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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): 18.0-999.0, Administration of Antibiotics in Intensive Care Units The patient (or his/her "trusted representative") must have given his/her informed and signed consent Antibiotic treatment is administered with beta-lactams or glycopeptides administered continuously or intermittently (Can be of the following: Amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin G, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; Vancomycin, teicoplanin) A vein or artery catheter is established to facilitate blood sampling (arterial catheter is preferred) None of the above-mentioned antibiotics are administered Impossible to establish venous or arterial catheter Consent not given Patient is pregnant, parturient or breastfeeding The patient is under tutorship or curatorship The patient is participating in another 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 Associated Diarrhea Male and female patients 18 years of age or older 2. Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA). 3. Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible) 4. Greater than 3 watery or unformed bowel movements in the prior 24 hours 5. Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures. 6. Patients should not consume alcohol at least 12 hours prior to dosing (i.e. in-house monitoring) and until 48 hours after the last dose of drug administration (until Day 14). 7. Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives 2. Life expectancy ≤ 60 days 3. Sepsis, severe sepsis, or septic shock 4. Signs or symptoms of peritonitis, megacolon or ileus 5. History of ulcerative colitis or Crohn's disease 6. Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs effective in treating DCAD (e.g., bacitracin, fusidic acid) within the 1 week prior to enrollment 7. Recent history of significant drug or alcohol abuse within 1 year 8. Any findings on physical examination, medical history, 12-lead ECG or clinical laboratory tests which, in the judgment of the Principal Investigator, would patients from participating in the study 9. Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system 10. Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 11. Pregnant or lactating female patients 12. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated 13. Unable to participate in the study for any reason in the opinion of the Principal Investigator | 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, Diarrhoea, Clostridium Difficile C. difficile-associated diarrhea at the time of enrollment years old and up Ability to take oral medications Negative urine pregnancy test for women of childbearing age Must have the ability to understand and the willingness to provide a written informed consent to participate in the study History of known allergy to silicates Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation Patients with hypotension (systolic blood pressure < 90 mm Hg) or septic shock requiring pressors Patients with other known causes of diarrhea or colitis Pregnancy or lactation History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up Participation in any other study where the subject is actively taking investigational medication within the last 30 days More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current C. difficile diagnosis. Administration of metronidazole or oral vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of C. difficile Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of C. difficile prior to or added to the subject's standard-of-care treatment regimen. Use of intravenous vancomycin is not exclusionary | 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): 21.0-999.0, Stage 5 Chronic Kidney Disease Hemodialysis Peritoneal Dialysis All chronic HD and PD patients who are on regular follow-up with nephrologists in the NUH outpatient renal or PD clinic, and who meet the following will be included in the study: male or female 21 years of age or older, with stage 5 CKD (eGFR <15 ml/min/1.73m2) and have been receiving HD or PD for at least 3 months Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Antibiotic Associated Diarrhea Clostridium Difficile Associated Diarrhea years of age or older admitted to SSH and prescribed antibiotics for an expected duration >3 days (may patients on antibiotics prior to admission) History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC <1000, AIDS/CD4 count <200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries | 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, Intracerebral Hemorrhage Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms Admission to the Neuro-ICU Baseline hematoma >15cc with or without IVH Need for mechanical ventilation GCS <6 Age <18 years Pregnancy Pre-morbid modified Rankin Scale (mRS) >2 Do Not Resuscitate (DNR) order "prior" to enrollment Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding [UGIB/LGIB]) Planned surgical decompression within 24 hours Secondary causes of ICH (ischemic stroke, coagulopathy [INR>1.4, aPTT> 1.5 times baseline, thrombocytopenia platelets <100,000/uL], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes) Evidence of sepsis Spontaneous hypothermia (core Temperature <36C) | 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): 20.0-75.0, Infection Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division Patients with SIRS (systemic inflammatory response syndrome) Intravenous vancomycin therapy deemed necessary Age less than 20 years Age more than 75 years Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation History of adverse events to vancomycin 5. Pregnant woman | 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 Colitis years old or older male or female testing positive for c. diff Pregnancy Less than 18 yrs of age Those sick enough to require surgery at diagnosis Severe ileus or small bowel obstruction | 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, Bacteremia Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic 2. Completion of the KeyPathTM BTA Test on the sample. 3. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples Samples from blood culture positives over 24 hours from alarm 2. Samples deemed contaminated. 3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under 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, Renal Insufficiency, Chronic Age 18-80 years CKD stage III or IV (eGFR with the 4-variable Modified Diet Renal Disease (MDRD) prediction equation: 15-60 mL/min/1.73m2; stable renal function in the past 3 months) An elevated high sensitivity C-reactive protein (hs-CRP) of > 2.0 mg/L and <30 mg/L on at least 2 consecutive weekly determinations Urine protein excretion < 5.0 g/24h estimated by a spot urine protein/creatinine ratio Ability to provide informed consent Patients with advanced CKD requiring chronic dialysis Active infection (chronic or acute (within 3 months) or antibiotic therapy (w/in 1 mo); history of recurrent infection Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year Expected to undergo living related transplant in next 6 months History of severe congestive heart failure (i.e., EF < 35%) Hospitalization in the past month Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hsCRP or immune function Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months Known malignancy HIV, active, chronic hepatitis B as evidenced by HBsAg positive and HBsAb negative, or hepatitis C positive | 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 Colonisation Impact of Enteral Probiotics on Certain Lab Parameters Anticipated need for intensive care 3 days or longer Patients condition allowing enteral nutrition to be started within 24 h from ICU admission Antibiotics on-going or planned Known positive test for Clostridium difficile within the last week Known ulcers in the mouth, oropharynx, esophagus and stomach Known immune deficiencies Enteral nutrition contra indicated Pancreatitis as admission diagnosis at the hospital or at the ICU ICU admission earlier during this period of illness Patient being moribund | 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): 18.0-75.0, Clostridium Difficile Adult outpatients (age ≥18 and <75) referred to one of the study centers after suffering a third (or further) documented episode CDI and 2. who have failed to maintain CDI cure after standard therapy with oral vancomycin Previous treatment with at least one course of tapered/pulse dose vancomycin as per SHEA-IDSA C difficile treatment guidelines or -Inability to taper or stop vancomycin without developing diarrhea requiring anti-infective therapy. - Patients who are aged 75 years or greater Patients who are pregnant Patients who are nursing Patients who are incarcerated Patients with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving their own informed consent Patients who are immunocompromised specifically HIV infection (any CD4 count) AIDS-defining diagnosis or CD4<200/mm3 Inherited/primary immune disorders Immunodeficient or Immunosuppressed due to medical condition/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): 18.0-999.0, End Stage Renal Failure Neuropathic Pain All adult patients > 18 years old with end stage renal disease on dialysis and critical ischaemia defined as rest pain most days for >3 months Pre-dialysis Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Diabetic neuropathy resulting in a loss of sensation Lack of capacity or inability to provide informed consent Declines participation in 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): 18.0-999.0, Unspecified Adult Solid Tumor, Protocol Specific Must have a histologically or cytologically confirmed malignant tumor that is advanced, metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective Tumors must carry the BRAF mutation Prior therapies There is no limit to prior cytotoxic regimens No more than three prior regimens of tyrosine kinase inhibitors are allowed; prior use of pazopanib and/or inhibitor dabrafenib is not allowed; prior use of vemurafenib and sorafenib is allowed Patients must not have received systemic chemotherapy, immunotherapy, biologic therapy or radiation therapy within 4 weeks of study Adverse events related to prior tumor-specific therapy must have been resolved to =< grade 1 prior to study enrollment except for alopecia Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy greater than 12 weeks Absolute neutrophil count (ANC) >= 1.5 X 10^9/L; for patients (pts) with hairy cell leukemia, ANC >= 1 X 10^9/L is required Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to study enrollment Patients who are receiving any other investigational agents Patients with symptomatic, untreated brain metastases; patients who are on a stable dose of corticosteroids for more than 1 month or off corticosteroids for 2 weeks can be enrolled; enzyme-inducing anti-epileptic drugs are not permitted; screening with central nervous system (CNS) imaging (computerized tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated Patients with a known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency; patients with G6PD deficiency are excluded from clinical trials because they may develop nonimmune hemolytic anemia in response to dabafenib, which contains a sulfonamide, a potential risk factor for subjects with this deficiency Patients taking prohibited medications within 7 days of entering study will be excluded due to potential serious interactions with dabafenib; patients taking therapeutic doses of warfarin will not be allowed on the study due to potential drug interactions (patient on prophylactic low dose warfarin are allowed) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because dabrafenib is an investigational agent with unknown teratogenicity and because pazopanib belongs to pregnancy risk factor group D (adverse effects were observed in animal studies); because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dabrafenib and pazopanib, breastfeeding should be discontinued if the mother is treated with these agents Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are excluded because of possible pharmacokinetic interactions of highly active anti-retroviral therapy (HAART) with dabrafenib and pazopanib; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Poorly controlled hypertension (defined as systolic blood pressure [BP] >= 140 and/or diastolic BP >= 90) measured on more than one occasion and not responsive to antihypertensives; Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry and during study if required; BP must be re-assessed on two occasions separated by a minimum of 1 hour; on each of these occasions, the mean systolic (S)BP/diastolic (D)BP values (of 3 readings) must be < 140/90 mmHg in order for a subject to be eligible for the study Prolongation of heart rate-corrected QT interval (QTc) > 480 msecs (using Bazett's formula) | 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, Candidemia In the ICU for >2 days AND Systemic antibiotics on days 1-3 of ICU OR Central venous catheter on days 1-3 of ICU AND at least 2 of Total parenteral nutrition on days 1-3 of ICU Any dialysis on days 1-3 of ICU Major surgery in the 7 days before admission in the ICU Pancreatitis in the 7 days before admission in the ICU Use of corticosteroids for at least 3 days in the 7 days before admission Use of other immunosuppressive agents in the 7 days before admission in the ICU Antifungal for >3 days Allergy to an echinocandin | 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, Advanced or Metastatic Hepatocellular Cancer Advanced or Metastatic Ovarian Cancer Metastatic Renal Cell Cancer Advanced or Metastatic Gastric Carcinoma All Patients: 1. Able and willing to provide written informed consent and to comply with the study protocol and procedures. 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Life expectancy greater than 3 months in the Investigator's opinion. 5. Disease progression during or after previous cancer treatment. 6. Measurable disease as per Response Evaluation in Solid Tumours (RECIST) (v1.1). 7. The following time must have elapsed between previous therapy for cancer and first administration of tasquinimod At least 2 weeks since previous systemic targeted therapy with small molecule inhibitors, which included any tyrosine-kinase inhibitor At least 4 weeks since the last dose of systemic anti-cancer therapy other than targeted therapy, which included cytotoxic agents, monoclonal antibody therapy, immunotherapy and prior radiotherapy At least 1 week since prior hormonal therapy At least 3 months since prior interferon therapy. 8. Recovery to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies. 9. At least 4 weeks since any major surgery or open biopsy and 7 days since a core biopsy before first study treatment. 10. Adequate renal function Creatinine ≤1.5 times upper limit of normal (ULN) or calculated creatinine clearance (CrCl) using the Cockcroft Gault formula ≥60 mL/min, or CrCl ≥60 mL/min. 11. Adequate hepatic function Serum bilirubin ≤1.5 mg/dL (≤25 μmol/L) for ovarian carcinoma, renal cell carcinoma and gastric carcinoma, serum bilirubin ≤3 mg/dL (≤50 μmol/L) for hepatocellular carcinoma cohorts Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver lesions were present i.e. liver metastasis or primary tumour of the liver for hepatocellular carcinoma cohort). 12. Adequate bone marrow function Absolute neutrophil count (ANC) ≥1.5 x 10^9/L Platelets ≥50 x 10^9/L All Patients: 1. Other primary malignancy within the past 3 years (except for fully-resected non-melanoma skin cancer, localised prostate cancer with normal prostate specific antigen level, or cervical cancer in situ). 2. Known central nervous system metastasis that was symptomatic and/or required treatment. 3. Malabsorption (other than in patients with gastric carcinoma and partial or complete gastrectomy) or intestinal obstruction. 4. History of pancreatitis. 5. Essential medications that are known potent inhibitors or inducers of CYP3A4. 6. Ongoing treatment with CYP1A2 (including warfarin) or CYP3A4 metabolised drug substance with narrow therapeutic range at the start of study. Treatment with low molecular weight heparin (LMWH) was permitted. 7. History of myocardial infarction, unstable angina, congestive heart failure New York Heart Association class III/IV, cerebrovascular accident, transient ischaemic attack, limb claudication at rest in the previous 6 months, or ongoing symptomatic dysrhythmias, or uncontrolled atrial, or ventricular arrhythmias, or uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg. 8. Evidence of bleeding diathesis or known coagulopathy. 9. History of venous thromboembolic disease within 3 months prior to first administration of study treatment. 10. The patient had current, severe and uncontrolled medical condition such as infection, diabetes mellitus or other systemic disease. 11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would have compromised patient safety or interfered with the evaluation of the safety of the drug. 12. Had known positive serology for human immunodeficiency virus. 13. Investigational drug within 28 days or within five times the elimination half-life (whichever was longest) prior to first dose of study treatment. 14. Known allergy to treatment medication or its excipients. 15. Breastfeeding Hepatocellular Carcinoma Cohort: 16. Fibrolamellar carcinoma Ovarian Carcinoma Cohort: 16. Non-epithelial cancer and borderline tumours (e.g. tumours of low malignant potential) Gastric Carcinoma Cohort: 16. Other histologic type than adenocarcinoma | 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 Renal Failure APD patient ≥ 18 years Prevalent patient with at least 3 months experience on APD prior to Patient is trained on and being treated with the sleep•safe APD cycler Patient treated on APD exclusively with registered conventional PD solutions CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 or CAPD 19 for at least 8 weeks prior to Patient is on stable diuretic treatment e.g no change in diuretic treatment within the last 30 days prior to Informed consent signed and dated by study patient and investigator/authorised physician Ability to understand the nature and requirements of the study Peritonitis treatment £ 4 weeks preceding APD patients treated with IPD modality (intermittent peritoneal dialysis) Malignant disease without remission Patients with artificial joints, amputations, stents, or pacemaker Patients with congestive heart failure or coronary artery disease NYHA (New York Heart Association) III and higher Active HBV (hepatitis B virus)or HCV(hepatitis C virus)infection HIV positive Participation in an interventional clinical study during the preceding 30 days Any condition which could interfere with the patient's ability to comply with 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): 18.0-75.0, Pain Disorder Sensory Deficit Adults ASA physical status I-III BMI<30 No contraindications to study procedures Pediatric patients ASA physical status IV BMI>30 Contraindications to study procedures Hypersensitivity to local anesthetics | 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): 38.0-65.0, Gulf War Veterans Illness Neurobehavioral Manifestations Memory Disorders Participants were recruited from the participants in a Department of Defense (DoD) study of a longitudinal cohort of Gulf War Veterans who returned from their deployment in 1991 through Ft. Devens, MA. This cohort has been followed at multiple time points since the end of war (Proctor et al., 1998), and through the VA Informatics and Computing Infrastructure (VINCI)/Corporate Data Warehouse (CDW) database, with approval from NDS. The San Francisco VA Medical Center (SF VAMC) was a second site on the study (35 Veterans were run in Boston; 12 were run in San Francisco on the same protocol.) Those recruited from the VINCI/CDW database, resided within a 25 mile radius of the Boston VA Healthcare System (VABHS) or 25 miles of the SF VA Medical Center (VAMC). The Institutional Review Board at the VA BHS and the SF VAMC (University of California, San Francisco) approved the study. In accordance with the Declaration of Helsinki, Informed Consent and HIPAA authorization was obtained from all participants. Participants answered 'Yes' to the following questions: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information Must be a Veteran deployed in 1990-1991 Gulf War, in the Kuwait Theatre Meets for GWVI as defined by "Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998). Participants must have the presence of 1 or more chronic symptoms (lasting >6 months) from at least 2 of 3 symptom categories from Fukuda et al., (1998): 1) musculoskeletal (muscle pain, or joint pain, stiffness); 2) mood-cognition 3) fatigue Ages 38 years Must be physically able to travel to the VA Boston Healthcare System, Jamaica Plain or San Francisco VA Medical Center, for Neuropsychological testing and transcranial LED treatments Must meet screening from the Screening: The following Neuropsychological (NP) tests were administered at Screening: Trail Making Test A & B (Reynolds, 2002); Controlled Oral Word Association Test (COWAT (FAS); Spreen & Benton, 1977; Benton and Hamsher, 1989); California Verbal Learning Test II (Delis et al., 2000); Color-Word Interference Test (Stroop; Delis, Kaplan, Kramer, 2001). Additional screening tests included: Short Form McGill Pain Questionnaire (Melzac, 1984); Overall VAS current pain rating (0-10); and the PTSD Checklist Civilian (PCL-C, Weathers et al., 1994). Participants were required to score at least 2 SD below the standardized norm (age, education, gender) on at least 1 NP screening test or 1 SD below the standardized norm on at least 2 NP screening tests. The Word Reading Subtest from the Wide Range Achievement Test-4 (Wilkinson and Robertson, 2006) was used to estimate premorbid level of cognitive functioning. The SD for each participant on each NP screening test was adjusted by his/her estimated premorbid cognitive level. The Test of Memory Malingering (TOMM, 1996) was administered. Participants who failed Trial 2, or Trial 1 and 2 were excluded from the study. If a participant failed Trial 1, but did not fail Trial 2, he/she was not excluded if he/she showed evidence of poor learning on other NP screening tests such as the CVLT (Schroeder et al., 2013, Arch Clin Neuropsych) Participants were required to have a level of pain 7/10 or less on the VAS and less than 38/50 on the McGill pain questionnaires at screening, as pain has been shown to influence cognition (Moriarty et al., 2011, Review) Presence of a neurodegenerative disease such as ALS, Parkinson's, Dementia Presence of a life-threatening disease such as cancer Presence of a severe mental disorder such as schizophrenia, or bipolar depression (not associated with PTSD) Current substance abuse or active treatment within last 6 months | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-75.0, Peritonitis age >/= 18 years old ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks presence of symptom or sign of peritonitis presence of WBC >100cell/mm3 with PMN >50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010 hospital-acquired peritonitis presence of catheter-related infection history of peritonitis within 4 weeks currently taking antibiotic allergic to the antibiotic that used in the study(penicillin or cephalosporin or quinolone or aminoglycoside) | 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, Diarrhea Death Pneumonia All patients admitted in intensive care unit Age more than 19 Diarrhea occurence within 1 week of ICU admission Recent history of probiotics use (within 1 month) GI obstruction History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.) immunocompromized patients | 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, Gastroesophageal Reflux Disease Written informed consent; ≥ 18 years of age; GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following Total Number of Reflux Events ≥ 73/24h DeMeester Score ≥ 14.7 Positive Symptom Index SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction; ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia >2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification >II | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, Pruritus Patients w/ histologically confirmed mycosis fungoides stage IB to IVA eligible to receive oral vorinostat Patients w/ stage IB to IV reporting pruritus Patients age 18-85 years, of any race, sex, and ethnicity Life expectancy > 24 weeks Patient must have performance status of ≤2 on the ECOG Performance Scale Patients w/ a min. of 3 weeks since their last systemic treatment Women who are not pregnant, lactating, or of childbearing potential Female patients w/ reproductive potential must use an adequate contraceptive method during treatment and for three months after completing treatment Male patient w/ reproductive potential, agrees to use an adequate method of contraception for the duration of the study and for 30 days beyond the duration of study Patients, or legal representative must to be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study Patients w/ a recent cardiac history, such as a myocardial infarct within the last year, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities Patients w/ a history of liver damage (2.5 x normal ALT, AST), leukopenia, or thrombocytopenia Women who are pregnant or nursing a child Patients w/ severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen Patients who have received and histone deacetylase inhibitor within the last 6 months Patients receiving valproic acid will be excluded unless there has been a wash-out period of 30 or more days Patients who will have received systemic therapy, radiation therapy or phototherapy within 3 weeks prior to initial dosing with study drugs or who has not recovered from adverse events due to agents administered more than 3 weeks earlier QTc prolongation greater than 500ms Patient w/ a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse | 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): 22.0-75.0, Recurrent Urinary Tract Infection Patients 18 years old or older or more culture documented urinary tract infections in the preceding 12 months Patients who had not taken antimicrobials within 4 weeks and were not pregnant or contemplating pregnancy Patients with evidence of upper urinary tract infection, such as temperature higher than 38 °C, flank/lumbar pain or tenderness | 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): 6.0-999.0, Cystic Fibrosis Informed consent Affiliated or benefit from a disease insurance regimen Men and women Aged from at least 6 years old Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs Patients able to produce sputum Pseudomonas aeruginosa Chronic infected patients Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents Subjet in period Law protected patient Realisation of sputum production is contra-indicated | 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, Diarrhea A participant is considered eligible for participation in the trial if the following are satisfied on admission (Day 1, before randomization) to the hospital: 1. Participant is a male between 18 and 65 years of age inclusive 2. Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission) 3. Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline) 4. Dipstick test/Dark-field examination positive for Vibrio cholera 5. Written informed consent is provided 6. Participant is willing and able to comply with all trial requirements A participant who meets any of the following on admission (before randomization) to the hospital will not qualify for the study 1. Evidence or history of any clinically significant illness as per the Investigator's discretion. 2. Known case of HIV or Hepatitis B 3. History of cancer 4. Known renal disease 5. Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years 6. History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission 7. Concomitant infection requiring antimicrobial therapy 8. Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation 9. Clinically significant abnormal laboratory test results as determined by the investigator 10. Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device 11. History of seizure (including febrile seizure) or loss of consciousness; 12. History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis 13. For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee 14. Prior enrolment in this trial | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-49.0, Growth; Stunting, Nutritional Anemia Study participants will be women who are rural residents of Chirumanzu or Shurugwi districts in Zimbabwe and who become pregnant during the enrollment period of the trial and are identified and consent to participation during pregnancy, and their live born infants. A total of 5280 women will be enrolled. Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine pregnancy test Women residing in the study districts who become pregnant during the enrollment period but do not consent to join the trial Women who reside in urban areas of these two districts Infants with major non-fatal abnormalities will not be excluded from study procedures, but will be excluded from the final analytic sample if the abnormality is likely to directly affect gut health/function or stature (e.g. neural tube defects, cerebral palsy, Down 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): 19.0-999.0, Healthy Must be willing to sign informed consent Female in age groups 19-25 years old and 60 years or older Must be of Caucasian descent, to avoid any ethnic differences in hair biology or pigment among different races Must be willing to have a thorough scalp and hair shaft examination Must be willing to discuss current and past hair care regimens Must have washed hair at least 48 hours, but not less than 12 hours prior to study visit Must be willing to not wash hair between Baseline and second visit Pregnant and nursing females will not be allowed in the study; a baseline pregnancy test will be done to pregnancy on females of childbearing potential Must be >6 months (26 weeks) postpartum Must have sufficient contrast between scalp skin color and hair color (Fitzpatrick skin type I-IV) Must not have hypertension, diabetes, or any neurological disease since all these can affect scalp blood flow Must not take any antihistamines for two weeks prior to the baseline visit and throughout the study Must not have any known allergy or past history of anaphylaxis to histamine May not have sewn-in or glued hair pieces or extensions at the time of the study Must not cut hair during the study Must not have hair loss beyond what is considered normal in the opinion of the Investigator at the time of the study Must not color hair or have other salon-type procedures (relaxer, permanent, highlighting, etc.) performed within 2 weeks of the initial visit Must not have any other underlying scalp disorder that could interfere with the test procedures or findings Must not have lost ≥10% of body weight within the past 12 months Must not have been on a weight reduction program overseen by a physician or nutritionist within the past 12 months | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.5-999.0, Clostridium Difficile Infection Recipient 1. Older than 18 months of age 2. FMT procedure has been decided by the treating gastroenterologist and was based on: 1. Recurrent or relapsing CDI and Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for <18years and insurance authorization may not be possible) At least 2 episodes of CDI requiring hospitalization 2. Moderate CDI not responding to vancomycin for at least a week. 3. Severe CDI with no response to vancomycin after 4 hours. 3. English speaking Recipient Lack of informed consent/assent. 2. Not eligible for FMT procedure | 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 Cancer Aim 1 Discovery Phase: The samples are from a large NIH-funded Genome-wide association study of squamous cell carcinoma of the head and neck (Shete; PI). A total of 2900 "case" patients and 1200 control patients were recruited for the study. In this study, we will only use cases who were: a) Newly diagnosed, untreated, histopathologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx; b) No previous cancers; c) Age 18 years or older; d) white Caucasian. 2. Aim 2: a) Newly diagnosed patients (have not had any prior cancer treatment) with loco-regional squamous cell carcinoma of the head and neck, b) Will receive cancer treatment at MDACC or at Ben Taub, c) Are 18 years or older, d) English or Spanish speaking; e) Able to understand the description of the study and give written informed consent; f) Will state that they will receive follow-up at MD Anderson post-treatment or at Ben Taub. This sample will also be included in the Validation Phase of Aim 1. We note that population stratification, i.e., the presence of a systematic difference in allele frequencies between subpopulations in a population possibly due to different ancestry, is an issue for genetic association studies. 3. Aim 3: Patients included in aims 1 and 2 for Aim 2: a) Patients with distant metastasis (Stage IVC); b. Patients participating in clinical trials/ investigational drugs for pain control. Aim 1 (discovery phase) and Aim 3 will use existing 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): 18.0-999.0, Type 1 Diabetes Mellitus Male or female of age 18 years or older with a history of T1DM for at least 12 months 2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results 3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL) 4. Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant 5. Current treatment at the time of screening with insulin <300 units per day (U/day) 6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average CGM use 5 or more days per week over the preceding 3 months) and those who do not routinely used CGM are both eligible for in the study. Intermittent use of CGM is also acceptable but will not be a criterion use for stratified randomization. 7. Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol Type 2 diabetes 2. Known or suspected allergy to any component of any of the study drugs in this study 3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator 4. History of transmural myocardial infarction, congestive heart failure and uncontrolled hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury [mmHg]) are exclusionary 5. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures 6. History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant 7. As judged by the Investigator, clinically significant findings in routine laboratory data at screening 8. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis. 9. Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator. 10. Current addiction to alcohol or substance abuse as determined by the Investigator. 11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study. 12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Carcinoma Transitional Cell Patients with histologically or cytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation. 2. Documented disease progression (according 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting). 3. An interval of >4 weeks since last anticancer treatment. 4. Archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. The most recent archival tissue is mandatory. Recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions. 5. At least one measurable lesion by MRI or CT-scan 6. ECOG performance status 0-1, in stable medical condition 7. Patients must have adequate organ function: Hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,000/mm3, platelets ≥ 100,000/mm, INR ≤ 1.5, total serum bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or <5.0 x ULN if hepatic metastases are present), creatinine £1.5 x ULN, fasting plasma glucose <140mg/dl, HbA1c < 8%. 8. Patients must be over 18 years old and able to give written informed consent. 9. Signed informed consent prior to beginning protocol specific procedure Non TCC bladder cancer 2. More than 2 prior chemotherapy regimens given for palliation. 3. Concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer) 4. Patient with active uncontrolled or symptomatic central nervous system (CNS metastases). 5. Significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias. 6. Other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …) 7. Other concomitant anticancer therapy. 8. Previous therapy with PI3K and/or mTOR inhibitors (sirolimus, temsirolimus, everolimus) 9. Concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of CYP3A4 10. Pregnancy or risk of pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-14.0, Japanese Encephalitis Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal Asexual Plasmodium falciparum parasites in blood Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes Pregnant or breastfeeding females Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex | 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, Active C. Difficile Colitis Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin <3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB treatment with major immunosuppressive agents including prednisone >10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine >4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be >1 yr. - | 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, Differentiated Thyroid Cancer Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline Participants must have experienced progression within 14 months and be RAI-refractory/resistant or unsuitable for RAI Thyroid-stimulating hormone (TSH) suppression below 0.5 mU/L is required World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Negative pregnancy test (urine or serum) for female participants of childbearing potential Inadequate organ function as defined by: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x upper limit of normal (ULN), or greater than 5.0 x ULN if judged by the Investigator to be related to liver metastases. (2) Serum bilirubin greater than 1.5 x ULN. This criterion does not apply to participants with known Gilbert's Disease. (3) Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula) Risk of prolonged interval between Q and T (QT) on an electrocardiogram (ECG) corrected for heart rate (QTc) as defined by: (1) Current therapy with any medication known to be associated with Torsades de pointes or potent inducers of cytochrome CYP3A4. (2) History of QT prolongation. (3) Congenital long QT syndrome. (4) QT interval corrected for heart rate by the Bazett's method (QTcB) correction unmeasurable or greater than 480 ms on screening ECG Previous therapy with approved or investigational tyrosine kinase or anti vascular endothelial growth factor (VEGF) receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib) RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomization | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 30.0-70.0, End Stage Renal Disease Pre-transplant ESRD patients between the ages of 30 and 70 years who are listed for renal transplantation Able to sign pre-transplant consent on their own will Have english as their native language Current use of antipsychotics or anti-epileptics Inability to read or write which will limit their ability to perform the cognitive tests Claustrophobia or inability to get MRI for other reasons Unable to sign consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 16.0-60.0, Antiviral Treatment of Chronic Hepatitis B This study focused on the subsequential antiviral therapeutic strategies for chronic hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation. Patients fullfilled the following criterias were chosen for screening: They were antiviral treatment naı¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at least 6 months, were positive for HBeAg and had an HBV DNA Level of more than 500,000IU/ml. Their serum alanine aminotransferase level was greater than 2 but less than or equal to 30 times the upper limit of the normal range, their peak value of total bililubin ranged from 2mg/ml to 20mg/ml and the prothrombin time activity was greater than 60%. ALL of these patients were hospitalized and pretreated with anti-inflammation and liver protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of nucleoside. Their ALT、TBIL and PTA were monitor weekly and level were measured every two weeks. Patients were eligible if their declined spontaneously by 2 log(10) IU/mL while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of pretreatment. Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient | 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, Ovarian Epithelial Cancer Recurrent Fallopian Tube Cancer Primary Peritoneal Cancer Female patients ≥18 years of age 2. Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component 3. Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments) 4. Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment 5. Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal [ULN]; SD was defined as stable disease according to radiological response with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase >15% within a time frame >7 days if above the ULN 6. Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded 7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease >6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy) 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 9. Recovered from all chemotherapy-related toxicities to Grade 1 or Grade 0 according to the NCI-CTCAE Version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤Grade 2) 10. Adequate bone marrow and hepatic function at Screening Hemoglobin ≥9 g/dL White blood cell count ≥3.0 × 109/L Absolute neutrophil count ≥1.5 × 109/L Platelet count ≥100 × 109/L Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × ULN (<5 × ULN in case of liver metastases) Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases) Creatinine <1.5 × ULN 11. Any patient with childbearing potential (i.e. not surgically sterile or post-menopausal for >1 year) had to use highly effective contraceptives with a Pearl index <1% according to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals" (CPMP/ICH/286/95) of the European Medicines Agency (EMA). (Although pregnancy was unlikely to occur in this patient population, any patient with childbearing potential had to be withdrawn from the study in the event of pregnancy) 12. Life expectancy >3 months 13. Ability and willingness to give written informed consent Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen) 2. Progression-free interval of >12 months after the most recent antecedent platinum-based chemotherapy regimen 3. Concomitant anti-tumor therapy or immunotherapy 4. Treatment with monoclonal antibodies or investigational agents ≤30 days before randomization (prior anti-MUC1 therapy was not permitted at any time) 5. Limited-field radiotherapy ≤30 days before randomization (extensive prior radiotherapy during or following the last line of chemotherapy was not permitted; radiotherapy prior to the last line of chemotherapy was permitted) 6. Prior allergic reaction to a monoclonal antibody, Grade 3 IRR or any Grade 4 reaction to a monoclonal antibody 7. Known sensitivity to any component of the test product 8. Contraindication to the pre-medication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, or steroids) 9. Clinical evidence of brain metastasis or leptomeningeal involvement 10. Patients with second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years 11. Primary or secondary immune deficiency 12. Clinically active infections >Grade 2 using NCI-CTCAE version 4.0 13. Active hepatitis B or C or infection with human immunodeficiency virus (HIV) 14. Myocardial infarction within 6 months prior to Screening 15. Symptomatic congestive heart failure (New York Heart Association Grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening 16. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery 17. Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (steroids used for pre-medication were permitted) 18. Active drug or alcohol abuse 19. Any uncontrolled medical condition that could have put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease 20. Pregnancy or lactation 21. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons 22. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEX™ administration | 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, Stage II Breast Cancer Stage IIIA Breast Cancer Pre-Registration Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition No inflammatory breast cancer No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled Patients must have completed all planned neoadjuvant chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. anthracycline/cytoxan or taxane chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes * Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy * Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of 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, Clostridium Difficile Infection Subject is at least 18 years old. 2. Subject has recurrent or relapsing CDI defined as At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg. 3. Subject is willing and able to provide informed consent. 4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment Subject is pregnant. 2. Subject is unable to comply with study requirements | 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, End Stage Renal Disease Kidney Failure Home Dialysis Patient in the home dialysis program (PD and HHD)and on of the following Discharge from hospital following an inpatient admissions Medical procedure (e.g. vascular access procedure) Treatment with antibiotics Completion of home dialysis training program Decline consent Unable to participate (e.g. no phone at home, language barrier) | 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): 0.25-5.0, Acute Diarrhea children of both sexes aged between 3 and 60 months, with acute watery diarrhea lasting more than 12 hours but less than 72 hours, requiring hospitalization. Children with clinical signs of mild to moderate dehydration (prolonged capillary refill time, abnormal skin turgor and 3-9% percentage loss of body weight) clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit were excluded. Other were use of antibiotics or probiotics 1 month before admission, severe malnutrition and chronic underlying disease including immunocompromised conditions | 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, Clostridium Difficile Infection Age greater than 18 yrs and less than 75 years Undergoing a clinically indicated colonoscopy Known, active or recurrent colonic disease including: Clostridium difficile infection, inflammatory bowel disease, microscopic colitis, colon resection for any reason, ischemic colitis, recurrent diverticulitis, colon cancer. Note: Diverticulosis without recurrent diverticulitis, colonic adenomatous or hyperplastic polyps or colonic arteriovenous malformations will not constitute an Diarrhea (an average of more than 3 bowel movements per day at baseline) Constipation (an average of fewer than 2 bowel movements per week at baseline) Use of systemic steroid or systemic immunosuppressive medication Severe renal impairment Relative contraindication to colon biopsy including a bleeding diathesis or anti-coagulant use. Note: nonsteroidal antiinflammatory drug or asprin use will not constitute a contra-indication | 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, Severe Acute Respiratory Failure Admitted to an Intensive Care Unit due to respiratory tract infection Recent onset (within 7 days prior to ICU admission) of at least one of the following manifestations: dyspnea, fever (≥ 38°C, possible, probable or microbiologically confirmed respiratory tract infection Patients less than 18 years of age Patients in whom the pneumonia cough and dyspnoea have been present for over seven days Any patients who are on invasive (through an endotracheal tube) mechanical ventilation prior to admission for any reason other than general anaesthesia for surgical procedures Any patients previously included in the study during the same 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, BRAF V600E Mutation Present BRAF V600K Mutation Present Metastatic Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Study participants must have histologically or cytologically confirmed unresectable or metastatic malignant melanoma Study participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Study participants must have completed any prior treatment at least 3 weeks prior to treatment on this protocol; prior treatments may have included chemotherapy however may not have included BRAF or MEK inhibitors or immunotherapies (interleukin-2, ipilimumab, anti-programmed death [PD]1 antibodies etc.) excluding vaccine therapy; prior treatment with interferon in the adjuvant setting is allowed, though prior treatment with ipilimumab in the adjuvant setting is not; prior radiation therapy is allowed though must have included no more than 3000 centigray (cGy) to fields including substantial marrow Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count (ANC) >= 1.2 x 10^9/L Hemoglobin >= 9 g/dL Platelets >= 100 x 10^9/L Albumin >= 2.5 g/dL Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert's syndrome Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN Prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study Study participants with a history of prior treatment with BRAF or MEK inhibitors Study participants who had prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) Study participants who have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study Study participants with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody and/or anti-PD-1 antibody Study participants with brain metastases are excluded unless these have been definitively treated and are radiographically stable for at least 1 month; the study participant must also demonstrate a stable physical exam and must have discontinued systemic steroids for treatment of edema related to brain metastases or treatment for over 7 days | 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 Clostridium Difficile Infection recurrent or refractory CDI previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis) no informed consent no ability to provide informed consent immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent > 20 mg for 14d or longer) lack of appropriate donor pregnancy | 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 Infection age>18 years A negative pregnancy test at and a commitment to use contraception for a period of six months from the date of transplant At least one of the following conditions : 1. An evidence of Clostridium infection recurrence within 6 months after completion of antibiotic course acceptable, which will at least 10 days of treatment Bmtronidzol a total dose of 500 mg x3 per day and / or Bonkomitzin dose of at least 125 mg 4x a day . Recurrence of infection is defined clinical and laboratory ≥ 3 diarrhea per day for at least two days in a row or ≥ 8 loose stools a day for 48 hours a positive stool test for Clostridium Difficile toxin, or PCR / antigen detection. 2. First infection not responding to antibiotics (at least 10 days Metronidazole dosage of 1500 mg per day , or Bonkomitzin total dose of at least 500 mg per day). 3. A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole Participation in another clinical study Inability to provide informed consent A pregnant woman or breastfeeding Severe neutropenia below 500 neutrophils (blood counts) A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks) Status of SIRS or hemodynamic/respiratory instability Toxic Megacolon, ischemic colitis, Fulminant colitis or a higher than usual risk of colon perforatin during colonoscopy HBV infection or hepatitis C or HIV The use of antibiotics for the treatment of another disease at the time of inclusion | 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): 0.083-4.0, Diarrhea Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea Signed informed consent Acute gastroenteritis within 3 days before admission Symptoms other than diarrhea suggesting gastroenteritis Use of probiotics within 7 days before admission Immunodeficiency disorders Breastfeeding >50% Underlying gastrointestinal tract disorder Malnutrition (weight/high <3pc) | 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 Patients > 18 years of age 2. The patient has been treated with appropriate antimicrobial therapy for CDI. 3. The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay. 4. Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study Patients will be excluded from study participation if one of the following categories of applies: 1. Patient is < 18 years of age 2. Patient has an absolute neutrophil count < 750 cells/mm3. Stool donors must: 1. be > 18 years of age 2. Complete a screening questionnaire: a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2 3. Be tested for communicable blood-borne and enteric pathogens: 1. One-time donors: Table 3 2. Designated, pre-screened donors: Table 4 Table 1: Questionnaire to screen one-time stool donors prior to FMT. You have been identified as a potential stool donor by __________________ , your (spouse/ son/ daughter/ mother/ father/ life partner), who has been referred for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors: Your name: ___________________________________________ Date: ___/___/ 2013 Your relationship to the patient: ___________________________ YES / NO 1. Have you ever been diagnosed with Clostridium difficile colitis? 2. Are you currently taking antibiotic medications? 3. Have you been prescribed antibiotics in the past six weeks? IF the potential stool donor answers YES to questions 1, 2, or 3 please STOP. Do you have a history of any of the following: (Please Circle) Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 YES / NO Infectious gastroenteritis or diarrhea YES / NO Did you answer YES to any of the above? YES / NO Table 2: Questionnaire to screen designated stool donors prior to each FMT. You have been identified as a potential stool donor for a patient who has been referred to Saint Francis Medical Center for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors: Your name: ___________________________________________ Date: ___/___/ 2013 Your relationship to the patient: ___________________________ YES / NO 1. Have you ever been diagnosed with Clostridium difficile colitis? 4. Are you currently taking antibiotic medications? 5. Have you been prescribed antibiotics in the past six weeks? IF the potential stool donor answers YES to questions 1, 2, or 3 please STOP. Do you have a history of any of the following: (Please Circle) Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 YES / NO Infectious gastroenteritis or diarrhea YES / NO Did you answer YES to any of the above? YES / NO Table 3: Required stool donor screening laboratory studies prior to FMT Stool: Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay Blood: HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab Table 4: Laboratory studies every 120 days for designated stool donors Stool: Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay Blood: HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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, Acute Pancreatitis Diagnosis of pancreatitis Typical pain Increase in serum lipase or amylase Onset of abdominal pain within <=72h before admission 2. The diagnosis of Severe Acute Pancreatitis is according to Atlanta revisited in 2012 3. no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on 4. Age from 18 to 65 years old Besides above, the patient should also satisfied one of these CBP 1. Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine > 1.5 times baseline，26.5umol/L increase, or urine output < 0.5ml/kg.h for 6 hours 2. Systemic Inflammatory Response Syndrome: temperature >38℃ or<36℃；heart rate respiratory rate White blood cell count >12*10^9/L，or< 4*10^9/L 3. Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective Pregnancy 2. Chronic pancreatitis 3. Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell < 0.5*10^9/L for 10 days | 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): 18.0-100.0, Peritoneal Infection Patients > 18 years Hospitalized CAPD patients with Gram positive peritoneal infection : ISPD criterias Presence of two clinical signs and symptoms : abdominal pain, nausea, vomiting, diarrhea, fever and cloudy dialysate Peritoneal dialysate WBC>100/µL with at least 50% polymorphonuclear neutrophil cells Demonstration of bacteria on Gram stain or culture on peritoneal dialysis for at least 3 months written consent, obtained from either the patient, one of his/her relatives, the trusted person who was designated beforehand or, if not possible, emergency enrollment patient has a life expectancy greater than 6 months Known allergy to daptomycin Peritoneal infection with Gram negative only Patient with CPK>5UNL patients already treated with antibiotics, antifungals within 4 weeks prior to the event Patient with hepatic impairment Patient with arguments for an extra-peritoneal site of infection Patient with severe intercurrent illness (eg, hematologic malignancies, patients on chemotherapy) Infection by daptomycin-resistant germ HMGCoA reductase, fibrates or ciclosporin treatment Pregnant or breast-feeding women | 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, Kidney Transplantation adult patients, aged 18-75 years of age in receipt of first donor kidney eligible to receive immunosuppressive treatment comprising IRL2, CellCept, cyclosporine and steroids eligible to receive oral treatment from the first day post-transplantation patients receiving a second or subsequent kidney transplant, or multi-organ transplant history of malignancy in the last 5 years (except successfully treated squamous cell or basal cell cancer and cervical cancer in situ) patients with active hepatitis B and/or hepatitis C, or HIV infection | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, End-stage Renal Disease Hypertension end stage renal disease hypertension (BP≥140/90mmHg) Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit | 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, Ulcerative Colitis Patients ages 18 years and up Patient has known UC according to physician discretion Patient has symptoms of fresh bleeding and/or bloody diarrhea and/or at least one positive inflammatory marker within the past three months from the following ESR CRP CBC Patient is indicated and eligible for a standard of care colonoscopy examination for evaluation of disease activity and not for routine screening for dysplasia or colorectal cancer Patient agrees to sign consent form Crohn's Disease Antibiotic Associated Colitis Stool positive for O&P and for C. difficile toxin within 3 months of enrollment Other known infectious cause of increased symptoms Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting Definite tight or long stricture seen on radiological exam Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment Suspected GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule | 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): 2.0-75.0, Exacerbation of Ulcerative Colitis Ulcerative Colitis, Active Severe Crohn's Colitis Children over the age the 2 years and adults of all ages with established diagnosis of UC using standard (26, 27) Admission for IV steroid therapy PUCAI of at least 65 points at admission (i.e. severe attack) PUCAI>45 at enrollment Ability to swallow antibiotics (pills or syrup) Change in dose or intervals of anti-TNF within the past 2 months prior to admission Disease confined to the rectum (Proctitis) Antibiotic use in the past 4 weeks Any known erosive inflammation anywhere in the small bowel or esophagus Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc Fever >38.5, or >38.0c thought to be unrelated to the inflammatory process of active UC The probable need for second line medical therapy (infliximab, cyclosporine, tacrolimus) or colectomy within 5 days of enrollment, as judged by the caring physician Known allergy to more than one antibiotic regimen from the list below Pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-65.0, Diarrhea Persons aged 15 years old Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for <3 days) to participating health care settings For whom the study physicians recommend antimicrobial treatment Is pregnant Requires hospitalization Has signs or symptoms of septicemia Has a primary complaint of another acute illness Has a serious chronic illness Has an allergy to aspirin Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment Previously enrolled in study | 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 Adult of either gender, 18 years or older, with C. difficile infection (CDI) Diarrhea associated with C. difficile positive stool assay Within 48 hours of receiving either metronidazole for mild-moderate disease or vancomycin for severe uncomplicated disease Admitted in the hospital at the time of enrollment Ability to provide informed consent Have an understanding of study procedures Ability to comply with study procedures for the entire length of the study Hypotension or shock Megacolon or moderate to severe ileus Acute abdomen Severe leukocytosis (WBC > 20,000 cells /µL) Admission to intensive care unit on enrollment Inability to tolerate oral medication Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease) Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) Enrollment in another investigational drug trial Currently receiving other alternative treatment for CDI (e.g. antibiotics other than metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant) | 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, C. Difficile Diarrhea Enterocolitis adult patients with microbiology-proven CDAD provides informed consent eligible to receive oral antibiotic therapy prisoners pregnant women children <18 years patients who have contra-indications for perianal swabs, those who has medical conditions that would invalidate the results of the swabs patients requiring intravenous therapy for treatment of CDAD patients who do not consent and those who withdraw consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Orthopaedic Trauma Any patient participating in the FIXIT, TAOS, VANCO or Pain studies returning for a 3 month follow-up visit is eligible for participation in the proposed study. Respondents who are unable to give informed consent (or would require a proxy) at the time of the 3 month visit will be excluded | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 16.0-999.0, Clostridium Difficile Infection Test positive for CDI on stool analysis Inpatient at Barts Health NHS Trust at time of diagnosis Nil specific | 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): 5.0-55.0, Secretory Diarrhea Approximately 170 adult (male and female) patients must be enrolled to ensure that 96 patients (48 active and 48 placebo) are evaluable in Part A. In Part B, approximately 156 pediatric patients will be enrolled to ensure that 120 pediatric patients (60 active and 60 placebo) are evaluable for the analysis of 24 hour stool output, the primary outcome measure. PART A ***Inclusion Criteria*** A patient will be considered eligible for participation in the study if the following are satisfied on admission (Day 1) to the Dhaka Hospital of icddr,b Adults aged 18 years to 55 years Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces Clinical signs and symptoms of severe dehydration (>10% loss of body weight based on rehydration weight) Stool RDT and/or stool DF microscopy demonstrating presence of V. cholerae Must have a purging rate greater than/equal to 20 mL/kg (5 mL/kg/h) during the initial 4 to 6-hour screening/observation period, and signs of clinical dehydration must be corrected Written informed consent for participation in the study (see Section 6.1.2 for details of the consent process) Negative urine pregnancy test for all female patients *** A patient with any of the following at screening for study enrollment will not qualify for the study Received antidiarrheal medication (eg, loperamide, diphenoxylate) within 7 days before screening Abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate Use of drugs metabolized predominantly via CYP2C9 within 7 days before screening (see Section 5.7) Concomitant infection requiring antimicrobial therapy other than the study drug that may interfere with the evaluation of either the efficacy or safety of the study drug Patients unwilling or unable to take part in this study or refusing to sign informed consent (patients who participate on the basis of proxy consent will be re-consented at the end of the screening/observation period; those refusing consent at that time will be excluded from further study participation) Patients previously enrolled in this or any other investigational study within the past 30 days PART B ***Inclusion Criteria*** A patient will be considered eligible for participation in the study if the following are satisfied on admission (Day 1) to the Clinical Research Ward (CRW) of Dhaka Hospital Pediatric population aged ≥ 5 years to < 18 years of age Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces | 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, C-difficile Patients must be 18 years of age or older 2. Patient must have a positive C. difficile test within the 10 days prior to the procedure 3. Continued symptoms of c-difficile infection 4. Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure - Under 18 years of age 2. Negative C. difficile test within the 10 days prior to the procedure 3. No symptoms of c-difficile infection 4. Less than two courses of appropriate antibiotic therapy for C. difficile infection | 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, Chronic Kidney Disease End Stage Renal Disease For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL. 2. Kt/V >1 3. INR not higher than 1.2 4. Serum albumin >3.5 5. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml) Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening). 2. Subjects who receive oral anti-coagulation treatment (e.g. warfarin) 3. Subjects who receive Acetyl Salicylic Acid (ASA) above 325 mg/day or patients who receive ASA treatment between 100mg/d and 325 mg/d who cannot discontinue it for 1 week prior to each procedure 4. Patients currently receiving injections of long-acting Erythropoiesis Stimulating Agents (ESA) (e.g. Aranesp, Mircera), a patient on long acting ESA can be switched to a short acting preparation (e.g Eprex) and enroll in the study after meeting the and not meeting any other 5. Congestive heart failure (New York Heart Association functional class III or IV). 6. Grand mal seizures within 2 years of the screening visit. 7. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of > 10 times the upper normal limits. 8. Major surgery within 12 weeks of the screening visit. 9. Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia). 10. Current systemic infection, active inflammatory disease, or malignancy under active treatment. 11. Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins. 12. Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma. 13. Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, uncompensated cirrhosis, active upper GI tract ulceration). 14. Subject is currently enrolled in, or has not yet completed a period of at least 30 days or five half-lives of the investigational drug whichever is longer, since ending other investigational device or drug trial(s) prior to Screening phase. 15. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study. 16. Female subjects of child-bearing potential and males that do not agree to use acceptable methods of contraception during the study. 17. Pregnant and lactating female subjects. 18. Chronic alcoholic or drug abuse subjects. 19. Steroid or other immunosuppressive treatment (other than topical or inhaled steroids). 20. Subjects unwilling or unable to comply with the study procedures. 21. EPO Naïve subjects. 22. Known sensitivity to Gentamycin and Amphotericin 23. History of chronic or active Hepatitis B and/or C infection or positive serology at screening and known positive HIV or positive serology at screening. 24. Subject had blood transfusion within 84 days prior to Screening visit. 25. Subject has a date for renal transplantation. 26. Subject has a temporary or permanent hemodialysis catheter, unless: Subject has a permanent hemodialysis catheter over 6 months without signs/events of line sepsis. 27. Refer to the USPI Depo-Medrol Methylprednisolone Acetate Injectable (Appendix A) for any concomitant drug taken by the patient which its interaction with Depo-Medrol will warrant from this protocol | 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, Metastatic (Stage IV) Melanoma Age>18 years Surgical biopsy for histologic diagnostic All melanoma subtypes Known genotype BRAF V600 Affiliation social security Consent form signed Patient with histories of cancer or the other synchronous cancer Pregnant women Breast-feeding women Vulnerable patients: major under guardianship; patient deprived of its rights | 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): 2.0-21.0, Clostridium Difficile Recipient Documented laboratory-confirmed clostridium difficile infection Documentation of ongoing diarrhea at time of recruitment Children ≥2 years old, <18 years old; young adults >18 years old, <21 years old Undergoing clinically-indicated colonoscopy Recurrent c-diff infection (three or more occurrences) Donor First-degree relative recommended, but not compulsory ≥ 18 years old In good health No antibiotic use within the last 90 days Recipient Severe comorbid condition (at discretion of the principal investigator) On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone) Severe or fulminant C. difficile colitis Toxic appearance Signs of hemodynamic instability Peritoneal signs on physical exam Anemia on complete blood count electrolyte imbalances on basic metabolic panel Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency | 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): 2.0-17.0, Egg Allergy Egg allergic children Uncontrolled asthma the day of immunization severe asthma treated by oral steroids or high dose of inhaled steroids urticaria on the day of immunization antihistamines taken in the previous 3 to 7 days of immunization acute disease on the day of immunization (fever,irritability, vomiting, diarrhea, pallor, cyanosis, diaphoresis, lethargy) immunosuppressed patients or health worker who should be in contact with immunosuppressed patients | 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): 18.0-48.0, GBS Positive Women in Labor Given Vancomycin for Prophylaxis Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis ability to give informed consent aged 18-48 English and or Spanish speaking, admitted in labor or undergoing induction of labor Inability to give consent currently receiving antibiotics for another indication recent antibiotic use (within the previous 7 days) allergy to vancomycin | 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 Transient Ischemic Attacks Intracranial Hemorrhage Atrial Fibrillation All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation | 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): 18.0-95.0, Clostridium Difficile Symptomatic recurrent C. difficile infection identified by positivity of C. difficile toxin in stools (ELISA) Possibility to undergo standard antimicrobial therapy for recurrent C. difficile infection Approval of informed consent Possibility to undergo protocol diagnostic and therapeutic procedures Stool negativity for parasites Stool negativity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile Blood negativity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL) Subjects <18 years old Main comorbidities Prior colectomy Negativity of C. difficile toxin in stools High risk of post-colonoscopy complications Other main gastrointestinal diseases (es. Crohn's disease or ulcerative colitis) Stool positivity for parasites Stool positivity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile Blood positivity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL) Pregnancy or breastfeeding | 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, Multiple Myeloma Amyloidosis Participant Participants with end-stage renal failure due to or in association with multiple myeloma or systemic AL amyloidosis which hematopoietic cell transplantation is appropriate and a ≥ 50% five-year survival probability with transplantation is expected. This includes, but is not limited to Multiple myeloma (MM), ISS stage II or III in complete or very good partial remission AL amyloidosis without significant cardiac disease Males or females 18 years of age Participants must have an HLA-matched or one of six HLA A, B, or DR antigen-mismatched related donor, with high resolution molecular class I and II allele typing Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 2 years following the transplant Participants should be on dialysis or have a CrCl <20 ml/min Patients should not have evidence of renal recovery of their renal failure over a 90 day period of therapy for their underlying malignancy or other blood disorder Evidence of active infection as defined by: a) clinical syndrome consistent with viral or bacterial infection (e.g., influenza, URI, UTI) or b) fever with a clinical site of infection identified, or c) microbiologically documented infection, including, but not limited to, bacteremia or septicemia Participation in other investigational drug use at the time of enrollment Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to horse serum in ATG) Serologic positivity to HIV or HCV Women of childbearing age in whom adequate contraception cannot be maintained AST/ALT > 3 x normal or bilirubin > 1.5 x normal (unless due to Gilbert's syndrome) Pregnancy or uncontrolled serious medical illness not related to underlying myeloma Cardiac ejection fraction < 40% by echocardiogram FEV1 < 50% predicted or corrected DLCO < 50% predicted ABO blood group incompatibility in the host-vs-graft direction | 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, Intradialytic Hypotension Must be able to give informed consent for participation in this study Age ≥ 18 years A body weight > 100 lb or a body mass index > 18.5 End-stage renal disease with hemodialysis in-center three times per week Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg) Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%) • Pregnancy (self-reported) Allergic to nylon, polyesters and latex Not able to understand the English language Not able to disengage the ACES from compression Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) Hemoglobin less than 9.0 g/dL or greater than 15 g/dL Excessive intra-abdominal fluid pressure Respiratory distress Bleeding in the chest and abdomen Bleeding dyscrasia causing serious coagulation problem | 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, Recurrent Mantle Cell Lymphoma Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization; all patients must have either t(11;14) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D1 Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm or a peripheral blood cluster of differentiation (CD)5+, CD19+ lymphocyte count of at least 5,000 cells/uL Subjects must have received at least one prior treatment regimen Subjects that have received a prior Bruton's agammaglobulinemia tyrosine kinase (BTK) inhibitor or cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition are ineligible Subjects that have undergone prior allogeneic stem cell transplantation will only be eligible if the transplant occurred at least 1 year prior to study entry, the patient is no longer taking any immunosuppressive therapy, and there are no significant ongoing transplant-related adverse effects Subjects must not have received chemotherapy =< 21 days prior to first administration of study treatment, monoclonal antibody =< 6 weeks prior to first administration of study treatment, and/or radiotherapy or other investigational agents =< 4 weeks prior to first administration study treatment unless the subjects' tumor has progressed on the previous therapy and the investigator believes that the patient should not postpone further therapy and, all treatment-related toxicities have resolved to Common Terminology for Adverse Events (CTCAE) version (v) 5 =< grade 1; subjects may be receiving equivalent to prednisone at a maximum dose of 20 mg/day orally Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Patients must have normal organ and marrow function, independent of transfusion or growth factor support within 14 days before enrollment; patients should not receive growth factors or transfusions for at least 7 days prior to the first dose of study drug, with the exception of pegylated GCSF (pegfilgrastim) and darbepoetin, which require at least 14 days prior to screening and enrollment Absolute neutrophil count (ANC) >= 750 cells/uL (within 14 days before enrollment) Platelets >= 50,000 cells/uL (within 14 days before enrollment) Subjects with known or suspected central nervous system (CNS) involvement are not eligible Subjects with serologic status reflecting active viral hepatitis B or C infection are not eligible; subjects that are positive for hepatitis B core antibody positive hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR-positive patients will be excluded.) Subjects with uncontrolled human immunodeficiency virus (HIV) are not eligible; controlled HIV is defined as a CD4 count > institutional lower limit of normal and no current co-infection; uncontrolled HIV is all other HIV infection; note that patients with controlled infection should be allowed to participate only if they are not receiving prohibited cytochrome P450 (CYP) interactive medications Subjects unable to swallow capsules or with disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption, such as malabsorption syndrome, resection of the stomach or small bowel, partial or complete bowel obstruction, or symptomatic inflammatory bowel disease are not eligible Subjects with uncontrolled 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 are not eligible; recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of the study drugs Subjects with uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) resulting in declining platelet or hemoglobin levels within the 4 weeks prior to first dose of study drug are not eligible Patients with transfusion-dependent thrombocytopenia are not eligible Subjects with acute coronary syndrome within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities are not eligible; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant Subjects with a history of stroke or intracranial hemorrhage within 6 months prior to enrollment are not eligible Subjects with a history of malignancy are not eligible with the exception of the following | 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): 18.0-130.0, Anemia Provision of Informed Consent prior to any study specific procedures 2. Age ≥18 years at screening visit 1 3. Previous versions of the protocol prior to US amendment ver 6.0 and outside of US amendment ver 7.0: Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) at least 30 days prior to visit 1. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place. Starting with US amendment ver. 6.0 and outside of US amendment ver 7.0 (changed to recruit incident dialysis patients only): Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) for a minimum of 2 weeks and a maximum of 4 months prior to randomization. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place. 4. Two central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <12 g/dL in patients currently treated with an erythropoietin analogue or <10 g/dL in patients not currently treated with an erythropoietin analogue. Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analogue for at least 4 weeks prior to visit 1. 5. Ferritin ≥100 ng/mL at randomization (obtained from screening visit) 6. TSAT ≥20% at randomization (obtained from screening visit) 7. Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit) 8. Serum vitamin B12 level ≥ LLN at randomization (obtained from screening visit) 9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN), and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit) 10. Body weight 45 to 160 kg (prescribed dry weight) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous randomisation in the present study 3. New York Heart Association Class III or IV congestive heart failure at enrolment 4. Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization 5. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis or fibrosis of the liver) 6. Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD 7. Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) 8. Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization. 9. Uncontrolled hypertension at the time of randomization (defined as systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa) 10. History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ or resected colonic polyps. 11. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab) 12. Chronic inflammatory diseases such as rheumatoid arthritis, SLE, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia 13. Known hemosiderosis, hemochromatosis or hypercoagulable condition 14. Any prior organ transplant with the exception of an autologous renal transplant or a renal transplant that was subsequently removed ("explanted") or scheduled organ transplantation date 15. Any red blood cell (RBC) transfusion during the screening period 16. Any current condition leading to active significant blood loss 17. Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) 18. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within the month preceding the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded) 19. History of alcohol or drug abuse within 2 years prior to randomization 20. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence (see Section 3.8) 21. Pregnant or breastfeeding females 22. Known allergy to the investigational product or any of its ingredients 23. Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment, or may interfere with 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): 20.0-999.0, Clostridium Difficile Inpatients who have symptoms of CDAD as defined by (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and (2)Presence of either toxin A and/or B of C. difficile in the stool Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study Life-threatening or fulminant CDAD Ileus paralytic or toxic megacolon Likelihood of death before the completion of study from any cause Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent Subjects who in the opinion of the investigator require other drugs to control diarrhea Need of change in dosage regimen of opiates during the study period Need of change in dosage regimen of probiotic products during the study period History/complications of ulcerative colitis or Crohn's disease Multiple occurrences of CDAD within the past three months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Post Stroke Gait Training Lower extremity weakness due to stroke minor functional impairment (MRC < 5) ability and willingness to participate severe spasticity of the lower extremities severe dementia severe depression any other contraindications against Lokomat training body weight > 135 kg | 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): 55.0-999.0, Clostridium Difficile Diarrhea Inpatients >55 Proton Pump inhibitor / Histamine-2 Blocker On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use Anticipated hospital stay >48 hours Mental capacity (able to give informed written consent) Admission for CDI Existing diarrhea at admission Passed prophylactic window (>48 hours on broad spectrum antibiotics) Unable to take PO at the time of evaluation for study entry No more than 14 days of broad spectrum antibiotics anticipated Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors) Inflammatory Bowel Disease Admission for colonic bowel surgery or h/o total/Subtotal colectomy) Hospice Mortality expected <7days | 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, ICU-ecology (Multidrug Resistant Bacteria) ICU-acquired Bacteraemia mechanical ventilation (only invasive ventilation: i.e. intubated patients or patients with tracheostomal ventilation) no planned extubation within 24 hours When mechanical ventilation is not started directly after admission but later in the course of their ICU stay, patients are still eligible to participate patients under the age of 18 patients with known allergy to any of the medications or agents used (i.e. colistin, tobramycin, nystatin or chlorhexidine ) pregnancy Participation ends as soon as the patient is extubated or after tracheostomal ventilation has stopped (weaning completed) | 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, BRCA1 Mutation Carrier BRCA2 Mutation Carrier Endometrial Adenocarcinoma Estrogen Receptor Negative HER2/Neu Negative High Grade Ovarian Serous Adenocarcinoma Progesterone Receptor Negative Recurrent Breast Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma Stage III Uterine Corpus Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Stage IV Uterine Corpus Cancer AJCC v7 Triple-Negative Breast Carcinoma Any histologically confirmed locally advanced recurrent endometrial adenocarcinoma (except for carcinosarcoma), recurrent high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is available will be eligible; any patient proven to have metastatic triple negative breast cancer, defined from standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) will be eligible Patients may have unlimited prior chemotherapeutic regimens for management of recurrent locally advanced endometrial carcinoma, recurrent ovarian carcinoma, or metastatic triple negative breast cancer; treatment as frontline therapy for metastatic disease is acceptable; patients who have received prior PARP inhibitors, MTOR inhibitors, and/or AKT inhibitors are allowed to participate; patients may have progressed on prior PARP inhibitor, MTOR inhibitor, or AKT inhibitor but they may not have discontinued drug for toxicity With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than Common Terminology for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of starting study treatment Patients should have measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) 1.1; if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with cancer antigen 125 (CA125) Gynecological Cancer Intergroup (GCIG) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from study entry until 30 days after last dose of study drug; male partners should be instructed to use contraception during the study period; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; if a woman becomes pregnant or suspects she is pregnant while on study, she should tell her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling 1 of the following at screening: a) post-menopausal defined as > 50 years old and amenorrheic for >= 12 consecutive months following cessation of all exogenous hormonal treatments; b) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation Women must not breast-feed while taking the study medications Absolute neutrophil count >= 1,500/mcL (measured within 28 days prior to entry/randomization) Hemoglobin >= 10 gm/dL (measured within 28 days prior to entry/randomization) Platelets >= 100,000/mcL (measured within 28 days prior to entry/randomization) Patients receiving any other investigational agents or any additional anti-cancer agents Patients who have endometrial carcinosarcoma; patients with ovarian cancer who have histology other than high-grade serous in the absence of a deleterious BRCA mutation; if the patient has a deleterious BRCA mutation, any histology will be accepted Patients who have recurrences that are amenable to potentially curative treatment with radiation therapy or surgery Patients who have a history of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years; patients may have dual primaries of endometrial, ovarian or breast cancer Patients who have a history of myelodysplastic syndrome Patients who have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids (except those prohibited per protocol) before/during study if these were started at least 28 days prior to entry Patients who have had prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 28 days of starting study treatment (not including palliative radiotherapy at focal sites), or corticosteroids that are prohibited per protocol within 14 days of starting study treatment Patients who have had major surgery within 28 days prior to entry into the study or be recovering from any effects of surgery; patients who have had minor surgery within 2 weeks prior to entry into the study Patients who have a resting electrocardiogram (ECG) with a Fridericia corrected QT (QTcF) interval of >= 470 msec at 2 or more time points within a 24 hour period or a family history of long QT syndrome Patients who have required a blood transfusion within 28 days prior to study start | 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 Hospitalized patient Patient diagnosed with CDI Patient already included in this study Patient is taking part in a clinical trial in the field of CDI | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-90.0, Diverticulitis Diverticulosis Diverticular Disease Groups A and B. Patients with acute diverticulitis patients presenting to A&E at King's College Hospital with new onset abdominal pain, with or without a known diagnosis of diverticulitis Groups C and D. Patients with asymptomatic diverticulosis and normal controls Patients being assessed through the 2ww Colorectal Cancer pathway with a chief complaint of fresh PR bleeding and no other 'red flag' symptoms, who are not overly anxious over their diagnosis as assessed by a physician outside the study team Groups A and B. Patients with acute diverticulitis Patients in extremis e.g. systolic blood pressure less than 80 on arrival or pulse greater than 115 Patients who have received antibiotics in the three months prior to presentation Vulnerable patient populations Groups C and D. Patients with asymptomatic diverticulosis and normal controls Patients with high levels of pre-test anxiety, as determined by their assessing physician, outside the study team Patients who received antibiotics for any reason in the 3 months prior to Vulnerable patient populations | 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, Clostridium Difficile Infection Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli | 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, Metastatic Melanoma Recurrent Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Unresectable Cutaneous Melanoma STEP 1 Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 The effects of dabrafenib and trametinib or ipilimumab and nivolumab on the developing human fetus are unknown; furthermore, dabrafenib has been reported to interfere with the effect of hormone based oral contraceptives; for this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for at least 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 7 months after the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately Patients must have unresectable stage III or stage IV disease Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive NOTE: Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the is eligible for participation in this trial; patients with uveal melanoma are not eligible for this trial Patients must have BRAF V600 mutation, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test, Foundation Medicine); prompt information on tumor BRAF mutation status can also be obtained via Novartis "knowNow" Program Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to entering the study and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 1 week prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration and patients must be fully recovered from post-surgical complications Women must not be pregnant or breast-feeding, as the effects of ipilimumab + nivolumab or dabrafenib + trametinib on the developing human fetus are unknown All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Patients must not receive any other investigational agents while on study or within four weeks prior to registration Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) could be eligible; patients must not have taken any steroids =< 10 days prior to randomization for the purpose of managing their brain metastases; repeat imaging after SRS or surgical resection is not required so long as baseline magnetic resonance imaging (MRI) is within 4 weeks of registration; patients with multiple brain metastases treated with SRS (with [w] or without [w/o] whole-brain radiotherapy [WBRT]), are not an exclusion; patients with definitive CNS metastases treated with only WBRT are ineligible; patients with potential CNS metastases that are too small for treatment with either SRS or surgery (e.g. 1-2 mm) and/or are of uncertain etiology are potentially eligible, but need to be discussed with and approved by the study principal investigator (PI) Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 2 years prior to the time of registration Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject's safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/international normalized ratio (INR) by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency Patients must not have a history of or evidence of cardiovascular risks including any of the following QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480 msec. at baseline History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration | 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 Kidney Disease Kidney Failure, Chronic Kidney Transplantation Diagnosis of end-stage renal disease (ESRD) and on dialysis for < 1 year English-speaking Subjects coming in for transplant medical evaluation Age > 18 years Severe cognitive or visual impairment | 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 In patients >19 years of age 2. History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode. 3. Patients started on antibiotics during current admission for any other indication at any point of time during hospital course Current diagnosis of CDI 2. First episode of CDI during this admission. 3. Allergy to Vancomycin or other known intolerance 4. Pregnant h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration | 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, Chronic Hepatitis C Hepatitis C Virus Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection Chronic HCV infection Participant had to be either HCV treatment-naïve or treatment-experienced Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only) History of severe, life-threatening or other significant sensitivity to any drug Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) HCV genotype performed during screening indicating co-infection with more than one HCV genotype | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-90.0, Enterocolitis Clostridium Difficile Recurrent Age > 18 and < 90 years at the time of Screening. 2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other. 3. CDI infection under symptomatic control with < 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure. 4. Those with ability to provide informed consent Those with complicated CDI, defined as white blood cell>35 or <0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure < 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission. 2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment | 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 Infection Diagnosis of active C. difficile infection, defined as > 3 diarrheal stools per day and a positive C. difficile PCR assay Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90 days after an index episode of CDI Pregnancy Neutropenia (absolute neutrophil count <1000/microliters) Contraindication for retention enema Food allergy not controlled in the donor diet | 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, Anemia End Stage Renal Disease (ESRD) Main Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization) Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN Main Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization Participant has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD) Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization Participant has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation | 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): 21.0-999.0, End Stage Renal Disease Patient willing and competent to sign the approved informed consent Patient must be at least 21 years of age or older.* Patient must weigh between 45 and 100kg, inclusive.* Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 3 times a week for at least 3 months prior to being enrolled.* Vascular access must be through a functioning double lumen catheter with no thrombolytic therapy or clotting of the catheter within the past 4 weeks.* Willing to comply with the requirements of experimental treatment with the WAK for up to 24 hours Expected survival of no less than 6 months.* Consent to allow review of their medical records by the investigators, and monitors Fluency in English Hemoglobin level ≥ 9.0 g/dL prior to WAK treatment • Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.** History (within the 12 weeks prior to the study) of cardiovascular events including:* Unstable angina Myocardial Infarction Stroke Clinical Significant Arrhythmia Life threatening arrhythmia within the past 30 days* Severe intradialytic hypotension within the last 30 days* Shock within the last 30 days* Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient* | 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, Enterocolitis Clostridium Difficile Recurrent ≥ 18 years Medical record documentation of recurrent CDI 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 C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment Requires antibiotic therapy for a condition other than recurrent CDI Previous fecal transplant prior to study enrollment History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis History of irritable bowel syndrome (IBS) History of chronic diarrhea History of celiac disease Colostomy Planned surgery requiring perioperative antibiotics within 6 months of study enrollment Life expectancy of < 12 months | 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, Leukocytosis Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System 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, Clostridium Difficile Infection The patients with the diagnosis of Clostridium difficile (ICD10-A07) Age of more than 18 years Data incompleted | 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): 18.0-49.0, West Nile Viral Infection Age >/=18 years and < 50 years 2.Able to read, sign, and date the informed consent document 3. Available and willing to participate for the planned duration of the study 4.Are in good health, as judged by the investigator and determined by vital signs, medical history, and physical examination 5.Sexually active males must agree to use a medically acceptable form of contraception* in order to be in this study and must agree to continue such use until day 30 after the last vaccination.Medically acceptable contraceptives (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. 6.Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination *Not sterilized via tubal ligation, bilateral oophorectomy, or hysterectomy and still menstruating or < 1 year of the last menses if menopausal 7. Women of childbearing potential must have used an acceptable method of contraception* in the 30 days prior to enrollment and must agree to continue such use until day 30 after the last vaccination. *Includes, but is not limited to, abstinence from sex with men,barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure, and licensed hormonal methods such as implants, injectables, or oral contraceptives Any clinically significant acute or chronic medical condition* or need for chronic medications** that, in the opinion of the investigator, will interfere with immunity or affect safety *Includes, but is not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions ** Receipt of systemic, prescription medications for the treatment of chronic medical conditions or variations of normal physiologic functions are permissible if, in the opinion of the investigator, they are used for conditions that are not clinically significant and would not impact the safety of the subject or the safety and immunogenicity outcomes of the protocol. Use of systemic, over-the-counter medications and PRN systemic, prescription medication are allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Topical (except corticosteroid) medications, nasal (including corticosteroid) medications, vitamins, and supplements are permissible 2. Asthma, other than mild, well-controlled asthma* *Cold or exercise induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Participants should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year 3. Diabetes mellitus 4. Unstable depression or bipolar disorder* *Has received <3 months of the same anti-depressant or bipolar disorder medication(s) (and dose) or has had a decompensating event during the previous 3 months or has depression or bipolar disorder that in the opinion of the investigator will compromise the subject's ability to comply with protocol requirements 5. Unstable seizure disorder (defined as requiring medication for seizure control or with seizure activity within the past 3 years) 6. Autoimmune disease (lupus, multiple sclerosis, rheumatoid arthritis, autoimmune thyroid disease, etc.); vitiligo, and mild eczema or mild psoriasis not requiring chronic therapy are permissible. 7. Known or suspected congenital or acquired immunodeficiency including anatomic or functional asplenia or immunosupppression as a result of underlying illness or treatment 8. Abuse of alcohol or drugs that, in the opinion of the investigator, may interfere with the subject's ability to comply with the protocol 9. Unstable hypertension (well-controlled hypertension with medication is permissible) 10. Body mass index (BMI) >/= 35 11. Known allergy to components of the study product .Including the following: aluminum hydroxide, sorbitol, potassium chloride, sodium chloride 12. Seropositive to West Nile virus 13. History of a visit to South America or sub-Saharan Africa lasting one month or more 14. History of military service 15. History of vaccination against yellow fever, tick-borne encephalitis, or Japanese encephalitis 16. History of vaccination with West Nile virus candidate vaccines. 17. Attended primary (grade) school in Austria, Germany, Japan, South Korea, India, Thailand, Nepal, Vietnam, or Taiwan (where tick-borne encephalitis vaccine is given) 18. History of dengue fever or receipt of a dengue fever vaccine 19. Active neoplastic disease* *Participants with a history of malignancy may be included if treated by surgical excision or if treated by chemotherapy or radiation therapy has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 36 months) 20. Chronic topical or systemic corticoste roid use* *Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed. Oral or parenteral (intravenous, subcutaneous or intramuscular) corticosteroids given for non-chronic conditions not expected to recur are permissible if, within the year prior to enrollment, the longest course of therapy was no more than 14 days and no oral or parenteral corticosteroids were given within 30 days prior to enrollment. Intraarticular, bursal, tendon, or epidural injections of corticosteroids are permissible if the most recent injection was at least 30 days prior to enrollment. 21. Are breastfeeding or plan to breastfeed at any time throughout the study 22. Receipt or planned receipt of inactivated vaccine or allergy desensitization injection 14 days before or after a study vaccination 23. Receipt or planned receipt of live attenuated vaccine 30 days before or after a study vaccination 24. Receipt of any other experimental agent within 30 days prior to vaccination or planned receipt prior to the end of the study 25. Plans to enroll in another clinical trial* that could interfere with safety assessment of the investigational product at any time during the study period *Includes trials that have a study intervention such as a drug, biologic, or device 26 Receipt of blood products or immunoglobulin within six months prior enrollment 27. Donation of a unit of blood within 56 days prior to enrollment or intends to donate blood during the study period 28. Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg 29.Resting heart rate <40 or >100 beats per minute 30.Oral temperature >/= 38 degrees C (100.4 degrees F) 31.Positive serology for HIV 1/2* *If the enzyme linked immunosorbent assay (ELISA) is positive, HIV confirmation should be performed. If the HIV Western Blot is not consistent with HIV infection, the volunteer may be enrolled. A past participant in an HIV vaccine trial who has a positive antibody ELISA may participate if the Western Blot is not consistent with pending seroconversion or positive or an HIV polymerase chain reaction (PCR) assay result is below the level of detection of HIV. 32. Positive hepatitis B surface antigen (HBsAg) 33. Positive antibody to hepatitis C virus (HCV) 34. Any Grade 1 or higher screening clinical lab value* (see Toxicity Table Appendix B) *Screening clinical labs blood tests (white blood cell [WBC] count, hemoglobin level, platelet count, creatinine, blood urea nitrogen, non-fasting glucose, potassium, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin) and urine tests (protein, glucose). 35. Plan to have a major change in exercise routine from 72 hours before any dose of study vaccine/placebo through 15 days after that dose 36. Acute febrile illness (oral temperature >/= 38 deg | 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 Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2 Patients with normal renal function or those with less advanced kidney disease Inability or unwillingness to provide consent Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant Patients who may be pregnant Hemodynamically unstable patients Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease Patients with ongoing or recent infection and those with history of C-diff infection Patients with abnormal bowel structure secondary to surgical or anatomic variations Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics | 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, Mycobacterium Infections, Nontuberculous Be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was completed no more than 12 months before screening 2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT 3. Be willing to adhere to multi-drug treatment regimen during the course of the study Patients with cystic fibrosis 2. Positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile. 3. Active pulmonary tuberculosis requiring treatment at screening 4. History of lung transplantation 5. Prior exposure to LAI (including clinical study) | 0 |
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