AST, ALT, total bilirubin, alkaline phosphatase, albumin, and urinalysis deemed not clinically significant by the investigator. 4. Hepatic impairment classified as Child-Pugh class A (mild), B (moderate), or C (severe) at screening for Groups 1, 2, or 3, respectively, and documented evidence of hepatic cirrhosis*. *by biopsy, nuclear scan, CT, MRI, ultrasound, or other clinically acceptable methods 5. If female, not of childbearing potential* or agrees to avoid becoming pregnant by using acceptable contraception** during the duration of the study. *Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men. 6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control* In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #5, and abstinence from sexual intercourse with women. 7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit. 8. Willingness to comply with all protocol requirements. for Non-Hepatically Impaired Controls (Group 4): 1. Subject is able to give voluntary written informed consent before any study related procedure is performed. 2. 18-70 years of age, inclusive. 3. Subject is a healthy volunteer as determined by no clinically significant findings from medical history, physical examination, vital signs, and 12-lead ECG as determined by the Site Investigator. 4. Acceptable laboratory values* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit. *Chemistry, complete blood count, AST, ALT, total bilirubin, alkaline phosphatase, albumin, and urinalysis within the reference range for the test laboratory, unless deemed not clinically significant by the investigator. 5. If female, not of childbearing potential* or agrees to avoid becoming pregnant by using acceptable contraception** during the duration of the study. *Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy. **Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men. 6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control*. *In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #5, and abstinence from sexual intercourse with women. 7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit. 8. Willingness to comply with all protocol requirements for Patients with Hepatic Impairment (Groups 1-3): 1. Hypokalemia (< 3.5mEq/L), severe hypomagnesemia (< 1.1 mg/dL) or severe hypocalcemia (< 7.5 mg/dL). 2. AST or ALT > 10 times the upper limit of normal. 3. Creatinine clearance < 60 ml/min. 4. Inability to swallow tablets. 5. Presence of any condition or finding* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments**. *in the opinion of the site investigator **e.g., inability to draw PK samples 6. History of fever or documented fever (oral temperature > / = 100.4 degrees F or > / = 38.0 degrees C) in the 48 hours prior to admission to the the confinement/hospital unit. 7. Currently breastfeeding. 8. History of chronic tobacco/nicotine use (> 10 cigarettes per day for 3 months minimum prior to admission). 9. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors). 10. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening. 11. Use of any over the counter (OTC) medication* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *including vitamins and herbal supplements, cough and cold medications. **in the opinion of the site investigator 12. Treatment with CYP450 enzyme altering drugs* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *except hormonal contraceptives **in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section. 13. Treatment with any drugs* known to prolong the electrocardiographic QT interval within 15 days prior to admission to the confinement/hospital unit.. *Including excessive chronic caffeine (> six 8 oz cups of brewed coffee daily or > 3 energy drinks daily), theophylline (> 600 mg/day), or ephedrine (> 300 mg/day) use. 14. A positive blood screen for HIV. 15. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse* at screening and at admission to the confinement/hospital unit Amphetamines, barbiturates, cocaine metabolites, marijuana, opiates, phencyclidine (PCP). NOTE: Results of the urine screen test can be ignored if in the opinion of the PI the results can be explained by the concomitant medications history. 16. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weight lifting, competitive sports) during the course of the study. 17. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12. 18. A QTcF interval > 440 msec (males) or > 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval. 19. A family history* of Long QT Syndrome, premature cardiac death**, or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death. *parents **due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women) ***such as known coronary artery disease, congestive heart failure, or terminal cancer 20. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit. 21. Donation of > 500 mL blood within the 30 days prior to admission to the confinement/hospital unit. 22. Plans to donate blood during the study or up to 14 days after dosing. 23. Persons with a transjugular intrahepatic portosystemic shunt for Non-Hepatically Impaired Controls (Group 4): 1. Inability to swallow tablets. 2. Presence of any condition or finding* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments**. *in the opinion of the site investigator **e.g., inability to collect PK samples 3. History of fever or documented fever (oral temperature > / = 100.4 degrees F or > / = 38.0 degrees C) in the 48 hours prior to admission to the confinement/hospital unit. 4. Currently breastfeeding. 5. History of chronic tobacco/nicotine use (> 10 cigarettes per day for 3 months minimum prior to admission to the confinement/hospital unit). 6. History of seizures (other than febrile seizures during childhood) or known or suspected CNS disorders that may predispose to seizures. 7. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors). 8. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening. 9. Use of any over the counter (OTC) medication* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *including vitamins and herbal supplements, antacids, cough and cold medications. **in the opinion of the site investigator 10. Use of prescription medication except hormonal contraceptives within 30 days prior to admission to the confinement/hospital unit, unless* the substance would not likely impact study result validity. *in the opinion of the site investigator 11. Treatment with CYP450 enzyme altering drugs* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *except hormonal contraceptives **in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section. 12. Treatment with any drugs* known to prolong the electrocardiographic QT interval within 15 days prior to admission to the confinement/hospital unit. *Including excessive chronic caffeine (> six 8 oz cups of brewed coffee daily or > 3 energy drinks daily), theophylline (> 600 mg/day), or ephedrine (> 300 mg/day) use. 13. A positive blood screen for HIV. 14. A positive blood screen for hepatitis B surface antigen (HBsAg), or hepatitis C antibody. 15. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse* at screening and at admission to the confinement/hospital unit. *Amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP). 16. A history of alcohol abuse or dependence within the past 1 month prior to admission to the confinement/hospital unit. 17. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weight lifting, competitive sports) during the course of the study. 18. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12. 19. A QTcF interval > 440 msec (males) or > 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval. 20. A family history* of Long QT Syndrome, premature cardiac death**, or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death. *parents **due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women) ***such as known coronary artery disease, congestive heart failure, or terminal cancer 21. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit. 22. Donation of > 500 mL of blood within the 30 days prior to admission to the confinement/hospital unit. 23. Plans to donate blood during the study or up to 14 days after dosing. 24. Persons with a transjugular intrahepatic portosystemic shunt | 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, Diarrhea Due to Clostridium Difficile Hospitalized Suffering from diarrhea related to C. difficile Confirmed diagnosis of CDI Informed consent by the patient Affiliated to the social security regime Out-patient No confirmed diagnosis of CDI Decline of participation Patient not affiliated to the social security regime | 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): 0.0-5.0, Malaria A cluster is defined to be a parish or neighboring parishes if the distance between any two private outlets located in each of the parishes is<1 km( to minimize possible spill over) Any of the 63 parishes/clusters in Mukono district will be eligible if: i) Contain more than 200 households to ensure a sufficient number of sick children visiting the private outlets ii) Contained at least one registered drug shop/private clinic with the district drug inspector (DDI). iii) Contain a health centre II, the lowest public health facility where early treatment is sought i) Unregistered drug shop/private clinic ii) No HFII government health facility located within the same parish iii) Fewer than 200 households in the parish where drug shop/private clinic is located iv) If the health facility does not have a qualified health worker. Some government health HCIIs in Uganda are run by nursing aides | 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, Atypical Hemolytic Uremic Syndrome Age >18 years Diagnosis of aHUS with or without identified genetic abnormalities in the complement system or thrombomodulin Stable chronic extracorporeal or peritoneal dialysis therapy since at least 6 months Written informed consent Women of childbearing potential or women who are breastfeeding Shiga toxin-associated HUS or secondary forms of thrombotic microangiopathy activity <10 % or circulating anti autoantibodies consistent with the diagnosis of thrombotic thrombocytopenic purpura Need for specific intervention with plasma therapy and/or complement inhibitors as deemed clinically appropriate Plasma therapy or treatment with complement inhibitors or antiplatelet and antithrombotic agents over the last two weeks Liver function impairment (serum liver enzymes or bilirubin levels >3 x upper limit of normal) Neutrophil count < 2000/μL or lymphocyte count < 1000/μL Infection requiring antibiotic treatment within the previous 4 weeks prior to screening Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose History or presence of any medical condition or disease which, in the opinion of the Investigator may place the subject at unacceptable risk for study participation | 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): 18.0-70.0, Alcoholic Hepatitis Alcoholic hepatitis Jaundice < 3 months Bilirubin > 5 mg/dl PTI (INR) Increased: >1.4 Leucocytosis >> 11,000/micro L. AST< 300 IU/l ; AST/ALT >2 2. Hepatic Encephalopathy 3. Men and women age > 18 years and above 4. DF>32 5. MELD≥21 6. Actively consuming alcohol within 6 weeks of entry into the study 7. Patient with controlled upper GI bleed, resolved sepsis and acute kidney injury can be enrolled 8. Voluntary informed consent Failure to obtain informed consent 2. Jaundice more than 3 months 3. AST>500 IU/L, ALT>300 IU/L 4. Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease 5. HIV positive 6. Cow milk allergy or severe lactose intolerance 7. Active Gastrointestinal bleeding 8. Acute kidney injury at time of randomization with Creatinine> 1.5 mg/dL 9. Evidence of acute pancreatitis or biliary obstruction 10. Subjects who are pregnant or lactating 11. Significant systemic cardio-pulmonary illness (what if on ventilator for HE or respiratory failure) These are terminally ill patients, hence be excluded 12. Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization 13. Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week. 14. Any patient who has received any investigational drug or device within 30 days entering into the study. 15. Patient who withdraw consent | 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 Patients hospitalized in the Nephrology department of the Besançon University Hospital Patients treated by continuous ambulatory peritoneal dialysis or ambulatory peritoneal dialysis for at least 6 months Absence of hospitalization caused by an infection in the month prior to Patients with a ratio (D / P) of the concentration of creatinine in the blood and dialysate between 0.5 and 0.8 on a checkup of less than 1 year No contraindication to the use of hypertonic bag Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study Affiliation to a French social security system or beneficiary Legal incapacity or limited legal capacity Patients unlikely to cooperate in the study and/or low cooperation anticipated by the investigator Patients without health insurance Pregnant women Patient being in the period from another study or planned by the "national register of volunteers" Hospitalization caused by an infection in the month prior to Patients with a peritoneal dialysis catheter dysfunction | 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, End-stage Renal Disease Renal Failure requires dialysis catheter insertion for maintenance peritoneal dialysis aged 18 or older willingness to give written consent and comply with the study protocol known contraindication to peritoneal dialysis participation in another interventional study within last 30 days of randomization history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures | 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, Colorectal Neoplasms Breast Neoplasms Patients must be at least 18 years of age Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities. Patients with any cardiac history of the following conditions within 1 year prior to study enrollment are excluded from the study Prior events including myocardial infarction, pericardial effusion, and myocarditis Prior cardiac arrhythmia including atrial fibrillation and atrial flutter, or requiring concurrent use of drugs or biologics with pro-arrhythmic potential NYHA Class II or greater heart failure If cardiac function assessment is clinically indicated or performed, an LVEF less than normal per institutional guidelines, or <55%, if threshold for normal is not otherwise specified by institutional guidelines QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment Hypertensive crisis or hypertensive encephalopathy Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm >5 cm or aortic dissection | 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): 0.083-95.0, End Stage Renal Disease All patients starting maintenance dialysis therapies at the participating centers Africans | 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, Clostridium Difficile Prescription of antibiotics for suspected or confirmed infection Admitted to the 2600 General/Medical ward at Delnor Hospital Antibiotics only for surgical prophylaxis Not mentally capable Cannot provide consent in English Pregnant Documented chlorhexidine allergy Patient is a prisoner Health system employee | 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, Peritoneal Fibrosis Patients with end stage renal disease recently started on peritoneal dialysis. Patients will be over the age of 18 | 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): 50.0-999.0, Infection in the Elderly patient aged 50 y and more with fever >38c that started in the 48 hours prior to admission leukocytosis >10.0 K/microLiter suspected source of infection by symptoms, lab results or imaging treatment with antibiotics started in the last 24 hours or is about to be started patients who cannot sign the informed concent ( dementia) patients with active malignancy patients who are under chemotherapy | 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, Kidney Failure,Chronic Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial | 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, Head and Neck Squamous Cell Carcinoma Pain Stomatitis Patients who are eligible for chemoradiation therapy of the head and neck Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal Have a clinical stage II-IV head and neck carcinoma Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Ability to swallow and retain oral medication or take through a feeding tube Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer Patients with known brain metastases will be excluded from this clinical trial Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing female patients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug Received an investigational agent within 30 days prior to enrollment Patients on medications that prolong QT interval Patients on dialysis or with transplanted organs | 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, Chronic Kidney Disease Fit CKD definition by National Kidney Foundation's Kidney Disease Outcome Quality Initiative（NKF-KDOQI, pre-ESRD stage IIIb~IV (GFR: 15-44). 2. at least 20 years old volunteers. 3. The participants had no allergy to acupuncture needle in the past, or without contraindications to acupuncture treatment. 4. The participants agreed to join the trial and sign informed consent form after thorough explanation Age less than 20 years old. 2. Using immunosuppressive drug or receiving chemotherapy. 3. Had substance abuse in the past, or having substance abuse. 4. Pregnancy women or breastfeeding women. 5. Mental or behavioral disorders which leads to inability to cooperation. 6. Arrhythmia patients who have pacemaker. 7. Patient who have skin infection or wound infection near acupoints. 8. Patient who have coagulation abnormalities or low platelet count by blood tests (platelet≤150000 / uL). 9. Participating other clinical trials. 10. Patient with serious diseases such as myocardial infarction, severe arrhythmia, heart failure, chronic obstructive airway disease, or cancer. 11. Patients who have limb edema and severe skin lesions not suitable for acupuncture or massage. 12. Patients who took Chinese herbal medicine or received acupuncture treatment in the past 2 weeks. 13. Patients who disagree to sign informed consent form | 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): 18.0-80.0, End-stage Renal Disease (ESRD) End stage renal disease maintained on outpatient hemodialysis at a healthcare center for > 3 months from screening with hemodialysis using heparin (unfractionated heparin or low-molecular weight heparin) 3 times per week for a minimum of 3 hours per dialysis session and plan to continue this throughout the study Documented thrombotic event (acute coronary syndrome, stroke or transient ischemic attack, venous thromboembolic event) in the past 3 months Active bleeding within the past 3 months from screening or documented bleeding diathesis (history of bleeding disorder) or Screening values of Platelet count < 150,000 cells/mm3 INR > 1.4 aPTT > upper limit of normal (ULN) Abnormal liver function at Screening ALT or AST > 2 x ULN Total bilirubin > ULN Concomitant medication restrictions: Concomitant use of anticoagulant/antiplatelet agents (e.g., dabigatran, rivaroxaban, clopidogrel) that may affect coagulation (except low dose aspirin (≤ 100 mg/day) during Treatment and Post-treatment Evaluation Periods is not allowed Uncontrolled hypertension as judged by the Investigator. Patients with a pre | 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, Hemorrhage Pre-treatment INR lab value greater than 1.5 Receipt of treatment with a 4-factor PCC for INR normalization due to warfarin-associated major hemorrhage Patients treated with a PCC for an urgent invasive procedure without active hemorrhage Patients treated with PCC not taking a VKA Unavailable pre or post-treatment INR lab values Pregnant 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): 18.0-99.0, End-stage Renal Disease Informed consent Patients with end-stage renal disease [5] undergoing any modality of renal replacement therapy (hemodialysis, hemodiafiltration or peritoneal dialysis) Malignancy Pregnancy Chronic inflammatory bowel disease Celiac disease Active alcohol abuse (>40g alcohol per day) Any severe organ dysfunction unrelated to renal dysfunction 20 healthy family members (living in the same household) of patients will be recruited as controls | 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): 3.0-999.0, Atypical Hemolytic Uremic Syndrome Children and adults under eculizumab treatment for aHUS (initial episode or relapse) defined by at least two of the following: thrombocytopenia (platelet count < 150 G/L), mechanical hemolytical anaemia (Hb < 10 g:dl, LDH > upper limit of normal, undetectable haptoglobin, presence of schizocytes on blood smear), acute kidney injury (serum creatinine and/or proteinuria/creatininuria > upper limit of normal for age or an increase > 15% compared to baseline levels ) 2. Patients not requiring dialysis. 3. Adults: HUS remission and normal or stabilized renal function under eculizumab treatment since at least 6 months (3 months in patients with MCP mutations) 4. Children: age > 3 years at eculizumab withdrawal; HUS remission and normal renal function under eculizumab treatment since at least 3 months in children with isolated MCP mutation, at least 6 months in children with complement mutation other than MCP Patients on dialysis. 2. Women treated with eculizumab starting or planning a pregnancy. Pregnancy including the post-partum period is high-risk periods for the occurrence of aHUS. 3. Patients who did not give informed consent. 4. Patients under protection of a judicial authority Patients can be enrolled in the study within ten weeks after Eculizumab stop | 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 ≥ 18 years old Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics A positive stool test for the presence of C. difficile within 60 days prior to enrollment A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment Requires continuous antibiotic therapy for a condition other than CDI Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant Previous treatment with RBX2660 Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria History of chronic diarrhea History of celiac disease Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile | 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): 18.0-120.0, Clostridium Difficile Admitted to Good Samaritan Hospital Placed on pneumonia order set Age 18+ Patient with inadequate coherency to understand consent Active Diarrhea at admission Non-controlled intestinal disease Documented positive C. difficile infection within the 3 months before enrollment Antibiotic use at hospital admission Immunosuppressive therapy Pregnancy Allergic to ingredients in Florajen-3 Allergic to ingredients in placebo Immunocompromised state including | 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): 0.0-999.0, Diarrhea-predominant Irritable Bowel Syndrome Female patients with diarrhea-predominant irritable bowel syndrome | 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 Adults greater than or equal to (>/=) 18 years of age ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (<) 10 milliliters per minute (mL/min) Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10 mL/min Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2) Use of contraception among women of childbearing potential Clinical significant comorbid disease or terminal illness Known human immunodeficiency virus (HIV) or hepatitis B or C History of drug or alcohol abuse within the prior year Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to Screening Participation in a clinical study with an investigational drug in the 3 months prior to study drug Pregnant or lactating women | 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): 0.0-999.0, Vancomycin (Glycopeptide) Resistant Enterococcus (VRE) Cancer Inpatient hospitalization during the study period on one of the participating wards 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, Hepatitis C HIV Male and females ≥18 years Documented HIV infection Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA Absence of advanced liver disease or clinical signs of extra-hepatic disease F0-F2 (< 9,5 kPa) established by transient elastography, and No clinical signs of extra-hepatic disease Not on HCV antiviral treatment Currently on/or history of hepatitis C treatment Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography) Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed 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): 18.0-80.0, Hyperphosphatemia to 80 years old Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods Males must agree to avoid fathering a child and agree to use an appropriate method of contraception Chronic maintenance hemodialysis 3x/week for at least 3 months Kt/V ≥ 1.3 at most recent measurement prior to screening Prescribed and taking at least 3 doses of phosphate binder per day Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening Serum parathyroid hormone >1200 pg/mL Persistent metabolic acidosis defined as serum carbon dioxide <18 mmol/L from two consecutive measurements during screening and washout periods Clinical signs of hypovolemia at randomization History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS-D) Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator Life expectancy < 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): 18.0-99.0, Clostridium Infections Patients with Clostridium difficile associated diarrhea Patients < 18 years old | 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): 4.0-99.0, Methicillin-Resistant Staphylococcus Aureus Cystic Fibrosis Male or female with a confirmed diagnosis of CF (clinical features and positive sweat test and/or identification of 2 CF disease causing mutations). 2. At least 4 years of age or older. 3. Chronic infection with MRSA defined as having had MRSA positive respiratory cultures for > 1 year with ≥ 50% of cultures being MRSA positive e.g. 2/4 of the most recent cultures grew MRSA. 4. Being able to expectorate sputum on a consistent basis, i.e. also at the end of IV therapy. 5. Having a pulmonary exacerbation defined for this protocol as the decision of the treating physician to start IV therapy in hospital or at home. Typically this occurs when there has been a >5% drop in FEV1 % predicted compared to the patient's baseline and increased respiratory symptoms. NOTE: Patients who had oral or inhaled antibiotics with or without MRSA activity but failed this outpatient therapy i.e. are changed to IV anti-MRSA antibiotics are allowed to participate.(Example: was on oral doxycycline and on admission changed to ceftaroline = eligible. On oral doxycycline that is continued on admission = not eligible) Patient enrollment should be prioritized to those receiving IV vancomycin or ceftaroline, with secondary consideration of patients who receive oral anti-MRSA therapy (TMP-SMX or a tetracycline derivative) that was initiated on hospital admission Patients on linezolid will not be included as this medication is given orally and IV and may confound analyses Presence / infection with B. cepacia genomovar III (=B. cenocepacia). Subjects who have undergone lung or liver transplant in the past (NOTE: patients listed for transplant are eligible) 2. Concomitant participation and/or use of an investigational drug within 30 days of this study. 3. Concomitant observational studies are allowed with TRI-STAR, if approved by the other study investigator or their proxy | 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, Multiple Myeloma Subjects must satisfy the following to be enrolled into the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first autologous stem cell transplantation (ASCT) are allowed), symptomatic multiple myeloma (MM) as defined by the below: MM diagnostic (all 3 required) Monoclonal protein present in the serum and/or urine Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma Any one or more of the following myeloma defining events: 1. one or more of the following Myeloma-related organ dysfunction (at least one of the following) (C) Calcium elevation (serum calcium >11.5 mg/dl )(>2.65 mmol/L) (R) Renal insufficiency (serum creatinine >2 mg/dl)(177 µmol/L or more) or creatinine clearance < 40 ml/min (A) Anemia (hemoglobin <10 g/dL or >2 g/dL below the lower limit of laboratory normal) (B) Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-computed tomography (PET-CT) 2. one or more of the following biomarkers of malignancy Clonal bone marrow plasma cell percentage ≥60% Abnormal serum free light-chain ratio ≥100 (involved kappa) or < 0.01 (involved lambda) The presence of any of the following will a subject from enrollment: 1. Previous treatment with anti-myeloma therapy (does not radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed) 2. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) < 1,000/μL 2. Untransfused platelet count < 75,000 cells/μL 3. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 2.5*upper limit of normal (ULN) 4. Serum total bilirubin > 1.5*ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome 5. Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L) 3. Renal failure requiring hemodialysis or peritoneal dialysis 4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment 5. Peripheral neuropathy ≥ Grade 2 6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis 7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative 8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C 9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti CTLA-4,anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines 10. Subjects has history of organ or allogeneic stem cell transplantation 11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia 12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone 13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment 14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment 16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection); 2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication); 17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: 1. Subjects with vitiligo or alopecia; 2. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or 3. Subjects with psoriasis not requiring systemic treatment; 18. History of primary immunodeficiency 19. Subject has incidence of gastrointestinal disease that may significantly alter the absorption of LEN 20. Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab 21. Unable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE) 22. Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study 23. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 24. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 25. Any condition that confounds the ability to interpret data from the 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, Clostridium Difficile Infection Adults aged ≥ 18 yrs of age. 2. Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral vancomycin or metronidazole) and a 6 week taper of oral vancomycin. 3. Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or polymerase chain reaction (PCR). 4. Presence of persistent diarrhea defined as ≥ 3 loose or watery bowel movements in 24hr continuing for >2 days and diarrhea ongoing at the time of inclusion Severely immunosuppressed patients will not be enrolled. This is defined as >20 mg prednisone/d for >1 month, recent transplant patients (haematological <2yrs and solid organ < 6 months), transplant with active graft versus host disease, HIV (with CD4<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor, rituximab), other high dose long term systemic immunosuppression) and severe congenital immunodeficiency. 2. Age <18 years old. 3. Pregnancy. 4. Patient expected to expire in < 30d. 5. Current hospital admission for an indication other than CDI or need for vasopressor medication | 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): 0.5-12.0, Gastroenteritis The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office The participant has mild-to-moderate dehydration The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office The participant has severe dehydration or severe malnutrition The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit The participant needs intravenous (IV) fluid replacement The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis | 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, Acute Diarrhoea Provision of written informed consent prior to any study related procedures Male or female subject (outpatient) legally considered as an adult (age of majority). In Czech Republic, the upper limit of age will be 70 years inclusive. In Egypt, the upper limit of age will be 60 years inclusive Subject has a diagnosis of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day within the last 48 hours without associated alarm symptoms Subject has, usually, normal bowel habits (Rome III criteria), i.e. at least 3 stools per week and no more than 3 stools per day Subject must be willing and able to comply with study restrictions and willing to return to the clinic for the follow up evaluation(s) as specified in the protocol related to the acute diarrhoea episode At least one of the following alarm symptoms Bloody diarrhoea* pus in the stools* fever ≥38°C* moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration* repeated vomiting* persistent abdominal pain* *These symptoms are considered as alarm symptoms other episode of acute watery diarrhoea within the previous 30 days persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more than 14 days | 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, Liver Transplantation First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O) Ages of 18 or older Patients receive liver transplantation due to benign end stage liver disease Patients or legal agent must be able to give informed consent Second or combined organ transplant recipient Combined transplantations such as simultaneous liver/kidney transplants Malignant disease Uncontrol bacterial, fungal, viral or parasitic infection Withdraw or unable to finish the follow-up Unwilling to sign informed consent | 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): 19.0-999.0, Clostridium Difficile Infection Diarrhea Patients who have Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN) Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral route), but have not yet started the regimen Consented to be randomized and take part in the study and are adults greater than 19 years of age Patients who are/have Tube feeding Undergoing dialysis and other renal treatment An existing C. difficile infection A recent history of C. difficile infection (within the last 3 months) A recent history of antibiotic use (within the last 3 months) Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal syndrome A history of acquired of genetic immunodeficiencies; active, acute or chronic serious infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy Allergy to milk protein | 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, Cancer of the Lung Lung Cancer Lung Neoplasms Adenocarcinoma of the Lung Non Small Cell Carcinoma of the Lung Small Cell Carcinoma of the Lung years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed) Prior history of cancer | 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, Hepatocellular Carcinoma Male or female patient over 18 years of age Patient who have a life expectancy of at least 12 weeks Biopsy proven diagnosis of hepatocellular carcinoma Liver lesions are visible and measurable of at least 3 cm in size Advanced HCC, defined by the presence of one of the followings Vascular invasion HCC with cancer-related symptoms with ECOG Score of 0, 1 or 2 Progression after resection or local ablation and not for further curative therapies Cirrhotic status of Child-Pugh class A and B (score ≤ 8) The following laboratory parameters Previous or concurrent cancer that is distinct in primary site or histology from HCC. Except Cervical carcinoma in situ Prostate cancer with good prognosis Treated basal cell carcinoma Superficial bladder tumors (Ta, Tis & T1) Any cancer curatively treated 3 years prior to entry is permitted A Child-Pugh rating of C at entry An ECOG performance score of 3 or 4 at entry Extensive extra-hepatic disease Tumor volume > 50% of liver volume | 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, Clostridium Difficile Infection Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin Pregnancy or breastfeeding 2. Does not speak or understand the Danish language 3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin 4. fulminant colitis which contraindicates medical treatment 5. physician's evaluation that the patient cannot tolerate project | 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, Diarrhea Male and female patients with recurrent C. difficile colitis Capable of giving informed consent Patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. Lactose intolerance or gluten enteropathy are not an provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations Patients not available for long-term follow-up (2 months) by their physician will be excluded from the study | 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): 45.0-70.0, Pain Neoplasms the patient was able to read Chinese and use smart phones the patient was diagnosed with cancer and has self-reported cancer pain within a month prior to the study the patient was being seen on a regular basis by the oncology team the patient was under standard analgesia treatments the patient was estimated to have over 3 months survival time the patients who self-reported to have severe cognitive impairments or major comorbid illnesses that would interfere with pain assessment | 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): 20.0-99.0, Infection Inpatient with infectious disease and under broad-spectrum antibiotics Poor prognosis was diagnosed or received conservative therapy only | 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, Stroke At least 18 years old Had stroke at least 6 months ago Right-hand dominant prior to stroke Some continued arm and hand weakness Some ability to move the arm and hand that is weaker from the stroke Acute medical issues that would interfere with participation Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease) Cannot undergo MRI scanning Severe apraxia or hemispatial neglect Pain in the arm that interferes with movement Difficulty maintaining attention or following directions | 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 Disease Congestive Heart Failure diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months) evidence of CKD stage 3-4 agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis available medical records 1 year before dialysis treatment unstable hemodynamic or respiratory condition need for vasopressor support patient refusal lack of family support or housing conditions needed for PD treatment evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study contraindications for peritoneal ultrafiltration treatment (active intraabdominal or abdominal wall inflammatory process, morbid obesity, multiple abdominal surgery in the past) non compliance with treatment protocol | 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, Suspected Infection With Vancomycin Susceptible Bacterial Strains patient hospitalized in intensive care unit under intravenous vancomycin started during current ICU hospitalization with at least one vancomycin serum concentration available under hemodynamic monitoring with the Picco ® device vancomycin treatment for less than 24 hours vancomycin concentration in serum unavailable rare comorbidities influencing vancomycin pharmacokinetics myeloma cystic fibrosis burn injury on more than 20 % of the body surface previous in present study | 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): 0.0-999.0, Escherichia Coli Infections Patients infected with ESBL producing E. coli Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli | 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, End-stage Chronic Kidney Failure Patient who have been informed about the research Patients with national health insurance cover Patients aged between 18 and 75 years Patients with stage 3 kidney failure (30 ml/min < cl creat < 59 ml/min) diabetic or not Patients with stage 5 kidney failure (cl creat < 15 ml/mn) diabetic or not and requiring dialysis Patients under guardianship Pregnant or breast-feeding women Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site) Neoplastic disease Systemic diseases in flare Patients positive for Human Immunodeficience Virus (HIV) Patients on immunosuppressants Patients taking antioxidants (selenium, vitamin C and/or E) Patient on statins | 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): 40.0-999.0, Lung Diseases, Obstructive Blood Eosinophil Count Glucocorticoids COPD Pulmonary Disease, Chronic Obstructive Patients hospitalized with Age ≥ 40 years Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%) Chronic Obstructive Lung Disease (GOLD) class C or D within 24 hours after admission Known with a diagnosis of asthma Life expectancy less than 30 days Serious exacerbation requiring invasive ventilation or admission to ICU Allergy to systemic corticosteroids Severe mental illness, which is not controlled by medication People who are detained under the act on the use of coercion in psychiatry Severe language problems or inability to provide written informed consent Pregnancy and lactation Systemic fungal infections | 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, Cholera Diarrhea for cholera cases Seeks treatment for acute non-bloody diarrhea (defined as 3 or more loose, watery or liquid stools in a 24-hour period with an onset of 3 days or fewer prior to presentation) at a participating study site Diarrhea episode is diagnosed as cholera, confirmed by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (i.e. ≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant during the vaccination campaign) for cholera cases < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign for non-cholera diarrhea cases Seeks treatment for acute non-bloody diarrhea (as defined above) at a participating study site Culture negative cholera by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant at the time of the campaign) for non-cholera diarrhea cases < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign for all controls | 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 ≥ 18 years old. 2. Able to provide informed consent, or have a caregiver able to provide consent 3. Meets the definition of non-severe recurrent CDI (see Section 2.1, above) AND 4. Has had a positive stool test for C. difficile within 60 days of enrolment 5. Able to undergo colonoscopy and enemas 6. Not pregnant 7. Willing to participate in follow up as part of the study In addition, the patient must agree to undergo stool testing and blood screening tests that are part of the study, including hepatitis and HIV testing Life expectancy < 6 months 2. Evidence of severe CDI ((neutropenia (ANC<1000) or WBC>30, creatinine >2X baseline, presence of toxic megacolon or intestinal perforation, admission to ICU) 3. History of chronic diarrhea 4. Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide) 5. Use of antibiotics for another infection (other than CDI) 6. Colostomy 7. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment 8. Pregnant or planning to get pregnant in the next 6 months 9. Unable to tolerate MET-2 for any reason 10. Any condition for which colonoscopy or enema may be contraindicated (e.g., neutropenia, thrombocytopenia, bleeding disorders, severe colitis, etc) 11. Any condition for which, in the opinion of the investigator, the patient should be excluded from the study | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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, Subarachnoid Hemorrhage Subarachnoid hemorrhage 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): 0.0-999.0, End Stage Renal Failure End Stage Renal Failure Refusal to participate | 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, Crohn's Diseases patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score >4; 2. patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4; 3. patients with high compliance accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock; 2. severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases; 3. parenteral infection such as urinary infection, pneumonia, etc; 4. steroids or biologicals use within 6 week; 5. intestinal fibrotic stenosis; 6. patients who are pregnant or going to be pregnant; 7. patients with mental disorders | 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, Ventilator-associated Pneumonia Age older than 18 yr Invasive mechanical ventilation for more than 48 h Tracheostomized patients receiving intermittent mechanical ventilation can be included VAP caused by Gram-negative MDR bacteria resistant to all β-lactams and fluoroquinolones Extrapulmonary Gram-negative MDR infection requiring intravenous colimycin VAP associated with bacteremia requiring combined treatment by nebulized and intravenous colimycin Hypersensitivity to colistimethate, colistin base, polymyxins and/or their excipients Porphyria Severe hypoxemia defined as PaO2 / FiO2< 100; if veno-venous ECMO is initiated, the patient can be included Severe brain injury (initial Glasgow coma score < 8) during the first 7 days before randomization Myasthenia cystic fibrosis Refusal to participate in the study Participation in any clinical study of a therapeutic investigational product within 30 days prior to the first day 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): 18.0-999.0, Plasmacytoma POEMS Syndrome POEMS syndrome requiring therapy, previously treated or untreated Plasma vascular endothelial growth factor (VEGF) > 2 x upper limit of normal (ULN) Presence of a plasma cell clone (any of the following) Monoclonal protein in the serum or urine Measurable light chains by free light chain assay Measurable plasmacytoma Monoclonal plasma cells in bone marrow Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3 Absolute neutrophil count (ANC) >= 1000/uL obtained =< 14 days prior to registration Platelet count (PLT) >= 75,000/uL obtained =< 14 days prior to registration Recent prior chemotherapy Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy Prior chemotherapy directed at a "myeloproliferative neoplasm" like hydroxyurea is not exclusionary Previously treated patients (group 2) Alkylators (e.g. melphalan, cyclophosphamide) =< 28 days prior to registration Anthracyclines =< 28 days prior to registration High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< 28 days prior to registration Requirement for concomitant high dose corticosteroids Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for adrenal insufficiency, rheumatoid arthritis, etc | 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): 18.0-70.0, Kidney Failure, Chronic maintenance hemodialysis patients(MHP),dialysis age>3 months signed informed consent intolerance to whole milk and dairy products patients with kidney transplant, with severe infections, sever heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring artificial feeding pregnant or nursing women patients with known gastro-intestinal disease (i.e.,inflammatory bowel disease,crohn's disease,ulcerative colitis),receiving or have received radiation to the bowel or large bowel resection use of antibiotics, prebiotics or probiotics in the past 4 weeks | 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): 18.0-75.0, Idiopathic Parkinson Patients Age ≥18，≤75，idiopathic Parkinson's disease，both male and female 2. MMSE score ≥24 3. H-Y score ≥2.0 on the medicine off situation 4. UPDRS-III score≥30 on the medicine off situation 5. The duration of this disease ≥5 years 6. Ability to provide informed consent as determined by preoperative neuropsychological assessment 7. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients 8. Excellent responsiveness to levodopa 9. ≥6h in medicine off state Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment 2. Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia 3. Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases 4. Patients who are unable to follow verbal instructions 5. Other severe pathological chronic condition that might confound treatment effects or interpretation of the data | 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): 35.0-55.0, Smoking Alcohol Drinking Prescription Drug Abuse Substance-Related Disorders Oral Intake Reduced Age 35-55 Experience of early adversity (EA) before age 18 (EA is be defined as a score of 4 or higher on the Adverse Childhood Experiences (ACEs) questionnaire [Felitti, Anda, Nordenberg, Williamson, Spitz, Edwards, et al., 1998]) IC difficulties such as disinhibited alcohol use, tobacco use, or food intake during adulthood. IC difficulties will be self-reported based on questions from the self-control questionnaire (Tangney, Baumeister, & Boone, 2004) modified to be specific to alcohol, tobacco, and energy-dense food intake (e.g., "I am self-indulgent with unhealthy food at times", "I refuse alcohol when offered") using a 4-point Likert-style scale Individuals over age 55 will be excluded because of established functional and structural neural changes that begin to escalate at that time (Good, Johnsrude, Ashburner, Henson, Friston, & Frackowiak, 2001; Grady, Springer, Hongwanishkul, McIntosh, & Winocur, 2006) Given the high rates of morbidity for such disorders among people with high EA, we will not based on past diagnoses for any of those disorders or based on current drug and alcohol use. However, we will individuals who do not pass a urine toxicology screen during either of the functional magnetic resonance imaging (fMRI) sessions to ensure that the neuroimaging data are as homogeneous and reliable as possible Participants who cannot undergo an MRI scan will be excluded; contraindications metal implants (e.g., braces, pins) or metal fragments, pacemakers or other electronic medical implants, claustrophobia, pregnancy, and weight greater than 550 lbs. Beyond these participants will be recruited without exclusions based on gender, race, or ethnicity, so our sample will reflect the diversity in the local population (Lane County, Oregon) with regard to gender, race, and ethnicity | 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, End-Stage Renal Disease ESRD patients who need urgent-start dialysis(Urgent-start dialysis is defined as ESRD patients who required initiation of dialysis in 2 weeks without pre-established functional vascular access or a PD catheter.) patients who signs a informed consent form patients with severe volume overload with pulmonary edema patients with hyperkalemia (>6.5 mmol/L) patients with uremia encephalopathy patients with severe risk of bleeding or hemorrhagic disease patients with severe hepatic failure patients with contraindications of PD including extensive peritoneal fibrosis adhesion, severe skin disease, extensive abdominal infection or extensive abdominal burns, uncorrectable mechanical problems such as herniation of the umbilicus, herniation of the abdomen, bifida of the bladder, valgus of the peritoneum, peritoneal cavity and chest leakage patients with Intracranial hemorrhage or increased intracranial pressure patients with uncorrectable shock patients who cannot establish a vascular access patients with malignancy | 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): 12.0-999.0, Atypical Hemolytic Uremic Syndrome (aHUS) Male or female ≥ 12 years of age and weighing ≥ 40 kg at the time of consent. 2. Evidence of thrombotic microangiopathy, including low platelet count, hemolysis (breaking of red blood cells inside of blood vessels), and decreased kidney function. 3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study drug. Participants who received a meningococcal vaccine less than 2 weeks before initiating ravulizumab treatment must have received treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Participants who had not been vaccinated prior to initiating ravulizumab treatment should have received prophylactic antibiotics prior to and for at least 2 weeks after meningococcal vaccination. Participants < 18 years of age must have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to national and local vaccination schedule guidelines. 4. Female participants of childbearing potential and male participants with female partners of childbearing potential had to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 deficiency (activity < 5%). 2. Shiga toxin-related hemolytic uremic syndrome. 3. Positive direct Coombs test. 4. Pregnancy or breastfeeding. 5. Identified drug exposure-related hemolytic uremic syndrome (HUS). 6. Bone marrow transplant/hematopoietic stem cell transplant within last 6 months prior to start of Screening. 7. HUS related to known genetic defects of cobalamin C metabolism. 8. Systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome. 9. Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage kidney disease) | 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): 65.0-999.0, Clostridium Difficile Infection Prophylaxis Vancomycin "High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists Selected antibiotics fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem Failure to meet all three requirements for "high risk" Vancomycin allergy Active clostridium difficile infection prior to Prophylactic oral vancomycin prior to study (i.e. prolonged vancomycin taper) Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin) Pregnant or breastfeeding | 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, Invasive Breast Carcinoma Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma STEP 1 Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR) and HER2-negative (triple-negative, TNBC) or ER-, PR weakly positive and/or HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2-positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2-negative and HER2-equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weakly ER or PR positive disease, defined as ER and/or PR less than or equal to (=<) 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) observed on pathologic exam NOTE: If the ER and/or HER2 results are discordant between the initial, pre-chemotherapy, and post-chemotherapy surgical tissue, the receptor status of the residual disease has to be used to determine eligibility. Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast to be eligible Patients must not have metastatic disease (i.e., must be clinically M0 or Mx; systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network [NCCN] and ASCO guidelines); patients must not have locally recurrent disease It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response; complete axillary lymph node dissection (ALND) after neoadjuvant chemotherapy is recommended in the following situations Patients had documented pathologic involvement of the axillary nodes (fine needle aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s) Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy | 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, Advanced Head and Neck Squamous Cell Carcinoma Lung Non-Small Cell Carcinoma Metastatic Lung Non-Small Cell Carcinoma PD-L1 Positive Recurrent Head and Neck Squamous Cell Carcinoma Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Unresectable Lung Non-Small Cell Carcinoma Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at the time of study treatment initiation Have pathologically confirmed diagnosis of NSCLC (Phase I, Phase II Studies A, C and Expansion Cohort AE) or squamous cell head and neck cancer (Phase II Study B) Must be eligible for treatment with nivolumab as standard of care (for nivolumab treatment groups only) Phase II Study A and Expansion Cohort AE: Patients with advanced (metastatic) NSCLC, whose disease progressed during or after platinum based therapy Phase II Study B: Patients with advanced recurrent head and neck squamous cell carcinoma Phase II Study C: Patients with unresectable NSCLC with PD-L1 expression >= 50% for first line therapy in advanced stage. In the rare event that there is a discrepancy in the results of PD-L1 testing (i.e. 2 or more specimens were tested, etc.), status will be per the discretion of the principal investigator (PI) after review of other available biomarker testing NSCLC patients in study A and expansion cohort AE with EGFR or ALK genomic tumor aberrations (determined through either tissue or liquid biopsy-based platform) should have disease progression on Food and Drug administration (FDA)-approved therapy for these aberrations prior to receiving nivolumabanti-PD1 therapy; patients with smoking history being considered for Study C may enroll and be treated pending results of molecular testing Have at least 6 month life expectancy Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug Previous anti-PD1 or PD-L1 immunotherapy is not allowed; treatment with other investigational agents within 6 half-lives of first administration of study drug is not allowed Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis; subjects must have recovered from all radiation related toxicities Active/untreated brain metastasis; whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug; previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy Leptomeningeal involvement regardless of treatment status Tumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such targeted therapy History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment; steroids for endocrine replacement or receipt of short-course of steroids during the preceding 4 week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Has known immunosuppressive disease (e.g. human immunodeficiency virus [HIV], acquired immune deficiency syndrome [AIDS] or other immune depressing disease); testing is not mandatory | 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 Expected duration of admission sufficient to complete screening and enrollment 2. Age ≥18 3. Able to give informed consent 4. Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin 5. Maximum expected duration of antibiotics 8 weeks 6. Able to take oral study medications 7. Able to provide a stool sample during hospitalization or within 3 days of discharge 8. Reasonably expected to be able to complete follow up Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness 2. CDI within prior 90 days 3. Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile 4. Current diarrhea 5. Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut 6. Pregnancy or breast feeding (determined prior to randomization) 7. Travel to an area of endemic diarrheal illness within the last 30 days 8. Life expectancy of less than 60 days 9. Known allergy to vancomycin 10. Participation with other research trials that could impact the results of this trial within the last 30 days 11. Previously enrolled in this study | 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): 2.0-21.0, Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia T Acute Lymphoblastic Leukemia For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 Direct bilirubin =< 2.0 mg/dL Shortening fraction of >= 27% by echocardiogram Known history of chronic myelogenous leukemia (CML) ALL developing after a previous cancer treated with cytotoxic chemotherapy Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation Down syndrome Pregnancy and breast feeding Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib | 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, Subarachnoid Hemorrhage, Aneurysmal Aneurysmal Subarachnoid Haemorrhage Patient in Neurosciences Critical Care Unit Patient likely to survive for at least 24 hours Patient unsuitable for microdialysis monitoring bleeding diathesis thrombocytopaenia (platelets < 100 x 10e9 per litre) 2. Non-survivable brain injury i.e. patient not expected to survive more than 24 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, Kidney Failure, Chronic Age over 18 years old Patients who diagnosed as ESRD with hemodialysis Fixed hemodialysis cycle (average 3 times a week) Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) Agree to sign the informed consent form Taking antibiotics or antifungal drugs within 30 days before the study Have serious allergic reaction to skim milk powder Researcher are not sure whether the subjects are willing or able to complete the study Subject participated in other research projects within two months before the study | 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, Osteomyelitis Diabetes Amputation Age 18 and 89 years 2. Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days > 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years 3. Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). must be present at some point within 90 days prior to enrollment. 4. All planned debridement has been completed prior to randomization. 5. A course of backbone antimicrobial therapy has been selected Patient unable to receive enteral medication. 2. Patient is allergic to or intolerant of rifampin. 3. Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk. 4. Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer. 5. Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C. 6. Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained. 7. Patient has an ALT > 3 times the upper limit of normal for the site laboratory, or total bilirubin > 2.5 times the upper limit of normal for the site laboratory*,***; INR > 1.5, OR patient has Child-Pugh Class C Cirrhosis. 8. Patient has a baseline white blood cell count (WBC) <2000 cells/mm3 OR platelet count <50,000 cells/mm3** OR hemoglobin <8.0 g/dL.**,*** 9. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test. 10. Patient is believed unlikely to be able to complete the trial due to medical conditions. 11. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses. 12. Patient refuses or is clinically unable to undergo the recommended level of debridement. 13. Indwelling hardware present in the foot, at the site of the index osteomyelitis. 14. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days. 15. Patient is receiving therapy for COVID-19 that interacts with rifampin Patients with total bilirubin > 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary may be considered for in the study Patients with platelet count <50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary may be considered for in the study If multiple laboratory values are available, the most recent value will be applied for eligibility | 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): 18.0-60.0, Allergy birch pollen allergy history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation | 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, Endstage Renal Disease Age 1. ≥45 years or 2. ≥18 with a history of diabetes 2. On dialysis ≥ 90 days 3. On either 1. Hemodialysis prescribed at least 2 treatments per week or 2. Peritoneal dialysis prescribed with at least 1 exchange daily 4. Provides informed consent Hyperkalemia 1. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or 2. Serum potassium >6.0 mmol/L during active run-in 2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone). 3. Known sensitivity or allergy to spironolactone 4. Current or planned pregnancy or breastfeeding 5. Scheduled living related donor renal transplant 6. Life expectancy < 6 months in the opinion of a treating nephrologist. 7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone. 8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated | 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, Pneumonia Hospitalized in ICU Under mechanical ventilation Developing early-onset (during the seven days following hospital admission) pneumonia caused by Gram positive and/or Gram negative bacteria Having an augmented or normal renal clearance defined by a directly measured creatinine clearance, using MD-RD normal clearance: between 80 and 130 mL/min/1.73m² augmented clearance: more than or equal to 130 mL/min/1.73m² Having one or more risk factors of multi drug resistant bacteria antibiotic treatment in last 3 months high level resistance in the unit immunosuppression one or more pneumonia risks factors, whose one hospitalization of more than 48 hours in past 90 days living in medical care house chronic hemodialysis home based wound care resistant bacteria in the family environment Morbidly obese subjects (BMI>40 kg/m²) | 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, Vitiligo Diagnosis of non-segmental vitiligo affecting at least 10% of BSA since at least 3 months Patient requiring a treatment by UVB For both female of childbearing potential and male patients: Use of an effective contraceptive method during the study period (see Annex 5 for details) Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted Able to adhere to the study visit schedule and other protocol requirements Patient registered to the French Social Security Segmental or mixed vitiligo 2. Other than vitiligo, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease. 3. Any condition which would place the subject at unacceptable risk if he/she were to participate in the study. 4. Any condition that confounds the ability to interpret data from the study. 5. Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception) 6. History of allergy to any component of apremilast 7. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease) 8. Active substance abuse or a history of substance abuse within 6 months prior to Screening 9. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening. 10. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence) 11. Evidence of skin conditions that would interfere with clinical assessments 12. Topical therapy within 2 weeks of randomization 13. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources 14. Prior treatment with apremilast 15. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA) 16. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, 17. Patients assessed to be uncooperative 18. Participants in other clinical studies 19. Vulnerable people: pregnant or breast-feeding women (an urinary pregnancy test will be realized in every visit), minors, adults under guardianship or guardianship, deprived of freedom 20. Patient with a rare hereditary disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome 21. Patient with severe renal insufficiency | 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, Hemodialysis Catheter Infection Hemodialysis patients with a dialysis catheter signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection Informed consent signed to be enrolled in the study Patient with identified cause of fever other than CRBSI | 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, Shock Adult patients aged ≥18 years a NEWS≥3 requiring a trolley • <18 years | 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, Pneumonia ICU patients with diagnosis of pneumonia patients with abdominal infections such as c diff | 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): 18.0-70.0, Psoriatic Arthritis Diagnosis of psoriatic arthritis according to the Classification for Psoriatic Arthritis (CASPAR criteria) Presence of active peripheral psoriatic arthritis defined as ≥ 3 swollen joints Methotrexate (≥ 15mg/week (maximal tolerable dosage)) for a minimum of 3 months prior to study inclusion Other inflammatory rheumatic diseases than PsA Current axial disease activity or severe peripheral joint activity demanding immediate change of treatment or contraindicating placebo treatment for 6 months History of severe MTX toxicity or allergic reactions Current biological treatment and biological treatment within the last 6 months Inflammatory bowel disease, celiac disease, food allergy, or other intestinal diseases Current cancer or severe chronic infections Pregnant or breastfeeding women Systemic and/or local intra-articular or peritendinous steroid injections within 3 months of inclusion Non-MTX DMARD treatment within three months of inclusion Antibiotics within 3 months of 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): 18.0-110.0, Vasospasm, Intracranial Subarachnoid Hemorrhage patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence patients under the age of 18, excluding minors from 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): 18.0-80.0, Ventilator Associated Pneumonia Infection Trauma adults >18 and < 80 years oldmultitrauma patients with at least two organ-system injury intubated immediately after injury likelihood that the patient would require mechanical ventilation with an endotracheal tube (or tracheostomy) for >10 days life expectancy > 15 days investigators unable to obtain informed written consent from patients' relatives administer the first dose of the study drug within 24 hours of intubation pregnancy; lactation; immunosuppression; hematologic disease; prosthetic cardiac valve or vascular graft; cardiac trauma; history of rheumatic fever, endocarditis, or congenital cardiac abnormality; oropharyngeal mucosal injury; recent history of sinusitis and respiratory tract infection obesity [BMI > 40] administration of antibiotics for > 3 days before recruitment into the study administration of probiotics before recruitment into the study history of infection from Hepatis B or C and HIV administration of < 90% of the predicted doses of probiotics during the study period | 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, Peritoneal Dialysis Quality of Life patients on either CAPD or CCPD and had both residual renal (RR) Kt/V ≥ 1.0 and total Kt/V values ≥ 1.7 patients who did not meet the values of RR Kt/V and total Kt/V specified above | 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): 18.0-70.0, Cervical Cancer criteria. 1. Patients who give their written consent to participate in the study. 2. Women, 18-70 years of age, considering the following • In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT). ii. The patient must accept the use of any contraceptive method approved by the attending physician during the study and 12 weeks after the end of treatment. • Postmenopausal women must meet at least one of the following parameters for i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age < 60 years, with amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal parameters. 3. Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm. 4. With histologic confirmation of squamous carcinoma, adenosquamous carcinoma, adenocarcinoma or glassy cells carcinoma. 5. Without previous treatment and medically able to receive gemcitabine. 6. Disease measurable by CT and/or MRI according to (v1.1) criteria. 7. Functional status of 0-3 according to WHO criteria. 8. Renal dysfunction defined by glomerular filtration (GF) <60 ml/min/1.73m2 calculated by the CKD-EPI formula. 9. Normal hematologic and liver function, as defined by the following parameters Hemoglobin > 10g/L. (Transfusion prior to the treatment is allowed to reach this level of hemoglobin) Leucocytes > 4000/mm3 Platelets > 100,000/mm3 Total Bilirubin ≤1.5 times the upper normal limit (UNL) Transaminases < 1.5 times the UNL. 10. Normal PA chest radiograph 1. Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma. 2. Patients with diabetes and/or hypertension with retinopathy or albuminuria >300. 3. Patients with evidence of active TB infection. 4. Patients infected with Human Immunodeficiency Virus (HIV). 5. Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage. 6. Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis. 7. Patients with uncontrolled intercurrent diseases including active infections that contraindicate QT, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, decompensated diabetes, difficult control hypertension and psychiatric illness. 8. Concomitant treatment with other experimental drugs. 9. Social, family or geographical conditions that suggest a poor adherence to the study. Study discontinuation criteria. 1. Evidence of disease progression, if the researcher considers that the patient would benefit more with other therapy. 2. At the request of the patient. 3. By unacceptable toxicity. 4. Pregnancy. Violation of starting criteria. must be followed punctually. If a patient were inappropriately included, she must be discontinued from the 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): 45.0-70.0, Osteoarthritis, Knee Clinical and radiological osteoarthritis of the knee and referred to physiotherapists. 2. Symptomatic daily during the last month. 3. Symptomatic for more than one year. 4. Able to walk up and down a flight of 10 stairs with or without walking aids. 5. Able to walk 3 stairs up and down without walking aids. 6. Understand Norwegian orally and in writing. 7. Body mass index below 35 Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain. 2. Body mass index above or equal to 35. 3. Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee. 4. Chronic generalized pain (American College of Rheumatology 2010). 5. Inability to understand Norwegian language | 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, Multiple Sclerosis Myelopathy of any cause with finger extension weakness Patients with peripheral neuropathy with finger extension weakness Healthy controls Pregnant subjects | 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, Hepatitis C Age > 18 years, male or female 2. Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking. 3. Able to provide written agreement (or witnessed in the case of patients who cannot read and write) 4. Have a diagnosis of hepatitis C (based on a hepatitis C point-of-care test and then confirmed by PCR) with or without HIV Additional for PK sub-study 1. HIV well-controlled on current therapy (co-infected patients only) 2. Willing and able to comply with the additional blood sampling in the PK-PD sub-study protocol for the duration of the study Current pregnancy (pregnancy test to be performed in women of child-bearing age) 2. Previous HCV therapy. 3. HCV PCR negative 4. Patients with significant renal impairment with Cr Cl < 50 ml/min. 5. Known hypersensitivity to any part of the drug regime. 6. Presence of significant comorbidity with life expectancy of less than 12 months. 7. Clinical evidence of decompensated cirrhosis with current or previous episode of ascites, variceal bleed, encephalopathy, and treated hepatocellular cancer (HCC) [Child-Pugh score B or C]. 8. Presence of concomitant medical or social situation that would make it difficult for the patient to comply with program protocol or put the patient at additional risk 9. Concomitant medications that cause unacceptable drug-drug interactions. Additional for PK sub-study 1. Anaemia (Hb <100 mg/L) | 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, Non Small Cell Lung Cancer NSCLC Non-small Cell Lung Cancer Small Cell Lung Extensive Stage Cohort A: Histologically confirmed stage IV squamous NSCLC Cohort B: Histologically confirmed extensive stage SCLC Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and for sequence and immunological analysis Measurable disease by 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions At least 18 years of age on the day of signing informed consent Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Normal bone marrow and organ function as defined in the table below within 10 days of study entry Absolute neutrophil count (ANC): ≥1500/µL Platelets: ≥100 000/µL Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks) Cohort A: Received any prior systemic therapy for cancer treatment Cohort B: May not have received more than one cycle of platinum doublet given with or without an anti-PD-1 or anti-PD-L1 immunotherapeutic Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline from adverse events due to previous therapies). Patients with ≤Grade 2 neuropathy may be eligible. Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment Received prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease Patients may not receive or have received any radiation therapy at the biopsy sites Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has had an allogeneic tissue/solid organ transplant Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone daily or any other form of immunosuppressive therapy within 7 days prior to Day 1 Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent Prior treatment with a cancer vaccine | 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, Clostridium Difficile Infection At screening has suspected or confirmed CDI, and is receiving or is planning to receive a 10 to 21-day course of antibacterial drug treatment for CDI At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees to follow contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study treatment Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary Has an uncontrolled chronic diarrheal illness Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days At screening has received any listed prohibited prior and concomitant treatments and procedures Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins Has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period | 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 Cohort 1 1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of study drug, and have completed their SERES-012 Week 8 visit. 2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment. 3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool test, and assessment by the investigator that the clinical condition of the subject warranted treatment. Cohort 1 Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. 2. Known or suspected toxic megacolon and/or known small bowel ileus. 3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable. 4. Absolute neutrophil count of <500 cells/ml3. 5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted). 6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months. 7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor). 8. Any history of fecal microbiota transplantation (FMT). Cohort 2 1. Subjects 18 years of age or older who had one or more CDI recurrence (as confirmed by a C. difficile stool toxin test) within 12 months and have responded to a course of standard of care antibiotic treatment. 2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment. Cohort 2 (all Cohort 1 [#1-8 above] plus the below addition criterion) 9. Previously enrolled in a Seres Therapeutics clinical study | 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, Clostridium Difficile Infection Age 18 years and older Any history of Clostridium difficile infection based on a positive Clostridium difficile stool test performed at a lab affiliated with Rochester Regional Health System or patient report A new in-patient admission, with an antibiotic treatment plan for greater than 48 hours Documented allergy and/or adverse drug reaction to vancomycin Pregnant Patients who are admitted with a current episode of Clostridium difficile infection Patients with total colectomy | 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): 12.0-999.0, Thrombotic Microangiopathies Atypical Hemolytic Uremic Syndrome Competent to provide informed consent, or if a minor, have at least one parent or legal guardian to provide informed consent with written assent from the subject Are at least 12 years old at screening (Visit 1) Have a clinically diagnosis of primary atypical hemolytic uremic syndrome (aHUS), with activity greater than 5% in plasma Plasma therapy-resistant aHUS patients must have a screening platelet count less than 150,000/uL, evidence of microangiopathic hemolysis, and serum creatinine greater than upper limit of normal Plasma therapy-responsive aHUS patients must have documented history of requiring plasma therapy to prevent aHUS exacerbation and received plasma therapy at least once every 2 weeks at an unchanged frequency for at least 8 weeks before first dose of OMS721 Have STEC-HUS, a direct positive Coombs test, history of hematopoietic stem cell transplant, and/or HUS from an identified drug History of vitamin B12 deficiency-related HUS, systemic lupus erythematosus, and/or antiphospholipid syndrome Active cancer or history of cancer (except non-melanoma skin cancers) within 5 years of screening Have been on hemodialysis or peritoneal dialysis for greater than or equal to 12 weeks Have an active systemic bacterial or fungal infection requiring systemic antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed) Baseline resting heart rate less than 45 beats per minute or greater than 115 beats per minute Baseline QTcF greater than 470 milliseconds Have malignant hypertension (diastolic blood pressure [BP] greater than 120 mm Hg with bilateral hemorrhages or "cotton-wool" exudates on funduscopic examination) Have a poor prognosis with a life expectancy of less than three months in the opinion of the Investigator Are pregnant or lactating | 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, End-Stage Renal Disease End stage renal disease patients on regular hemodialysis Patient known have ischemic heart disease (coronary artery disease) Pregnant women Patient who have impaired liver function or hepatitis VIRUS positive Patient who HIV positive and patient currently use of GUM Arabic | 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): 18.0-111.0, Acute Upper Gastrointestinal Bleeding Tumor Bleeding Patients with overt signs of acute upper GIB (melena, hematemesis, drop in hemoglobin with or without hypotension) documented bleeding lesions suitable for standard endoscopic treatment during endoscopy without a full informed consent from the patient or his legally-acceptable representatives Age <18 years Pregnant Lactating women Moribund patients not considered for active treatment | 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): 18.0-60.0, Thyroid Cancer Parathyroid; Absent Hypocalcemia Hypoparathyroidism Postprocedural Thyroid cancer patients undergoing thyroid cancer surgery Preoperative examination were all ready for surgery Diagnosed with thyroid cancer by fine needle puncture before surgery Patients enrolled into another clinical study Pregnant patients Patients diagnosed with another life-treating disease Patients with surgical contraindication | 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, Hemorrhagic Stroke The will be as follows: 1. patients with a first time intracerebral (either cortical or subcortical) hemorrhage with unilateral hemiparesis/ hemiplegia confirmed by magnetic resonance imaging or computed tomography; 2. patients with no contraindications to being mobilized (early intervention) within 24 hours of stroke onset (based on the medical team's clinical judgment: including systolic blood pressure (SBP)<160mmHg in resting; resting heart rate (HR)<130 bpm; no hydrocephalus; 80< mean arterial pressure (MAP)<110 mmHg before intervention); 3. patients with National Institutes of Health Stroke Scale (NIHSS) scores at admission ranging from 1 to 20; 4. patients with total activity of living independence pre-stroke; and 5. patients between 20 and 80 years old. The will be as follows: 1. patients with mild to moderate deficits as described above (3); 2. patients who are unable to complete the baseline survey because of serious aphasia, language difficulties, or cognitive deficits; 3. patients with other medical conditions, such as severe heart failure, acute coronary syndrome, or lower-limb disorders, that prevent early mobilization; and 4. patients who are unable to provide informed consent. In addition, we will those showing rapid early deterioration of symptoms, as well as those with a concurrent diagnosis of rapidly deteriorating disease (e.g., terminal cancer) | 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, Acute Heart Failure ED physician clinical diagnosis of AHF; 2. Planned admission for AHF 3. Systolic blood pressure > 100mmHg, heart rate < 115bpm* 4. Previous history of HF *Patients with atrial fibrillation but controlled HR are eligible For Caregiver Burden assessments. The for a caregiver: 1) person either self-identifies, or when asked identifies themselves, as the primary caregiver for the patient. If there are multiple caregivers, the person who self-identifies as providing the most care will be asked to provide verbal informed consent. 1. Transplanted organ of any kind or ventricular assist device patient; 2. End stage renal disease, on dialysis, or eGFR < 20 mL/min; 3. Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS); 4. Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay; 5. Patients who require ventilatory support of any kind or intravenous vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an intravenious vasodiolator, but are no longer on this medication, are eligible. 6. Pregnant patients or any patient who has been pregnant in the last 3 months 7. < 18 years of age 8. Any patient who in the opinion of the clinician or investigator requires hospitalization or ICU level care or will require rehabilitation or skilled nursing after discharge from the ED or hospital 9. Planned discharge from the emergency department 10. Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible. 11. De Novo (new Onset) AHF | 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, Atypical Hemolytic Uremic Syndrome Willing to provide written informed consent and to comply with the study requirements 2. Age 18 years or older 3. Clinical diagnosis of primary aHUS 4. Clinical thrombotic microangiopathy (TMA) activity 5. Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception 6. Previously vaccinated with meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine or willingness to receive these vaccinations 7. >10% or other proven aHUS-associated mutation Clinically significant abnormal laboratory results 2. Positive Shiga toxin producing Escherichia coli test at Screening 3. Suspected secondary aHUS, in the opinion of the Investigator (unless there is a documented aHUS-associated genetic mutation) 4. Positive direct Coombs test 5. Patients who have received hemodialysis for >3 months 6. Bone marrow transplant recipients 7. Organ transplant recipients, except for kidney transplant recipients with primary aHUS (confirmed by known genetic mutation and kidney biopsy) 8. Known history or evidence of systemic lupus erythematosus or antiphospholipid antibody syndrome 9. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc 10. Malignancy (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years 11. Patients with a poor prognosis that is expected to limit their life expectancy to less than 3 months, in the opinion of the Investigator | 0 |
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