topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Liver Cancer Underwent open hepatic resection Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients Previously underwent exploratory laparotomy Laparoscopic surgery Known Central Nervous System tumors including metastatic brain disease History of organ allograft Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Urinary Incontinence Overactive Bladder Key Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary. Key Any current condition (other than NDO) that may impact on bladder function Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments) Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Urinary Incontinence Overactive Bladder Key Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary. Key Any current condition (other than NDO) that may impact on bladder function Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments) Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Overactive Bladder Main Female patient 18 to 75 years old diagnosed with idiopathic OAB Patient has symptoms of OAB for ≥ 3 months prior to screening Patient is a non-responder to pharmacologic therapy or has intolerable side effects or is not compliant to the treatment On screening three-day voiding diary Patient has a frequency of at least 8 micturitions per 24 hours & Total of ≥3 urgency urinary incontinence (UUI) episodes Patient is willing and able to initiate self catheterization post-treatment, if required Patients has PVR ≤100 ml. Patient with a single PVR of >100 ml and followed by two consecutive PVR measurements of <100 ml may be included in the study). Main Patient currently uses CIC or indwelling catheter to manage their urinary incontinence Patient who has clinically significant Bladder Outlet Obstruction (BOO) Patient with active urinary tract infection OAB due to any known neurological reason Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening visit Predominance of stress incontinence in the opinion of the investigator, determined by patient history Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any indication Patient with prior use of Botulinum toxin therapy of any serotype for any urological condition Patient with previous pelvic radiation therapy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Functional Dysphagia Ineffective Esophageal Motility Diagnosis of IEM per Chicago Classification, v3.0 as noted above Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction Esophageal biopsies negative for eosinophilic esophagitis Pregnant women Prisoners Currently on other serotonin modulating medications | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Lower Urinary Tract Symptoms Patients selected for this study must meet all of the following Age ≥ 50 years Lower urinary tract symptoms secondary to BPH as defined by IPSS Symptom Index ≥ 12 Maximum Uroflow rate (Qmax) of ≤ 12cc per sec Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS) Patients meeting any of the following will be excluded from the study Age less than 50 years Prostate cancer Bladder cancer Severe, life-threatening allergy to iodinated contrast Bilateral internal iliac artery occlusion Causes of obstruction other than BPH such as stricture disease Neurogenic bladder or other causes of bladder atonia Post void residual greater than 250 cc Any contraindication to embolization, including | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 35.0-75.0, Diabetes Mellitus, Type 2 Diabetic Nephropathies Caucasian* Both genders (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L) Age: 35 years BMI: >25 kg/m2 HbA1c: 6.5 0% Diabetes Control and Complications Trial (DCCT) or 48 mmol/mol International Federation of Clinical Chemistry (IFCC) Treatment with a stable dose of oral antihyperglycemic agents for at least 3 months prior to Metformin monotherapy History of unstable or rapidly progressing renal disease Macroalbuminuria; defined as albumin-creatinine ratio of 300mg/g Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation) Current/chronic use of the following medication: thiazolidinedione (TZD), SU derivative, Glucagon like peptide 1 receptor agonist (GLP-1RA), (dipeptidyl peptidase 4 inhibitor) DPP-4I, SGLT-2 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing History of diabetic ketoacidosis (DKA) requiring medical intervention (eg, emergency room visit and/or hospitalization) within 1 month prior to the Screening visit Current urinary tract infection and active nephritis Recent (<6 months) history of cardiovascular disease, including Acute coronary syndrome | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Small Bowel Obstruction CT A/P showing high grade obstruction (all patients will obtain a CT A/P as per Level 1 recommendations based on EAST practice guidelines) High grade bowel obstruction is defined as Transition point Distal small collapse with proximal dilatation Small bowel feces sign difference in caliber change between proximal dilated bowel and distal decompressed bowel Intra-abdominal free fluid without clinical signs of ischemia Hemodynamic instability (SBP<90) Peritonitis Enterocutaneous fistula Cirrhosis previous enterolysis (more than 1) Contraindication to laparoscopic surgery Pregnancy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.083-18.0, Neurogenic Bladder Catheter-Related Infections neurogenic bladder use of intermittent catheterisation for neurogenic bladder management informed oral and written consent from the child and both parents/legal guardian Congenital anomalies of urinary tract or genitals Immunodeficiency Urinary tract fistula | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urinary Tract Infection All patients presenting in general practice with symptoms of UTI who has not formerly participated in the study Acute admission to hospital | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-65.0, Hemophilia A Previously treated male participants aged 18 to 65 years (inclusive) at the time of screening 2. Diagnosis of severe hemophilia A (Factor VIII level <1%) 3. Previously treated with FVIII concentrates for ≥150 documented Exposure Days (EDs) 4. Karnofsky performance score of ≥60 5. Human immunodeficiency virus negative (HIV-); or HIV+ with stable disease 6. Hepatitis C virus negative (HCV-); or HCV+ with chronic stable hepatitis as assessed by the investigator 7. Able to understand and have provided written informed consent including signature on an informed consent form (ICF) approved by an ethics committee (EC) 8. Have provided written authorization for use and disclosure of protected health information 9. Agree to abide by the study schedule and to return for the required assessments 10. Willing and able to comply with the requirements of the protocol Detectable FVIII inhibitor at screening, with a titer ≥0.6 Bethesda Unit (BU) 2. Documented history of FVIII inhibitors with a titer ≥0.4 BU at any time prior to screening 3. Known clinical hypersensitivity towards mouse or hamster proteins or to polysialic acid (PSA) 4. Scheduled elective surgery during study participation 5. Severe chronic hepatic dysfunction 6. Severe renal impairment 7. Currently receiving, or has recently received (less than 3 months prior to study participation), or is scheduled to receive during the course of the study, other PSA-ylated drugs 8. Have received another investigational drug within 30 days prior to study entry and/or is scheduled to receive additional investigational drug during the course of the study in the context of another investigational drug study 9. Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A 10. Currently receiving, or scheduled to receive during the course of the study, an immune-modulating drug other than antiretroviral chemotherapy 11. Has a clinically significant medical, psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect the safety or compliance of the participant during the study 12. Is a family member or employee of the investigator | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Rectal Cancer Surgery Age over 18 years Pathological rectal carcinoma Male patients Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Laparoscopic surgery for rectal cancer Written informed consent Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function History of previous pelvic surgery Severe mental disease | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Colon Cancer Age > 18 years Documented CRC by histopathology Patient not consenting to the study or refused Metastatic disease at the time of diagnosis Contraindications to insulin Pregnancy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 6.0-999.0, Lower Urinary Tract Symptoms Age ≥6 years, and 2. Spina bifida and neuropathic bladder, as determined by the attending physician, and 3. Utilization of intermittent catheterization for bladder management, and 4. History of 2 or more urinary tract infections (UTIs) in the past year, and 5. Community dwelling Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral reflux, bladder stones, kidney stones, etc), and/or 2. Uses prophylactic antibiotics, and/or 3. Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or 4. Has psychologic or psychiatric conditions influencing the ability to follow instructions, and/or 5. Participates in another study in which results would be confounded, and/or 6. Is pregnant or breastfeeding, and/or 7. Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic serious infections (e.g. viral hepatitides, HIV/AIDs), and/or 8. Has cancer or an autoimmune disorder, and/or 9. Has a serious allergy to any component or excipients in the live bacterial combination product, and/or 10. Has had a change in neurologic status in the previous 2 weeks, and/or 11. Has taken antibiotic for any reason in the previous 2 weeks, and/or 12. Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or 13. Has a current urinary tract infection or urinary tract infection within the previous 2 weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 30.0-80.0, Lung Neoplasms Breast Neoplasms Colonic Neoplasms Lymphoma Age 30-80 years old ( might differ based on certain cancer type) Newly diagnosis of solid tumor proved by imaging Pathology proved to be primary solid tumor First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery No other anti-tumor treatments except for that required during the trial Written and informed consent with signature before the study Complete medical history and clinical record (including physical examination, electrocardiogram, hematology, biochemistry, tumor pathology etc) Follow-up of PSF and OS over a year Pregnancy, lactation, and impaired renal or liver function Receive additional anti-tumor treatments (including surgery) other than that required during the trial Poorly controlled diabetes Poor compliance Failed to perform scans Contrary to the standard operating procedures Without a definite pathologic diagnosis or follow-up results Not suitable for clinical trials (for example with mental illness) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Infiltrating Bladder Urothelial Carcinoma Recurrent Bladder Carcinoma Stage I Prostate Cancer Stage I Renal Cell Cancer Stage II Bladder Urothelial Carcinoma Stage II Renal Cell Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage III Renal Cell Cancer Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information NOTE: HIPAA authorization may be included in the informed consent or obtained separately Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 14 days prior to being registered for protocol therapy Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal Females must not be breastfeeding Cohort A T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligible Cohort B | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia 50 to 80 years of age 2. Baseline IPSS score > 13, and a baseline Quality of Life (Qol) question score > 3 3. Prostate volume 25 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days 4. Anterior prostatic urethral length 2.5 0 cm by cystoscopy, as measured from bladder neck to verumontanum. TRUS will be accepted as a primary screening measure. 5. Failed or intolerant to medication regimen for the treatment of LUTS New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. exemptions for these patients are described in 4a, 5a and they are exempt from #6. Participants will be excluded from participating in this trial if they meet any of the following 1. Obstructive median prostatic lobe or high bladder neck 2. Urethral stricture, meatal stenosis, or bladder neck obstruction either current, or recurrent requiring 2 or more dilatations 3. Elevated Prostate Specific Antigen (PSA) (age 50-70 PSA ≥4; age 70+ PSA ≥6.5) unless negative biopsy within last 3 months, or a positive biopsy 4. Post-void residual volume (PVR) > 250 ml, if not in acute retention 4a. No maximum post void residual volume required if patient in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) 5. Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline. 5a. No maximum urinary flow or minimum voided volume required if participant in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) 6. History of chronic urinary retention. (New Zealand Only, up to 5 patients) 7. History of neurogenic bladder 8. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) 9. Concomitant Urinary Tract Infection (UTI) 10. Concomitant bladder stones 11. Confirmed or suspected prostate/bladder cancer 12. Previous pelvic irradiation or radical pelvic surgery 13. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate 14. Chronic prostatitis, or recurring prostatitis within the past 12 months 15. Serious concurrent medical conditions such as uncontrolled diabetes 16. Known allergy to nickel 17. Life expectancy less than 12 months 18. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function 19. Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure. 20. 5--reductase inhibitors within 6 months of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study). 21. -blockers within 2 weeks of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study). 22. Future fertility concerns 23. Any severe illness that might prevent study completion or would confound study results | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 16.0-75.0, Complication of Surgical Procedure Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis antimicrobial drugs been administered in the latest month immunosuppressor been administered in the latest month urinary tract infection or positive urine culture results history of urinary calculi surgery diabetes chronic renal failure patients neurogenic bladder dysfunction abnormal anatomy of the kidney neuromuscular dysfunction (spina bifida, paraplegia, green Barry syndrome, or quadriplegia) more than 90 minutes operation time | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Complications; Catheter, Urinary Infection or Inflammation Adult patients (≥18 years) Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or silicone At least 3 documented CAUTI infections during last year Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/ weeks) Children (˂18 years) Participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study Stones (calculi) in the urinary tract (these patients can be included after the stones have been removed) Patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance)) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Nephrolithiasis Urinary Tract Infection (UTI) Sepsis Age: >17 years of age Gender: both men and women included. We anticipated enrolling a study population of approximately 60% men and 40% women based on a higher incidence of kidney stones among men in data. Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. Health status: see below for specific inclusion/ Renal stone of any size for which PCNL is recommended Positive preoperative urine culture within 3 months Current internalized ureteral stent, nephrostomy tube, nephroureteral stent Patients age <18 Active pregnancy Patients receiving antibiotic doses (other than prescribed for the study) within the seven days preceding surgery | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 20.0-999.0, Urinary Bladder, Overactive Aged >=20 years at the time of signing the informed consent Subject has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented subject history. In addition: 1. Spinal cord injury subjects must have a stable neurological injury level C5 or below occurring >=6 months prior to screening. 2. Multiple sclerosis subjects must be clinically stable in the investigator's opinion, for >=3 months prior to screening and have an Expanded Disability Status Scale score <=6.5 Subject has NDO for a period of at least 3 months prior to screening, determined by documented subject history. The presence of an involuntary detrusor contractions (IDC) must also be demonstrated during the urodynamic assessment during the screening period or Day 1 (prior to randomization) Subject has not been adequately managed with one or more medications (i.e., anticholinergics or beta-3 adrenergic receptor agonist) for treatment of urinary incontinence due to NDO . Not adequately managed is defined as: An inadequate response after at least a 4-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s), i.e., subject is still incontinent despite medication(s) for urinary incontinence due to NDO, or Limiting side effects (i.e., condition that subject reduced dosage or discontinued the medication due to side effect) after at least a 2-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s) Subject has >=6 episodes of urinary incontinence, with no more than one urgency incontinence-free day in the 3-day subject bladder diary completed during the screening phase Subject currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Subjects currently on CIC should be willing to maintain a CIC schedule of at least 3 times per day throughout the study. Caregiver may perform CIC Body weight >=40 kilogram (kg) at screening Males or females： 1. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit Vasectomy with documentation of azoospermia Male condom plus partner use of one of following the contraceptive options:Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label; or oral contraceptive, either combined or progestogen alone These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception 2. Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine or serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. • Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until the study exit. This list of highly effective methods (approved in Japan) is provided below, and it does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Intrauterine device or intrauterine system that meets the SOP effectiveness including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Subject has a history or evidence of any diseases, functional abnormalities or bladder surgery, other than NDO, that may have affected bladder function including but not limited to: 1. Bladder stones (including bladder stone surgery) within 6 months prior to screening or confirmed occurrence of bladder stones at the screening phase 2. Surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence or pelvic organ prolapse 3. Current use of an electrostimulation/neuromodulation device for treatment of urinary incontinence. Note: Use of any implantable device is prohibited within 4 weeks prior to initiation of Screening phase and throughout the study period. Use of any external device is discontinued at least 7 days prior to the start of the screening phase 4. Current use of a baclofen pump 5. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 6. Past or current evidence of hematuria due to urological/renal pathology or uninvestigated hematuria. Subjects with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction by the investigator (or subinvestigator) 7. Past or current history of bladder cancer or other urothelial malignancy, positive result of urine cytology or uninvestigated suspicious urine cytology results at the Screening phase. Suspicious urine cytology abnormalities require that bladder cancer or other urothelial malignancy has been ruled out to the satisfaction of the investigator according to local site practice. 8. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 9. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of >10 nanogram (ng)/milliliter (mL) at Screening. Subjects with a PSA level of >= 4 ng/mL but <= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator (or subinvestigator) according to local site practice. 10. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) Subject has a serum creatinine level >2 times the upper limit of normal (ULN) at screening Alanine aminotransferase (ALT) > 2×ULN; and bilirubin > 1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening Subject has current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: 1. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis 2. Chronic stable hepatitis B and C (example, presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody [HCVAb] test result within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry QTc >450 milliseconds (msec) or QTc >480 msec in subjects with Bundle Branch Block from the result of ECG at screening. Notes: 1. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read 2. The specific formula that will be used to determine and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to or discontinue the subject from the trial Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis Subject changes or initiates or discontinues anticholinergic, beta-3 adrenergic receptor agonist or any other medications or therapies to treat urinary incontinence due to NDO, within 6 days prior to the start of the screening phase Subject has been treated with any intravesical pharmacologic agent (e.g., capsaicin, resiniferatoxin) for urinary incontinence due to NDO within 12 months prior to initiation of Treatment phase 1 (Week 0) Subject has previous or current use of botulinum toxin therapy of any serotype for the treatment of any urological condition Subject has previous use within 12 weeks prior to initiation of Treatment phase 1 (Week 0) or current use of botulinum toxin therapy of any serotype for any non-urological condition or beauty care | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Amoxicillin Crystalluria The patients included will be all patients aged 18 years or more consecutive for which treatment by IHDA (> 150mg / kg / day) has been initiated in a unit participating in the study or within 48 hours before admission to this Service . for non-inclusion: Patients on dialysis or kidney transplant receiver will not be included Patients who did not receive treatment until at least the first urine direct examination and patients for whom it is not feasible for technical reasons will also be excluded | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Escherichia Coli Infections Patients infected with ESBL producing E. coli Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-45.0, Other Menstruation Disorders Women within ages of 18 to 45 years old with good health and regular menstrual cycles with last menstrual cycle occurred within 5 weeks of enrolment; subjects can be rescreened after completion of menstrual cycle 2. Women who use sanitary pads as their only menstrual hygiene product. 3. Women who agree to use only the study menstrual hygiene device and not sanitary pads or other menstrual hygiene products for menstruation during the night time of study duration. 4. Women who are able to understand instructions for correct use of study menstrual hygiene product (i.e. the investigational device). 5. Literate women who can complete the study questionnaire on their own in a language of their choice which are English, Malay and Chinese; and attending all study visits Known history of vaginal or uterine infection(s), and/or urinary tract infections; these subjects can be rescreened after 14 days after successful treatment. 2. Ongoing or past history of sexually transmitted disease, pelvic inflammatory disease, and/or injuries to the pelvis requiring surgical intervention and/or pelvic floor physiotherapy. 3. Female subject who is pregnant (established by urinary pregnancy test). 4. Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic. 5. Staff who work directly under the investigators and/or employed directly by the device manufacturers, sponsor and study team. 6. Moving outside Sibu area during study period and have difficulty to return for Visit 2. 7. Female subjects who have menopause (absence of menstruation for more than 6 months in female) or any other circumstances that cause secondary amenorrhea (absence of menstruation for more than 6 months in a normal female of reproductive age that is not due to pregnancy) such as side effect from hormonal contraceptive. 8. Use any medications or preparation applied topically to the perineum or intravaginally to the genitalia but subjects can be rescreened 14 days after the recovery if the application is for acute illness. 9. Use of any medications which known to influence menstruation or study results for any reasons within 14 days, 30 days before Visit 1 and during the intended study duration. 10. Subject participating in another clinical study involving menstrual hygiene device. 11. Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as axillary / tympanic / rectal temperature ≥ 38°C. Subjects can be rescreened 14 days after the recovery; 12. Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; 13. Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system(s) or psychiatric disease or other conditions that may interfere with the health conditions (such as in case the women subject become pregnant), or would place the subjects at increased risk, as determined by the investigator(s). Significant is defined as any disease/condition that, in the opinion of the researcher, would put the subject's safety at risk through study participation, or which would confound the interpretation of the study results if the disease/condition exacerbated during the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Neurogenic Bladder Dysfunction Refractory LUTD due to a neurological disorder Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks) Combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks) Age >18 years Informed consent Botulinum A toxin injections in the detrusor and/or urethral sphincter in the last 6 months Age <18 years Pregnancy Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences www.samw.ch/en/News/News.html) No informed consent | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Arterial Embolization Subject is aged 18 years or over 2. Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment 3. Subject has provided written consent for the procedure. 4. Subject agrees to all follow up visits required by the protocol 5. The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization. 2. The subject has had acute cerebral bleeding within the last 6 months. 3. The patient is participating in another research study involving another investigational device, procedure or drug. 4. The brain AVM or DAVF or tumor has been previously treated with another embolization agent. 5. The subject has a bleeding disorder. 6. The subject is female and has a positive pregnancy test. 7. The subject has a life expectancy of less than 1 year. 8. Subject has a known allergy to contrast media used for radiography. 9. Subject has a known allergy to Dimethyl Sulfoxide DMSO (solvent for the embolic product). 10. Subject has a condition that would prevent them attending follow up visits for up to 1 year. - | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Retention Urinary Tract Infections Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit) Patient has a Foley urethral catheter in place The physician has ordered the Foley urethral catheter to be discontinued Age less than 18 years Prisoners Women who are pregnant | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 12.0-75.0, Hemophilia A Participant requires a major or minor elective surgical, dental or other invasive procedure 2. Participant is male and ≥ 12 to ≤ 75 years old at the time of screening 3. Participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements 4. Participant has severe (factor VIII (FVIII) level < 1%) or moderately severe (FVIII level ≤ 2%) congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) of ≥ 0.6 Bethesda units (BU), as tested at screening at the central laboratory 5. Participant is not currently receiving or has recently received (< 30 days) immune tolerance induction (ITI) therapy 6. Participant has a Karnofsky performance score of ≥ 60 at screening 7. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3 at screening 8. Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing; or HCV+ with chronic stable hepatitis disease. Positive serologies will be confirmed by PCR testing. 9. Participant is willing and able to comply with the requirements of the protocol The participant requires emergency surgery 2. Severe chronic liver dysfunction or disease (e.g., ≥ 5 × upper limit of normal [ULN] alanine aminotransferase [ALT], as confirmed by central laboratory at screening or a documented prothrombin time/international normalized ratio [PT/INR] > 1.5) 3. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening 4. Anti-porcine factor VIII (pFVIII) inhibitor > 10 BU prior to surgery 5. Platelet count < 100,000/μL at screening 6. Participant has another active coagulation disorder, other than hemophilia A, as per the medical history 7. Planned use of α-interferon with or without ribavirin for HCV infected patients or planned use of a protease inhibitor for HIV infected patients. Patients currently taking any of these medications for ≥ 30 days are eligible 8. Known hypersensitivity to recombinant porcine factor VIII (rpFVIII), or hamster or murine proteins 9. Participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (DIC) 10. Participant has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study 11. Participant is unable to tolerate quantity of blood to be drawn for protocol procedures 12. Participant is a family member or employee of the Investigator | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 65.0-999.0, Frail Elderly Exercise Therapy Physical Therapy Techniques volunteers above the age of 65 who are community residents and classified as frail according to the established by Fried et al. will be selected for in the study previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-85.0, Post-operative Urinary Retention Male patient age 50 years Undergoing elective spine surgery at least 5 days after enrollment Preop visit done at office practice Currently on tamsulosin or other alpha-adrenergic blocking drug Allergy to tamsulosin Allergy to lactose Serious or life-threatening allergy to sulfa drugs Emergent procedure History of spinal trauma, spinal infection or spinal cord tumor Pre-existing indwelling urinary catheter History of orthostatic hypotension or current orthostatic hypotension History of prostate, urethral or bladder surgery Renal failure | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Infection Cancer Male patients of at least 18 years of age Histologically proven rectal adenocarcinoma Stage T1-4 Nx Mx With or without neoadjuvant treatment TME and low anastomosis (colorectal or coloanal, stapled or handsewn) With or without loop ileostomy Open or laparoscopic approach Patient and doctor have signed a study specific informed consent form Colonic and upper third rectal cancer (No or Partial Mesorectal Excision) Abdominoperineal resection Associated prostate, and/or seminal glands and/or bladder resection Infected tumour, Emergency surgery Epidural analgesia Patient with antibiotic therapy (other than prophylaxis) Previous treated/untreated known prostate or bladder carcinoma Patient with symptomatic preoperative voiding dysfunction (IPSS score >19) Medical history of bladder catheterization for obstruction, or urethral surgery Patient necessitating urinary output monitoring (impaired renal function etc) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Cancer Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract Participants with measurable and/or non-measurable disease according to v1.1 Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2 Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation 1. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible 2. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1 Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol Significant renal disorder indicating a need for renal transplant | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Ureteric Calculus Sepsis Hydronephrosis Ureteric calculus with proximal hydronephrosis confirmed on CT KUB White cell count >12,000mm3 and/or temperature >38C Uncorrected coagulopathy Urethral or ureteric stricture disease Urinary diversion Pregnancy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urolithiasis UTI Age: >=18 years of age Gender: both men and women included. We anticipated enrolling a study population of approximately 60% men and 40% women based on a higher incidence of kidney stones among men in data. Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. Health Status: see below for specific inclusion/ Patients with indwelling ureteral stents placed within the 2 weeks prior to the procedure visit for removal Patients having underwent kidney stone treatment surgery (shockwave lithotripsy [SWL], ureteroscopy [URS], retrograde intrarenal surgery [RIRS], percutaneous nephrolithotomy [PNL]) Patients with indwelling urethral catheter Patients with indwelling suprapubic catheter Patients with indwelling nephrostomy tube Patients who perform clean intermittent catheterization Pregnancy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture Males Age ≥ 18 years Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram or voiding cystourethrogram Age <18 Females Prior urethroplasty Urethral fistula Allergy or sensitivity to CHC Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day Untreated urinary tract infection Inability to perform intermittent self-catheterization | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital) Positive urinalysis tests (U-Nitrit and/or U-LPK) Have a pre-treatment baseline urinary culture obtained Require iv antibacterial treatment of the presumed infection Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC Signed informed consent Have a documented history of hypersensitivity or allergic reaction to any beta-lactam Pregnant or nursing women Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin Known chronic renal insufficiency (creatinine clearance < 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis Known colonization with ESBL Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Cancer Autoimmune Disorders Be male at any age Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function Have two testicles if undergoing elective removal of all or part of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Consent for serum screening tests for infectious diseases [HIV-1, HIV-2, Hepatitis B, Hepatitis C], to be performed at the time of testicular tissue harvesting Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon Participating in long term follow-up is a requirement of the protocol Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-60.0, Lymphoma, Large B-Cell, Diffuse NCCN-IPI>1 Known IPI, cell of origin and DHL at time of diagnosis Negative pregnancy test Men must agree not to father a child during the therapy to 8 cycles R-CHOP/like, total of 8 x Rituximab CR, CRu Transformed lymphoma Secondary malignancy HIV positive Evidence of CNS involvement Cardiac dysfunction (systolic ejection fraction <50%) Creatinine > 2.0 mg/dl | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-45.0, Urinary Tract Infections Non pregnant pre menopausal women Minimum age 18 years Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes esterase and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+ clinical symptoms) and an evaluation of the presence of typical related symptoms. In particular, frequency (frequent voiding of urine), urgency (the urge to void immediately), dysuria (painful voiding), and/or suprapubic pain Verbal and Written Informed Consent for participation in the study Acute cystitis symptoms for >1week before the first visit Diabetes mellitus Congenital urinary tract abnormality Lactating women Female who intend to become pregnant during the study or within 3 months after the completion of the study Vaginal discharge + fever (>37.5oC) Diagnostic of sexually transmitted diseases Use of an indwelling catheter or an intermittent self-catheterisation program Presence of neurogenic bladder, or Use of any antibiotic 2 weeks before Day 1 in the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-70.0, Prostatitis Chronic Prostatitis Interstitial Cystitis Painful Bladder Syndrome Bladder Pain Syndrome Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board Agreement: Participant agrees to participate in study procedures Age: Participant is at least 18 years of age Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months Urethral conditions: Participant has an ongoing symptomatic urethral stricture Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome) Psychiatric conditions: Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.) Malignancy: Participant has a history of cancer (with the exception of skin cancer). Control group In addition to the listed above, additional for control subjects are as follows Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region for a period longer than 3 months within the preceding year | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Pseudomonas Aeruginosa Pneumonia Informed consent ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only) pneumonia due to P. aeruginosa ventilated intubated II score between 10 and 35 (main criteria) being moribund effective antibiotic therapy ≥48 hours immunocompromised underlying pulmonary disease that may preclude the assessment of a therapeutic response | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Complicated Urinary Tract Infections Male or female participant with either: 1. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), or 2. cUTI with at least one of the following conditions associated with a risk for developing cUTI Indwelling urinary catheter Urinary retention (at least approximately 100 milliliters (mL) of residual urine after voiding) History of neurogenic bladder Partial obstructive uropathy (for example, nephrolithiasis, bladder stones, and ureteral strictures) Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (>20 milligrams [mg]/deciliters [dL]) and the serum BUN:creatinine ratio is <15 Surgically modified or abnormal urinary tract anatomy (for example, bladder diverticula, redundant urine collection system) except urinary tract surgery within the last 30 days (placing of stents or catheters is not considered to be surgical modification) 2. At least 18 years of age at time of consent 3. Able to provide informed consent 4. At least two of the following signs or symptoms: 1. Chills, rigors, or warmth associated with fever or hypothermia 2. Flank pain (pyelonephritis) or pelvic pain (cUTI) 3. Nausea or vomiting 4. Dysuria, urinary frequency, or urinary urgency 5. Costo-vertebral angle tenderness on physical examination 5. Urine specimen with evidence of pyuria 1. Dipstick analysis positive for leukocyte esterase (where positive result is at least "++" as indicated on the urine dipstick provided in the laboratory kit), or 2. ≥10 white blood cells (WBCs) per cubic millimeter, or 3. ≥10 WBCs per high power field 6. If male: must agree to use an effective barrier method of contraception (for example, condom) during the study and for 14 days following the last dose if sexually active with a female of childbearing potential 7. If female, not pregnant or nursing or, if of childbearing potential: must commit to either use at least two medically accepted, effective methods of birth control (for example, condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring) during study drug dosing and for 14 days following last study drug dose or practicing sexual abstinence Use of systemic antibiotics effective in cUTI within 72 hours prior to enrollment except under the following circumstances: 1. Participants with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI 2. Signs and symptoms of cUTI developed while on the antibiotic for another indication 2. History of an ertapenem-resistant urinary tract infection within 1 year of enrollment 3. Likely to require >10 days of antibiotic treatment to cure the acute cUTI or likely to receive ongoing antibacterial drug prophylaxis prior to the Follow Up visit (21-28 days after randomization) [for example, participants with chronic vesiculo-ureteral reflux] 4. Unlikely to survive at least through the duration of the study 5. Hypotension, systolic blood pressure ≤90 millimeters of mercury [mmHg] 6. Complicated pyelonephritis with complete obstruction or known or suspected renal or perinephric abscess, emphysematous pyelonephritis, or Any condition likely to require surgery to achieve cure (this does not procedure to place catheters or obtain diagnosis) 7. Known or suspected urinary fungal infection 8. Uncomplicated lower urinary tract infections 9. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis 10. High risk for cUTI due to Pseudomonas (for example, history of prior cUTIs due to Pseudomonas, ≥20 mg once a day prednisone or equivalent steroid, and other risk factors as perceived by the Investigator) 11. History of renal transplantation 12. Presence of an ileal loop 13. Any history of trauma to the pelvis or urinary tract occurring within 30 days of screening 14. Indwelling urinary catheters present at screening which are not expected to be removed or replaced within 72 hours of enrollment (for example, nephrostomy tubes, stents, urethral and suprapubic catheters). 15. Known concomitant human immunodeficiency virus (HIV) infection with CD4 counts below 200 within the last six months, or an acquired immune deficiency syndrome (AIDS) defining diagnosis within the last six months 16. Neutropenia (Absolute neutrophil count <1,000 polymorphonuclear leukocytes [PMNs]/microliters [µL]) 17. Participation in a study with an experimental drug or device within 30 days prior to enrollment 18. Known or suspected hypersensitivity to tetracyclines, carbapenems, or β-lactams 19. History of seizures 20. Any other unstable or clinically significant concurrent medical condition (for example, immunosuppressive therapy, chemotherapy, class IV heart or lung disease, end stage renal disease, or requiring hemodialysis) that would, in the opinion of the Investigator, jeopardize the safety of a participant and/or their compliance with the protocol | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-90.0, Diffuse Large B-cell-lymphoma Classical Hodgkin Lymphoma Histologically confirmed diagnosis of classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma Age ≥18 years The need of anti-neoplastic treatment Written informed consent Carriers of cardiac pacemakers Carriers of metal mesh implants, tissue expanders (breast) Holders of metal implants, cochlear implants and stapedial prostheses, plates or screws, wires, nails, spinal-column distractors, ferromagnetic vascular clips, mechanical heart valves, Swan-Ganz catheter, endocorporal electrodes, neurostimulators, vascular filters, stents and metal spirals that they do not know the characteristics (the manufacturer, type and date of implant) and/or secure magnetic compatibility Holders of metal fragments in the eye, visceral or intracranial Tattoo holders executed by less than 6 months Claustrophobic patients Pregnant patients Patients with uncontrolled diabetes mellitus Patients who do not provide written informed consent to the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-100.0, Recurrent Urinary Tract Infection English speaking Meet for recurrent urinary tract infections A. Each infection with bacterial colony count of greater than 100,000 AND B. 2 culture proven urinary tract infections within the preceding 6 months or culture proven urinary tract infections within the preceding 12 months Failed conservative management of recurrent urinary tract infections A. Completed 6-month trial of Macrobid, Trimethoprim or Methenamine suppression OR B. Completed 6-week series of intravesical instillations with DMSO or heparin/lidocaine Pregnant Managed with a colostomy Managed with a suprapubic catheter Known renal abscess Acute or chronic renal failure Cardiac disease Rectal prolapse or bleeding Colon surgery in preceding 12 months | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 19.0-999.0, Helicobacter Pylori Infection Gastric Ulcer Duodenal Ulcer Stomach Cancer Over 19 years old 2. Patients with gastric ulcer 3. Patients with duodenal ulcer 4. Patients with stomach cancer 5. Patients with gastrointestinal discomfort symptoms Patients who has done helicobacter pylori eradication 2. Patients who has undergone gastrectomy 3. Patients who has undergone endoscopic submucosal dissection 4. Patients with active upper gastrointestinal bleeding | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Neurogenic Bladder patients with chronic SCI causing NDO and urinary incontinence patients did not present with urinary incontinence patients are known to be allergic to onabotulinumtoxinA patients cannot be followed up regularly active urinary tract infection | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Community-Acquired Infections Methicillin-resistant Staphylococcus Aureus Patients (Child, Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids Patients with S. aureus from anterior nares or throat swabs cultures for colonization screening purpose | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 75.0-999.0, Frail Elderly Syndrome Bladder Disease Nutrition Disorders Cognitive Symptom Informed Consent as documented by signature (Appendix Informed Consent Form) ≥ 75 years old Fried frailty score ≥2 Cystectomy with urinary diversion No contra-indication for spinal or epidural anesthesia Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Women who are pregnant or breast feeding (not applicable as recruitment concerns patients with ≥75 yrs of age) Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Enrolment of the investigator, his/her family members, employees and other dependent persons Specific exclusions for the disease under study Specific concomitant therapy washout requirements prior to and/or during study participation Dietary restrictions: milk allergy Refusal to regional anesthesia Risk of aspiration | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Diseases Any patient over 18 years with a standard indication for difficult urinary catheterization Any patient younger than 18 years of age, pregnant patients | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-70.0, Overactive Bladder Overactive Detrusor Urgency-Frequency Syndrome UTI y/o-70 y/o Able to consent Urgency /Frequency Urge incontinence PUF score ≤ 4 Bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot" Pregnant Pelvic radiation Chronic pelvic pain Urinary retention Greater than Stage 2 prolapse Renal calculi Recurrent UTI (2 in 6 months) Immunosuppressed Neurologic disorder No antibiotics in the past 4 weeks | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 21.0-70.0, Urologic Injuries Urologic Diseases Bladder Infection Urinary Tract Infections Mucosal Inflammation Mucosal Infection Bladder Injury Catheter-Related Infections Catheter Complications Catheter; Infection (Indwelling Catheter) Pelvic Floor Disorders Urinary Incontinence Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Intravesical Bacteriophage Treatment for Urinary Tract Infections Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes Written informed consent Fever >38°C CRP >100mg/L Acute prostatitis Concomitant fungal urinary tract infection Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other are met including obtaining a pre-treatment qualifying baseline urine culture) Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock No informed consent | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-45.0, Recurrent Urinary Tract Infection Safety Issues Subject is premenopausal, aged ≥ 18 and ≤45 years Subject had recurrent UTI's (≥3 documented UTI's in the last year with documented symptom-free interval of at least 2 weeks) following the definition of a urinary tract infection: the presence of significance bacteruria (10^3 CFU/ml or more), pyuria and fever plus one or more of the following signs and symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria Subject has a documented urinary tract infection (see definition), for which oral antibiotic therapy has been initiated Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby Subject is able to communicate well with the investigators and is available to attend all study visits Subject has signed informed consent Subject will remain available during the first 3 weeks of the study period (recruiting, intervention and first follow-up) Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, immune-deficient, psychiatric and other disorders, which could compromise the health of the recipient during the study. These but are not limited to, any of the following: positive HIV, HBV or HCV screening tests; the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period Documented vesico-urethral reflux Documented urinary retention > 100 milliliters post-void residual urine Anatomic urogenital abnormalities Urolithiasis Nephrostomy catheters Extra-urogenital infections that require prolonged antibiotic therapy Pregnancy Use of probiotics and or cranberry juice Allergy or intolerance for multiple common prescribed antibiotics | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 35.0-70.0, Chronic Interstitial Cystitis Painful Bladder Syndrome Recurrent Urinary Tract Infection CIC/PBS patients with urinary tract pain or discomfort and dysuria that is present for > 6 months and is not due to acute urinary tract infection, stones or other urinary pathology rUTI patients with greater that 2 urinary tract infections in 6 months or greater than 3 urinary tract infections in one year. A UTI is defined as symptomatic complaints of dysuria, increased frequency of urination, and hesitancy to urinate and a clean catch urinary culture with >103 colony counts of bacteria per milliliter Inability to provide written informed consent Inability or unwillingness to adhere to 40 HBOT treatment sessions over an 8-10 week time period or to complete follow up questionnaires/telephone contacts Confinement anxiety and inability to enter the hyperbaric chamber for a 90 minutes treatment session Inability to effectively equalize the middle ear during changes in ambient pressure. This will patients with a history of tympanic membrane perforation, head and neck surgery with compromised Eustachian tube function, including but not limited to tracheostomy, mastoidectomy, middle ear surgical procedures and cochlear implants Presence of an indwelling urinary catheter Any acute or chronic urinary condition that is not rUTI or CIC/PBS such as but not limited to urinary bladder stones, tumors, urinary retention, adynamic urinary bladder, chemotherapy related hemorrhagic cystitis, radiation cystitis or other pathology Active or uncontrolled cancer diagnosis Active or uncontrolled psychiatric disease American Heart Association Class III or greater congestive heart failure or symptomatic coronary artery disease | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Hemoglobinopathies Patients with hemoglobinopathies, chronic hepatitis due to HCV and the presence of fibrosis (defined as Fibroscan® stiffness ≥10 kPa) or a bioptic evaluation of cirrhosis (same ISHAK fibrosis score) determined within 6 months previously. Patients with extrahepatic manifestations of chronic hepatitis C virus infection (cryoglobulinemia with organ damage, B-lymphoproliferative disorders) were also included Patients with active cancer, including hepatocellular carcinoma, and pregnant or lactating females were excluded from the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urinary Stones Ureteral Calculus the patients with large stones (>1.8 cm in size) of the upper ureter male patients the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone female patients non operable patients | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 19.0-70.0, Urinary Tract Infection Men or non-pregnant women over 18 years of age with cUTI in One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation One or more of the following underlying conditions suggestive of cUTI Indwelling urinary catheter Neurogenic bladder Obstructive uropathy due to lithiasis, tumor or fibrosis Acute urinary retention in men History of allergy to quinolones Are unable to take oral medication Have an intractable infection requiring > 14 days of therapy Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium Have prostatitis or epididymitis Have had a renal transplant Have ileal loop or vesica urethral reflux Have significant liver or kidney impairment Have a history of tendinopathy associated with fluoroquinolones | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.083-2.0, Urinary Tract Infections Patient is between 1 to 24 months of age Patient has reported or measured fever >38.5 degrees C (101.3 degrees F) RSV Positive at time of urine collection Flu Positive at time of urine collection Known GU abnormality Neurogenic bladder Frequent catheterizations Indwelling catheter Antibiotics in the last 7 days | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis) Clinical signs and/or symptoms of pyelonephritis or a cUTI Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism Negative urine pregnancy test result confirmed by a blood test Agreement to remain abstinent or use a contraceptive method Has a concomitant infection requiring antibacterial therapy, in addition to study drug Confirmed fungal urinary tract infection Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis) Suspected or confirmed perinephric or intra renal abscess Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion History of epilepsy, brain lesions or other significant neurological disorders | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-0.5, Urinary Tract Infections Infants less than 6 months of age who require a urine sample for urinalysis and culture as part of their PED visit (as determined by the treating physician) are eligible for Parents / caregivers do not speak English Parents / guardian unavailable to sign consent Evidence of injury / infection to the abdomen / back precluding completion of the bladder stimulation technique Known medical condition rendering it impossible to obtain a sample using the stimulation technique (e.g. urostomy) Critical illness and/or hemodynamic instability Current antibiotic therapy or antibiotics within 14 days of enrollment Previous enrollment | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 19.0-999.0, Urinary Tract Infections Patients presenting without a prescription for antibacterials from another health care practitioner with symptoms of urinary tract infection that is found to be uncomplicated. Or patients presenting with a prescription for an antibacterial from another health care practitioner that is found to either have uncomplicated urinary tract infection or asymptomatic bacteriuria Patients with complicated urinary tract infections or symptoms suggestive of pyelonephritis or systemic illness | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-70.0, Spinal Cord Injuries Urinary Bladder, Neurogenic The subject has a neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12 The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic) There is urodynamic documentation of neurogenic detrusor overactivity (NDO) The subject is on a stable dose of oxybutynin IR three times daily The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures The subject has taken mirabegron within one month of the Screening Visit The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit The subject is allergic to mirabegron The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg) The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction The subject has a known history or treatment for a non-neurogenic bladder or prostate problem (prostate cancer, bladder cancer) The subject has recurrent UTIs, defined as a UTI more than every three months The subject has untreated Grade 3 or above vesicoureteral reflux If female, the subject is pregnant (documented by a urine pregnancy test) or breastfeeding The subject has taken another investigational drug within 30 days before screening | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 10.0-18.0, Diabetes Mellitus, Type 2 Signed Written Informed Consent Target Population Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA HbA1c between 6.5% and 10.5% obtained at screening Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subject's therapeutic regimen had been previously made but had not been successful Age and Reproductive Status Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug Women must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion Target Disease Exceptions Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes Previous diagnosis of monogenic etiology of Type 2 diabetes Diabetes ketoacidosis (DKA) within 6 months of screening Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors) Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study Medical History and Concurrent Diseases Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Sleep Apnea Syndromes Epilepsies, Partial Male or female age ≥ 18 Patient suffering of pharmacoresistant epilepsy Frequency of epilepsy crisis : minimum 4 per month Antiepileptic drug on a stable dose for at least 2 months SA-SDQ score ≥ 25 Written informed consent obtained Patient affiliated with a social security regimen Pregnant females (female subjects who are lactating are not excluded) Anterior CPAP treatment Central apnea >20% during the initial polysomnography Mental retardation or severe cognitive impairment Presence of pseudo-crisis | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Lymphoma Age greater than or equal to18 years First allogeneic HCT for cHL Patients with prior autologous HCT for cHL Any conditioning regimen, graft source or donor type For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months Patients with nodular lymphocyte-predominant HL Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-65.0, Perianal Fistula Cryptoglandular Perianal Fistula Crohn's Perianal Fistula Males and females 18-65 years of age. 2. Residents of the United States. 3. Single draining perianal fistula for at least three months despite standard therapy 4. Concurrent therapies are permitted (such as antibiotics, corticosteroids, thiopurines). 5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 6. Ability to comply with protocol 7. Competent and able to provide written informed consent 8. Patients that were treated with an MSC-coated fistula plug in the study IRB#12-009716 or IRB#15-003200 Inability to give informed consent. 2. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. 3. Specific exclusions: Evidence of hepatitis B, C, or HIV 4. History of cancer including melanoma (with the exception of localized skin cancers) 5. Investigational drug within thirty (30) days of baseline 6. A resident outside the United States 7. Previous allergic reaction to a perianal fistula plug. 8. Allergic to local anesthetics 9. Pregnant patients or trying to become pregnant or breast feeding. 10. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, AIDS-Related Lymphoma Ann Arbor Stage II Diffuse Large B-Cell Lymphoma Ann Arbor Stage III Diffuse Large B-Cell Lymphoma Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive or negative diffuse large B-cell lymphoma (DLBCL) Tissue available from the diagnostic biopsy in the form of blocks, tissue cores, or slides available for submission to central pathology is required for all participants enrolled to this study; formalin-fixed paraffin-embedded tissue from diagnostic tissue is acceptable and recommended; submission of the institutional diagnostic slides is also preferred for all participants enrolled in the study Stage II-IV disease; participant will need measurable disease by computed tomography (CT) or positron emission tomography (PET) scans if enrolled in the dose-expansion cohort HIV positive; documentation of HIV-1 infection by means of any one of the following Documentation of HIV diagnosis in the medical record by a licensed health care provider Documentation of receipt of ART (at least three different medications) by a licensed health care provider (documentation may be a record of an antiretroviral therapy (ART) prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name) HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay NOTE: a "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay, which is required for all investigational food drug (IND) studies Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1) Participants who have had chemotherapy other than R-EPOCH or R-CHOP, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks Prior cytotoxic chemotherapy or radiotherapy for this lymphoma Rituximab within 12 months prior to study registration; only exception will be if rituximab was given for indications other than the treatment of aggressive lymphoma, or for one prior cycle of treatment Participants who are receiving any other investigational agents Participants who have previously received ibrutinib for another indication Expected survival < 2 months Participants with a history of an opportunistic fungal infection or active fungal infection requiring, or at high risk of requiring, prophylactic or treatment with fluconazole, voriconazole or posaconazole Participants with known brain metastases from solid tumors should be excluded from this clinical trial Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma (KS) that requires systemic therapy In the dose-finding portion of the study, participants with known or suspected parenchymal brain, spinal cord, leptomeningeal disease prior to study enrollment will be excluded; in the dose-expansion portion of the study, known or suspected parenchymal brain or spinal cord disease, and/or suspected or symptomatic leptomeningeal disease prior to study enrollment will be excluded; asymptomatic leptomeningeal disease only will be allowed in the dose-expansion cohort | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-999.0, Lower Urinary Tract Symptom Benign Prostatic Hyperplasia (BPH) A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included. B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS. C. Prostate volume > 50 mL. D. Urinary flow rate <15 mL / sec. E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate If patients meet any of the following they may not be entered into the study: A. Major pelvic disease, or other malignancies. B. Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL). C. Had Prostate surgery. D. Chronic bacterial prostatitis. E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction. F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration. G. White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable . H. Unable to follow-up by MRI 3 times. I. Unable to follow-up by ultrasound or CT scan. J. Unwilling to sign a written informed consent form. K. Allergic to Iodine or other injections. L. Acute bacterial prostatitis. M. Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis. N. Cases of biopsy proven prostate, bladder, or urethral cancer. O. Patients with glomerular filtration rates less than 40 who are not already on dialysis. P. Patients with bilateral internal iliac arterial occlusion. Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc). R. Patients with neurogenic or bladder atonia. S. Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue. T. Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.). U. Patients with urethral stents. V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery. W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization. X. Allergic to pharmaceutical excipients related to Microspheres | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Urine sample present at the laboratory weekdays At least 11 ml of urine in sample Admitted to surgical or medical ward Urine sample taken on admission to hospital Rapid diagnostics suggesting mono microbial growth of > 100.000 microbes/ml urine Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery Other simultaneous infections that warrant systemic antimicrobial therapy or surgery | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 21.0-65.0, Urologic Diseases Male Urogenital Diseases Urethral Stricture Urethral Injury Stricture of the anterior urethra meeting the following 1. History of at least one previously failed attempt at conservative management, at least 6 months prior to study. 2. Urethral stricture of 10-60 mm in length, as determined by urethrography. 3. Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed. 2. Patients must be available for all follow-up visits. 3. Ability to speak English Any of the following is regarded as a criterion for excluding a subject from the study: 1. Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures <10 mm or >60 mm, as determined by urethrography, and for bulbar urethral strictures excluding those with strictures <20 mm and >60 mm, as described by urethrography. 2. Presence of untreated urinary tract infection. 3. Presence or prior history of lichen sclerosus et atrophicus (previously termed 'balanitis xerotica obliterans'). 4. Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders. 5. Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment). 6. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease. 7. Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment. 8. Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >3 times the upper limit of normal. 9. Subjects with an albumin value <3.0 g/dL. 10. Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders. 11. Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment. 12. Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms. 13. Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids [≤0.25 mg/kg prednisone or equivalent per day] are permitted). 14. Any history of alcohol and/or drug abuse. 15. Current smoker. 16. Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV). Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study. 17. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study. 18. Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury. 19. Any circumstance in which the investigator deems participation in the study is not in the subject's best interest. 20. Inability to participate in all necessary study activities due to physical or mental limitations. 21. Inability or unwillingness to return for all required follow-up visits. 22. Inability or unwillingness to sign informed consent. 23. Patients requiring concomitant use of or treatment with immunosuppressive agents. 24. Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single lesion anterior urethral stricture less than or equal to 3 cm 4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections). 6. IPSS (International Prostate Symptom Score) score of 13 or higher 7. Lumen diameter <12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax <12 ml/sec 10. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. History of over active bladder or stress incontinence 9. Previous radical prostatectomy 10. Previous pelvic radiation 11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-110.0, Pyelonephritis Urinary Tract Infections E.coli in blood culture AND identical isolate in urine sample (>= 1.000 CFU) OR relevant clinical signs of UTI Bacterial infection origin from another organ (e.g. pneumonia) Severe sepsis with multiorgan failure Perinephritic abscess Pyonephrosis requiring drainage Allergy to pivmecillinam E.coli isolate resistant to pivmecillinam Pregnancy/breastfeeding Severe neutropenia Prostatitis Severe kidney failure (eGFR<15 ml/min) | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urinary Catheters Retention, Urinary Incontinence, Urinary Anesthesia, Local The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use The patient provides informed consent prior to any study specific procedures The patient is considered to benefit from participation in the clinical study The patient do not consent to participate in the study Trauma to urethra or bladder Infection to urethra or bladder Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Outcomes of Trabeculectomy With MMC Fesh trabeculectomy surgeries recurrent surgeries | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-60.0, Surgery--Complications Renal Calculus Nephrolithiasis Urolithiasis 10-20mm lower pole renal stone measured by KUB or CT; 2. Age between 18-60 years, no gender limitation; 3. Participators can understand the research and sign the consent form without mental illness nor language disorder; 4. Low pole renal stone left after lithotripsy; 5. Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30 degree; 6. Asymptomatic patients with positive urine white blood cells and negative preoperative urine culture should be treated with antibiotics for 3days before operation; 7. Patients with symptoms of urinary infections, positive urine withe blood cells and positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 7days before operation Transplant kidney stone; 2. Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney, horseshoe kidney, etc.; 3. Combine other part of urinary stones need to be handle at the same procedure, for example ureteral stone, renal pelvic stone, middle or upper pole renal stone; 4. Hematological Disease or Coagulation disorders; 5. Withdraw anticoagulant medicine less than two weeks; 6. Fever or urinary infections without treatment according to the criteria; 7. Sevier renal dysfunction(endogenous creatinine clearance rate≤50ml/min) 8. Middle or severe hydronephrosis(dilatation of the renal pelvis ≥20mm by ultrasound); 9. Women in menstrual period or pregnancy; 10. Patients have severe disease, such as heart disease, lung dysfunction, and multiple organ failure that cannot tolerate anesthesia or operation | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Marginal Zone Lymphoma Patients must have a proven pathological diagnosis of MZL. Patients must meet all of the following to be eligible for participation in this study Confirmed CD20 positive de novo MALT Lymphoma following or being not eligible for local therapy (including surgery, radiotherapy) and antibiotics for H. pylori-positive gastric lymphoma arisen at any extranodal site Confirmed CD20 positive de novo splenic MZL following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) with symptomatic disease Confirmed CD20 positive de novo nodal MZL Patients in need of treatment: For patients with symptomatic splenic, nodal, or non-gastric extranodal MZL disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator. For patients with symptomatic gastric extranodal MZL: Helicobacter pylori-negative disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator, or H. pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator At least one bi-dimensionally measurable lesion (> 2 cm in its largest dimension by CT scan or MRI). In patients with splenic MZL, an enlarged spleen on CT scan or extending at least 2 cm below the costal margin by physical examination will constitute measurable disease providing that no explanation other than lymphomatous involvement is likely. For an enlarged liver to constitute the only measurable disease parameter, a liver biopsy showing proof of NHL in the liver is required. For SMZL Bulky progressive or painful splenomegaly one of the following symptomatic/progressive cytopenias : Hb < 10 g/dL, or Plat < 80.000 /microL, or neutropenia < 1000 /microL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration) enlarged lymphoadenopathy or involvement of extranodal sites with or without cytopenia splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites The presence of any of the following will a subject from enrolment ECOG performance status >2 History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for ≥3 years Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma Ann Arbor Stage I disease Ongoing immunosuppressive therapy other than corticosteroids Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrollment visit Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension Ongoing alcohol or drug addiction Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Abdominal Aortic Aneurism Pneumothorax Gallbladder Diseases Hydronephrosis Pregnancy, Ectopic Ascites Pleural Effusion Pericardial Effusion Emergency department patient A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis Emergency medicine specialist or resident decides to perform a POCUS exam age under 18 not able to give informed consent in Finnish | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-999.0, Urinary Retention Males > 50 years of age Signed subject informed consent (see Appendix "A") Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter will start once the M3 is placed and a functioning bladder is demonstrated Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture) Gross hematuria Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Mixed Cryoglobulinemia hepatitis C virus (HCV) infected patients symptomatic or asymptomatic mixed cryoglobulinemia coinfected or not with HIV treated by direct-acting antiviral (DAA) treatment at least one cryoglobulin measurement before and after DAA | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Urosepsis Age greater than or equal to 18 years; 2. Admitted to the hospital through the ED; 3. Primary reason for admission is treatment of UTI with or without sepsis (i.e., ED diagnosis of UTI and/or sepsis); and 4. Provide verbal or written consent to participate in the study or if patient is unable to provide consent (e.g., altered mental status), consent obtained from a legal authorized representative patients will be later excluded if : 1. they are unable to provide a urine specimen for culture; or 2. their urine culture yields no growth or is contaminated (see definition of positive urine culture below). Note: If participant's urine culture is contaminated but their blood culture is positive for a uropathogen, they will not be excluded | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 21.0-999.0, Urinary Retention Urinary Bladder, Neurogenic Intermittent Catheterization Patients with Bladder Dysfunction requiring mechanical drainage. 2. Patients with actual urinary retention Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture) 2. Gross hematuria | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Bell Palsy Adult patients 18 years old or more, diagnosed with Bell's palsy who cannot receive oral steroid treatment for their condition, due to to pregnancy, diabetes, high blood pressure etc Children under the age of 18 Patients who can receive oral steroid treatment for their condition Patients with internal ear problems. * Patients who already recieved treatmetn for their condition | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Decision Support Systems, Clinical Prostate Cancer Male >=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months) Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following PSA test at diagnosis <=15 ng/ml Localized PCa (cT1/T2,N0,M0) Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma) ***A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging No treatment yet No previous radiation or simultaneous use of androgen deprivation Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug English language proficient and ability to provide informed consent Managing urologist considers them a candidate for active surveillance Participants will be ineligible if they: 1. have pursued any active therapy for prostate cancer will be excluded; 2. are unable to read/speak English; or 3. if their managing urologist does NOT deem them as a candidate for active surveillance | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Bladder, Neurogenic Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD) Must be clinically suitable and capable of safely managing bladder using an intermittent voiding strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months OR: Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions) Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase) Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath Device after UTI has been treated) Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) Significant risk profile or recent history of clinically significant autonomic dysreflexia (e.g. History of hospitalization due to AD within past 12 months) Significant intermittent urinary incontinence (between catheterizations) Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. botox injections) Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy, urine analysis, and blood labs) Urinary tract inflammation or neoplasm Urinary fistula Bladder diverticulum (outpouching) > 5cm in size Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Hospital-acquired Infections Male or female of any age admit at Sunpasitthiprasong Hospital At least one of the six organisms, which Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter spp., isolated from clinical specimen >48 hours after admission Acquired Bloodstream infection (BSI), Lower-respiratory tract infection(LRTI), Skin/Soft tissue infection (SSTI), Surgical-site infection (SSI), Urinary tract infection (UTI) or infection at other body sites >48 hours after admit at the hospital • Clinical symptoms of current infection presented ≤48 hours of admission | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 20.0-64.0, Healthy Volunteers Japanese healthy male volunteers (20 to 64 years old) 2. BMI（Body Mass Index）should be within a range of 17.6 and 26.4. 3. Subjects who agreed not to smoke or drink during hospital stay. 4. Subjects who do not excessively consume alcohol and those who do not excessively smoke 5. Subjects who are not judged as abnormal during the screening period in the physical examinations including 12-lead ECG, clinical symptoms, clinical examination, immunological examination (hepatitis B examination, hepatitis C examination, AIDS examination, syphilis examination). 6. Subjects who are not judged as abnormal during the before administration in blood electrolyte. 7. Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator Subjects who had previous significant gastrointestinal surgeries. 2. Subjects with a history of 12-lead ECG abnormality. 3. Subjects who have constipation（less than 2 bowel movement per week） 4. Subjects who have addictive of diarrhea 5. Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.). 6. Subjects who have history of drug allergy. 7. Subjects who donated 200 mL or 400 mL of whole blood 4 weeks or 12 weeks respectively prior to the administration of investigational drug, or who donated blood component last 2 weeks. 8. Subjects who have participated in an investigational study within 4 months before signing the consent. 9. Subjects who is participating in the other investigational study 10. Subjects who received NPF-08 in the past 11. Subjects who are judged by the investigator as not adequate to participate the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Catheter; Infection (Indwelling Catheter) Catheter Infection Catheter-Related Infections Catheter Bacteraemia Urinary Tract Infections Provide written informed consent and the willingness and ability to comply with all aspects of study requirements 2. Male 3. Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal Patients planned for discharge with an indwelling catheter in place 2. Patients unable to report urinary symptoms accurately 3. Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds 4. Clinical signs or symptoms of urinary tract infection at the time of consent 5. Patients currently being treated for UTI 6. Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole. 7. Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents 8. Patients with history of bladder cancer, pelvic radiation or interstitial cystitis 9. Patients unable to comply with study requirements 10. Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-65.0, Chronic Spinal Cord Injury Neurogenic Bowel 65 years old Neurologically stable SCI for ≥ 6 months Intermittent catheterization to empty bladder Stable bladder medications for ≥ 3 months Multiple medications for the bladder Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.) pitting edema that does not resolve Known peripheral neuropathy or injury to the path of the tibial nerve Demand-type cardiac pacemaker or implanted defibrillator Cancer in the tibial nerve path and/or bladder Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit Inability to understand directions Non-English speaking | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 3.0-18.0, Prevention of Urinary Tract Infections in Children recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls ≥1 episode of urinary tract infection in the last 6 months intake of probiotic preparations for ≥1 month in the last 3 months known allergy to the study products immunosuppression therapy disease with immune deficiency children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma Recurrent Lung Non-Squamous Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7 FOR STEP 0 Patients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine to Arm T; the study chair, co-chair, biology co-chair, or a delegate must review the molecular testing and agree that the testing meets one of the molecular below ROS1 gene rearrangement by fluorescence in situ hybridization (FISH) or deoxyribonucleic acid (DNA) analysis (may have progressed on prior crizotinib therapy) MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy) MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed) RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed) Institutions will be notified of the patient's status for Arm T within two (2) business days of submission of the molecular testing reports If patients do not have tumors with the above molecular alterations noted proceed directly to step 1 FOR STEP 1 For patients with known molecular alterations, institution has been notified that patient is deemed eligible for Arm T per review of molecular testing reports | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Neurogenic Bladder Dysfunction Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis Neurologically stable Skeletally mature, over 18 years of age Reflex bladder contractions confirmed by cystometrogram At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis Able to understand and comply with study requirements Able to understand and give informed consent Active sepsis Open pressure sores on penis Significant trauma, erosion or stricture of the urethra Pregnancy Individuals who do not speak English | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Marginal Zone Lymphoma Patients must meet all of the following to be eligible for participation in this study Confirmed CD20 positive MALT Lymphoma de novo or relapsed following or being not eligible for local therapy (including surgery, radiotherapy) and antibiotics for H. pylori-positive gastric lymphoma arisen at any extranodal site OR Confirmed CD20 positive de novo or relapsed splenic MZL following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) with symptomatic disease OR Confirmed CD20 positive de novo or relapsed nodal MZL Tissue diagnostic procedures must be performed within 12 months prior to study entry and have to diagnostics by a reference pathology center. Biopsy material from an excisional or core biopsy must be submitted for retrospective central confirmation. Tissue samples dated > 12 months prior to informed consent can be accepted only if tissue material is available for retrospective confirmation, if there is no clinical indication for transformation of disease, and if the request for additional biopsy would be unethical treatment of the patient. In patients with splenic MZL without splenic tissue available for histologic review, the diagnosis may be confirmed by the presence of splenomegaly and typical morphologic and immunophenotypic findings in the blood and bone marrow. Bone marrow (acceptable up to 12 weeks before start of treatment) must be submitted for retrospective central confirmation Patients in need of treatment: For patients with symptomatic splenic, nodal, or non-gastric extranodal MZL disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator. For nodal MZL and extragastric MALT lymphoma At least one bi-dimensionally measurable lesion (≥ 1.5 cm in its largest dimension by CT scan or MRI). Please refer to Appendix C. For SMZL: For splenic MZL, an enlarged spleen on CT scan and lymphoma cell infiltration has to be seen in bone marrow and/or peripheral blood. Please refer also to Appendix E. At least one of the following must be met Bulky progressive or painful splenomegaly one of the following symptomatic/progressive cytopenias: Hb < 10 g/dL, or Plat < 80.000 /µL, or neutropenia < 1000/µL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration) SMZL with concomitant hepatitis C infection which has not responded to or has relapsed after Interferon and/or Ribavirin and/or direct antiviral agents (patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA) splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites if not being eligible for local therapy. For gastric MALT lymphoma: For gastric MALT lymphoma, the clinical evidence of the MZL as seen by gastroendoscopy is sufficient. There is no need to show a measurable lesion by CT scan or MRI. Please refer to Appendix D. is possible for patients with The presence of any of the following will a subject from enrolment ECOG performance status ≥ 2 History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for ≥3 years Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma Ongoing immunosuppressive therapy including corticosteroids (exception < 4 weeks administered at a dose equivalent to ≤ 40 mg/day prednisone is allowed) Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrolment visit Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cholangitis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension Ongoing alcohol or drug addiction Treatment with any other investigational agent within 30 days or within 5 x the half-life (t1/2) of the investigational product, whichever is longer, or participating in another trial within 30 days prior to entering this study Breastfeeding or pregnancy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infection Complicated Acute Pyelonephritis Patients willing to provide informed consent and who are willing to or likely to comply with all study requirements 2. Patients of either gender must have age ≥ 18 years 3. Patients with suspected cUTI based on clinical signs and symptoms 4. Urine culture results confirm bacterial urinary tract infection caused by β-lactamase producing gram negative bacteria requiring intravenous therapy 5. Patients with indwelling catheters should have the catheter removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization 6. Obstructive uropathy, where the obstruction is likely to be relieved by stent or nephrostomy tube no later than 24 hours after randomization 7. Patients having received antibiotics for complicated urinary tract infection only if the duration of therapy was ≤ 24 hours within 72 hr of enrollment 8. Patients having received prior antibiotics and not showing any clinically significant improvement irrespective of duration of therapy 9. Females of childbearing potential require a negative urine pregnancy test and must agree to abstinence or to use an effective method of contraception Patients with clinically significant cardiovascular, renal, hepatic, gastrointestinal conditions, neurological, psychiatric, respiratory, other severely immunocompromised, haematological, or malignant disease and other condition which may interfere with the assessment. History of uncontrolled diabetes mellitus, HIV and hepatitis B were excluded. 2. Patients with history of resistance to any of the investigational drugs were excluded from the study 3. Patients with history of hypersensitivity or allergic response, any contra-indications to penicillin, cephalosporin groups of drugs 4. Patients with creatinine clearance below 30 mL/min 5. Patients having abnormal laboratory parameters which in the opinion of PI are clinically significant enough to pose any undue safety concern for the patient or can interfere with patient's assessment 6. Perinephritic abscess or renal corticomedullary abscess, polycystic kidney disease, only one functional kidney, chronic vesicoureteral reflux 7. Uncomplicated UTI 8. Previous or planned renal transplantation or cystectomy 9. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery to relieve obstruction, to place a stent or nephrostomy) 10. Patients with a Body Mass Index ≥ 35 kg/m^2 11. Pregnant or lactating women 12. Participation in any clinical study within the previous 6 months | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Management of Obstructed Infected Kidney Adult Patients with infected hydronephrosis. 2. Infected hydronephrosis due to ureteric stone or ureteric stricture. 3. Uremic and non uremic patients Patients with a contraindication to either form of drainage (uncorrected coagulopathy, urethral stricture disease, bladder outlet obstruction, pregnancy, ureteral stone greater than 15 mm., or Steinstrasse) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty. 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's). 6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present) 7. Lumen diameter ≤ 12F by urethrogram 8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present) 9. Guidewire must be able to cross the lesion Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3. 3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment. 4. Previous urethroplasty within the anterior urethra 5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation) 6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 8. Diagnosis of untreated and unresolved BPH or BNC 9. Untreated stress urinary incontinence (SUI). 10. History of diagnosed radiation cystitis. 11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years 12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator. 13. Diagnosis of chronic renal failure and treatment with hemodialysis 14. New diagnosis of OAB (overactive bladder) within the last six (6) months 15. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.) 16. Dependence on Botox (onabotulinumtoxinA) in urinary system 17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate 18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO) 20. Previous hypospadias repair 21. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment 22. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires 23. Unwilling to use protected sex for thirty (30) days' post treatment 24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential. 25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed. 27. Current active infection in the urinary system 28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes 29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function. 30. Visible hematuria in subject's urine sample without known contributing factor 31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Sjogren's Syndrome Physician Primary physician specialty identified as Rheumatologist Physicians who currently treat 7 or more pSS subjects in a typical month Physicians who are actively involved in the management and treatment decisions of pSS subjects Subject Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or Systemic Sclerosis For main sample (6 subjects per rheumatologist) Subjects with age >=18 years and with confirmed diagnosis of pSS and are currently, or have previously, exhibited disease activity in one or more of the categories: fever of non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal involvement, myositis, peripheral nervous system involvement, central nervous system involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received immunosuppressant or biologic treatment For oversample (1 subject per rheumatologist) Subjects with age >=18 years and with confirmed diagnosis of pSS that fit the following Has never exhibited disease activity in any of the categories above, Moderate or severe fatigue (in the opinion of the rheumatologist) Not applicable | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Urinary Tract Infections Spinal Cord Injuries Spinal Cord Diseases Neurogenic Bladder Provision of signed and dated informed consent form History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction At least 6 months post-initial hospital discharge following SCI/SCD onset Neurogenic bladder Ability to perform daily instillation on self or with help of others and willingness to adhere to the study regiment History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (prior to screening) Have a designated physician or health care provider for routine care Use of clean intermittent catheterization or catheterization through a stoma (i.e. Mitrofanoff) as their primary method of bladder management Concurrent use of systemic oral or intravesical antibiotic prophylaxis Documented or self-reported history of gentamicin allergy Female patients who are currently pregnant or attempting to become pregnant Patients with a history of 8th cranial nerve disorder Co-morbidities like cancer and chronic disease that could impact patient safety OR significantly affect the rate of UTIs and/or quality of life (QOL) substantially Urological co-morbidities like bladder cancer and history of kidney disease Current UTI at baseline visit (assessed via urine analysis and culture and symptoms) Concurrent enrollment in a similar clinical trial Concurrent use of contraindicated diuretics (ethacrynic acid, furosemide) Current use of other contraindicated or disallowed concomitant medications or receiving treatments that may influence the results from this study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-70.0, Urinary Tract Infections Written informed consent At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis Duration of UTI symptoms for more than 7 days before physician's visit Clinical signs of invasiveness such as fever (axillary body temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting Known or suspicion of anatomical or functional abnormality of the urinary tract Vaginal symptoms: discharge, irritation Diabetes mellitus Immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia) Any other serious comorbidity as judged by the treating physician Bladder catheter in situ or during the past 30 days Pregnancy Recurrent urinary tract infection (more than 3 infections during the last 12 months) | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months 4. For healthy volunteers without UTIs: No diag-nosed UTIs within the last year 5. For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics) Be treated for urinary tract infection at time of enrolment 2. May not take prophylactic treatment for urinary tract infections (antibiotics only) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Patient has signed informed consent Patient age is 18 years or older at time of informed consent Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Patient is unable or unwilling to provide follow-up information Patient is undergoing prostatic artery embolization for reasons that do not symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Any other reason the investigator deems cause for | 0 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.