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Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, ESRD Hyperkalemia End Stage Renal Disease Subjects on stable hemodialysis for more than 90 days Age 18-85 years Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than 2 occasions during the previous 3 months Use of pre or probiotics during the past 2 months Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic Presence of chronic wound infection and osteomyelitis Inflammatory bowel disease, chronic diarrhea, current C. difficile infection Liver cirrhosis or chronic active hepatitis Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone > 10 mg in the last 3 months Anticipated kidney transplant within 9 months Expected survival < 9 months Pregnancy, anticipated pregnancy, or breastfeeding | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, Cerebral Hemorrhage Brain Hemorrhage Cerebral Parenchymal Hemorrhage Intracerebral Hemorrhage Patient age ≥ 18 and ≤ 80 2. Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method) 3. Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis) 4. NIHSS ≥ 6 5. GCS ≥ 5 and ≤ 15 6. Historical mRS 0 or 1 7. Symptom onset < 24 hours prior to initial CT/MR 8. MIS must be initiated within 72 hours of ictus/bleed 9. SBP must be < 180 mmHg and controlled at this level for at least 6 hours Imaging 1. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage 2. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm 3. Hemorrhagic conversion of an underlying ischemic stroke 4. Infratentorial hemorrhage 5. Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus) 6. Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed) 7. Midbrain extension/involvement 8. Absolute contraindication to CTA, conventional angiography and MRA 2. Coagulation Issues 1. Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation) 2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 3. Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction 4. INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant) 5. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours 3. Patient Factors 1. Traumatic ICH 2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis 3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD 4. Unable to obtain consent per Institution Review Board/Ethics Committee policy 5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment 6. Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment 7. Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis 8. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days 9. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule 10. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements 11. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible | 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): 21.0-75.0, Subarachnoid Hemorrhage Aneurysmal subarachnoid hemorrhage patients within the first 72 hours or Healthy volunteers Previous neurological diseases such as stroke or dementia | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Hemodialysis Complication ESRD Renal Failure Patients with stage 5 chronic kidney disease (CKD) with estimated glomerular filtration rate of less than 10 ml/min/1.73m2 (using CKD-EPI equation for eGFR). 2. Residual urine volume at least 0.5 L/day or more Children < 18 years of age. 2. Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant. 3. Recent (within 3 months) acute kidney injury (AKI). 4. Urine output less than 0.5 L/day. 5. Active malignancy at time of inclusion. 6. Active inflammatory disease with immunosuppressive treatment. 7. Decompensated Liver disease, Hepatorenal syndrome. 8. Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome | 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, Enterocolitis Recurrent Clostridium Difficile Infection at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other. 2. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment 3. Ability to provide informed consent. 4. Females and males must agree to use effective contraception for the duration of the study as applicable Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care. 2. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment. 3. Taking or planning to take an investigational drug within 3 months of enrollment. 4. Immunosuppression 5. Chemotherapy or radiation therapy 6. oropharyngeal or significant esophageal dysphagia 7. Ileus or small bowel obstruction 8. Subtotal colectomy 9. Pregnancy or planning to become pregnant within 3 months of enrollment 10. Breastfeeding or planning to breastfeed during the trial 11. Active infection requiring antibiotic therapy. 12. Life expectancy <6 months - | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-3.0, Persistent Diarrhea Children aged > 6 to 36 months, having diarrhea for 14 days or more (up to 29 days) either at admission or developed at some point during their treatment period in hospital Children able to take oral feeds at the time of randomization Children whose parents/care givers do not provide consent Growth of Shigella, Salmonella or Cholera in rectal swab culture Children having WLZ/WHZ < -5 SD or +++ edema The children presented with septic shock, convulsion or any other illness that needs ICU support during the admission Birth defect like complex congenital heart diseases, cleft lip and cleft palate, Down syndrome and cerebral palsy and others that may itself cause digestive problem or failing to thrive Children diagnosed as having apparent or known tuberculosis or HIV or chronic (> 30 days)/organic diarrhea (where the cause is known e.g. crohn's disease, ulcerative colitis, celiac disease etc.) | 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, Aspergillosis; Pulmonary, Invasive (Etiology) Written informed consent must be obtained from the patient or his/her legal representative prior to any study procedures 2. Adult patient (≥ 18 years) 3. PCR-confirmed influenza based on nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) within 7 days before ICU admission or within 48 hours after ICU admission. If PCR is not available a positive result of a rapid test is required (a negative rapid test does not imply absence of influenza and thus requires confirmation by PCR) 4. Influenza symptoms present for no more than 10 days before ICU admission 5. Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with an respiratory rate ≥ 25x/min and a paO2/fiO2-ratio (fraction of inspired oxygen) ≤ 300 with or without (bilateral) infiltrates Patients with age < 18 years 2. Pregnant women (based on a positive serum sample) 3. Expected survival on ICU admission ≤ 48h 4. Patients having influenza symptoms for more than 10 days before ICU admission 5. Patients being transferred from another hospital ward or another hospital who already have mycological evidence for an IAA-infection (based on sputum, BA or BAL culture, BAL or serum GM) 6. Patients with known intolerance or hypersensitivity to posaconazole or other azole antifungal agents 7. Patients that are being treated actively with antifungal agents for invasive aspergillosis 8. Patients with a QTc (corrected QT interval) interval ≥500 msec 9. Patients with liver cirrhosis (Child C) 10. Participation in another interventional clinical 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): 18.0-65.0, Oral Mucositis (Ulcerative) Due to Radiation Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition) Karnofsky Performance Status Scale between 80-100 WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min Sign the informed consent Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas Younger than 18 years old or older than 70 years old Pregnancy or lactation Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes Have suffered from other tumor or now suffering from other tumor Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases Refuse to give up smoking/drinking/betel chewing suffering from other active infection diseases and in need of treatment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 21.0-75.0, Osteoarthritis, Knee Knee pain for at least 6 months Clinically diagnosed knee osteoarthritis Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV) Confirmation of exposed subchondral bone by high-resolution knee ultrasonography Anticoagulation therapy Inflammatory or post-infectious knee arthritis Systemic inflammatory conditions Knee flexion of less than 100 degrees Knee extension of less than 165 degrees Any Valgus Varus more than 15 degrees Any knee injection in the past 3 months BMI more than 40 Gross synovial folds on ultrasound | 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, Pneumonia Key Subject has received mechanical ventilation for at least 48h at the time of the randomisation Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization Presence of new or progressive infiltrate on chest X-ray Presence of clinical consistent with VABP High probability of VABP caused by Pseudomonas aeriginosa Key Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction Severe liver or renal impairment Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control | 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, Cardiotoxicity HER2/Neu Positive Metastatic Malignant Neoplasm in the Brain Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 STEP 1 Patients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy Trastuzumab Trastuzumab + chemotherapy or hormonal therapy Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab) Ado-trastuzumab (Kadcyla) NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted Patients must be at increased risk for cardiotoxicity defined by at least one of the following Previous anthracycline exposure, OR or more of the following risk factors for heart 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): 18.0-80.0, Hyperphosphatemia Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods Males must agree to avoid fathering a child and agree to use an appropriate method of contraception Chronic maintenance hemodialysis 3x a week for at least 3 months Chronic maintenance peritoneal dialysis for a minimum of 6 months Kt/V ≥ 1.2 at most recent measurement prior to screening Prescribed and taking at least 3 doses of phosphate binder per day Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit Serum/plasma parathyroid hormone >1200 pg/mL Clinical signs of hypovolemia at enrollment History of IBD or IBS-D Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator Life expectancy <6 months Previous exposure to tenapanor | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Pseudomembranous Colitis Recurrent C. difficile infection (identified by positivity of C. difficile toxin in stools) with severe clinical picture (defined by the Guidelines published in 2014 Debast et al, Clin Microbiol Infect 2014) Possibility to undergo standard antimicrobial therapy for recurrent C. difficile infection Approval of informed consent Possibility to undergo protocol diagnostic and therapeutic procedures Stool negativity for parasites Stool negativity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile Blood negativity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL) Subjects <18 years old Prior colectomy Negativity of C. difficile toxin in stools Mild clinical picture of C. difficile infection High risk of post-colonoscopy complications Other main gastrointestinal diseases (es. Crohn's disease or ulcerative colitis) Stool positivity for parasites Stool positivity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile Blood positivity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL) Pregnancy or breastfeeding | 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, Anemia; Hemodialysis Dependent Chronic Kidney Disease Diagnosis of CKD Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis Being treated with ESAs for the recent 8 weeks prior to the screening period Mean of the two screening Hb levels closest in time to the baseline visit is ≥9.5 g/dL and ≤12.0 g/dL Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period Folate and vitamin B12 ≥ lower limit of normal during the screening period Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia Active bleeding or recent blood loss within 8 weeks prior to the screening period RBC transfusion within 8 weeks prior to the screening period Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) at the first day of the screening period and Day 1 Ophthalmic examinations during the screening period correspond to either of the following criteria No available fundal findings Findings indicating the presence of active fundal disease Severe heart failure (New York Heart Association Class IV) | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Age 40-80 years Patients hospitalized with a primary diagnosis of an acute exacerbation of COPD Body mass index (BMI) ≤ 35 kg/m2 Cognitively and linguistically able to follow instructions given in English and provide informed consent To be discharged to home following the hospitalization Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust in a home environment deemed safe by the investigators to perform home assessments Previous home PAP (CPAP or NIV) therapy use within the past year, or post-discharge Allergies to latex, metals or local anaesthetic agents Wound or inflamed skin at parasternal location (2nd intercostal space) History of skin allergies or sensitivity to cosmetics and lotions Psychological and social factors that would impair compliance with study protocol and schedule Any major non-COPD chronic disease or condition, such as severe heart failure (LVEF<30%), malignancy (active treatment and palliation), end stage renal failure/dialysis, significant neuromuscular disease (e.g. NMD, MD) determined by review of medical history and / or patient reported medical history that may contribute significantly to risk of readmission, as determined by PI Length of stay ≤ 24 hours Planned travel away from home within the 30 day post discharge period | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Vancomycin Staphylococcal Infections Adverse Effect Acute Kidney Injury Cross-sectional Study Using Vancomycin ≥18 years old Medical records were incomplete Had been diagnosed with stage 5 CKD or were regularly receiving dialysis SCr were not being adequately monitored to detect the development of AKI Had undergone nephrectomy | 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, Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Male and female ≥18 years Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement Rheumatoid arthritis Correction of functional deformity Voluntary written Informed Consent obtained Pre-operative Prospect for recovery to independent mobility compromised by known coexistent medical problems Requiring revision hip replacement Requiring bilateral hip replacement Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points Likely post-operative leg length inequality >5cm Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity) Primary or metastatic tumour involving this hip Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint Previous organ transplant | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Recurrent Clostridium Difficile Infection Clostridium Difficile Infection CDI C.Difficile Diarrhea C. Diff Colitis C.Difficile Colitis Willing to provide informed consent Willing to comply with all study procedures and be available for the duration of the study Documented diagnosis of at least one CDI within the last 180 days with treatment completed Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion Have received no more than 72 hours of non-CDI antibiotics History of hypersensitivity or allergy to oral vancomycin Current use of oral vancomycin Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus Dysphagia (inability to swallow capsules) or unwilling to swallow capsules Major gastrointestinal surgery within 3 months of enrollment (does not appendectomy or cholecystectomy) Any history of total colectomy or bariatric surgery Unable or unwilling to fulfill study requirements Expected life expectancy < 6 months Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Age ≥18 years 2. Previous CDI diagnosis 3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome) 2. Previous adverse reactions to oral vancomycin 3. Requiring metronidazole during hospitalization 4. Known pregnancy 5. Expected survival <72 hours 6. Patients receiving antibiotics only for surgical prophylaxis 7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Cost-effectiveness Analysis Chronic Kidney Disease Requiring Chronic Dialysis Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication Transitions between HD and PD Patients with functional arteriovenous fistula entering hemodialysis Patients with functional PD access implanted ate least 48h before the first use Patient or family trained in PD and/or with the right adequacy of the home | 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, Stage IV Cancer Age of 18 and over, male or female; 2. Patients with histologically confirmed advanced (stage IV) gastric cancer, NSCLC, breast cancer or ovarian cancer, who choose monotherapy of oral vascular targeting drug (apatinib) due to intolerability or inappropriateness of other therapies; 3. Presence of measurable lesions (≥10mm on spiral CT scan) subject to 1.1; 4. Blood pressured controlled at 150/100 mHg following drug administration; 5. An ECOG PS score of between 0 and 1; 6. Findings of hematology and laboratory tests at the baseline that meet the following Hemoglobin ≥80g/L; Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥90×10^9/L; ALT/AST ≤ 2.5×ULN; or ALT/AST ≤ 5×ULN for patients with hepatic metastases; Serum total bilirubin ≤1.5×ULN; Serum urea nitrogen and creatinine ≤ 1.5×ULN; Serum albumin ≥30g/L; Coagulation function (INR≤1.5, APTT≤1.5 ULN); 7. A life expectancy of at least 3 months; 8. Subjects who volunteer to participate in this study and have signed the Informed Consent Form (ICF), with good compliance with treatment and follow-up Confirmed allergy to apatinin and or its excipients; 2. Hypertension (high blood pressure) that can not be controlled by drugs; 3. A history of active hemorragge, ulcer, intestinal perforation, intestinal obstruction, or major surgery no older than 30 days; 4. NYHA III-IV heart function, or severe hepatic or renal insufficiency (Grade 4); 5. Presence of multiple factors that affect oral medications, such as difficulty swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction; 6. Pregnant or lactating women, or women of child-bearing potential who have planned a pregnancy, or male and female patients who do not agree to practice adequate contraception during this study; 7. Patients who have a history of psychotropics abuse and can not quit, or who have mental disorders; 8. Participation in other drug clinical trial within the last 4 weeks; 9. Prior therapy with VEGFR inhibitors such as sorafenib and sunitinib; 10. Presence of comorbidities that seriously affect the patient's safety or ability to complete the study, in the investigator's judgment; 11. Patients who can not tolerate apatinib treatment as judged by the investigator depending on the their medical history; 12. Patients that are considered ineligible for this study by the investigator | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 6.0-999.0, Crohn Disease Group 1 Males or females 6-18 years of age Current weight >10 kg (or 22 lb) Ability to swallow pills Normal kidney function Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase Active CD or IBDU defined as PCDAI ≥ 30 C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)>350mcg/g (within one month of enrollment) Have been treated with one of the following therapies for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages Known allergy or intolerance to aminoglycosides or any of the medications used in this study Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole Known diagnosis of diabetes mellitus Known or suspected structuring disease producing obstructive symptoms Active Clostridium difficile infection Prolonged QTc interval as seen on enrollment EKG Current use of antibiotics Starting or increasing the dose of an IBD related medication within 4 weeks of screening Group 2 Males or females 10 years of age and older Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA) | 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 Recurrent Clostridium Difficile Infection C. Diff CDI Recurrent C. Diff rCDI C. Difficile Recurrent CDI FMT Fecal Microbiota Fecal Transplant Ability to provide written informed consent; 2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI 3. An outpatient prior to Treatment 4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period Pregnant, breast-feeding, or considering becoming pregnant during the study 2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) 3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome 4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization 5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study 6. Major intra-abdominal surgery within the past 60 days prior to Screening 7. Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry 8. History of total colectomy/ileostomy or bariatric surgery 9. Planned hospitalization or invasive surgery during the study 10. Severe acute illness unrelated to CDI | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Clostridium Difficile Infection Anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested Any repeat samples | 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, Bone Loss, Alveolar Dental Implant Failure Nos Any healthy patient scheduled for an implant-supported restoration will be considered for in this study, independently of the implant and prosthetic protocols used general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV) patients <18 years of age smoking habit (>10 cigarettes/day) sites with acute infection or requiring regenerative procedures Full Mouth Plaque Score Full Mouth Bleeding Score >25 % pregnant and lactating | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Muscle Weakness Age ≥ 18 years Deeply sedated (Riker 1-2) patients, admitted in intensive care unit B of ST-Etienne hospital Without curare since 12 hours Normothermic or with a controlled fever (central temperature between 36 and 38°C) Without haemodynamic instability (mean arterial pressure > 65mmHg and < 120mmHg, systolic arterial pressure > 90mmHg and < 200mmHg, Norepinephrine < 4mg/h) Without respiratory instability (respiratory rate < 35/min, pulse oxymetry > 90%, inspired oxygen fraction < 60%, PaO2/FiO2 ratio > 250, Peep < 10cmH2O, with invasive mechanical ventilation) Without neurological instability (diastolic velocities in mean cerebral artery > 30cm/s, mean velocities > 50cm/s, pulsatility index < 1.2, intracranial pressure < 20mmhg, brain tissue oxygenation tension > 15mmHg) Patient whose family has given informed and written consent to the patient's participation in the study Pregnant woman Patients with peripheral nerve damage prior to or at the time of measurement Curarized patients (non-efficacy of neurostimulation) Presence of a catheter in the stimulation zone (femoral artery or vein) Patients with lower limb, pelvic or spine fracture Patients with continuous renal replacement therapy Patients with circulatory assistance Patients with wounds in electrodes placement area Morbidly obesity with Ideal Body Weight > 40kg/m2 Patients with pacemaker | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-30.0, Childhood Hepatocellular Carcinoma Childhood Malignant Liver Neoplasm Fibrolamellar Carcinoma Hepatoblastoma Hepatocellular Malignant Neoplasm, Not Otherwise Specified Patients in Group F must have a body surface area (BSA) >= 0.6 m^2 Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2 For Groups B, C and D, rapid review is required if patients are either >= 8 years of age or have an alphafetoprotein (AFP) =< 100 at diagnosis For all Groups E and F patients, rapid central pathology review is required In emergency situations when a patient meets all other and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy Clinical situations in which emergent treatment may be indicated but are not limited to, the following circumstances Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.) Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible Patients who are currently receiving another investigational drug Patients who are currently receiving other anticancer agents Patients with uncontrolled infection Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma Patients with hypersensitivity to any drugs on their expected treatment arm Group C: Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD) Group D Patients with chronic inflammatory bowel disease and/or bowel obstruction Patients with concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Patients aged 18 years or older Patients able to give informed consent (IC) after an explanation of the proposed study Patients who have Kt/Vurea > 1.2 for the last 2 measurements, where the most recent Kt/Vurea measurement is taken within 4 weeks before or during study screening Patients with dialysis prescription (dialyzer, time, blood flow rate [QB], dialysis fluid flow rate [QD]) stable over 6 most recent treatments. The dialysis treatment duration time should be 3.5 5 hours per session, with QB of 220 mL/min and QD of 500 mL/min Patients who are on stable anticoagulation prescription and dose Patients with ESRD receiving chronic HD treatment with a history of thrice weekly HD, and at least 1 HDF session or HFHD, within 1 month prior to study Patients must be stable on in-center HD and/or HDF for >3 months prior to study enrollment Patients who have an adequate arteriovenous fistula (AVF) or graft, capable of providing a blood flow rate of at least 220 mL/min Patients who have acute renal failure with the chance for recovery Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy Pregnant and lactating women Patients with positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders Patients with active or ongoing infection per investigator's judgement Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study Patients with a history of severe mental disorders Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 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, End Stage Renal Disease Patients aged 18 years or older Patients who are able to give IC after an explanation of the proposed study Patients who have Kt/Vurea > 1.2 for the last 2 measurements, with the most recent Kt/Vurea measurement taken within 4 weeks before or during study screening Patients with a dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), blood flow rate (QB)) stable over 6 recent treatments. The dialysis treatment time should be 3.5 to 4.5 hours per session with minimum QB of at least 250 mL/min and QD of 500 mL/min Patients who are on stable anticoagulation prescription and dose Patients with ESRD receiving chronic HD treatment with a history of thrice weekly HD, and at least 1 HDF session within 1 month prior to study Patients who have been stable on in-center HD for >3 months prior to study enrollment Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumen tunneled catheter capable of providing a blood flow rate of at least 250 mL/min Patients with a minimum total convective volume (including ultrafiltration (UF)) of 16 L post-dilution for the most recent HDF treatment Patients who receive in-center treatment hemodialysis at a site that routinely implements high flux dialysis and HDF Patients who have acute renal failure with the chance for recovery Patients who are pre-scheduled for a living donor kidney transplant within the next six months, who plan a change to PD within the next six months, or who require single-needle dialysis therapy Pregnant and lactating women Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody), HIV and Syphilis Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or patients with Hgb >130g/L for coagulation risk Patients who are severely malnourished or with significant disease that interferes with liver synthetic function, e.g. with serum albumin <35 g/L Patients with active or ongoing infection as per investigator's judgement Patients with history of solid tumors requiring anti-cancer therapy in the past or next 6 months, or life expectancy less than 1 year, or patients or with history of hematology neoplasm Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study Patients with a history of severe mental disorders | 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, Adverse Event Physiotherapy Intensive Care Units Cardiac Surgery Postoperative Patients undergoing cardiac surgery Age ≥ 18 years old Patients who are receiving any physiotherapy intervention Neurological and cognitive impairment | 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, Lung Cancer Stage IV Age ≥ 18 years of age Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted) Stage IV disease Sufficient FFPE tumour tissue for OCCP testing Performance status 0-2 Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist Prognosis > 6 months Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 16.0-999.0, Clostridium Difficile Infection Recurrence Clostridium Difficile Infection Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy Failed standard therapy with oral metronidazole and/or oral vancomycin One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity Age <16 years old patients with acute severe colonic dilation at risk for colonic perforation | 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): 18.0-70.0, Subarachnoid Hemorrhage, Aneurysmal Radiological confirmatory evidence of an aneurysmal subarachnoid hemorrhage (by digital subtraction angiography, CT angiography, or magnetic resonance angiography) Presentation less than 96 h from ictus Patients taking glibenclamide therapy at presentation Pregnancy Hunt & Hess V Known renal or hepatic impairment Patient not fully independent before bleed Strong suspicion of drug or alcohol misuse Patient taking warfarin-type drugs Suspected additional life-threatening 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, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Patients who are eligible for chemoradiation therapy of the head and neck Patients must have adequate renal function to undergo platinum based chemotherapy. This will mean a baseline creatinine level (Cr) no greater than 1.5 times the upper limit of normal Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Ability to swallow and/or retain oral or per tube medication Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Any patients prescribed medications for chronic and/or long term pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs. Acute post-op medications are allowed if the patient has discontinued them prior to initiating study Any patients prescribed a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), monoamine oxidase inhibitors (MAOIs), dextromethorphan, triptan, tryptophan supplements, IV methylene blue, linezolid or any other medication that may increase risk of serotonin syndrome, as deemed by the investigator?s opinion Any patients with suspected or known, current or recent (within last 5 years) use of cocaine, amphetamines, lysergic acid diethylamide (LSD), 3,4- methylenedioxymethamphetamine (MDMA), or any other drug of abuse that may increase risk of serotonin syndrome, as deemed by the Investigator?s opinion Any patients with history of suicide-related events, or those exhibiting a significant degree of suicidal ideation Patients with acute narrow-angle glaucoma Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing female patients Unwilling or unable to follow protocol requirements | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-65.0, Vancomycin In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is >60ml/min women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min | 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): 18.0-89.0, Severe Infection Sepsis Severe Sepsis CBC-DIFF upon presentation Adults (18-89) of all races & ethnicities Signed Informed Consent Previously enrolled Incomplete Informed Consent Subject discharged <4 hours from presentation PCT or CRP not performed per protocol Pregnancy Prisoners Subjects Under Custody or Guardianship | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Age 18 or older Hospitalized patient with documented positive stool test for CDiff Able and willing to provide informed consent Pregnancy Breastfeeding Known allergy to BSS or other salicylates, including aspirin History of bleeding disorder History of gastrointestinal bleed History of gastrointestinal ulcer Chronic use of anticoagulants Chronic NSAID 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): 18.0-999.0, Clostridioides Difficile Infection Patients are eligible to be included in the study only if all the following apply: 1. Patient must be at least 18 years of age, at the time of signing the informed consent. 2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization. 3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization). 4. Male or Female Male patients: • A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period. Female patients: • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment. 5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC) Patients are excluded from the study if any of the following apply: 1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization. 2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis). 3. Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization. 4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not appendectomy). The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study. 5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon. 6. History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/suppressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study. 7. Have had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole). 8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization. 9. Are unable to discontinue products used affecting disease progression at randomization. 10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI. 11. Have received an investigational vaccine against C. difficile. 12. Patients that the Investigator feels are inappropriate for the study this would those; 1. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for in the study. 2. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy. 3. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients 4. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws | 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, Clostridioides Difficile Infection Patients are eligible to be included in the study only if all the following apply: 1. Patient must be at least 18 years of age, at the time of signing the informed consent. 2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization. 3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization). 4. Male or Female Male patients: • A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period. Female patients: • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment. 5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC) Patients are excluded from the study if any of the following apply: 1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization. 2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis). 3. Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization. 4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not appendectomy). The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study. 5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon. 6. History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/suppressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study. 7. Have had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole). 8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization. 9. Are unable to discontinue products used affecting disease progression at randomization. 10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI. 11. Have received an investigational vaccine against C. difficile. 12. Patients that the Investigator feels are inappropriate for the study this would those; 1. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for in the study. 2. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy. 3. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients 4. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 6.0-65.0, Cystic Fibrosis Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment Diagnosis of Cystic Fibrosis confirmed Chronic infection by Pseudomonas aeruginosa Patients can be treated with any inhaled antibiotic before or after AZLI treatment Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI For lung transplant patiens, only data before the transplant will be collected Non applicable | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 20.0-999.0, Protein-Calorie Malnutrition Maintenance Hemodialysis Patients (MHD) patients from multiple centers identified by the risk models as high-risk patients Acute patients Terminal Cancer Patients with life expectancy < 3 months Age < 20 year-old Active infection, including Tuberculosis and AIDS Patients received ONS 1 month before enrollment Pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Diarrhea, Clostridium Difficile Patients hospitalized on antibiotics (single or multiple; oral or IV) assuming that they are able to eat/drink so that they can take the pills Regimen started within 48 hours of first course of antibiotics Able to sign a consent form diarrhea on admission; bowel pathology that could result in diarrhea (eg. IBD), bowel surgeries and pouches; immunocompromised state (including febrile aplasia, immunosuppressive therapy, ICU patients, HIV-positive patients and renal transplant patients); prosthetic heart valves or history of endocarditis and rheumatic heart disease; use of metronidazole, vancomycin or fidaxomycin prior to stool culture for Clostridium difficile toxins | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Clostridium Difficile Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for C. difficile toxin or toxigenic C. difficile, or colonoscopic findings of pseudomembranous colitis (PMC) Patients aged over or equal to 18 years old Patients able and willing to provide informed consent Patients with concomitant infection by other microbes such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli Patients under 18 years old Patients who cannot give consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-70.0, Hypertension Genetics Hypertension The subjects evaluated in this protocol are hypertensive and carry the Striatin rs254093 risk allele or both Striatin rs888083 and rs6744560 risk alleles. Most will be recruited from the HyperPATH cohort. The HyperPATH cohort was developed under a SCOR in Hypertension program. This program has demographic data and DNA on more than 4000 subjects. Currently, nearly 2000 of them have undergone an extensive phenotyping protocol. All hypertensive medications have been stopped for 4 weeks before study except agents that interfere with the renin-angiotensin-aldosterone system (RAAS) are stopped for three months and amlodipine and/or hydrochlorothiazide is added if necessary for blood pressure control until one month before study initiation. Then each subject is studied twice on a diet consisting of 100 mmol potassium, 800 mg calcium, isocaloric, 2500 ml. The two times they are studied are after one week of a liberal sodium diet (200 mmol) and after one week of a low sodium diet (10 mmol). Blood is obtained supine, upright and after a 3 ng Ang II infusion and a norepinephrine dose response curve. BP and renal plasma flow are assessed in response to the diet and the Ang II infusion and 24 hour urines are collected on each diet. An oral glucose tolerance test is performed on each subject and blood is obtained for DNA. In addition to hypertensives, the nearly 2000 intensively studied cohort consists of 75 individuals in 10 families, 225 sibling pairs with hypertension, 525 normotensive individuals without a family history of hypertension or diabetes before the age of 60, and 250 type II diabetic subjects with or without hypertension. On most of the 4000 subjects serum, plasma, urine and DNA is available for measurements and analyses. Currently the data set consists of approximately 2100 data points of demographic data, family history, biomarkers, and genotypes. The subjects have been recruited from Boston MA, Salt Lake City UT, Paris France, Rome Italy and Nashville TN. The demographics consists of the following: 52% male, 18% of African descent, 3% Asian descent, age 17-66, hypertension stage 1-2, diet or oral medication controlled diabetes (80% of the total diabetics). A few subjects will be recruited from advertisements on the Internet and in local newspapers, from fliers and postings in the hospital, through mailings to households located in the Boston areas and through patient registries at Brigham and Womens Hospital. As an example of the richness of these sources is the Research Patient Data Registry (RPDR). RPDR is a centralized clinical data registry of 2.8 million Brigham and Womens Hospital and Massachusetts General Hospital patients. With approval of the Institutional Review Board, investigators may use the RPDR Data Acquisition Engine to obtain medical record information for patients with a specific diagnosis. Patients who meet for a specific study can be identified. Potential research subjects may be contacted by his/her physician to inform the patient of the possibility of participating in a research study and to provide the patient with the information for contacting the study personnel. Investigators from Brigham and Womens Hospital may apply to use the RPDR. RPDR contains over 90,000 hypertensives, ages 17-65 years with 13.5 % of African descent and 52.8 % women. We reported in our studies using the HyperPATH cohort that there was no racial, age or ethnic differences in the salt sensitive blood pressure responses related to Striatin allele variants. Thus, an equal number of females and males and the same proportion of Africans as in the HyperPATH cohort will be studied. Subjects in HyperPATH and those recruited for the new study in this project will have the similar characteristics. The range in age is >17; however, it is anticipated that the clear majority will be between the ages of 40 and 60 years. Hypertensive patients previously treated will be weaned off medications for two-four weeks except agents that interfere with the renin-angiotensin-aldosterone system (RAAS) are stopped for three months and amlodipine and/or hydrochlorothiazide is added if necessary for blood pressure control until one month before study initiation. Thus, these subjects will match the characteristics of subjects recruited in HyperPATH. They must have a diastolic blood pressure between 95 and 105 mm Hg off medication in each of three screening visits. Subjects with diastolic blood pressures greater than 105 mm Hg or systolic blood pressures greater than 180 mm Hg will be excluded. Subjects with only elevated systolic blood pressure (but diastolic less than 95 mm Hg) will be excluded because such subjects were not in the HyperPATH cohort. Based on individual statements, subjects with current excessive alcohol use (greater than 12 oz/ETOH/week) or recreational drug use will be excluded. Subjects taking other medications (except thyroid supplements) or weighing more than 150% of an ideal body weight will be excluded. Subjects with other major cardiovascular diseases, diabetes, asthma, or other major medical illness will be excluded. Subjects who smoke will be excluded. In addition, subjects must have normal values for the following screening tests: CBC, serum electrolytes, liver enzymes, TSH, urinalysis, 24-hour urine excretion of catecholamines and cortisol, and ECG. Specifically, estimated GFR must be > 60 ml/min and serum potassium < 5.0 mmol/l. Subjects with hypokalemia while on diuretics will be evaluated for hyperaldosteronism before in this study. Cushings syndrome will be ruled out clinically, and with a 24-hour urine cortisol if there is clinical uncertainty. For the more difficult question of renal artery stenosis, we will perform renal artery digital subtraction angiogram in patients with hypertension and a two-component abdominal bruit. Patients with greater than 50% renal artery stenosis will be further evaluated, but excluded from this study. Subjects with a known sensitivity to any of the agents, such as amlodipine or eplerenone will be excluded. Women who are pregnant will be excluded and will be dropped from the study if they become pregnant during the study because eplerenone has not been approved for use in pregnancy and the activity of the RAAS is dramatically altered by pregnancy. The screened, eligible hypertensives will enter a two-week single blind placebo washout phase. Pill count will be used to determine compliance. Those with BP between 145-170/90-109 mmHg and pill count between 80-100% will enter the randomized phase, counseled regarding salt intake, and randomized double blindly into one of our two treatment arms. We will recruit approximately 105 individuals to have 45 individuals in each drug group for analyses. This assumes that we will have 10-15% non-completers. 1. rs2540923A allele carrier OR both Striatin rs888083 and rs6744560 risk allele carrier 2. ages >17 years; 3. hypertension as defined by primary physician; 4. not on more than two anti-hypertensives; 5. normal renal, metabolic, electrolyte, complete blood cell count, and lipid profile laboratory tests; 6. if on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or mineralocorticoid receptor antagonist, needs to be washed out for 3 months known cardiac disease other than hypertension 2. renal, circulatory or neurologic diseases 3. diabetes; smoking 4. secondary hypertension as indicated by history, physical examination or screening blood and urine tests; any drug therapy, except for anti-hypertensives and replacement thyroid 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): 18.0-75.0, Hypertension,Nephropathy Age over 18 years old and <75 years. 2. Diagnosed as chronic kidney disease 5th stage in accordance with the KDIGO guide 2012 (egfr < 15 ml/ (min 1.73m2)). 3. Accept 3-5 bags daily, continous ambulatory peritoneal dialysis for >3 months. 4. Ambulatory blood pressure monitoring indicates nighttime systolic blood pressure (SBP) > 120mmHg and / or diastolic blood pressure (DBP) > 70mmHg Night learning or work, irregular rest for a long time. 2. Moderate and severe edema in difficult to correct 3. Persistent atrial fibrillation. 4. Severe anemia and severe dystrophy. 5. Patients with postural hypotension or symptomatic hypotension. 6. Severe side effects or contraindications of valsartan treatment. 7. Treatment of corticosteroids or other hormones at present. 8. Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring. 9. Ineffective ambulatory blood pressure data. 10. The clinical data were incomplete during the treatment period; end-point events occurred within 6 months or follow-up time was less than 6 months. 11. In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke. 12. There were complications such as vascular disease, infection and bleeding within 1 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): 18.0-69.0, Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diagnosis of CLL according to the National Cancer Institute (NCI)/International Workshop on Chronic Lymphocytic Leukemia (IWCLL) or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria. This includes previous documentation of Biopsy-proven small lymphocytic lymphoma OR Diagnosis of CLL according to the NCI/IWCLL as evidenced by all of the following Peripheral blood lymphocyte count of greater than 5 x10^9/L Immunophenotype consistent with CLL defined as The predominant population of lymphocytes share both B-cell antigens (CD19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc) Clonality as evidenced by kappa or lambda light chain restriction (typically dim immunoglobulin expression) Negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D1 staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy) No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL Has met at least one of the following indications for treatment Patients must not have any of the following conditions Congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration Recent infections requiring systemic treatment; need to have completed anti-biotic therapy > 14 days before the first dose of study drug Cerebral vascular accident or intracranial bleed within the last 6 months Infection with known chronic, active hepatitis C Positive serology for hepatitis B defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a hepatitis B deoxyribonucleic acid (DNA) test will be performed and, if positive the subject will be ineligible; if the hepatitis (Hep) B DNA test is negative (i.e. viral load undetectable) then the individual is eligible; if a patient who is HBsAg negative, HBcAb positive, and Hep B DNA negative is enrolled, they should be considered for either prophylactic anti-viral therapy (J Clin Oncol. 2013 Aug 1;31(22):2765-72) or careful monitoring for Hep B reactivation (J Clin Oncol. 2014 Nov 20;32(33):3736-43) Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor Patients may not have received the following within 7 days prior to the first dose of study drug Steroid therapy for anti-neoplastic intent | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Bleeding Gastric Varices Cirrhosis Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources Hemodynamically stable patient (systolic pressure above 90 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration Patients listed for liver transplantation can be included if the expected time on waiting list is up to 2 months Written informed consent obtained Pregnant woman or breastfeeding Minor and patients older than 75 years Non cirrhotic portal hypertension Hepatocellular carcinoma outside the Milan or other cancer at a palliative stage Child Pugh score > 13 History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding Congestive heart failure History or presence of pulmonary hypertension Patients with other indication for TIPS Uncontrolled gastric variceal bleeding | 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 Myeloid Leukemia Patients with AML who are newly diagnosed according to the WHO 2016 Classification and previously untreated with the exception of hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients with AML arising from an antecedent hematologic disease (AHD) including MDS, may have been treated for their prior hematologic disease (except for allogenic transplant) AML patients de-novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML) For a diagnosis of AML, a bone marrow or peripheral blast count of 20% or more is required In AML with monocytic or myelomonocytic differentiation, monoblasts and promonocytes, but not abnormal mature monocytes, are counted as blast equivalents Patients must be ≥18 and ≤60 years old Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. (See protocol Appendix D.) LVEF ≥ 45% by MUGA or ECHO at screening Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula Adequate liver function as demonstrated by aspartate aminotransferase (AST) ≤ 2.5 × ULN* Subject has acute promyelocytic leukemia, inversion16, t(8;21) or FLT3 mutant AML as described below. Contact PI with questions Inversion 16 and t(8;21): CBF chromosomal abnormalities may be assessed by molecular (PCR), metaphase cytogenetics, or FISH FLT3: ITD or a point mutation in the TKD loop of variant allele fractions ≥5% by PCR, capillary electrophoresis, or NGS panel capable of defining FLT3 allelic burden Subject has known active CNS involvement with AML Subject has tested positive for HIV (due to potential drug-drug interactions between antiretroviral medications and venetoclax, as well as anticipated venetoclax mechanism-based lymphopenia that may potentially increase the risk of opportunistic infections). Note: HIV testing is not required Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+] are allowed Subject has received the following within 7 days prior to the initiation of study treatment Strong or moderate CYP3A inducers (see Appendix C) Strong and moderate CYP3A inhibitors (see Appendix C) Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Septic Shock Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility) Patients not appropriate for study as determined by provider discretion Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2) Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis Any patient receiving greater than one dose of hydrocortisone 100 mg Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-99.0, Clostridium Difficile Infection age 18 or higher documented recurrence of Clostridium difficile none | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, ESRD CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days Prolonged RRT access is not available No dialysis treatment was given within 1 months The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization Able to understand the whole process of the trial, voluntarily participate in and sign informed consent Maintenance RRT alraedy Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours Hypertensive emergencies(diastolic blood pressure>130mmHg) Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs High catabolic state eg. severe inflammation or trauma Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (<1month), multiple abdominal surgeries Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure <80mmHg) Pregnant Expected to survive for less than 1 years Plan for kidney transplantation within 3 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridia Difficile Colitis Clostridium; Sepsis > 18 years old, diagnosed C diff colitis requiring surgical intervention CHF previously diagnosed, pregnancy, prisoners/ incarcerated, previous administration of IVIG within 30-days of randomization | 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): 50.0-70.0, Knee Osteoarthritis III and IV levels of knee osteoarthritis according to Kellgren-Lawrence Had at least six months of symptoms resistant to at least three months of conservative methods (lifestyle modification, weight reduction, regular exercise, physiotherapy, non-steroidal anti-inflammatory drugs, intraarticular injection methods) - With rheumatic diseases, immune diseases or other systemic inflammatory diseases With active infection, osteomyelitis or history of chronic infection around knee joint Had undergone previous operation on knee Had bleeding tendency (hereditary or acquired) Pregnant patients | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-80.0, End Stage Renal Failure on Dialysis >3 months on automated peritoneal dialysis treatment Signed informed consent ESRD of inflammatory cause (lupus, vasculitis, collagenopathies) Intake of probiotics, prebiotics or fiber in the last 3 months Use of anti-inflammatory drugs or nutritional supplements (immunossuppresants, pentoxifylline, NSAIDs, omega-3) Treated with antibiotics or sevelamer Treated with research drugs or participants in any clinical trial Peritonitis or active infection 2 weeks prior the study Any medical condition affecting intestinal absorption (inflammatory bowel disease, short bowel syndrome, bariatric surgery) or severe dysmotility Severe malnutrition Previous kidney transplantation Serious diseases altering the fina outcomes of the study: decompensated heart failure, chronic liver disease, cancer, AIDS | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Non-squamous Cell Non-Small Cell Lung Cancer Signed the informed consent form prior to patient entry Male or female patients aged 18-75 years old； Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, Neoadjuvant chemotherapy, or postoperative adjuvant chemotherapy or neoadjuvant chemotherapy combined with postoperative adjuvant chemotherapy or targeted chemoradiotherapy for local advanced disease recurrence within 6 months after completion Patients with negative driver genes who had previously only received first-line platinum double-drug therapy progression or intolerance In the past 3 months at least one target lesion that had not previously been irradiated,and at least one direction with the longest diameter at baseline greater than 10 mm (shorter diameter required not less than 15 mm if lymph nodes are involved)could be imaged by CT scan or MRI Expected Survival Time: Over 6 months had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher scores indicating increasing disability) If there is central nervous system metastases,they must be asymptomatic central nervous system metastases The main organs function are normally, the following are met:(1)Blood routine examination should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥80×10^9/L;(2)Biochemical examinations must meet the following TBIL<1.5×ULN; ALT and AST < 2.5×ULN, and for patients with liver metastases < 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula) Women of child-bearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study and treatment.Before starting administration, the pregnancy test was negative, or one of the following was met to prove that there was no risk of pregnancy: 1. Postmenopause is defined as amenorrhea at least 12 months after age 50 and cessation of all exogenous hormone replacement therapy; 2. Postmenopausal women under the age of 50 May also be considered postmenopausal if their amenorrhea is 12 months or more after the cessation of all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the reference value range of laboratory postmenopausal; 3. has undergone irreversible sterilization surgery, including hysterectomy, bilateral ovectomy or bilateral salpingectomy, except for bilateral tubal ligation. For men, consent is required to use appropriate methods of contraception or to be surgically sterilized during the trial and 8 weeks after the last administration of the trial drug Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer),Lung sarcomatoid carcinoma Had histologically confirmed lung squamous cell carcinoma, or adenosquamous carcinoma EGFR、ALK mutation-positive by genetic testing technology (pathological examination results of other hospitals are acceptable) and who receive EGFR-TKI and ALK-TKI targeted drug therapy,except EGFR/ALK status cannot be determined for various reasons Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor have used Pemetrexed before and progressed Patients with uncontrolled pleural effusion need to be treated with other chemotherapy drugs Significant weight loss (more than 10% weight loss in the previous 6 weeks) Medical history and combined history： 1. Had clinically symptomatic central nervous system metastasis(a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms or metastases in midbrain, pons, cerebellum, medulla oblongata, or spinal cord); 2. The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks; 3. Had malignant tumors except NSCLC within 5 years before enrollment(except for patients with cervical carcinoma in situ , basal cell or squamous cell skin cancer who have undergone a curative treatment, local prostate cancer after radical resection, ductal carcinoma in situ or papillary thyroid cancer after radical resection); 4. Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) who have not recovered to NCI-CTCAE ≤1; 5. Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;Note: Under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes; 6. Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g; 7. The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma; 8. Severe acute or chronic infections requiring systemic treatment; 9. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%; 10. There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma; 11. Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; 12. Long-term unhealed wounds or fractures; 13. Decompensated diabetes or other ailments treated with high doses of glucocorticoids; 14. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 15. Clinically significant hemoptysis (daily hemoptysis greater than 2.5ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis; 16. Events of venous/venous thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 17. Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment or planned systemic antitumor treatment within 4 weeks before grouping or prior to receiving the test drug including cytotoxic therapy, signal transduction inhibitors, immunotherapy( or use mitomycin C within 6 weeks prior to receiving the test drug).Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks before grouping or limited-field radiotherapy to be evaluated for tumor lesions within 2 weeks before grouping Physical examination and laboratory findings 1. a known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS); 2. untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection; 3. serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Patients All ESRD patients >18years old in Assuit University Hospital dialysis unit Patients on regular haemodialysis for more than six months ESRD patients<18years old patients with acute kidney injury patients on haemodialysis for less than six 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 Infection Recurrence Clostridium Difficile Infection Clostridium Difficile CDI Partial 1. Able and willing to provide written informed consent 2. Subjects with a qualifying CDI episode who have a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence (≥ 65 years of age) 3. CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization 4. The diarrhea is considered unlikely to have another etiology. 5. Complete an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration 6. Have a positive C. difficile stool 7. Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization. Partial History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4 weeks) that is not related to C. difficile infection within the 3 months prior to randomization. 2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization. 3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus). 4. Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea 5. History of administration of fecally-derived investigational live biotherapeutic products, or fecally-derived live bacterial isolates for CDI-associated diarrhea including fecal microbiota transplantation (FMT) within the last 6 months. 6. Use of drugs that alter gut motility 7. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization. 8. Subjects with compromised immune system 9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen. 10. History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-70.0, Acute Myeloid Leukemia History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow) 2. Relapsed or refractory AML 1. AML relapse after intensive chemotherapy OR 2. AML relapse after allogeneic HCT OR 3. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR 4. No response to at least 4 cycles of low intensity therapy 5. AML refractory to 2 cycles of induction chemotherapy 3. Presence of > 5% of blasts in bone marrow or peripheral blood smear 4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT) 5. Considered suitable for lymphodepleting chemotherapy 6. Age 18 years up to the age of 70 (≤ 70) 7. Life expectancy of at least 3 months 8. Karnofsky performance status ≥ 50% 9. Available related HLA-haploidentical or HLA-matched donor 10. Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed. 11. Patient able to understand and sign written informed consent Uncontrolled infections 2. Renal insufficiency: creatinine > 180 μmol/L or on dialysis 3. Heart failure: EF < 40% 4. Respiratory insufficiency: oxygen therapy required at in the study 5. Significant liver impairment: bilirubin > 50 μmol/L, AST or ALT > 4 times normal upper limit 6. Treatment with bisphosphonates (2 months before start) 7. Active autoimmune disease or GvHD 8. Pregnant or breastfeeding 9. Patient of fertile age not using two-barrier method of birth control | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Clostridium Difficile Infection Older than 18 years With recurrent CDI Older than 18 years - | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Vancomycin Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included Chronic renal dysfunction and acute renal injury patients treated with Renal Replacement therapy VTL was not retained at steady-state Vancomycin treatment time≤48h Vancomycin dose did not meet study definitions Palliative care | 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, Ischemic or Hemorrhagic Stroke Patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h Post stroke delay of 15 days to 2 months Existence of moderate to severe phasic disorders on Aphasia Rapid Test score (ART, score> 6, scale of 26 items) Patient able to read and understand French Rightful Normal and corrected vision and hearing Absence of pre-existing degenerative neurological disorder Patient having signed his consent Age ≥ 18 years Patients with contraindications to MRI or claustrophobic Patients under legal protection Patients with behavioral disorders or disabling neurovisual disorders making participation in art therapy impossible Mute patients, illiterate patients Patients leaving the neurological SSR department prematurely Patients not affiliated to a social security scheme 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, Septic Shock Patients admitted to medical intensive care unit (MICU) for less than 24 hours, who are hypotensive despite a fluid bolus of 30 mL/kg and who are requiring pressors to keep MAP > 65 of at least 5 mcg/min of levophed or equivalent and whose shock is clinically suspected to be secondary to sepsis In addition, stress dose corticosteroids, hydrocortisone 50mg IV Q6hrs, will have to have been started or intended to be started Contraindication to corticosteroids, thiamine, or vitamin C Treating physician opposed to administering corticosteroids to the patient Age < 18 years Pregnancy DNR/DNI/limitations of care Patients with a fatal underlying disease who are unlikely to survive to hospital discharge Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma Requirement for immediate surgery Patients with HIV and a CD4 < 50 mm2 Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.8 | 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 Infection Age ≥ 12 years or older Able to provide informed consent Willing and able to comply with all the required study procedures A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months History of at least ≥ 2 recurrent CDI where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily Symptoms of CDI diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea Planned or actively taking another investigational product CDI symptom-free for 3 or more weeks following completion of CDI treatment Patients with neutropenia with absolute neutrophil count <0.5 x 109/L Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter Presence of colostomy Unable to tolerate FMT or enema for any reason Requiring systemic antibiotic therapy for more than 7 days Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed Severe underlying disease such that the patient is not expected to survive for at least 30 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): 0.0-999.0, Clostridium Difficile Patients located on inpatient wards for whom C. difficile test is ordered at Foothills Medical Center. Usually defined by having 3 or more loose bowel movements in a 24 hour period No diagnostics for C. difficile requested. Inpatient at a different facility. All outpatients | 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, Myocardial Fibrosis End Stage Renal Failure on Dialysis Chronic Kidney Disease, Stage IV (Severe) Chronic Kidney Disease Stage V Heart Failure Patients with a diagnosis of Chronic Kidney Disease stage 4 and above 2. Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis) 3. of macrovascular cardiac disease within the last 3 years 4. Access for haemodialysis planned via tunnelled central venous catheter Age under eighteen 2. Patients with a diagnosis of Diabetes Mellitus 3. Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment 4. Previous or current treatment with immunosuppressive/modulatory therapy 5. Current Malignancy 6. Current use of Metformin 7. Pregnancy 8. Contraindication to MRI Imaging 9. Patients lacking capacity or unable to consent and non-English language speakers 10. Immediate modality switch after commencement on renal replacement therapy i.e. transplantation 11. Plan for treatment centre change/move outside of Imperial College Healthcare NHS Trust following commencement on renal replacement therapy 12. Patients currently participating in an active CTIMP trial | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, End-Stage Renal Disease Patients ≥18 to ≤75 years of age with diagnosis of ESRD Patients on thrice weekly HD for a minimum of 3 months who received at least one 4 hour HDF treatment in the past two weeks prior to study enrollment with a total convection volume (VCtot) (including UF) of equal or greater than 16 L post-dilution Body weight (BW) ≥ 40 Kg Patients with stable dialysis profiles: 1. Kt/Vurea ≥ 1.2 which is taken within 4 weeks before study enrollment 2. Dialysis prescription stable over 6 recent treatments Patients on stable anticoagulation dose Patients who have an adequate arteriovenous fistula (AVF) or graft, capable of providing a QB with 200-300 mL/min range Patients able to give informed consent (IC) after an explanation of the proposed study Patients who receive in-center treatment HD at a site that routinely implements high flux dialysis and/or HDF Patients who are human immunodeficiency virus (HIV) positive, or with active Hepatitis A (HAV), Hepatitis B (HBV) or Hepatitis C (HBC) Patients with known hemodynamic instability, bleeding risks and coagulation disorders Patients with active or ongoing infection Patients with advanced liver, heart or pulmonary disease, as judged by the Investigator, that would not be suitable for participation in the study Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator Patients who are currently participating in other interventional clinical trials or have participated in another interventional clinical trial within one (1) month of the current study that may interfere with this study as judged by the Investigator Pregnant women, lactating women and women or men who plan to have a baby and refuse to apply the effective contraceptive methods during the study period Patients with active cancer Patients who have acute renal failure Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months, or who require single needle dialysis therapy | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Recurrence (Interventional) i) age 18 years or older ii) diagnosis of multi-recurrent CDI, defined as passage of 3 or more loose stools in 24 hours or less for at least 2 consecutive days and a positive stool test for toxigenic C. difficile (nucleic acid amplification test [NAAT] and toxin enzyme immunoassay [EIA] positive), with 2 or more confirmed prior CDI episodes iii) receiving or planning to receive a 10 to 14-day course of SOC therapy with oral VAN followed by a tapered VAN regimen for at least 4 weeks iv) patient highly unlikely to become pregnant due to being female and not of reproductive potential or female of reproductive potential agreeing to be abstinent or using 2 acceptable methods of birth control starting at enrollment and through the 16-week study period; and v) patient or legal representative voluntarily agreeing to participate by providing written informed consent after the nature of the study has been fully explained. (Historical Control) i) age 18 years or older ii) diagnosis of multi-recurrent CDI iii) received 10 i) active chronic diarrheal illness, such as (but not limited to) ulcerative colitis or Crohn's disease or with a condition such that they routinely pass loose stool ii) planned surgery for CDI within 24 hours iii) positive pregnancy test in the 48 hours before the infusion or unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child iv) breastfeeding or planning to breastfeed prior to the completion of the study period v) previous receipt of BEZLO vi) receipt of immune globulin within 6 months prior to enrollment or planning to receive immune globulin prior to completion of the 16-week study period vii) receipt of non-SOC CDI therapy within 14 days prior to enrollment viii) planned treatment with SOC therapy for longer than 6 weeks ix) receipt of medications to control diarrhea such as loperamide, diphenoxylate hydrochloride/atropine sulfate at any time prior to completion of the 16-week study period x) medical history of decompensated congestive heart failure | 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): 18.0-70.0, Renal Impairment Tuberculosis Subject for Patients with Renal Impairment (Groups 2-5) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB 2. Agree to abide by the study restrictions. 3. Are between the ages of 18 and 70, inclusive, at the time of enrollment. 4. Must have mild, moderate, severe or end stage renal disease but are not on dialysis. 5. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 6. Have QTc interval on electrocardiogram (ECG) < 500 msec. 7. Have a body mass index of 18 to 35 kg/m^2. 8. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study. **Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year has passed since the last menses if menopausal. ***Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 9. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #8, and/or abstinence from sexual intercourse with women. 10. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Healthy Subjects (Groups 1A-1D) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB. 2. Agree to abide by the study restrictions. 3. Are healthy male or non-pregnant female, between the ages of 18 and 70, inclusive, with normal GFR > / = 90 at screening. 4. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 5. Have a normal QTc interval < 500 msecs on electrocardiogram (ECG). 6. Have a body mass index of 18 to 35 kg/m^2. 7. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 8. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #7, and/or abstinence from sexual intercourse with women. 9. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Patients with Renal Impairment (Groups 2-5) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)). 5. Any clinically significant ECG abnormality at screening* *Note: the following can be considered not clinically significant Heart rate < / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) Right or left axis deviation Incomplete right bundle branch block Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects 6. History of or screening results show a QTc interval > / = 500 msecs. 7. Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death ***such as known coronary artery disease or congestive heart failure (CHF) or terminal cancer. 8. Inability to swallow tablets. 9. History of fever or documented fever (oral temperature > 100.4 degrees Fahrenheit) in the 48 hours prior to admission to the hospital. 10. Resting pulse rate <50 or > 100 bpm at Screening. 11. At Screening blood pressure > / = 20 mm Hg systolic or 10 mm Hg diastolic above baseline**** (sitting). ****Baseline is most recent blood pressure in the last 3 months if not similar to control group. 12. Current hypokalemia or hypomagnesemia. 13. Positive result of urine drug screen or blood alcohol screen prior to hospital admission. 14. Significant history of drug and/or food allergies (as deemed by the PI). 15. For women, subject is pregnant (positive test for urine HCG at Screening or Check-in), breastfeeding or planning to conceive for the duration of the study. 16. Women who are breastfeeding or lactating. 17. Any contraindication to the use of nitromidazoles, or prior treatment with pretomanid or delamanid. 18. Treatment with strong CYP450 enzyme inducers or inhibitors***** within 7 days prior to admission or during the study, unless****** the substance would not likely impact the validity of the study results. *****except hormonal contraceptives ******in the opinion of the site investigator 19. Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine, etc.) within 30 days prior to dosing and during the entire study. 20. Use of St. John's Wort within 7 days prior to admission and during the entire study. 21. Consumption of products containing grapefruit within 5 days prior to dosing until discharged from the hospital. 22. Donation of whole blood or blood products > 500 mL within 30 days and plans to donate during the study or up to 14 days after dosing. 23. Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit. 24. Hemoglobin < 9.0 g/dL in both men and women at the screening visit. 25. Positive Screening test for HCV, HBV, or HIV. 26. Renal transplant. 27. Scheduled for hemodialysis or peritoneal dialysis 28. Presence of any condition or finding******* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments. *******In the opinion of the investigator 29. Semen donation for the duration of the study. 30. AST and ALT > 2.0 x ULN. 31. Hyperbilirubinemia > 1.5 x ULN. Subject for Healthy Subjects (Groups 1A-1D) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI). 5. Any clinically significant ECG abnormality at screening*. *Note: the following can be considered not clinically significant Heart rate > / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Chronic Diarrhea of Unknown Origin Patients with chronic diarrhea (defined as 3 non-bloody loose stools per day or more than 20 non-bloody loose stools per week for more ≥ 4 weeks) and Bristol Stool Form Scale for stool consistency of 6/7 with >50% stool without an obvious cause after evaluation for organic etiologies Patients from any ethnicity Hematochezia (potentially related to an organic cause) Subjects less than 18 years of age more than 75 years of age (safety and effectiveness of crofelemer has not been established in these age groups) Pregnant females (crofelemer is a Category C drug due to lack of well-controlled studies to study its effects in this population) Lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants) HIV positive individuals Persons within ability to provide consent and understand the study Persons with history of alcohol abuse or binge drinking Persons with history of surgical bowel resection or bariatric surgery in the past 12 months Persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months Persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Peritoneal Dialysis patients treated by peritoneal dialysis in Caen University Hospital refusal to participate | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 14.0-99.0, Coccidioidomycosis Pneumonia Step 1 Subject 1. Aged > / = 14 years and presenting for clinical care in coccidioidomycosis endemic areas. 2. Diagnosis of community acquired pneumonia (CAP) established by a health care provider. 3. Pulmonary opacity on chest X-ray or computerized tomography (CT) scan consistent with CAP. 4. Onset of symptoms related to current CAP diagnosis within 28 days prior to enrollment. 5. Must be able to understand the study and provide informed consent.* *If aged < 18 years, the parent(s) or guardian must be able to understand the study and provide informed consent, with the assent of the minor. 6. Willing and able to comply with study procedures and complete study visits. 7. Willing to allow access to medical records, and medical records are available to the study team. Step 2 Subject 1. Aged > / = 14 years 2. Presence of at least one influenza-like sign or symptom (e.g. fever, chest pain, cough, myalgia, arthralgia, and headache. 3. Onset of any symptoms no earlier than 7 weeks prior to enrollment into Step 2. 4. Opacity/pleural effusion diagnosed by chest radiograph or computerized tomography (CT) scan . 5. Positive result for any serologic test confirming coccidioidomycosis obtained within 21 days prior to enrollment into Step 2.* * The assays considered for this criterion are: coccidioidal immunoglobulin M (IgM) by immunodiffusion, enzyme immunoassay (EIA), latex agglutination or tube precipitin OR coccidioidal immunoglobulin G (IgG) by immunodiffusion, EIA, or complement fixation. The interpretation of positive or negative is per the reporting laboratory instructions 6. Must be able to understand the study and provide informed consent.** **If aged <18 years, the parent(s) or guardian must be able to understand the study and provide informed consent, with the assent of the minor. 7. Willing and able to comply with study procedures and complete study visits. 8. Willing to allow access to medical records, and medical records are available to the study team Step 1 Subject Have documented microbiologically or serologically-confirmed past infections with Coccidioides.* *An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible. 2. Hospitalization within 14 days prior to the onset of pneumonia symptoms. 3. Presence of cavitary lung disease. 4. Evidence of disseminated, extrathoracic disease. Step 2 Subject Have documented microbiologically or serologically-confirmed past infections with Coccidioides.* *An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible. 2. Presence of cavitary lung disease. 3. Evidence of disseminated, extrathoracic 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): 25.0-70.0, Type1diabetes Understand the purpose of clinical trials, willing to participate and sign informed consent; 2. Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year; 3. Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml 4. Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months. 5. Age 25-70 years old, gender not limited; 6. Body mass index (BMI) : between 19 and 28kg/m2; 7. from the date of screening to the end of follow-up, male or female subjects of childbearing age will voluntarily take precautions Pregnancy; Urine pregnancy test was negative when screening women of childbearing age, and serum pregnancy test was performed when necessary to clearly pregnancy.- Patients with gestational diabetes or other special types of diabetes; 2. Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month; 3. Patients who have received other stem cell therapy before screening; 4. Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening; 5. Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened; 6. Patients who have used insulin for less than 1 year before screening and only injected insulin subcutaneously once a day within the past 3 months; 7. Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors; 8. Patients with other malignant tumors or suspected tumor tendency;Or in the active phase of various infections (including active stage of HBV or HCV infection);Immunodeficiency virus (HIV) positive patients; 9. Patients with other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, immune system and blood system); 10. For patients with liver and kidney dysfunction, for example, serum bilirubin TBIL exceeds 1.5 times of the normal upper limit, AST and ALT exceed 2.5 times of the normal upper limit, and serum creatinine Cr exceeds 1.2 times of the normal upper limit; 11. Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy; 12. Disabled patients (blind, deaf, dumb, mentally retarded, physically disabled) as stipulated by law, pregnant women and lactating women;People suffering from mental illness;Patients who take drugs or have a history of adverse drug abuse and alcohol dependence within 5 years; 13. Patients with contraindications or allergies treated in this study; 14. Subjects who have participated in other clinical studies in the past 3 months | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 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 Infection Communicable Diseases ≥ 18 years old. 2. Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization. 3. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.] Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment. 2. Requires systemic antibiotic therapy for a condition other than CDI. 3. Fecal microbiota transplant (FMT) within the past 6 months. 4. FMT with an associated serious adverse event related to the FMT product or procedure. 5. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year. 6. CD4 count <200/mm^3 during Screening. 7. An absolute neutrophil count of <1000 cells/µL during Screening. 8. Pregnant, breastfeeding, or intends to become pregnant during study participation | 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, Joint Arthroplasty Knee and Hip Patient's 18 years or older Patients who recently underwent a primary total hip or total knee arthroplasty Patient who recently underwent a total hip or total knee revision Patients who lack the ability to provide informed consent Patients with previous total joint replacement within the last 6 months Patients with complications following surgery such as DVT/PE/Infection | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease on Dialysis (Diagnosis) Male and female subjects at least 18 years of age Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) prior to first study injection Must be clinically stable and in the opinion of the investigator able to comply with all study procedures Must be able and willing to provide informed consent Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study injection Women of childbearing potential (WOCBP) must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening visit through 4 weeks after the last dose of study injection. Acceptable birth control methods but are not limited to oral contraceptive medication, an intrauterine device (IUD), an injectable contraceptive (such as medroxyprogesterone acetate or Depo-Provera®), a birth control patch, or a barrier method (such as condom or diaphragm with spermicide) Previous receipt of any hepatitis B vaccine History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or antibody to HIV or HCV History of sensitivity to any component of study vaccine Substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results Recent or ongoing history of febrile illness (within 7 days of the first study injection) Has received any of the following prior to the first study injection Within 14 days: a. Any inactivated vaccine Within 28 days: 1. Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids 2. Any live virus vaccine 3. Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) 4. Any other investigational medicinal agent Within 90 days: 1. Blood products or immunoglobulin If female and pregnant, nursing, or planning to become pregnant during the study | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 16.0-999.0, Traumatic Brain Injury Deep Vein Thrombosis Acute Lung Injury Ventilator Associated Pneumonia Age ≥ 16 years 2. Admission to critical care 3. moderate/severe, non-penetrating traumatic brain injury 4. Abnormal brain CT Scan 5. Post resuscitation Glasgow coma score (GCS) ≤12, or GCS motor component ≤5 6. Able to complete consent and first USS within 72 hours of injury Normal brain CT scan 2. Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Consultant Neurosurgeon treating the patient 3. Contra indication to normal prophylactic measures, including heparin, were indicated 4. Known blood clotting disorder or thrombophilia 5. Significant pelvic or lower limb trauma 6. Malignancy 7. Pregnancy or recently post-partum | 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): 60.0-999.0, Clostridium Difficile C diff diagnosed within 90 days Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting Age 60 years and older Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs Not Expected to survive 8 weeks Prior or planned fecal microbiota transplant or Bezlotoxumab use Congestive heart failure (a potential risk of Bezlotoxumab) | 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): 18.0-70.0, Ulcerative Colitis Ultrasound Therapy; Complications Definitive diagnoses of Ulcerative colitis Mayo clinical score ≥8 Need for Hospitalization and intravenous corticosteroid treatment Age between 18-70 Ability and willingness to give written consent and comply with study protocol Contraindicators for infliximab Bowel infection Crohn's disease Ultrasonographic inflammation in terminal ileum other than backwash ileitis Bowel wall thickness <3 in Sigmoid colon Minors Known malignant disease Pregnancy Immune modulating therapy at admission apart from corticosteroids, mesalazine or azathioprine. Contraindicators = Patients suffering from moderate to severe heart failure, hypersensitivity to murine proteins, severe bacterial infection | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-67.0, Low Back Pain NSLBP for > 3 months, and reported that their pain was provoked by postures, movement and daily activities Pain intensity measured with a numerical rating scale (NPRS) over the last 14 days >3/10 Roland Morris Disability Questionnaire (RMDQ) ≥ 7 was necessary to be admitted to the study Ørebro Musculoskeletal Pain Questionnaire-short form (ØMPQ-SF) was used to examine the participants risk profile pre-treatment, and had to be ≥ 30, on a scale from 0-100 Continuous sick-leave duration ≥ 4 months Acute exacerbation of LBP a Specific LBP diagnosis radicular pain, disc herniation, spondylolisthesis, stenosis, Modic changes Any low limb surgery in the last 3 months; surgery involving the lumbar spine Pregnancy Diagnosed psychiatric disorder Active rheumatologic disease, progressive neurological disease Serious cardiac or other internal medical condition Malignant diseases, acute traumas, infections, or acute vascular catastrophes | 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, Intracerebral Hemorrhage Patient with a diagnosis of spontaneous intracerebral hemorrhage who is diagnosed in any of the participant hospitals Traumatic intracerebral hemorrhage >24 hours from onset to admission Prior Rankin scale score >3 | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, 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, Autosomal Dominant Polycystic Kidney Disease Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2010 January 1st and 2015 December 31 Must have an abdominal tomodensitometry in 2 years around start (between 1 year before and 1 year after) Must have an intraperitoneal pressure measurement in the first year of peritoneal dialysis Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2015 January 1st and 2017 December 31 Non-inclusion Lack of tomodensitometry or intraperitoneal pressure History of nephrectomy or arterioembolism | 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 Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline. 2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment. 3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above). 4. Age ≥ 18 years. 5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention Evidence of colon/small bowel perforation at the time of study screening 2. Goals of care are directed to comfort rather than curative measures. 3. Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia. 4. Known food allergy that could lead to anaphylaxis. 5. Pregnancy a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration 6. Meeting for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) (which heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms). 7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Hereditary Spastic Paraplegia One of the following: 1. Primary participant: Clinical or genetic diagnosis of HSP or a related disorder 2. Secondary participant: Unaffected family member (1st or 2nd degree relative) of primary participant (with the above-mentioned restrictions for special populations) able to give informed consent 3. Unrelated healthy control able to give informed consent AND Written informed consent AND Participants are willing and able to comply with study procedures Missing informed consent of primary or secondary participant/ healthy control/ legal representatives For controls: evidence of a neurodegenerative disease or movement disorders; inability 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 Clostridium Difficile Infection Recurrence Patients admitted to Tampa General Hospital or outpatients at Infectious Disease Associates of Tampa Bay clinics who are receiving systemic antibiotics and have a history of at least one episode of CDI that was diagnosed on or after 4/1/2017 Participants must at least 18 years of age to participate Participants must be able to understand and sign a written informed consent form prior to initiation of study procedures Expected to receive at least 3 days of systemic antibiotics Life expectancy greater than 6 months Current CDI Completion of treatment for CDI within the last 15 days Concurrent use of drugs that have activity against C. difficile such as metronidazole, fidaxomicin, nitazoxanide, tigecycline, or rifaximine Concurrent use of cholestyramine Concurrent use of bezlotoxumab Concurrent use of probiotics Concurrent use of Imodium or other antidiarrheal agents Chronic suppressive antibiotics Condition which causes chronic diarrhea such as inflammatory bowel disease Bacterial gastroenteritis other than CDI | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Acute Myeloid Leukemia History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow) 2. Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy. 3. Presence of > 5% of blasts in bone marrow or peripheral blood smear 4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT) 5. Considered suitable for lymphodepleting chemotherapy 6. The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip. 7. Patient's main organs function well. A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN); B. total bilirubin≤34.2μmol/L; C. Renal function: Creatinine < 220μmol/L; D. Pulmonary function: Indoor oxygen saturation≥95%; E. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%; 8. Life expectancy of at least 3 months 9. Patient ECOG score≤2, Estimated survival time≥3 months. 10. Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed. 11. The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia). 12. Patient able to understand and sign written informed consent 13. Age 18 years up to the age of 75 (≤ 75) Women who are pregnant (urine/blood pregnancy test positive) or lactating. 2. Male or female with a conception plan in the past 1 years. 3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment. 4. Uncontrolled infectious disease within 4 weeks prior to enrollment. 5. Active hepatitis B/C virus. 6. HIV infected patients. 7. Suffering from a serious autoimmune disease or immunodeficiency disease. 8. The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines. 9. The patient participated in other clinical trials within 6 weeks prior to enrollment. 10. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids). 11. Have a history of epilepsy or other central nervous system diseases. 12. Having drug abuse/addiction. 13. According to the researcher's judgment, the patient has other unsuitable grouping conditions | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Metastatic Breast Cancer Participants must be females of post-menopausal status with HR+, HER2 breast cancer that has spread to internal organs Participants must have had at least one endocrine therapy Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study Participants must not have breast cancer that has spread to the brain if untreated and with symptoms Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy Participants must not have certain active infections including HIV or hepatitis Participants must not be pregnant or breastfeeding Participants must not have certain types of cancers or certain previous cancer treatments Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma of Uvea Stage IV Small Cell Lung Cancer Stage III Malignant Melanoma Cancer patients with stage IV NSCLC or stage IV malignant melanoma Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response ECOG PS 1-2 Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation 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, Heart Failure End Stage Renal Disease ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months previous switch of the type of renal replacement therapy from HD to PD or vice versa age <18 years pregnancy plasma exchange or apheresis in the past 6 months unipolar pacemaker history of whole extremity amputation | 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, Intracerebral Hemorrhage Subarachnoid Hemorrhage Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage Treatment in Centers with neurocritical care expertise Language other than German and English Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives Admission > 48 hours after symptom onset Hemorrhage due to trauma | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 6.0-14.0, Respiratory Tract Infections Urinary Tract Infections in Children Male or female children ages≥6 years to< 14 years Weight≥18kg who in hospital or outpatients with good compliance The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic and should be treated with systemic antibiotics Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range) Subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics Patients with specific infections who require treatment with other antimicrobial agents Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time Patients at risk of serious drug interactions due to combination of medications Patients who have other diseases and thought to affect efficacy evaluations or be poor compliance Attended clinical trial in three monthes | 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 (ESRD) Age ≥18 years Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months A stable clinical condition during the two weeks immediately prior to randomization Blood hemoglobin concentration above 8,5 g/100ml Has not experienced peritonitis episodes in the last 3 months Treated with Extraneal for at least 1 month Peritoneal Equilibration Test (PET) performed in the last three months Has understood and signed the Informed Consent Form History of drug or alcohol abuse in the six months prior to entering the protocol Acute infectious condition History of severe congestive heart failure and clinically significant arrhythmia Malignancy within the past 5 years, including lymphoproliferative disorders A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug A clinically relevant under-hydration as judged by the treating physician History of L-Carnitine therapy or use in the month before entering the study Received any investigational drug in the 3 months before entering the study Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures | 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, Clostridium Difficile Infection Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks Metronidazole Vancomycin At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year Severe C Diff infection requiring hospitalization and non responsive to maximal medication therapy advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) cirrhosis of the liver recent bone marrow transplants medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk) pregnancy Toxic megacolon or ileus present | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-3.0, Iron Deficiency, Anaemia in Children Male or female children ages 6-36 months Fever ( > 37.5C) and/or signs of illness Signed or fingerprinted or personally marked written informed consent obtained from their parent/guardian Parent/guardian plans for subject to reside in study site area and are able and willing to adhere to all protocol visits and procedures Critically unwell requiring stabilisation and transfer i.e. scores 3 on initial assessment 2. Sickle cell disease 3. Evidence of hookworm infection by stool microscopy 4. Administration of immunosuppressants or other immune-modifying agents within 90 days prior to study IP administration (e.g., systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone for more than 14 days; topical steroids including inhaled and intranasal steroids are not exclusionary). 5. Administration of systemic antibiotic treatment within 3 days prior to study enrolment. 6. Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition*, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease). * Other than the exclusionary clinical diagnosis of malnutrition for all subjects, in children 2 to 5 years of age, malnutrition is also defined as a weight-for-height Z-score of less than -3 as per WHO reference standards. 7. Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections. 8. Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures 9. Participation in another MRC 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, DISTAL MALIGNANT BILIARY OBSTRUCTION Age ≥18 years Patients with distal malignant biliary obstruction Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter Agree to receive follow up phone calls Able to provide written informed consent Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000 Use of anticoagulants that cannot be discontinued Pregnant women Inability to sign the 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, Sepsis Septic Shock Patients> 18 years of age with diagnosis of septic shock and multiorgan failure admitted to our Unit Entry into the ICU once diagnosed with sepsis and / or septic shock. The first 24 hours after admission to the ICU will be established as an limit Written informed consent Patients under 18 Pregnancy Coexistence of other types of shock at admission Limitation of therapeutic effort or ICT (Conditional Intensive Therapy) upon admission to the ICU. It refers to patients in whom, prior to admission to the ICU, it was decided not to perform any or some of the usual treatment measures for sepsis, or in which a time limit is established in which in case of non-response they would withdraw intensive measures. This limitation will be indicated by your treating physician and if it exists, the patient would be excluded from the study Patient with a history of previous intake of ascorbic acid, thiamine or corticosteroids in the month prior to admission to the ICU Patients considered immunodeficient (More than 10 mg of prednisone or its equivalent per day in the last 2 weeks, immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome) | 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): 12.0-999.0, Stage IV Prostate Cancer Stage IV Colon Cancer Stage IV Breast Cancer Stage IV Cancer of the Cervix Age: Greater than 12 years Documented histologic evidence of cancer Staged as stage IV World Health Organization (WHO) Performance Status of between 0 and 2 Radiological confirmation of metastases with bone scan or X ray, CT and/or MRI scan Cancer stages less than stage 4 Pregnant women Children 0 years | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Kidney Failure, Chronic Exercise Physical Fitness Adult (age≥18) with stable ESRD Receiving≥3 months HD HD 3 times per week Volunteer for participating this trial Unable to exercise (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted) (walking device such as cane or walker allowed) Had shortness of breath at rest or with activities of daily living (NYHA Class IV) Had mental disease, disturbance of consciousness and couldn't cooperate with investigations and exercise | 2 |
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