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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): 19.0-999.0, Wound Infection Age >19 years Gestational age > 37 weeks Booked elective cesarean section Gestational age < 37 weeks Premature rupture of membranes Onset of labor prior to procedure Evidence of maternal sepsis; maternal fever > 38.5C LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction | 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): 0.0-60.0, Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Histologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or epithelial carcinoma of the fallopian tubes, meeting 1 of the following Stage III or IV disease that was treated with initial therapy comprising a standard platinum-containing regimen Must have < 2 cm of residual disease with no evidence of disease progression after initial chemotherapy AND have no disease progression immediately prior to stem cell collection Patients initially presenting with stage IV disease who have achieved a clinical response (complete response [CR] or partial response [PR]) after initial therapy are eligible Responding recurrent disease Patients who have had recurrence with elevated CA 125 levels (> 100 U/mL) and who have achieved a reduction of CA 125 level by 50% for 4 weeks following the most recent course of reinduction chemotherapy are eligible Patients who have achieved a CR or PR after salvage chemotherapy for relapsed disease are eligible Patients with measurable or evaluable disease must have achieved a PR after prior therapy No clinically significant pleural effusions Karnofsky performance status 70-100% | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease adult >= 18 years of age end stage renal disease, undergoing concurrent dialysis treatment poorly controlled blood pressure on at least 2 antihypertensive drugs agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits competent and willing to provide written, informed consent to participate in this clinical study renal arterial abnormalities myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months hemodynamically significant valvular heart disease implantable cardioverter defibrillator (ICD) or pacemaker respiratory support pregnant, nursing or planning to be pregnant other | 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): 18.0-90.0, Hospital Acquired MRSA Community Acquired MRSA No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. Subjects must provide signed written informed consent Inability to provide written informed consent | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, Allogeneic Stem Cell Transplant Leukemia Non-Hodgkins Lymphoblastic Lymphoma Myelodysplastic Syndrome Paroxysmal Nocturnal Hemoglobinuria (PNH) Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome HLA 6/6 or 5/6 antigen matched related or unrelated donor creatinine = normal or if not, CrCl > 60 ml/min/1.73ml total bilirubin < 2.5, AST < 2xnl, cardiac function > 50% pulmonary function asymptomatic or if not DLCO > %50% (corrected for Hgb) Karnofsky performance status > 70% negative pregnancy test (where applicable) signed informed consent of patient and donor Pregnancy or lactation unwillingness to comply with protocol treatment or follow-up uncontrolled infection HIV or HTLV positivity active CNS/skin disease | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Males or females at least 18 years old. 2. Patient has not been previously enrolled in the genebank registry. 3. Patient able to give informed consent. 4. Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year. 5. Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 6. Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only). 8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only). (Cleveland Clinic will follow 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8). 9. Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments. 10. Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D). 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias None except as noted in the | 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, Antibiotic-Associated Diarrhea Clostridium Difficile Patients with diarrheal stools considered to be antibiotic associated Inability of sign consent Patient with other known gastrointestinal disease Patients receiving tube feeding or fecal incontinence prior to receiving antibiotics | 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, Cirrhotic Portal Hypertension Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods Refractory or recurrent ascites or difficult to treat Refractory Hydrothorax Non cirrhotic HTP CHILD C ≥12 Complete portal vein thrombosis Usual contra-indication for TIPS Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein >100 UI/mL associated with the presence of at least one hepatic nodule Cardiac insufficiency defined by a ventricular fraction of ejection < 40% with the echocardiography preliminary to the procedure Pulmonary arterial hypertension (PAP > 40 mmHg) Hepatic polycystosis Intra-hepatic bile ducts dilatation Spontaneous clinical recurrent hepatic encephalopathy | 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): 0.0-18.0, Growth Hormone Deficiency Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease Greater than 18 years old Not a patient at the UC Davis Medical Center pediatric clinic | 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 Difficle Colitis Clostridium Difficle Associated Disease Patients on enteral vancomycin therapy Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, Chronic Kidney Disease End Stage Renal Disease Death All CKD patients older than 18 y/o Refusal to participate in the trial | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Staphylococcal Infections Patients need to be administered Linezolid in order to be enrolled in the surveillance Patients not administered Linezolid | 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): 10.0-90.0, Chronic Renal Failure chronic renal failure on peritoneal dialysis malignancy, peritonitis | 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): 18.0-60.0, Cholera Age: 18 years Gender: Male Duration of diarrhoea: Not exceeding 24 hours Written informed consent for participation Dehydration status: Severe dehydration Positive stool dark-field microscopic examination for V. cholerae & culture positive for V cholerae For patients assigned to receive ciprofloxacin, an MIC of the V. cholerae isolates to ciprofloxacin of > 0.190 µg/ml and to azithromycin of ≤ 0.125 µg/ml History of receiving an antimicrobial agent known to be effective in cholera in adults Concomitant infection requiring antimicrobial therapy other than the study drugs Chronic illness | 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): 12.0-999.0, Cystic Fibrosis Aged 12 years and older Male or female Non-pregnant women who are to remain non-pregnant for 3 months after the end of the study. Women of childbearing potential must use a reliable method of contraception. Reliable methods of contraception for female patients the following barrier type devices (e.g., female condom, diaphragm and contraceptive sponge) used ONLY in combination with a spermicide intrauterine devices oral contraceptive agent Depo-Provera™ (medroxyprogesterone acetate) levonorgestrel implants Abstention, the rhythm method or contraception by the partner alone are NOT reliable methods of contraception. A woman is considered to have child-bearing potential unless she meets at least one of the following weeks post-surgical bilateral salpingo-oophorectomy or hysterectomy Premature ovarian failure confirmed by a specialist gynecologist Age > 50 years and not treated with any kind of HRT for at least 2 years prior to screening, and with amenorrhea for at least 24 consecutive months prior to screening and a serum FSH level of > 40 IU/L at screening Any condition prohibiting the correct measurement of the NPD such as upper respiratory tract infection Acute upper respiratory tract or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of screening Severe renal impairment (creatinine clearance < 30 mL/min as per Cockroft and Gault) Female patients of childbearing potential who will not undergo a pregnancy test prior to enrollment into the study History of significant lactose intolerance History of neuropathy Presence of clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause within 1 month prior to screening Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease FEV1 < 25% of predicted normal Oxygen saturation at rest < 88% | 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, Renal Failure Multi Organ Failure ICU patients with sepsis/multi-organ failure with acute renal failure | 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, Anemia The patient was a man or woman 18 to 90 years of age, inclusive. 2. The patient had CKD and met 1 of the following 1. Had been on dialysis for ≥6 months prior to enrollment, or 2. Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study. 3. The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment. 4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during screening period, with the difference between the mean of the first 2 consecutive Hb values and the mean of the last 2 consecutive values being ≤1.0 g/dL The patient had known bleeding or coagulation disorder. 2. The patient had known hematologic disease or cause of anemia other than renal disease (i.e., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiplemyeloma, hemolytic anemia, and myelodysplastic syndrome). 3. The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days prior to enrollment). 4. The patient had advanced chronic CKD defined by New York Heart Association Class III or IV. 5. The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment. 6. The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor | 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, Acute Renal Failure Acute renal failure of any cause Use SLEDD-f as renal replacement therapy Priscribe vancomycin for a known or suspected infection None | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Pelvic Inflammatory Disease women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000 | 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): 18.0-88.0, Crohn's Disease Age: > 18 years Diagnosis of CD, re-established by endoscopy and/or X-ray and/or surgery in the last 36 months CD in active phase since at least 2 weeks before screening CDAI between 220 and 450 CDEIS > 8 Ulcerations greater than aphthous ulcers in at least 1 of the bowel segments from ileum to rectum If any on-going treatment with corticosteroids (prednisone, prednisolone or budesonide), it must be at a dose equivalent to or less than 30 mg/day prednisone, or 9 mg of budesonide, and in use for at least one month and at a stable dose for at least two weeks before patient enrolment If any on-going treatment with immunosuppressant (azathioprine, 6-mercaptopurine, methotrexate), it must be in use for at least 3 months before patient enrolment If any on-going treatment with 5-aminosalicilates, it must be in place for at least 4 weeks before patient enrolment, at a dose > 2 g Females of childbearing potential with negative pregnancy tests Treatment in the 2 months with anti-TNF-alfa antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs Primary failure to previous treatment with anti-TNF-alfa antibodies- Current bowel obstruction or any condition that may predispose to its development (e.g. clinically significant unresolved intestinal stricture, adhesions or any other condition that would place the patient at risk for developing overt bowel obstruction) or intestinal perforation or significant GI hemorrhage Expected surgery for the duration of the study Any ostomy or extensive bowel resection Positive serological anti-HCV and anti-HIV testing and positive testing for active HBV replication, e.g. HBV-DNA or HBsAg or HBeAg (to be performed at screening) Other on-going clinical relevant viral infections (e.g. herpes zoster, Epstein-Barr, CMV), systemic fungal infections or history of recurrent serious bacterial infections Signs and symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure QTc interval > 450 msec at pre-treatment evaluation | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-60.0, Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Adult L1 Acute Lymphoblastic Leukemia Adult L2 Acute Lymphoblastic Leukemia Adult T Acute Lymphoblastic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL), with evidence of ALL involvement in bone marrow and/or blood; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia are not eligible for this study; patients with L3 (Burkitts) are also not eligible For ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell); NOTE: appropriate marker studies including cluster of differentiation (CD)19 (B cell), CD10, CD5, and CD7 (T cell) must be performed; co-expression of myeloid antigens (CD13 and CD33) will not patients; if possible, the lineage specific markers cytoplasmic CD22 or CD79a (B cells), cytoplasmic CD3 (T cells) and cytoplasmic myeloperoxidase (MPO) (myeloid cells) must be determined Patients may have received no more than one course of remission induction therapy for ALL; patients who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible; (patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy); patients may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to registration; any prior induction chemotherapy must have been completed no more than 28 days prior to registration NOTE: If the patient has been initiated on the protocol defined regimen (i.e. the hyper-CVAD regimen without a tyrosine kinase inhibitor) before the Philadelphia chromosome (Ph)/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to day 14 (i.e. if the patient is registered on day 5 and starts therapy on day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on day 14) For patients who have received any prior therapy that was NOT remission induction therapy, one of the following must be true At least 6 weeks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given, and all toxicities of the remission induction therapy must have resolved to grade =< 2 The patient must have rapidly progressive disease (per institutional guidelines) For previously treated patients, the study chair must be contacted before registration, in order to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive as confirmed by standard cytogenetics, fluorescent in situ hybridization (FISH), and/or polymerase chain reaction (PCR) testing performed by local laboratory; NOTE: samples will be submitted centrally for verification of results Patients must have a bilirubin =< 3.0 x institutional upper limit of normal (IULN) within 14 days 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, Diarrhea Male or female at least 18 years of age Acute diarrhea illness with symptoms onset within 48 hours of study entry Minimum of 3 unformed stools in 24 hours before study entry Most recent stool is unformed Abdominal discomfort/wind (intensity mild to severe) within 4 hours of study entry Women of childbearing potential must have a negative pregnancy test at screening Willing to adhere to the prohibitions and restrictions specified in this protocol Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Requiring hospital admission, parenteral hydration or antibiotic therapy Axillary temperature >38.2°C or oral temperature >38.6°C History or clinical evidence of gross blood or pus in stool in current illness Signs or symptoms of orthostatic hypotension Unable to take medication and fluids by mouth History of chronic gastrointestinal disease, hepatic or renal insufficiency, or other significant medical condition that could be aggravated by untreated acute diarrhea Immunodeficiency (e.g. those with acquired immunodeficiency syndrome [AIDS] or known human immunodeficiency virus [HIV] infection, or undergoing chemotherapy or radiotherapy) Intake of antibiotics, oral antifungals, quinidine or ritonavir within 7 days, antidiarrhoeal, promotility drugs (e.g., metoclopramide, domperidone), antiflatulents (e.g., simeticone, activated charcoal) or probiotics or bismuth salts within 48 hours, or any analgesic within 6 hours prior to study entry Hypersensitivity to loperamide, yeast, or any component of study formulations Pregnant or breast-feeding Unable to comply with the protocol requirements and schedule Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Intracerebral Hemorrhage Acute, spontaneous ICH (including bleeding in cerebellum) diagnosed by non-enhanced CT scan within five hours of symptom onset. (Time of onset is defined as the last time the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep) Age >/= 18 years through 80 years (candidates must have had their 18th birthday, but not had their 81st birthday) For spot positive patients, dosing of study drug within 90 minutes of enrolling CT scan Time of symptom onset of ICH is unknown or more than five hours prior to baseline CT scan ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment of any condition (e.g., myocardial infarction, cerebral infarction, etc.), central nervous system (CNS) tumor or CNS infection Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled) Serum creatinine > 1.4 mg/dl (123 μmol/L). Sites that currently perform CTA as standard of care for ICH will follow their standard procedures regarding renal insufficiency Known allergy to iodinated contrast media Intravenous or intra-arterial administration of iodinated contrast media within the previous 24 hours of baseline CT scan Known hereditary (e.g., hemophilia) or acquired hemorrhagic diathesis, coagulation factor deficiency, or anticoagulant therapy with international normalized ration (INR) > 1.2 Known or suspected thrombocytopenia (unless current platelet count documented above 50,000 / μl) Unfractionated heparin use with abnormal partial thromboplastin time (PTT) Low-molecular weight heparin use within the previous 24 hours | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Atypical Hemolytic Uremic Syndrome Critera: 1. Male or female patients' ≥18 years of age who have been diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS). 2. Patients must be receiving PT for aHUS and must be observed to receive ≥ 1 PT treatment every two weeks and no more than 3 PT treatments/week (at an unchanged frequency) for at least 8 weeks before first dose of IP. 3. Platelet Count Pre-PT Baseline Set-Point (collected in the hours before the Qualifying PT Episode) is within 75% of the average of the Pre-PT platelet counts collected at Screening and during the Observation Period. 4. Known complement regulatory protein genetic abnormality. 5. Lactate dehydrogenase (LDH) level at screening or at the onset of the current aHUS episode was ≥ ULN. If LDH is normal at screening, other markers indicative of ongoing hemolysis such as haptoglobin, schistocytes should be evaluated and discussed with Sponsor. 6. Creatinine level ≥ ULN for age. 7. Female patients of childbearing potential must be practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period and for up to 5 months following eculizumab treatment discontinuation. 8. Able to give written informed consent. 9. Able and willing to comply with study procedures TTP, (defined as activity <5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory. 2. Malignancy within 5 years of screening. 3. Typical HUS (Shiga toxin +). 4. Known HIV infection. 5. Identified drug exposure-related HUS. 6. Infection-related HUS. 7. HUS related to bone marrow transplant. 8. HUS related to vitamin B12 deficiency. 9. Patients with a confirmed diagnosis of sepsis. 10. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease. 11. Pregnancy or lactation. 12. Unresolved meningococcal disease. 13. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome. 14. Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 15. Patients who have received previous treatment with eculizumab. 16. Patients receiving IVIg within 8 weeks or Rituximab therapy within 12 weeks of the screening visit. 17. Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, [2] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and [3] dose of such medications have been unchanged for at least 4 weeks prior to the screening period and throughout the Observation Period or [4] patient is experiencing an acute aHUS relapse immediately after transplant. 18. Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of ESA therapy. 19. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial. 20. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients | 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, Peptic Ulcer Hemorrhage Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy Patients who refuse endoscopic procedure Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation) Pregnancy Patients with serious concurrent diseases such as malignant tumors or end-stage diseases History of previous gastrectomy or vagotomy Known hypersensitivity to proton pump inhibitors Elderly patients Epilepsy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-60.0, Leukemia Myelodysplastic Syndromes Diagnosis of one of the following Myelodysplastic syndromes Acute myeloid leukemia (AML) No acute promyelocytic leukemia with t(15;17)(q22;q12), PML/RAR, or other variants Planning to undergo AML-like intensive induction chemotherapy (e.g., "7+3" or regimen with similar or higher intensity) for untreated or relapsed disease within 1 week after study entry OR has started therapy within the past 72 hours No hypersensitivity or allergy to fluoroquinolones, triazoles, or acyclovir ECOG/WHO/ZUBROD performance status 0-1* Total bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is thought to be due to Gilbert's syndrome or hemolysis)* AST and ALT ≤ 1.5 times ULN* Serum creatinine ≤ 1.5 times ULN* | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End-Stage Renal Disease Age ≥18 years Have a diagnosis of ESRD and have been on Automated Peritoneal Dialysis (glucose 1.5 or 2.5 % w/v) for at least 3 months Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators) Have not experienced peritonitis episodes in the last 3 months Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit Be treated by the participating clinical Investigator for a period of at least three months Have a history of drug or alcohol abuse in the six months prior to entering the protocol Be in treatment with androgens Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations) Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit) Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) Have a history of congestive heart failure and clinically significant arrhythmia Have an history of epilepsy or any NCS disease Have malignancy within the past 5 years, including lymphoproliferative disorders Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year Have a history of L-Carnitine therapy or use in the month prior to entering the protocol | 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 Age > 18 Hospitalized for peritoneal catheter placement for peritoneal dialysis Pregnancy Hiperkalemia (K> 5.5meq/l) Intolerance to spironolactone | 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, Irritable Bowel Syndrome IBS subjects with and without comorbid somatization features will be recruited from the sources highlighted above To be eligible, subjects will have to be between 18 and 90 years of age (inclusive) and qualify for a diagnosis of irritable bowel syndrome according to the set forth in the Rome III for the Diagnosis of Functional GI Disorders IBS patients will then be assessed in terms of comorbid somatization as determined using the Patient Health Questionnaire-15 (PHQ-15) For this particular study, only subjects with high somatization (PHQ ≥ 10 or low somatization (PHQ ≤5) will be considered for enrollment Verification of somatization status will be performed using a formal structured interview process (Diagnostic Interview Schedule, DIS) Persons are eligible to participate without regard to race or ethnicity Given sex differences in cerebral responses to noxious stimuli and the greater prevalence of IBS in women, only female participants will be sought in this study Also, in view brain hemispheric differences between left and right-hand dominant individuals and the greater prevalence of right-handedness, all participants must be right-handed Persons are excluded from participation for having various psychiatric, medical, and other characteristics Psychiatric/cognitive exclusions any of the following: active suicidal or homicidal ideation or a history of attempted suicide, current excessive alcohol use or other substance abuse disorders, active major depression, anxiety disorder, bipolar depression or any psychotic disorder, unwillingness to be randomized or provide informed consent, inability to communicate with staff or significant cognitive impairment Medical and other exclusions any of the following: renal or hepatic disease or impairment, diabetes, cardiovascular disease, cardiac arrythmia, cerebrovascular disease, or breastfeeding, pregnant, or imminent intention of pregnancy, history of seizures or primary neurological disorder, head trauma, brain damage, hyper or hypothyroidism, history or abdominal surgery (other than cholecystectomy/appendectomy), or known structural GI disorder (Crohn's disease, etc.), contraindication to MRI (metallic implant, pacemaker), or rectal balloon distention (e.g., proctitis/colitis) Exclusions related to medications: 1. Analgesics (narcotics, NSAIDs; acetaminophen OK) 2. Muscle relaxants 3. Psychoactive agents (antidepressants, antipsychotics) 4. Other medications (phenytoin; amphetamines, prescription weight-loss drugs, or benzodiazepines) 5. Thyroid medication 6. Anticholinergic medications or other IBS medications (hyoscyamine, dicyclomine) 7. Cytochrome p450 substrates 8. Participation in any clinical trial using any other drug | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 22.0-999.0, Hypertension Practicing physician at 1 of 2 medical groups Be a general internist of family physician Provide ongoing clinical care to at least 25 adult patients with uncontrolled hypertension. Additional patient include years or more on date of physician randomization Charlson score less than 4 Be linked to a primary care physician who has consented to the study Have 2 consecutive office blood pressure readings above the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) goal, within a 12 month time period Physicians practicing at a second clinic for more than 1 day per week. Additional patient criteria Less than 22 years of age Charlson score of >= 4 | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Atypical Hemolytic Uraemic Syndrome. cases: endstage renal failure due to atypical hemolytic uraemic syndrome treated with hemodialysis controls: endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis | 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): 20.0-999.0, End-Stage Renal Disease Clinical diagnosis of end stage renal disease Must be at least 20 years of age Dialysis must be initiated in Korea Informed consent Scheduled to receive kidney transplantation within 3 months Scheduled to emigrate to foreign country within 3 months Clinically suspected as acute renal failure | 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, Functional Dyspepsia Small Intestinal Bacterial Overgrowth Chronic Abdominal Discomfort Must have FD based on the most recent Umbrella of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB Inflammatory bowel disease Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT Anti/pro-biotics last 3 months Previous LBT (Lactulose Breath Test) Narcotic Dependence Pregnancy Control subjects will be excluded if they have symptoms of heartburn, retrosternal chest pain, chronic cough, nausea or regurgitation suggestive of gastroesophageal reflux disease | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-60.0, B-Cell Lymphoma Age 18 to 60 y.o Aggressive Large B-Cell Lymphoma (CD20+) Ann Arbor stage III, IV IH or high adjusted IPI signed inform consent Age < 18 ou > 60 y.o other type of lymphoma serology VIH + other neoplasms apart from basal cell carcinoma or situ carcinoma | 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, Diarrhoea Adults aged 18 or older Hospital inpatients On systemic antibiotics for an infection Antibiotics started within last 48 hours Diarrhoea at screening Unable to take enteral meds Patients on intensive care units Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy) Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis) Regular consumption of probiotics until 1 week prior to admission Acute severe pancreatitis Persistent vomiting (two days or more) | 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, Chronic Kidney Disease Secondary Hyperparathyroidism Hemodialysis Male or female patients >= 18 years old. 2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening. 3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study. 4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of iPTH level 130 to 700 pg/mL Serum Total Alkaline Phosphatase level >= 40 U/L Calcium level <= 10.0 mg/dL (2.49 mmol/L) Calcium-phosphorus product (CaxP) <= 75 mg2/dL2 (US) and <= 70 mg2/dL2 (non-US) Patient had a history of parathyroidectomy. 2. Patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator. 3. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have been required. 4. Patient was known to be human immunodeficiency (HIV) 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, HIV Infections Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study ("ACTG parent study participant") or not enrolled in one of the ACTG parent studies, but receiving routine HIV patient care at an institution that was also an ACTG-funded site ("ACTG clinic patient participant") Virologic failure on combination antiretroviral therapy (ART), with an HIV-1 genotype conducted on or soon after the failure, within 16 weeks prior to entry. Availability of HIV-1 genotype results at entry History of prior nonadherence to ART during the past year documented either by patient self-report or recorded in the patient's medical record Most recent HIV-1 RNA value of at least 200 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA Initiating or restarting an ART regimen with 2 or more active ARV medications within 3 days after randomization. The regimen must have been selected for the participant prior to the time of randomization for A5251. An active ARV medication was defined as a medication to which the participant was expected to be susceptible based on HIV-1 resistance testing, as specified in the ACTG parent study, or determined by the participant's health care provider per standard of care No regular access to a phone. Candidates without phones may have elected to participate by calling the HIV nurse specialists using an 800 number, rather than being called by the HIV nurse specialist Coenrollment in another adherence trial, unless approved by the A5251 study chair Current incarceration Any condition that, in the opinion of the site investigator, would have compromised the candidate's ability to participate in the study | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Stroke Adult(> 18 yrs) Clinical stroke syndrome with limb weakness lasting at least 1 hour i.e. not likely to be a transient ischaemic attack) Limb weakness (SNSS Arm <6 and/or Leg <6) Onset < 48 hours Conscious (Glasgow Coma Scale > 8) Independent prior to stroke (pre-morbid Rankin scale < 2) Meaningful consent, or assent from a relative or carer Definite need for nitrate therapy Contraindication to nitrate therapy Definite need for prior antihypertensive or anti-anginal medication Definite need for antihypertensive therapy during acute stroke Systolic blood pressure <140 mmHg or >220 mmHg Patients expected to require surgical intervention Known intracerebral pathology other than stroke Other serious condition which is likely to prevent outcome assessment at 3 months Previous enrollment in ENOS or current involvement in another trial of an experimental drug intervention Not available for follow-up -Females of childbearing potential, pregnancy or breastfeeding. - | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Gastrointestinal Hemorrhage All patients with GI bleed if the following are met has received 4 units of PRBCs within a 24-hour period, or has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or if the MAP remains below 60mmHg after fluid resuscitation, and written informed consent is obtained from the subject or legally authorized representative Pregnant or lactating women Known to have gastrointestinal malignancy On anticoagulation therapy Patients with history of thromboembolism Patients with history of myocardial infarction or ischemic cerebrovascular accident Patient with end stage renal disease Patients with DNR status Incarcerated individuals | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-120.0, Brain and Central Nervous System Tumors Histologically confirmed diagnosis of 1 of the following Any intracranial high-grade glioma (phase I*) Glioblastoma or gliosarcoma (phase II*) Patients whose original histology was low-grade glioma are eligible provided they were subsequently diagnosed with glioblastoma or gliosarcoma Unequivocal radiographic evidence for tumor progression by MRI within 14 days prior to registration and with a stable or decreasing dose of steroids at least 5 days prior to scanning OR recent resection (registration within 30 days of resection) as long as all of the following conditions are met Patients must have recovered from the effects of surgery Residual disease following resection of recurrent glioblastoma is not mandated for into the study; to best assess the extent of residual disease post-operatively, a post-operative MRI scan should be performed within 28 days prior to registration and within 96 hours post surgery (although 24 hours would be optimum) Prior radiation is required for the phase I* arm Patients must have completed a course of radiation therapy and at least 2 consecutive adjuvant cycles of temozolomide (phase II*) A stable or decreasing dose of steroids at least 5 days prior to scanning is not mandated for patients who had a recent resection | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 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): 21.0-999.0, Breast Cancer Female Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab AI therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue AI-associated musculoskeletal symptoms, defined as Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy Average pain of ≥4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory ECOG performance status 0-2 Willing and able to sign an informed consent document Known hypersensitivity to duloxetine or any of the inactive ingredients New musculoskeletal pain that is due specifically to fracture or traumatic injury Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by the Cockroft-Gault equation Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder Pregnant or breast feeding History of alcohol or other substance abuse or dependence within the year prior to enrollment Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Gastrointestinal Hemorrhage To be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena) Age under 18 Pregnancy Hemorrhage during hospitalisation red rectal bleeding No consent signed | 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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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 Cancer Non Small Cell Lung Cancer Prostate Cancer Colorectal Cancer Gastric Cancer Esophageal Cancer Cancer of Head and Neck Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck Have measurable disease defined by Response Evaluation in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants) Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Are willing to follow study procedures for the duration of the study Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment Have a serious preexisting medical condition that would preclude participation in the study Are pregnant or lactating Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG) Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to 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): 19.0-999.0, Infections Age 19 years and over Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will any patient who is other concomitant antibiotic(s) such as Vancomycin Subject admitted to SMH medical unit(s) Pregnant patient (or patients wishing to become pregnant) Age less than 19 years Granulocytopenia (< 1x109/L) Allergy or intolerance to meropenem or piperacillin-tazobactam Febrile Neutropenia Cystic Fibrosis | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 12.0-999.0, Clostridium Difficile Patients older than 12 months of age Having diarrhea Inadequate volume of sample to perform all three diagnostic tests (less than 3mL Formed stools | 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): 16.0-75.0, Peritonitis Malnutrition uremia patient under chronic peritoneal dialysis ≧ 3 months Age between 16 and 75 years uremia patient with advanced malignance disease uremia patient had more than 2 episode of G(+) peritonitis within the last one year uremia patient with expected life ≦ 1 years uremia patient with the history of drug or alcohol abuse uremia patient with poor drug compliance uremia patient with active infection disease uremia patient with uncontrolled autoimmune disease such as SLE | 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): 55.0-999.0, Diarrhoea Clostridium Difficile Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis. Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days | 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, Peritonitis Catheter-related Infections Renal Insufficiency years or older Renal insufficiency, stage V (HAS 2007 classification) Requires incident peritoneal dialysis No signs of peritoneal infection on signed consent affiliated with a social security system Patient will have a renal transplant in the upcoming year following dialysis Survival prognosis for one year is weak allergy to citrate, (cyclo)-taurolidine, or heparin patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine patient has a thrombopenia caused by heparin impossible to inform the patient correctly patient under guardianship patient already included in another biomedical research protocol no signed consent no social security system | 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, Stage 2-5 Chronic Kidney Disease Predialysis Male or female 21 years of age or older CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR <15 ml/min/1.73m2) Not receiving over-the-counter or prescription vitamin D therapy On a stable dose of phosphate binder (if any) for at least 1 month prior to the study History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies Use of corticosteroids, anticonvulsants or vitamin D compounds Use of an investigational agent within 30 days of study entry | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.167-3.0, Dehydration Cardiac Output Pediatrics patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration Patient has not successfully received oral or IV fluids immediately prior to enrollment patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration patient in shock or a life-threatening situation immunocompromised, history of abscess or cellulitis, abscess &/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (MRSA), family history of abscess or cellulitis requires IV therapy for another indication has an indwelling catheter has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment has a condition precluding sub-q injection or infusion site evaluation in the upper middle back area or at another elected site of infusion has a reason for hospital admission or extended ED stay other than dehydration has an known hypersensitivity to hyaluronidase or another ingredient in the formulation of Hylenex has a know hyponatremia < 130 milliequivalents per liter (mEq/L) or hypernatremia >155 mEq/L has a know hypokalemia <3.0 mEq/L | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Adult Alveolar Soft Part Sarcoma Adult Angiosarcoma Adult Desmoplastic Small Round Cell Tumor Adult Epithelioid Hemangioendothelioma Adult Epithelioid Sarcoma Adult Extraskeletal Myxoid Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Mesenchymoma Adult Malignant Peripheral Nerve Sheath Tumor Adult Rhabdomyosarcoma Adult Synovial Sarcoma Adult Unclassified Pleomorphic Sarcoma Chondrosarcoma Clear Cell Sarcoma of the Kidney Conjunctival Kaposi Sarcoma Dermatofibrosarcoma Protuberans Gastrointestinal Stromal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Osteosarcoma Ovarian Sarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Adult Unclassified Pleomorphic Sarcoma of Bone Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Kaposi Sarcoma Recurrent Osteosarcoma Recurrent Uterine Corpus Sarcoma Small Intestine Leiomyosarcoma Stage III Adult Soft Tissue Sarcoma Stage III Uterine Sarcoma Stage IV Adult Soft Tissue Sarcoma Stage IV Uterine Sarcoma Unclassified Pleomorphic Sarcoma of Bone Patients must have histologically or cytologically confirmed sarcoma All Patients must have measurable disease as defined by 1.1 Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) There is a minimum of 1 prior therapy; however, there are no minimum systemic therapy requirements for well differentiated or de-differentiated liposarcoma, clear cell sarcoma, chondrosarcoma, alveolar soft part sarcoma and chordomas which have no effective therapies; for Phase Ib, there are no maximum limits to number of prior therapies; for Phase II, there is a maximum of 5 prior chemotherapy regimens including tyrosine kinase inhibitors (TKI); the last dose of systemic therapy (including TKI) must have been given at least 2 weeks prior to initiation of therapy; patients receiving nitrosourea (such as BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy; patients receiving bevacizumab must wait at least 4 weeks; patients receiving experimental immunotherapy or antibody based therapies must wait a minimum of 4 weeks or 4 half-lives, whichever is longer; this should be discussed with the principal investigator before registration; tumor biopsies should be performed only after meeting these requirements; patients should recover to less than Common Terminology for Adverse Events (CTCAE) grade 2 toxicities related to previous therapies to be eligible Patients with metastatic or locally advanced (inoperable) gastrointestinal stromal tumor (GIST) must have progressed on imatinib and sunitinib or be intolerant to both drugs; the last dose of tyrosine kinase inhibitors imatinib or sunitinib should be given at least 2 weeks prior to initiation of therapy Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months following the procedure with no neurological signs or symptoms and no requirement for systemic glucocorticoids are eligible for study Patients must not have current evidence of another malignancy except non-melanoma skin cancer and superficial bladder cancer Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Hemoglobin >= 9 g/dl Patients may not receive other investigational agents within 2 weeks of enrollment in this study; patients treated with bevacizumab should be off therapy for 4 weeks; other experimental or immuno therapies should wait for 4 half-lives or 4 weeks, whichever is longer; prior exposure to Notch or Hedgehog inhibitors is not allowed; patients who have not recovered to less than CTCAE grade 2 from prior therapies are ineligible History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or RO4929097 used in the study Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible; patients on warfarin may be considered for enrollment after cessation of warfarin and appropriate transition to alternate anti-coagulation agents Preclinical studies indicate that RO4929097 is a substrate of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and inducer of CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk; the following medications with strong potential for interaction are not allowed: indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone Caution should be exercised when dosing GDC-0449 concurrently with medications that are substrates of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8), CYP2C9, and CYP2C19 and have narrow therapeutic windows; caution should be exercised when dosing GDC-0449 concurrently with inhibitors of CYP3A4 Patients must be able to swallow pills; patients with malabsorption syndrome or other condition that would interfere with intestinal absorption Patients with clinically active liver disease, including active viral or other hepatitis or cirrhosis, are ineligible Patients with uncontrolled electrolyte abnormalities including hypophosphatemia, hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia or defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, a history of torsades de pointes or other significant cardiac arrhythmias that require antiarrhythmics or other medications known to prolong corrected QT interval (QTc); psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with GDC-0449 and/or RO4929097 | 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, Bacterial Infection Patients with bacterial infection receiving FOM for clinical purposes will be included into the analysis | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-30.0, Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome Hypodiploid B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 B-ALL patients must have an initial white blood cell count < 50,000/uL Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932 Patients receiving prior steroid therapy may be eligible for AALL0932 Patients with central nervous system 3 (CNS3) leukemia CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy B-ALL patients with testicular leukemia are not eligible for AALL0932 For B-LLy patients the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Atypical Hemolytic-Uremic Syndrome Patient must be willing and able to give written informed consent. 2. Patient's age > 18 years. 3. Patients exhibit thrombocytopenia, hemolysis and elevated Serum Creatinine. 4. Patients with diagnosis of aHUS with or without an identified complement regulatory protein genetic abnormality or anti-complement factor antibody and for whom etiologies of hemolytic uremic syndrome have been ruled out as confirmed in the 5. Female patients of childbearing potential must be practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period. At the time of the last follow-up visit, patients must agree to continue to use adequate contraception methods for up to 5 months following discontinuation of eculizumab treatment. 6. Able and willing to comply with study procedures 1. Chronic dialysis. 2. Prior eculizumab use or hypersensitivity to eculizumab, to murine proteins or to one of the excipients. 3. Known familial a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) deficiency (ADAMTS-13 <5%). 4. Typical Hemolytic-Uremic Syndrome (HUS) (known Shiga toxin +). 5. History of malignancy within 5 years of screening. 6. Known human immunodeficiency virus (HIV) infection. 7. Identified drug exposure-related hemolytic-uremic syndrome (HUS). 8. Infection-related HUS. 9. HUS related to bone marrow transplant (BMT). 10. HUS related to vitamin B12 deficiency. 11. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome. 12. Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive. 13. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease. 14. Pregnancy or lactation. 15. Unresolved systemic meningococcal disease. 16. Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 17. Patients receiving chronic intravenous immunoglobulin (IVIg) within 8 weeks or chronic Rituximab therapy within 12 weeks of screening visit. 18. Patients receiving other immunosuppressive therapies such as steroids, mechanist target of rapamycin (mTOR) inhibitors, calcineurin inhibitors (e.g., cyclosporine or tacrolimus) are excluded unless: [1] part of an established post-transplant anti-rejection regime, or [2] patient has confirmed anti-Complement Factor Antibodies requiring immunosuppressive therapy, or [3] steroids are being used for a condition other than aHUS (example asthma). 19. Participation in any other investigational drug trial or device trial, or procedures beginning 4 weeks prior to screening and throughout the entire 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): 0.5-6.0, Diarrhea Gastroenteritis Healthy Children with non-bloody diarrhea illness defined as loose or watery stools Symptoms must be present for greater than 24 hours but less than 72 hours Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6 months), Diabetes may be enrolled in the study Children with symptoms less than 24 hours Children with symptoms greater than 24 hours Failure to thrive G or J tube Major surgery within last 3 months Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month Followed by GI service for any reason (crohns, ulcerative colitis, constipation) Developmental delay, patient >1 year behind milestones Current brain tumor Currently being treated for cancer or in remission < 6 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Recurrent Clostridium Difficile Infection Age 18 years or older 2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy 3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture 4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 5. Understand the nature and purpose of the study including potential risks and side effects 6. Willing to comply with the requirements of the study History of 2 or more clostridium difficile infections at any time prior to the current episode 2. Presence of severe chronic and/or inflammatory condition 3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy 4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer 5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition 6. Use of proton pump inhibitors 7. Pregnant female or breastfeeding 8. Eating disorder 9. History of alcohol, drug, or medication abuse 10. Daily consumption of probiotics, fermented milk, and/or yogurt 11. Known allergies to any substance in the study product 12. Participation in another study with any investigational product within 3 months of screening | 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): 20.0-999.0, End Stage Renal Disease Peritoneal Dialysis Male or female subjects at least 20 and older at that time of obtaining informed consent Subjects performing CAPD or APD Subject with a total Kt/V≥ 1.7 at baseline Subjects who have undergone abdominal surgery within the last 30 days except for PD catheter insertion Subjects who is planned for renal transplantation or hemodialysis within 1 year following the date of informed consent Subjects who have received antibiotics for the treatment of peritonitis, exit-site or tunnel infection within the last 30 days Subjects who have active liver disease such as cirrhosis of the liver, active hepatitis or other active liver disease as evidenced by biopsy, laboratory (unstable liver enzymes over the last 90 days) or clinical examination | 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, Breast Cancer Histologically proven primary invasive breast carcinoma. 2. Tumor pathologically determined <= 5cm in diameter. 3. Single, discrete, well-defined primary tumor. 4. Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications. 5. Pathologically negative surgical margins. 6. Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling. 7. ECOG performance status 0-2. Contraindications: 1. Multicentric disease and/or diffuse malignant appearing microcalcifications. 2. Evidence of metastatic breast cancer. 3. Axillary lymph node involvement. 4. Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy. 5. Prior irradiation to the ara of planned radiation field. 6. Pregnant or lactating 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): 18.0-999.0, End Stage Renal Disease >18 2. Usually used heparin with HD Plt <100 2. Pregnancy 3. H/o bleeding diathesis 4. H/o CVA 5. Pt on Ticlid/plavix/warfarin 6. SBP >200 7. PTT>50 8. INR>1.6 | 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, Dialysis Intolerance Criteria:Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months aged more than 18 years on chronic thrice-weekly HD symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment dialysis session time: 4 hours (as much as possible) Signed inform consent form Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min) Patients in a pregnant state Patients whose life expectancy is less than study period Patients with progressive acute pathology (neoplasia…) Patients included in an other protocol Psychiatric patients or patients unable to consent or unable to follow the study | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, HIV Infection Recurrent Anal Cancer Recurrent Breast Cancer Recurrent Esophageal Cancer Recurrent Gastric Cancer Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Non-small Cell Lung Cancer Recurrent Ovarian Epithelial Cancer Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Salivary Gland Squamous Cell Carcinoma Stage IV Anal Cancer Stage IV Breast Cancer Stage IV Esophageal Cancer Stage IV Gastric Cancer Stage IV Non-small Cell Lung Cancer Stage IV Ovarian Epithelial Cancer Stage IV Salivary Gland Cancer Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IV Verrucous Carcinoma of the Larynx Stage IV Verrucous Carcinoma of the Oral Cavity Unspecified Adult Solid Tumor, Protocol Specific Patients must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and is therefore incurable; although the focus of this trial will be on upper aerodigestive cancers (non-small cell lung cancer, head and neck squamous cell carcinoma, and non-gastroesophageal junction esophageal cancer), patients with other incurable solid tumor with disease potentially sensitive to carboplatin and/or taxanes (including but not limited to salivary gland cancer, gastric cancer, breast cancer, ovarian cancer, or anal cancer, BUT excluding Kaposi sarcoma), will be eligible Up to 1 prior systemic therapy regimen will be permitted for palliative treatment of metastatic or unresectable relapsed disease; however, previous chemotherapy delivered with curative-intent (i.e., chemoradiotherapy or adjuvant [postoperative] chemotherapy at a time disease was considered potentially curable) will be permitted; prior taxane (including paclitaxel or docetaxel) and/or platinum exposure will be permitted; however, patients must not experience disease progression within 3 months of platinum-based therapy; at least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C; toxicities from prior anticancer therapy must have recovered to =< Grade 1 Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive Western Blot, or any other federally approved licensed HIV test; a positive HIV viral load prior to study entry will also be permitted Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%) Documented life expectancy of greater than 12 weeks Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Total bilirubin within normal institutional limits Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal 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 (toxicities not improved to =< Grade 1) due to agents administered more than 4 weeks earlier; additionally, patients experiencing disease progression within 3 months of platinum-based therapy will be excluded from trial participation Due to availability of effective first and second-line therapies (as well as disease-specific clinical trials), patients with diagnosis of active Kaposi sarcoma will be excluded from study participation; however, persons with other active malignancy with prior history of Kaposi sarcoma can be considered for participation at the discretion of the Study Chair Patients may not be receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents used in study (including hypersensitivity to paclitaxel, Cremophor, or platins) For subjects assigned to take vorinostat, inability to take oral medications; vorinostat capsules must be administered whole; note: this criterion does NOT apply to subjects treated on the Expansion Cohort (accruals post February 1, 2013) As ketoconazole may inhibit paclitaxel metabolism, patients receiving ketoconazole for any treatment indication are ineligible; patients receiving any other medications or substances that are inhibitors or inducers of CYP450 enzymes will be eligible; however, use all such medications or substances must be documented in the Case Report Forms For subjects assigned to take vorinostat, prior exposure to vorinostat or other known histone deacetylase (HDAC) inhibitors for cancer therapy; patients should not have taken valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior to study enrollment; note: this criterion does NOT apply to subjects treated on the Expansion Cohort (accruals post February 1, 2013) Since zidovudine and stavudine have potential for severe hematological toxicity potentially overlapping with toxicities of the study therapy, treatment with these agents will be disallowed | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-1.0, Rotavirus Gastroenteritis Healthy child aged 6 to 12 months, families resident in the study area, willing to participate and available for follow up for a period of one year Normal birth weight (> 2.5 kg), child exclusively breast fed for at least four months Families not available for a follow up period of one year Children with any atopic conditions Children with gross congenital anomalies including cardiovascular, renal or hepatic disease Children with syndromic or serological evidence of 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): 20.0-60.0, Chronic Hepatitis C for Study Group Men and women between the ages of 25 and 55 Diagnosis of chronic hepatitis C for Study Group Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates Has acute hepatitis C infection Has chronic hepatitis B infection Had gastric bypass surgery Has chronic kidney disease for Control Group Men and women between the ages of 20 and 60 Has a body mass index (BMI) between 20 and 35 for Study Group Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates | 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): 0.25-18.0, Diarrhea Children with suspected severe Salmonella enterocolitis defined as those with a high fever (core body temperature ≥ 38.5℃) persisting for longer than 48 hours diarrhea with mucous and bloody-tinged stool Children with a toxic appearance, severe vomiting and abdominal distension suggestive of sepsis or toxic megacolon, those with an increased risk of invasive NTS diseases immunosuppressive illnesses had taken antibiotics during the 7 days before the 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): 18.0-999.0, End Stage Renal Disease ≥ 18 years of age Incident or prevalent patients with End Stage Kidney disease treated with either CAPD (continuous ambulatory peritoneal dialysis) or CCPD (continuous cycling peritoneal dialysis) Patients must maintain modality of either CAPD or CCPD throughout duration of study Able to provide informed consent Pregnant or lactating women Recent (< 3 months) history of peritonitis CCPD utilizing Baxter cycler (due to inability to connect Delflex solution to cycler) Anticipated renal transplant within 6 months of 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): 3.0-18.0, Antibiotic Associated Diarrhea Clostridium Difficile Infection Gastroenteritis years of age Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older Available throughout the study period No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used) Subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol Three or more soft and unformed or watery stools per day at admission Receiving chemotherapy or radiation therapy Diagnosis of inflammatory bowel disease Enteral or parenteral nutrition only Requiring care in an intensive care unit Status post-bowel resection during hospitalization Receiving antibiotics four weeks prior to hospitalization Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases) Pregnancy Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Infection Hospitalized pediatric oncology patients Patients under vancomycin treatment | 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): 25.0-89.0, Pneumococcal Infection Able to understand and give informed consent. 2. Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years Prior vaccination with pneumococcal vaccine. 2. Receipt of any of the following products: 1. Blood products within 3 months prior to study entry or expected receipt at any time after study entry*. 2. Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*. 3. Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria** Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids*** (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids**** or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency. 4. Conditions that could affect the safety of the volunteers such as: o Severe reactions to prior vaccinations. o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80) History of Guillain-Barré syndrome History of bleeding disorders. 5. Volunteers with any acute illness* including, but not limited to fever (> 100.4 F [> 38 C], regardless of the route) within 3 days prior to study entry. 6. Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation. 7. Pregnant or breast feeding or women expected to conceive within 30 days after vaccination ***** An individual who initially is excluded from study participation based on one or more of the time-limited (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria Grade 4 hypertension per CTCAE is defined as Life threatening consequences(e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) urgent intervention indicated. ***Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 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): 18.0-999.0, Clostridium Difficile Colitis ICU patient positive c. diff PCR or visualization of pseudomembranes on colonoscopy able to give consent or have representative to give consent ability to drink contrast or have a previously placed nasogastric tube approval from the intensivist on duty/ICU Attending physician Under age 18 pregnant need for gastric motility medications need for anti-diarrheal medication need for surgery previous small bowel or gastric surgery inability to drink nuclear tracer without nasogastric tube in place hypotension requiring vasoactive agents II score greater than 30 | 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): 33.0-88.0, Type 2 Diabetes Mellitus Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0). 2. Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2). 3. Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place). 4. Was receiving specific diet and exercise (if any) therapies during the observation period Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0). 2. Had a history or symptoms of cardiac failure | 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): 20.0-64.0, Type 2 Diabetes Mellitus Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12). 2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0). 3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4). 4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place). 5. Was receiving specific diet and exercise (if any) therapies during the observation period Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0) | 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): 26.0-64.0, Type 2 Diabetes Mellitus Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0). 2. Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4). 3. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place). 4. Was receiving specific diet and exercise (if any) therapies during the observation period Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). 2. With a history or symptoms of lactic acidosis | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Infection Bacteremia Patients with probable or definite diagnosis of uncomplicated gram positive bacteremia that have at least one positive blood culture including 20 patients with Staphylococcus aureus and the other 20 patients will any of the following organism ( CNS, Enterococci, streptococci, pneumococci, Corynebacterium, and Propionibacterium or Bacillus species).If the positive blood culture involves a commensal skin organism such as CNS, Corynebacterium, Propionibacterium, Micrococcus and Bacillus, then at least > 100 colonies/ml will be required or a time to positivity =/< 16 hours (as it has been shown to reflect a high grade bacteremia), or two positive blood cultures. (Time to positivity of a blood culture bottle is recorded in the microbiology laboratory by the automatic culture detector (Bactec 9240 and Bactec Plus Aerobic/F; Becton Dickinson) which records culture positivity every 15 min according to changes in fluorescence related to microbial growth). 2. Patients must have at least two signs of sepsis from the list below, in any combination at any time, within 48 hours prior to Telavancin therapy: a. Core temperature =/>38.0 degrees C or =/<36.0 degrees C, measured orally, rectally, tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the measured temperature; b. Pulse rate =/> 100 beats/min.; c. Respiratory rate =/> 20/min.; d. WBC count =/>12,000/mm^3, =/<4,000/mm or differential count showing >10% band forms; e. Systolic blood pressure =/<90 mm Hg. Patient will still be eligible for the study if the participants white blood cell count (WBC) is outside normal limits due to chemotherapy treatment or underlying conditions. 3. Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years. 4. Signed informed consent. 5. Female patients must be at no risk for pregnancy for one of the following reasons: - Postmenopausal for at least one year Post-hysterectomy and/or post-bilateral ovariectomy If of childbearing potential, having a negative serum human chorionic gonadotropin (hCG) pregnancy test with in 5 days prior to enrollment and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula using ideal body weight) at the time gram positive bacteremia was diagnosed unless the patient is on dialysis. 2. Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was diagnosed. 3. Treatment with an antibiotic, such as vancomycin, linezolid, tigecycline or Telavancin, effective against resistant gram positive bacterial infections, such as methicillin resistant staphylococci, for more than 48 hours within 72 hours of study medication initiation, unless treatment failed that is defined as a persistent fever and/or leukocytosis for 72 hours or longer of appropriate antibiotics treatment. 4. History of hypersensitivity to lipoglycopeptides. 5. Presence of deep-sited intravascular source of infection with same organism cultured from blood, e.g. endocarditis (as evidenced by vegetations on an echocardiogram), or septic thrombosis. 6. Presence of a prosthetic valve. 7. Oliguria defined as urine output of <20 cc/hour averaged over 24 hours | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Hemorrhagic Stroke Patients who confirmed diagnosis of first spontaneous hemorrhagic stroke Patients with hemorrhagic stroke in Putamen Patients who admitted to the hospital within 24 hours of onset of hemorrhagic stroke Patients who signed the informed consent form Patient with hemorrhage in the area out of Putamen or primary subarachnoid hemorrhage, Arteriovenous malformation (AVM) or brain tumor hemorrhage Patient who performed craniotomy Patient who suffering from cirrhosis, uremia with dialysis, bleeding tendency, severe cardiopulmonary disease or mental disorders would be unable to comply with the study by investigators' decision Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening Female patients are pregnant or breast-feeding | 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, Colitis SICU patient positive c. diff toxin assay visualization of pseudomembranes on colonoscopy able to give consent or have representative to give consent Under age 18 pregnant absence of a colon or surgical discontinuity of bowel allergy to vancomycin need for anti-diarrheal medication need for prolonged antibiotics for other cause need for probiotics need for other medications with action against C. diff need for surgery, colon perforation recent IV IG use | 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, Uremia Inflammation Patients receiving maintenance hemodialysis or continuous ambulatory peritoneal dialysis, and dialysis vintage more than 3 months Patients aged between 18 and 80 years older VitC < 4ug/ml and hsCRP > 3mg/L for HD patients, Kt/V > 1.2 per session, at least 3 sessions per week, 4 hours per session for PD patients, Kt/V > 1.7 per week age and gender matched health control Active autoimmune disease, malignancy, hepatitis Positive HIV serology Any kind of acute infection within one month, chronic infection Currently using steroids or immune-suppressants Pregnancy or breast feeding | 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 Renal Insufficiency Acute Renal Failure Age between 18-80 years, informed consent Groups 1a, 1b, 2a, 2b, 3a, 3b Patients with chronic kidney disease as defined previously [65] either 1a) with an eGFR between 30 and 45 (KDIGO 3B) 1. b) with an eGFR between 15 and 30 (KDIGO 4) 2. a) undergoing hemodialysis for ESRD 2b) undergoing hemodiafiltration for ESRD 3a) undergoing peritoneal dialysis for ESRD without signs of infection 3b) undergoing peritoneal dialysis for ESRD with peritonitis ≥2 out of the 4 (>100 leucocytes/50%neutrophils, cloudy peritoneal dialysate, typical clinical presentation with fever and abdominal pain, positive culture from the peritoneal dialysate) Group 4 Patients with acute kidney injury (AKIN 3 [66] defined as an increase in serum creatinine to 300% (3-fold) from baseline or serum creatinine 4.0 mg/dl with an acute rise of at least 0.5mg/dl or urine output of < 0.3ml/kg/h 24h or anuria 12h) Initiation of acute renal replacement therapy Group 5 Stable patients after kidney transplantation with either an eGFR > 45, between 30 and 45 or < 30 Group 6: Healthy controls Malignancy, pregnancy,chronic inflammatory bowel disease, celiac disease, active alcohol abuse, any severe organ dysfunction unrelated to renal dysfunction Groups 1a, 1b, 2a, 2b, 3 Organ transplantation Clinical evidence of active infection (except for group 3b) Treatment with antibiotics within the last 2 weeks (except for group 3b) Group 4 Preexisting ESRD Group 5 Clinical evidence of active infection Treatment with antibiotics within the last 2 weeks Group 6: Any evidence of acute or chronic disease | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Congestive Heart Failure Ambulatory. 2. Chronic systolic heart failure ≥ 12 months. 3. NYHA II IV for at least 45 of the last 60 days. 4. Last documented left ventricular ejection fraction ≤ 35% by any imaging modality. 5. Age 18 years. 6. Under the care of a cardiologist at study site. 7. On appropriate evidenced -based heart failure medications ACE inhibitor, ARB or sacubitril/valsartan [LCZ-696]; beta blocker; aldosterone antagonist; hydralazine/long-acting nitrate [required of African-American subjects only] for ≥ 3 months absent contraindications or intolerances. 8. Has ICD or CRT-D. If CRT-D, present for ≥ 3 months. 9. Demonstrated advanced heart failure, including any one of the following*: i. Serum sodium ≤ 135 mEq/L (obtained as an outpatient)** ii. Serum BNP ≥ 750 pg/mL or NT-proBNP ≥ 3000 pg/mL** (obtained as an outpatient) iii. Seattle Heart Failure Model (SHFM) one year predicted survival ≤ 85%** iv. Heart Failure Survival Score (HFSS) ≤ 7.19** v. Peak VO2 ≤ 55% of predicted for age by Wasserman equation or ≤ 14 ml/kg/min, with RER ≥ 1.05*** vi. VE/VC02 slope > 40*** vii. 6 minute walk test (6MWT) distance ≤ 350 m without significant non-cardiac limitation** viii. Currently listed as Heart Transplant Status II due to heart failure limitation Or History of one (1) hospitalization (≥ 24 hours) for acute or acute on chronic heart failure in the past year with additional history to i. Serum BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL** (obtained as an outpatient) Or History of two (2) hospitalizations (≥ 24 hours) for acute or acute on chronic heart failure in the past year. * Qualifying measure must be the most recent of that type of measure obtained (i.e., a BNP ≥ 1000 obtained 2 months prior would not qualify the heart failure subject if a more recent BNP was < 1000) **Using values obtained within the prior 90 days, except for peak VO2 within 365 days ***Obtained within the prior 365 days 10. Willingness to continue to receive heart failure care from the enrolling advanced heart failure clinic over the next two (2) years and to come for all scheduled study visits. 12. Written Informed consent given Known serious medical problem other than heart failure that would be expected to limit 2-year survival (≥50% mortality within 2 years from non-heart failure diagnosis). 2. Patient is not likely to be compliant with the protocol, in the opinion of the Investigator. 3. Currently hospitalized. 4. Current use of an intravenous inotrope. 5. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival. 6. Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment. 7. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality. 8. Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient. 9. Cardiac conditions that are amenable to surgical or percutaneous procedures (other than VAD or transplant) that would substantially improve prognosis and for which this subject is a reasonable candidate, regardless of whether the procedure will or will not be performed. 10. Uncorrected hyperthyroidism or hypothyroidism. 11. 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): 40.0-999.0, Knee Osteoarthritis Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle: 2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3 3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study Clinically significant apparent large effusion of the target knee; 2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator; 3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease 4. Medical history of anaphylactic reactions 5. History of septic arthritis in any joint 6. Females who are pregnant or breast-feeding | 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 patients with recurrent CDI that have failed standard therapy critically ill patients | 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): 18.0-95.0, SIRS Sepsis Severe Sepsis Septic Shock Age> = 18 years Patient hospitalized in ICU with a diagnosis of SIRS Temperatures above 38 ° C or below 36 ° C At least one other criterion from Heart rate> 90 bpm Respiratory rate above 20 breaths / min or PaCO2 <32 mmHg Leukocytosis greater than or less than 4000/mm3 12000/m3 Patient admitted in intensive care for less than 12 hours Patient does not preclude its participation in the study Decision to limit treatment before potential in the study No affiliation to a social security scheme (beneficiary or assignee) | 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): 13.0-999.0, Tuberculosis HIV Infections HIV-1 infection Tuberculin skin test (TST) reactivity greater than or equal to 5 mm or a positive interferon gamma release assay (IGRA) at any time prior to study entry, OR living in a high TB burden area. More information on this criterion can be found in the protocol Laboratory values obtained within 30 days prior to study entry: 1. Absolute neutrophil count (ANC) greater than 750 cells/mm^3 2. Hemoglobin greater than or equal to 7.4 g/dL 3. Platelet count greater than or equal to 50,000/mm^3 4. AST (SGOT) and ALT (SGPT) less than or equal to three times the upper limit of normal (ULN) 5. Total bilirubin less than or equal to 2.5 times the ULN Chest radiograph or chest CT scan without evidence of active tuberculosis, unless one has been performed within 30 days prior to entry Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days prior to study entry. More information on this criterion can be found in the protocol All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive while receiving RPT and for 6 weeks after stopping this drug. More information on this criterion can be found in the protocol Weight of greater than or equal to 30 kg Participant or legal guardian is able and willing to provide informed consent Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior to study entry or, at screening, presence of any confirmed or probable TB based on listed in the current ACTG Diagnosis Appendix History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDR TB) at any time prior to study entry Treatment for more than 14 consecutive days with a rifamycin or more than 30 consecutive days with INH at any time during the 2 years prior to enrollment For participants taking antiretroviral therapy (ART) at study entry, only approved nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) or nevirapine (NVP) for at least 4 weeks were permitted History of liver cirrhosis at any time prior to study entry Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to study entry Diagnosis of porphyria at any time prior to study entry Peripheral neuropathy greater than or equal to Grade 2 according to the December 2004 (Clarification, August 2009) Division of AIDS (DAIDS) Toxicity Table, within 90 days prior to study entry Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Subjects of either sex, aged 18 years or older at time of randomization. 2. Subjects diagnosed with ESRD (glomerular filtration rate [GFR] ≤ 15 mL/min/m2 body surface area [BSA]) and predicted by the investigator to need dialysis therapy within 10 weeks after the pre-screening period. 3. Subjects who, as judged by the investigator, are able to comprehend the pre-defined, standardized, modality education program and have undertaken this education during the screening period. 4. Subjects, or their legal representative, who, as judged by the investigator, are capable of being trained for home-based PD. 5. Subjects, or their legal representative, who are able to understand and voluntarily sign an ICF. 6. Subjects who are able to adhere to the study visit schedule and other protocol requirements. 7. Subjects who are able to regularly visit a HD center for HD therapy (≥ 3 times per week). 8. Subjects who, as judged by the investigator, are expected to remain on dialysis for at least 48 weeks. 9. Subjects who have normal liver function, as judged by the investigator. 10. Female subjects of childbearing potential who have a negative serum or urine pregnancy test at screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the investigator, while in the study Subjects who are HIV positive. 2. Subjects who have already received a permanent PD catheter or HD access that is intended for permanent use before receiving modality education or have already received permanent dialysis. Subjects are not excluded if an access is present within 4 weeks before screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities, or fluid overload. 3. Subjects who have a serious, uncontrolled medical disorder or active infection, which, as judged by the investigator, would jeopardize their ability to receive the prescribed dialysis treatment. 4. Subjects who have dementia or a mental status that would significantly affect the subject's understanding of the Informed Consent Form (ICF). 5. Subjects who are pregnant, intend to become pregnant during the study period, or are breast-feeding. 6. Subjects with a history of drug (defined as illicit drug use) or alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) abuse in the 2 years before screening. 7. Subjects who have previously received renal transplantation and are still being prescribed immunosuppressive therapy. 8. Subjects who are currently using or have used an investigational product within five half-lives of the physiological action or 30 days, whichever is longer, before screening. 9. Subjects who are unwilling or expected to be unable to fully comply with the visits and assessments required by the protocol. 10. Subjects who have previously been randomized in this study. 11. Subjects who are not eligible for either PD or HD, as judged by the investigator, due to: PD: documented extensive intra-peritoneal adhesions or other condition contraindicated for PD. HD: severe cardiac instability or other condition contraindicated for HD. 12. Subjects who have a serious or acute condition that, as judged by the investigator, would preclude participation in the study. 13. Subjects who have a malignancy requiring chemotherapy or radiation therapy. 14. Subjects undergoing temporary dialysis treatment between the screening visit and Day 1 that is expected to exceed 6 weeks in duration. 15. Subjects who have a life expectancy of less than 48 weeks | 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, Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min Absolute neutrophil count >= 1000/mL Untransfused platelet count >= 75000/mL Hemoglobin >= 8.0 g/dL Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens Measurable disease of multiple myeloma as defined by at least ONE of the following Serum monoclonal protein >= 1.0 g/dL >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis Recent prior chemotherapy Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration Anthracyclines =< 14 days prior to registration High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide) =< 7 days prior to registration Prior therapy with any proteasome inhibitor other than bortezomib or carfilzomib Concomitant high dose corticosteroids other than what is part of treatment protocol (concurrent use of corticosteroids); patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, i.e., adrenal insufficiency, rheumatoid arthritis, etc Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection Any of the following Pregnant women or women of reproductive ability who are unwilling to use 2 effective methods of contraception from the time of signing the informed consent form through 90 days after the last dose of study drug Nursing 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): 16.0-999.0, Vancomycin Therapy All patients in general wards requiring routine treatment with vancomycin GFR < 30mL/min(as measured by Cockcroft Gault equation) Age < 16 yrs Weight > 200kg Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc) Vancomycin infused at a rate other than 500mL/min | 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 (ESRD) Chronic Kidney Disease (CKD) Age 18 or older End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years Self-reported as African-American English Speaking Dementia Prior Kidney Transplant Non-English Speaking Cancer within 2 years prior to recruitment date Stage 4 Congestive Heart Failure End Stage Liver Disease Unstable Coronary Artery Disease Pulmonary Hypertension Severe Peripheral Vascular Disease Chronic Debilitating Infections | 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): 20.0-80.0, Fatty Liver ESRD patients undergoing maintenance HD or PD for more than 6 months 2. Age>20 Recent hospitalization duet active medical or psychiatric problems 2. Active malignancy 3. Patient refusal | 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): 18.0-79.0, Irritable Bowel Syndrome Meet Rome III for IBS and have no red flags Must have had a colonoscopy within the previous 5 years to inflammatory or other bowel disease Be fluent and literate in English Must either be of non-childbearing potential or agree to utilize approved birth control for the duration of the study Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening Any other diagnosis to explain the abdominal pain Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or any disease that may interfere with the subject successfully completing the trial Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >3 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL) Has disease affecting electrolytes balance, such as SIADH with serum Sodium less than 130mmol/L Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year Any surgery on the stomach, small intestine or colon, excluding appendectomy A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 1 year History of attempted suicide or uncontrolled bipolar disorder Currently using antidepressants for psychiatric conditions like major depression. Use of TCA or SSRI class antidepressant acceptable if being used specifically for treatment of bowel symptoms and patient is willing to taper off the medication | 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): 7.0-21.0, C. Difficile Infection Aspirate at colonoscopy positive for C. diff Any gender Any race Age between 7-21 Greater than 21 kg Able to swallow pills Abdominal tenderness and distention with minimal diarrhea History of inflammatory bowel disease Fever Systemic toxicity or allergy to metronidazole Short bowel syndrome History of bowel resection vii History of abdominal surgery (excluding appendectomy or cholecystectomy) History of hirschsprungs disease x Pregnant Inability to participate in phone surveys | 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, Diabetic Nephropathy Age > 18 years Evidence of CKD Stages II, III or IV Stage II CKD; eGFR 60-89 ml/min Stage III CKD: eGFR 30-59 ml/min Stage IV CKD: eGFR 15-29 ml/min Proteinuria (>200 mg/day or 300 mg/gm creatinine on a spot urine) on urinalysis on two occasions within 18 months of recruitment Diagnosis of diabetes and receiving at least one medication for diabetes mellitus HbA1c>6.5% Age <18 Patients receiving active treatment for hyperphosphatemia Biopsy proven renal disease other than diabetic nephropathy Hypophosphatemia Hypercalcemia Any history of significant gastrointestinal disorders Any history of significant gastrointestinal surgery such as ileostomy, colostomy and colectomy | 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, Intraventricular Hemorrhage Intracerebral Hemorrhage Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the neurosurgical intensive care unit Age greater than 18 years No evidence of ischemic cerebrovascular injury Concomitant traumatic brain injury Antibiotics on admission to the NICU Immunocompromised by chemotherapy or HIV positive or patient with neutropenia (ANC <1000) Women who are pregnant and/or of childbearing age where a pregnancy test has not already occurred | 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 Diarrhoea Lymphocytic Colitis Collagenous Colitis Patients with chronic non-bloody diarrhea for at least one month Patients who decline to participate Unable to give informed consent | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Participant has a diagnosis of CDI defined as: a) presence of diarrhea (passage of 3 or more loose stools in 24 or fewer hours); and b) positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion Participant is receiving SOC therapy (i.e., oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole) for CDI Participant is highly unlikely to become pregnant or to impregnate a partner by meeting at least one of the following a) females not of reproductive potential (i.e., one who has either (1) reached natural menopause, defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range, or 12 months of spontaneous amenorrhea not including cases with an underlying disease, such as anorexia nervosa, that causes amenorrhea; (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation); or b) participants of reproductive potential who agree to remain abstinent or use (or have their partner use) two acceptable methods of birth control (i.e., intrauterine device [IUD], diaphragm with spermicide; contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or progestational agent including oral, subcutaneous, intrauterine, or intramuscular agents) starting at enrollment and throughout the 12-week study Participant with an uncontrolled chronic diarrheal illness such that their normal 24-hour bowel movement habit is 3 or more loose stools Participant with planned surgery for CDI within 24 hours Female participant with a positive pregnancy test in the 48 hours before infusion and pre-menopausal females who are not sterilized and therefore have the potential to bear a child who are unwilling to undergo pregnancy testing Female participant breast feeding or planning to breast feed before completion of the 12-week study Female participant planning to donate ova before completion of the 12-week study and male participants planning to impregnate or donate sperm before completion of the 12-week study Participant has previously participated in this study, has previously received MK-3415 or MK-6072 (either alone or in combination), has received a C. difficile vaccine, or has received another experimental monoclonal antibody against C. difficile toxin A or B Participant plans to donate blood and/or blood products within 6 months after infusion Participant has received immune globulin within 6 months before infusion or is planning to receive immune globulin before completion of the 12-week study Treatment with SOC therapy is planned for longer than 14 days Participant has received more than a 24-hour regimen of cholestyramine, colestimide, rifaximin, or nitazoxanide within 14 days before infusion or plans to receive these medication before completion of the 12-week study period | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Urothelial Carcinoma of the Bladder Pure or mixed variant urothelial carcinoma o Allowable mixed variant subtypes squamous differentiation glandular differentiation nested pattern microcystic micropapillary lymphoepthelioma-like plasmacytoid and lymphoma-like sarcomatoid/carcinosarcoma giant cell trophoblastic differentiation clear cell lipid cell undifferentiated Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks Pathologic T3 or higher stage disease, N0-2, M0 (AJCC, 7th Ed., Appendix C) No clinical evidence of residual or recurrent disease based on the following minimum diagnostic work-up within 8 weeks of a patients consent to participate History and physical examination Chest imaging by x-ray (PA and lateral views) or CT scan (with or without IV contrast) Axial abdominal and pelvic imaging by MRI (preferably with gadolinium) Bone scan Patients with microscopically involved (positive) surgical margins, but no grossly evident residual disease by imaging or physical exam are eligible. The patient is a candidate for definitive external beam radiotherapy No prior radiotherapy to the region of study No inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist; Age ³18 years ECOG performance status: 0-2 Concurrent noninvestigational medications will be permitted Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are preformed (this does not routine laboratory testing or imaging studies required to establish study eligibility) Unstable renal function in the month prior to registration defined as a creatinine rise of 1 mg/dL Prior partial or complete small bowel obstruction either before or after radical cystectomy Prior radiotherapy to the pelvis; o Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participants prior and current course of radiation therapy, radiotherapy was completed more than four weeks from enrolling in this study. Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments o Prior chemotherapy or investigational drug for bladder cancer or a different cancer is allowed, provided that: The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation The participant has recovered to Grade 1 toxicity from agents previously administered Subtotal surgical resection with clinically evident residual disease by physical exam or axial imaging. Prior or concurrent second invasive malignancy other than prostate and non-melanoma skin cancers, unless disease free for a minimum of five years. If a patient had a concurrent prostate cancer, then it must have been resected to negative margins. Known severe, active co-morbidity, defined as follows: o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patients ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results | 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, Atypical Hemolytic-Uremic Syndrome Male or female patients of any age, including minors, who have been diagnosed with aHUS Patients with or without an identified complement pathogenic variant or anti-complement factor antibody Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)] > 5%, if performed Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]) | 0 |
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