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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, Urethral Stricture Males > 21 years of age 2. Recurrent stricture of the bulbar urethra: 1. < 50 mm in length on urethrography; and which 2. has a segment unable to accommodate a 16Fr flexible cystoscope 3. Healthy tissue on both sides of stent 4. Urinary flow in the abnormal range of the Siroky nomogram. 5. Written informed consent obtained prior to participation in the study 6. Patients must be available for all follow-up visits Strictures: 1. outside the bulbous urethra 2. associated with, or suspected to be, urethral carcinoma 3. secondary to pelvic distraction injuries 2. Inability to enlarge the bulbar urethral stricture to > 26 Fr. 3. Presence of any other urologic implant 4. Presence of urethral diverticuli 5. History of hypospadias repair 6. Presence or prior history of balanitis xerotica obliterans. 7. Uncontrolled bleeding disorder 8. Active urinary tract infection 9. Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation. 10. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease 11. Concurrent participation in another clinical investigation 12. Current illness that might confound the results of this investigation 13. Inability to participate in all of the necessary study activities 14. Inability or unwillingness to return for all required follow-up visits 15. Inability or unwillingness to sign the patient informed consent document | 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): 15.0-64.0, Urinary Tract Infections years or older Living in institutional or non-institutional settings months post spinal cord injury (SCI) prior to entry or have Spina Bifida Loss of bladder function Loss of normal bladder sensation Selected in-patients involved in the Rehab I program Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management Two or more urinary tract infections (UTI) within the 12 months prior to the study Capable of understanding the purpose of the study and providing informed consent to participate Pursue appropriate follow-up over the course of the study Any bladder stone(s) Kidney stone(s) greater than 1 cm in size Any obstructing kidney stone regardless of size Nephrostomy tube(s) Supravesical diversion (original bladder is no longer part of the collection receptacle for urine) Congenital genitourinary anomaly that predisposes to UTI Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer) Current immunosuppression Vascular prosthesis Congenital or acquired cardiac disease susceptible to vegetative infections | 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 Traumatic spinal cord injury within 3 months prior to Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily Has symptoms of UTI at Treated with prophylactic antibiotics to prevent UTIs Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract Has used intermittent catheterization for more than 10 days prior to | 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, Overactive Bladder Urinary Incontinence Urge Incontinence Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months Clinically significant outflow obstruction Significant post void residual volume Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator Patient with a neurological cause for abnormal detrusor activity Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs | 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): 18.0-85.0, Atrial Fibrillation Adult patients (Age>=18) undergoing elective coronary artery bypass grafting with cardiopulmonary bypass by 4 surgeons at the London Health Sciences Centre Patients at high risk of developing postoperative atrial fibrillation--patients are required to meet one or more of the following Age >=65 Ejection Fraction <50% or Left Ventricle Grade of 2-3 Diabetes Mellitus (independent of type of management) Any documented prior history of atrial fibrillation (paroxysmal/chronic) Contraindication to Beta Blockers Severe COPD with intolerance to Beta Blockers Concomitant non-CABG procedure Enrollment in another RCT Inability to obtain informed consent Patients' inability to attend follow-up visits Grade IV left ventricle (EF <20%) Redo CABG procedure Off-pump coronary artery bypass 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): 18.0-70.0, Hepatopulmonary Syndrome Diagnosis of HPS, based on all of the following: evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography (CT) scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation, and/or hepatic vein wedge pressure greater than 12 mm Hg) Intrapulmonary shunt on contrast echocardiography (CE) AaDO2 greater than 20 mm Hg on standing, room air arterial blood gas (ABG) OR Pre-HPS with elevated exhaled Nitric Oxide: evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography (CT) scan or ultrasound, and or splenomegaly with no other explanation, and/or ascites with no other explanation, and/or hepatic vein wedge pressure greater than 12 mm Hg) IPVDs diagnosed on contrast echocardiography (CE) exhaled nitric oxide level greater than 12.6 ppb Significant pre-existing respiratory disease (in these cases, the diagnosis of HPS or pre-HPS is uncertain, given that observed elevations in AaDO2 may be from underlying lung disease): forced expiratory volume in 1 second (FEV1) less than 70 percent of predicted forced vital capacity (FVC) less than 70 percent of predicted FEV1/FVC less than 0.7 inability to perform pulmonary function tests (for the same reasons, it is important to document normal underlying lung function) echocardiographic estimated right ventricular systolic pressure 50 mm Hg or right heart catheterization mean pulmonary artery pressure greater than 25 mm Hg (pulmonary hypertension may result in progressive hypoxemia due to intracardiac shunt or right ventricular failure) inadequate echocardiographic window to allow for accurate transthoracic contrast (bubble) echocardiogram (CE) (this is the test used to identify IPVDs) antibiotic use within the last 1 month (this is the intervention being tested) (note that all subjects will be under the concurrent care of a gastroenterologist or hepatologist, and some patients may accordingly be on prophylactic antibiotic therapy for prior SBP or variceal hemorrhage; these patients will be excluded) (20 percent expected rate of due to this criterion) current use of exogenous nitrates (may increase exhaled NO levels) norfloxacin intolerance (norfloxacin administration is the study intervention): allergy or intolerance to norfloxacin or other fluoroquinolones history of tendon rupture associated with norfloxacin or other fluoroquinolones glucose 6-phosphate dehydrogenase deficiency (possibility of hemolytic reactions with norfloxacin) known prolongation of the QTc interval to a duration that is > 50% of the R-R interval, subjects taking QTc-interval prolonging drugs, subjects with uncorrected hypokalemia, clinically significant bradyarrhythmias or acute myocardial ischemia (norfloxacin may worsen this) pregnancy (norfloxacin contraindicated) age less than 18 or greater than 70 expected death/transplantation within 3 mo (treating physician's discretion) lactose intolerance (placebo contains lactose) Smoking within the last 1 month | 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, Spinal Cord Injury Urinary Tract Infection Patients followed at the who have sustained spinal cord injury > 12 months earlier, suffer from neurogenic bladder, practice intermittent bladder catheterization, and who have had at least 1 symptomatic UTI in the past will be enrolled will obstructive urolithiasis, indwelling bladder or nephrostomy catheters, supravesical urinary diversion, vesicoureteral reflux, active malignancy, uncontrolled diabetes mellitus, AIDS, requirement for immunosuppressive medication, or current antibiotic therapy. Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded | 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, Urinary Incontinence Spinal Cord Injury Spina Bifida Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale. 2. Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management. 3. Neurogenic bladder documented by urodynamic testing. 4. Stable neurogenic bladder dysfunction of at least 1 year or more. 5. Compliant bladder wall. 6. Normal renal function History of bladder cancer, augmentation, or radiation. 2. Bladder capacity less than 100 milliliters (ml). 3. Anatomic outlet obstruction or urethral strictures. 4. Vesico-ureteric reflux grade 2 or higher. 5. Presence of an ileal conduit or supra-pubic catheter drainage. 6. Contraindications to general anesthesia or surgery. 7. Inability to complete follow up visits for 3 years. 8. Inability to comprehend and answer self-administered questionnaires | 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 Patient has a complicated urinary tract infection Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture Patient is indian and 18 years of age or greater Patient had a kidney transplant Patient had been given antibiotic therapy for condition Patient had poor liver function Patient has complete obstruction of urinary tract Patient has history of serious allergy to antibiotics and multivitamins Patient is pregnant Patient not likely to respond to 10 to 14 days of antibiotic therapy Patient not likely to survive 4 week study period | 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): 12.0-70.0, Systemic Lupus Erythematosus Males or females between 12 and 70 years old Diagnosis of Systemic Lupus Erythematosus (SLE) Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study Ability to have weekly intravenous (IV) administration of study drug Prior exposure to abetimus sodium within 6 months prior to screening Patients not on stable medications for 30 days prior to screening Patients with acute or chronic infections | 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, Gram-negative Bacterial Infections Patients with positive gram-negative bacteria Less than 18 years of age | 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): 18.0-120.0, Marginal Zone Lymphoma ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months) Measurable and evaluable disease All stages are eligible Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B) Willing and able to provide written informed consent Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment Life expectancy of at least 6 months Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment ≥ 25% lymphoma bone marrow involvement Platelet count < 100,000 cells/mm³ Neutrophil count < 1,500 cells/mm³ Known history of HIV infection Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection Physical or mental condition that makes patient unable to complete specified follow-up assessments | 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): 18.0-64.0, Urinary Tract Infection(UTI) Patients followed at the Houston VA Medical Center (VAMC) who have sustained spinal cord injury >18 months earlier, suffer from neurogenic bladder, require an indwelling urinary catheter (either transurethral or suprapubic), and do not have vesicoureteral reflux will be enrolled Women and members of minority groups and their subpopulations will be included in this protocol. We anticipate that the gender and minority representation will match the demographic mix for the SCI Unit of the Houston VAMC. We will initially target inpatients for enrollment simply for the patients' convenience, but we will have a low threshold for enrolling suitable outpatients or patients about to be discharged who live close enough to the VAMC to make home visits feasible urolithiasis, indwelling nephrostomy catheter, supravesical urinary diversion, vesicoureteral reflux, current antibiotic therapy, uncontrolled diabetes mellitus, and immunosuppression Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded | 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, Distal Urethral Cancer Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Urethral Cancer Associated With Invasive Bladder Cancer Histologically or cytologically confirmed transitional cell cancer of the urothelium or bladder Metastatic disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan No known brain metastases ECOG performance status 0-2 Life expectancy ≥ 12 weeks Platelet count ≥ 100,000/mm^3 WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Bilirubin normal | 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, Surgery Medico-surgical pre-operative decision of post-operative ICU admission (because of co-morbidities or/and the surgical procedure) Age > 18 yr Elective surgery No informed consent Cardiac arrhythmias Body mass index > 40 Patients undergoing surgery with an open thorax Patients undergoing neurosurgery Enrolment in any other protocol | 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 Men or non-pregnant women, 18 years of age or older with a suspected complicated urinary tract infection with an onset of symptoms 72 hours or less prior to study entry Patients must present with a least one sign or symptom of a lower UTI (dysuria, urgency, frequency, suprapubic pain) or for spinal cord injury patients if such symptoms are not present, at least one of the following: fever (T > 38º C or 100.4º F orally), onset of urinary incontinence, increased spasticity, autonomic hyperreflexia, increased sweating, or cloudy and odorous urine Patients must have at least one of the underlying conditions Indwelling urinary catheter or intermittent catheterization mL of residual urine after voiding Neurogenic bladder Obstruction due to nephrolithiasis, tumor or fibrosis Urinary retention due to benign prostatic hypertrophy, bladder cancer or other urological anatomic abnormalities Patients must have pyuria prior to enrollment (within 48 hours) defined as > 10 leukocytes/mm3 in unspun urine by hemocytometer or > 5 leukocytes/hpf in resuspended sediment of centrifuged urine Patients must have one clean-catch, midstream urine culture or culture from catheter (obtained using sterile technique, not from a Foley bag) that was obtained within 48 hours of enrollment and had a positive results: 1. Defined as >= 100000 CFU/mL (>= 10000 CFU/mL for S. saprophyticus) for a causative pathogen 2. If more than 1 pathogen is identified, each should be present at a colony count >= 100000 CFU/mL (>= 10000 CFU/mL for S. saprophyticus) to be included in the analysis 3. For catheterized patients two or more pathogens (>= 100000 CFU/mL) (>= 10000 CFU/mL for S. saprophyticus) isolated from a baseline urine culture will be considered contaminants unless simultaneous blood culture yields the same pathogen(s) 4. The causative pathogen must be susceptible to ciprofloxacin on in vitro susceptibility testing 5. Enrollment and start of treatment is permitted prior to the availability of the culture report Have a history of allergy to quinolones Are unable to take or inability to tolerate oral medications History of prostatitis or epididymitis Have signs and symptoms of pyelonephritis [all of the following: fever (T>38° C/100.4° F orally), chills, and flank pain or costovertebral angle tenderness] Have an intractable infection requiring > 14 days of therapy Have an uncomplicated UTI Have a renal transplant Have ileal loops or vesico-ureteral reflux Have a ciprofloxacin-resistant pathogen upon urine or blood culture Have received systemic antimicrobial therapy within 48 hours prior to enrollment | 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): 18.0-79.0, B-cell Lymphoma Adult patients, ≥ 18 and < 80 years of age CD20-positive diffuse large B-cell lymphoma Low-intermediate, high-intermediate, or high risk disease and/or bulky tumor (largest diameter ≥ 7.5 cm) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Prior treatment for diffuse large B-cell lymphoma Types of non-Hodgkin's lymphoma other than diffuse large B-cell lymphoma (DLBCL) Central nervous system (CNS) involvement of lymphoma | 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): 45.0-999.0, Lower Urinary Tract Symptoms Prostatic Hyperplasia male patients with LUTS associated with BPH diagnosed > 3 months IPSS score > 13 voiding and storage symptoms maximum flow rate of > 4 mL/s and < 15 mL/s post void residual volume > 200 mL symptomatic 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): 25.0-80.0, Prostate Cancer for trial group Age between 45 and 80 years old Presumably Stage 2 and higher prostate carcinoma as determined by the PI At least 6 weeks after the last biopsy session Prior to any PC treatment. for control group Age between 25 and 35 years old No family history of PC No lower urinary tract symptoms for both groups History of hemorrhoids History of prostetitis | 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, Lymphoma Histologically confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL) Stage I-IV disease All IPI risk groups Must be positron emission tomography (PET)-positive At least one measurable lesion ≥ 15 mm in its shortest axis (greatest transverse diameter) for jugulodigastric and infra-carinal lymph nodes with CT scan (MRI is allowed only if CT scan cannot be performed) Otherwise the shortest axis (greatest transverse diameter) must be ≥ 10 mm Lesions should be selected according to the following features Clearly measurable in two perpendicular dimensions From as disparate regions of the body as possible mediastinal and retroperitoneal areas of disease whenever these sites are involved Secondary DLBCL (in transformation) Evidence of symptomatic CNS disease ECOG or WHO performance status 0-2 Cardiac ejection fraction ≥ 50% as assessed by echocardiography Sufficient hematological values, hepatic and renal function Patient condition, compliance, and geographic proximity must allow proper staging and completion of treatment and follow-up Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study therapy Prior or concurrent hematological malignancies | 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 Tract Infection Patients followed at the Require an indwelling bladder catheter (either transurethral or suprapubic) Have a history of at least 1 UTI in the past will be eligible for enrollment Have pre-existing bladder colonization obstructive urolithiasis percutaneous nephrostomy catheters supravesicular urinary diversion vesicoureteral reflux active malignancy uncontrolled diabetes mellitus AIDS requirement for immunosuppressive medication, expected survival < 6 months, creatinine clearance > 2.0 mg/dL, or current antibiotic therapy Latex allergy Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible | 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): 19.0-999.0, Coronary Artery Disease Inflammatory Response Atherosclerosis Age > 18 hs CRP >3mg/L and <10 mg/L Active infection Systemic Inflammatory Disease Currently on warfarin Cr > 2.0 Fish Allergy Pregnancy or unwillingness to use some form of birth control | 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 Bladder, Neurogenic Patients suspected or at risk for complicated urinary tract infections Gross contamination of urine samples at the time of collection | 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, Overactive Bladder History of non-neurogenic overactive bladder for at least 12 months prior to study entry Intolerance to medical therapy or persistence of symptoms despite medical therapy Subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence Use of Botulinum Toxin A injections into the bladder within the previous 6 months Presence of a neuromodulator Using catheterization as a way to control incontinence History of bladder cancer | 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, Diabetes Mellitus Healthy male or female subject. 2. Age ≥ 18 and ≤ 45 years. 3. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive. 4. Non-smoker, defined as no nicotine consumption for at least one year. 5. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) Previous participation in this trial or other clinical trials within the last 3 months. 2. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant). 3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial. 4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator. 5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. 6. History of alcohol or drug abuse. 7. Any positive reaction of drugs of abuse. 8. Hepatitis B or C or HIV positive. 9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. 10. Use of any insulin product for therapeutic purposes in the past. 11. Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol is permitted. 12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 13. Blood donation of more than 500 ml within the last 12 weeks. 14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 15. Known or suspected allergy to trial product or related products | 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): 20.0-75.0, Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma or mantle cell lymphoma Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy Patients aged from 20 to less than 75 years Performance Status (P.S.): 0 or 1 Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions) Patients from whom written consent to participate in this study has been obtained Patients who meet any of the following will be excluded Patients with apparent infections Patients with serious complications (hepatic failure or renal failure) Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease) Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea) Patients who are known to be positive for HBV, HCV or HIC Patients receiving other investigational drugs within 3 months before registration in the study Patients with allogenic bone-marrow transplant Women who are pregnant, of childbearing potential, or lactating Patients who do not agree to contraception | 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, Multiple Sclerosis Neurogenic Bladder Spinal Cord Diseases Written informed consent has been obtained Subjects with neurogenic detrusor overactivity due to Multiple sclerosis(MS)(EDSS≤8) or Spinal cord injury(SCI)(partial or complete lesions) MS or SCI symptoms should be stable for >= 6 months Neurogenic detrusor overactivity symptoms should be stable for >= 6 months Subject is willing and able to perform clean, intermittent, catheterization, if required Subject is willing and able to take study medication in compliance with the protocol Subjects with neurogenic detrusor overactivity due to Parkinson's or cerebrovascular disease Subjects with Sjögren's Syndrome or any similar symptoms Subjects with evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator Subjects with evidence of pressure sores >= grade 2 Subjects with a history of bladder sphincterotomy Subjects with known history of vesico-ureteral reflux without upper urinary tract infection Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber Subjects undergoing hemodialysis Subjects with severe hepatic impairment | 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, Staphylococcal Infections Patients need to be administered Linezolid in order to be enrolled in the surveillance Patients not administered Linezolid | 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, Lymphoma Newly diagnosed patients with symptomatic macroglobulinemic lymphoma are eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven small lymphocytic lymphoma or chronic lymphocytic leukemia and monoclonal IgM. Also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia. 2. Patients must have adequate liver function (bilirubin <2.5 mg%) and renal function (creatinine <2.0 mg%) None | 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 The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main 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 mL of residual urine after voiding Neurogenic bladder Obstructive uropathy due to lithiasis, tumor or fibrosis Acute urinary retention in men Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally), chills and flank pain (all 3 signs/symptoms must be present) Have a 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 | 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, Stage III or Stage IV Melanoma At least 18 years of age Ability to understand and the willingness to sign a written informed consent document Subject must have a pathologic diagnosis malignant melanoma (stage III or IV) Subject must have at least one of the following: 1. Melanoma that was previously treated with at least one complete or partial course of therapy for melanoma with either a poor to no response or evidence of disease progression; 2. Melanoma that cannot be treated with first-line therapies because of medical comorbidities/risk of toxicity; or 3. Melanoma that has not been treated with first-line therapies because of patient refusal If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection The subject must have measurable disease, as defined by the presence of at least one measurable lesion, defined as having longest diameter greater than or equal to 20 mm by conventional measurement techniques (e.g., measurement of evaluable cutaneous metastases) or greater than or equal to 20 mm by imaging studies Subject must have an ECOG performance status of 0, 1, or 2 Subject must have the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines. Alternatively, if the subject is mentally incompetent for medical decision-making, a parent, legal guardian, or power of attorney has the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines Subject must be able to comply with office visits as required by the protocol The effects of Investigational product on the developing human fetus is at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Subjects with medical co-morbidities, which in the judgment of the investigator, place them at an unacceptable level of risk for participation in this study Pregnant women, since the prenatal effects of CADI-05 have not been characterized Subjects with HIV, AIDS, or chronic immunosuppression for organ transplantation Subjects who are unable to comply with office visits as required by this protocol or would suffer great hardship by participating in the study History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study Clinically significant active 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): 18.0-65.0, Complicated Urinary Tract Infection Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens ileal loops or vesicoureteral reflux complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess fungal urinary tract infection permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry history hypersensitivity to study medication | 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): 18.0-50.0, Neurogenic Bladder Dysfunction Nos Spinal Cord Injury Male or Females between ages of 18-50 Patient weighs over 111 pounds Patient has documented Spinal Cord Injury T10 or above Thoracic Level by ASIA Score less than 8 weeks prior to the start of the study. Both complete and incomplete spinal cord injuries will be included in this study Ability to complete all study requirements including voiding diary and to attend all scheduled study visits, in the opinion of the investigator Written informed consent has been obtained Patient has negative pregnancy test result if female and of child-bearing potential Written authorization for use and release of Health and Research Study Information has been obtained Patient or family member is willing and able to perform clean intermittent catheterization for duration of this study Patient has received anticholinergic medication for the treatment of overactive bladder before randomization into the study Patient has history or evidence of any pelvic or urological abnormalities, bladder or urethral surgery or disease, other than neurogenic bladder related to spinal cord injury, that may impact bladder function Patient has significant stress urinary incontinence, determined by patient history, in the opinion of the investigator Neurogenic detrusor overactivity (greater than 10cm elevation in pdet pressure) at baseline urodynamic screening (Day 0) Patient found to have significant baseline renal pathology (e.g. hydronephrosis, stones, renal mass) at Day -7 Patient has a history of two or more treated urinary tract infections within 6 months of screening Day -7 Patient has urinary tract infection defined as a bacteriuria count of greater than 105/ml conjoint with leukocyturia greater than 5hpf at screening Day -7 Patient has asymptomatic urinary tract infection, defined as positive nitrites, leukocyte esterase and or blood on urine dipstick reagent strip at randomization Day 0 Patient has history of unexplained hematuria or unexplained hematuria if greater than 5 RBC's/hpf are present at screening Day -7 Patient has active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening Day -7 | 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, Diabetes Healthy male or female subject 2. Age between 18 and 45 years (both inclusive) 3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. 4. Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 (both inclusive) 5. Non-smoker, defined as no nicotine consumption for at least one year. 6. Signed and dated informed consent obtained before any trial-related activities Previous participation in this trial or other clinical trials within the last 3 months. 2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures. 3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. 4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator. 5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. 6. History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening. 7. Positive test for hepatitis B or C or HIV positive at screening or in the past. 8. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. 9. Use of any insulin product in the past. 10. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen will be permitted. 11. Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks. 12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 13. Known or suspected allergy to trial products or related products. 14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-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, Spinal Cord Injury Neurogenic Bladder Urinary Tract Infection Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study will septicemia, chronic antimicrobial therapy and inability, or unwillingness to give 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): 19.0-65.0, Hemiplegia Cerebrovascular Accident Hemiplegia due to CVA In physiotherapy treatment Acceptance in join the research Less then 6 months of diagnostic | 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, Crohn's Disease The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry were: 1. Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows: 1. The patient completed 5 treatment courses in the previous trial. 2. The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included. 3. The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication. 4. The patient did not meet any discontinuation criterion in previous trial. 2. Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05. 3. Patients could not take any other investigational therapies during the course of this study. 4. Men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used. 5. Patients had to be able to adhere to the study visit schedule and/or protocol requirements Could not have met any of the for the CD02, 03, 04 or 05 studies | 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, Knee Pain Knee Osteoarthritis To be included in the study, patients must be between the 18 and 70 years of age Completed a pre-surgery psychological evaluation, and have had intermittent knee pain for at least a year The bariatric surgery requirement involves a bypass of the stomach Standard of care guidelines for this surgery require that these patients' previous dieting attempts were without success Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation, and joint pain Patients will have a WOMAC pain scale score > 3, according to the study by Miller, et al Patients will have a standing AP, lateral and Merchant radiographic scan taken to confirm that they have OA Patients will be ineligible for the study if any of these are not met | 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): 0.25-17.0, Urinary Tract Infection Girls Age 3 months to 18 years Spina bifida as a sole urologic diagnosis Informed consent and assent (7 years of age and older) Males Females over 18 years and older Prophylactic antibiotics Immunosuppression from corticosteroids, transplant recipients or children with congenital immunodeficiencies Poorly controlled diabetes Untreated HIV infection Chronic indwelling catheters in the bladder Malnourished Pregnancy Any form of urinary division other than appendicovesicostomies is not permitted | 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 Patient has a clinically suspected and /or bacteriologically documented complicated UTI or acute pyelonephritis judged by the investigator to be serious Patient has one positive urine culture within 48 hours of enrollment Patient has one or more signs or symptoms of either upper or lower UTI Patient is male with or without a bladder catheter or urologic abnormalities; OR patient is a female with a history or clinical evidence of one or more urologic abnormalities Patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics Patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study Patient has complete obstruction of any portion of the urinary tract. Patient has a history of seizures other than an uncomplicated febrile seizure | 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): 18.0-75.0, Atrial Fibrillation Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months, at least 1 episode of PAF must be documented Age 18-75 Documented effectiveness failure of at least 1 AAD including beta-blockers AAD usage < 3 half life periods (except beta-blocker) LA size > 55 mm LA thrombus Previous LA ablation/surgery, structural heart disease, heart failure class III-IV Hypertrophic cardiomyopathy Mitral prosthesis Unstable angina Uncontrolled hyperthyroidism Stroke or TIA within 6 months Myocardial infarction within 2 months | 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, Urodynamics Acute Urinary Retention Written informed consent Open kidney surgery with lumbotomy Thoracic epidural analgesia Significant renal dysfunction (creatinin >200mol/l) Contraindications to epidural anesthesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 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, Cystitis Urinary Tract Infections Non-pregnant adult females; 2. 18 years of age or older; 3. Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry; 4. One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf. 5. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism Males; 2. Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control; 3. Three or more episodes of acute uncomplicated UTI in the past 12 months; 4. Known structural abnormality that would predispose the participant to reflux or urinary retention; 5. Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder; 6. Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV; 7. Patients with onset of symptoms > 72 hours prior to entry; 8. Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection; 9. Patients with purported hypersensitivity to iodine; 10. Patients with history of thyroid disease; 11. Patients who received treatment with other antimicrobials within 48 hours prior to entry; 12. Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse; 13. Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study | 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 Infection Competent patient aged 18 years or above One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain) Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy Known allergy to fluoroquinolones Female patients who are pregnant or lactating Patients with known polycystic kidney disease Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis) Patients with history of kidney transplantation Residence outside country of enrolment Inability to speak or read Dutch Isolated causal uropathogen resistant to ciprofloxacin Renal abscess Chronic bacterial prostatitis | 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, Urinary Frequency Urinary Urgency Nocturia Written informed consent obtained Male patients greater than 18 years of age with continued OAB symptoms after successful PVP for BPH Patients may be included if they have previously been treated with FDA approved anticholinergic agents for the treatment of OAB such as Oxybutynin chloride(generic oxybutynin chloride, Ditropan XL, or Oxytrol) Tolterodine tartrate(Detrol or Detrol LA), or trospium chloride(Santura) and are no longer receiving such treatment for a minimun of 14 days prior to study Previous treatment with darifenacin Urinary obstruction as defined as a Qmax < 12 ml/sec at time of study entry Urinary retention as defined as PVR > 150 ml Neurogenic Bladder Prostate Cancer Chronic inflammation( i.e. interstitial cystitis) Bladder stones History of bladder cancer Urinary tract infection Uncontrolled narrow-angle glaucoma | 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, Diabetic Peripheral Neuropathic Pain Established diagnosis of type 2 diabetes mellitus according to American Diabetes Association History of daily lower extremity pain or discomfort (burning, tingling or other paresthesias) for a period of at least 3 months immediately prior to enrollment Presence of neuropathy, as determined by evaluation at the VACHS Neuromuscular Disease and Neuropathy Clinic at the time of the baseline examination Judgment of the study endocrinologist (EH) that the patient is not experiencing a paradoxical precipitation of neuropathy following institution of good control which can be expected to resolve spontaneously Confirmation of the study neurologists that pain is not attributable to other medical conditions that could mimic DPNP (e.g., HIV, Hepatitis C, cryoglobulinemia, pernicious anemia, untreated hypothyroidism) Documentation of treatment of neuropathic pain with the maximum dose of one of the medications identified as a first line or second line treatment in either VA guidelines28 or other published consensus recommendations27 with maximum dose defined as either the maximum allowable dose or the maximum tolerated dose for the recommended duration of an adequate trial, unless otherwise contraindicated or patient refusal) Continued use of a guideline endorsed medication for neuropathic pain (unless otherwise contraindicated or patient refusal) Continued refractory pain despite pharmacological intervention as described above (as determined by a pain intensity score at least 4 on a 0-10 numeric rating scale) No medical condition that could impair the subject's ability to participate (e.g., unstable angina, severe COPD, limb amputation, intermittent claudication) No psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair subjects' ability to participate as defined by their responses to the SCID and BDI (e.g., presence of major Depressive Disorder and BDI score 30 or greater or presence of suicidal intent; presence of these conditions will require immediate medical/psychiatric attention to assure safety and institution of appropriate treatment) No history of Type 2 diabetes mellitus Any life threatening illnesses or acute physical disease Any current psychiatric condition (psychosis, substance abuse/dependence) Any current suicidal thoughts or ideations The presence of profound cognitive impairment rendering successful participation in CBT or ED impossible prior or current psychological treatment for chronic pain The presence of physical disabilities resulting in an inability to attend treatment sessions and/or inability to participate in telephone interventions (e.g., severe dysarthria) No access to touch tone telephone | 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, Waldenstroms Macroglobulinemia Each patient must meet all of the following to be enrolled in this study Clinicopathological diagnosis of Waldenstroms macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstroms macroglobulinemia All patients with the diagnosis of WM will be evaluable for response according to the response No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed. In that case baseline monoclonal protein levels for assessment of response will be the levels prior to plasmapheresis, if this is the higher value prior to treatment initiation Patients must have at least one of the following indications to initiate treatment as defined by Consensus Panel Two recommendations from the Second - International Workshop on Waldenstroms Macroglobulinemia Recurrent fever, night sweats, weight loss, fatigue Hyperviscosity Lymphadenopathy which is either symptomatic or bulky (>5cm in maximum diameter) Symptomatic hepatomegaly and/or splenomegaly Patients meeting any of the following are not to be enrolled in the study Prior systemic treatment with WM (plasmapheresis is allowed) Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Cardiac amyloidosis Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3 | 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, Endometrial Carcinoma Patients must have histologically confirmed primary Stage III or Stage IV (see FIGO staging-Appendix I) or recurrent endometrial carcinoma with disease whose potential for cure by radiation therapy or surgery alone or in combination is very poor. Recurrent disease must be biopsy confirmed Patients may have received prior cytotoxic chemotherapy (1 therapy) excluding a platinum/taxane. Patients may have received prior hormonal therapy or therapy with biologic agents, but such therapies must be discontinued 4 weeks prior to entry on this study Patients in whom both radiation and chemotherapy is planned may receive radiation prior to entry on this study (order not specified). At least four weeks should have elapsed since completion of RT involving the whole pelvis or over 50% of the spine Patients must be 18 years of age or older Patients with a concomitant malignancy other than Genentech, Inc Page 27 of 62 Bevacizumab Protocol 03-10-08 Page 27 non-melanoma skin cancer. Patients with a prior malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy Patients in whom pathological confirmation of the tumor is not obtainable Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient Patients with third degree or complete heart block are not eligible unless a pacemaker is in place. Patients on medications which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator Life expectancy of less than 12 weeks Patients who are sensitive to E. Coli-derived drug preparations Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of 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, Urinary Retention Neurogenic Bladder Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City Able to complete study measurements alone or with the help of a family member or caregiver Able to communicate with the study personnel in English Have access to a telephone for data collection Terminally ill Cognitively impaired No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more) | 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): 18.0-70.0, Lymphoma, Large B-Cell, Diffuse Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Patients with one of the following B-cell Lymphoma, CD 20 positive Mantle cell, Marginal zone, follicular Histological transformation from low grade to high grade Diffuse large B cell Aged from 18 to 70 years WHO performance status 0, 1 or 2 Signed inform consent Life expectancy of ≥ 90 days (3 months) Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure Previous treatment with immunotherapy or chemotherapy except Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before Rituximab alone during less than three months, if stopped more than one year before Previous radiotherapy except if localized to one lymph node area Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative Central nervous system or meningeal involvement Contraindication to any drug contained in the chemotherapy regimen HIV disease, active hepatitis B or C Any serious active disease or co-morbid medical condition (according to investigator's decision) Any of the following laboratory abnormalities | 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): 40.0-999.0, Urinary Incontinence, Stress The subject has agreed to be implanted with the AMS Male Transobturator Sling System. 2. The subject is willing and able to give valid informed consent. 3. The subject is > 40 years of age. 4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management. 5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day. 6. Internal sphincter contractility confirmed by endoscopic view. 7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy 8. Pre-existing urological conditions, other than incontinence have been treated and are under control. 9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. 10. The subject is a good surgical candidate The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods. 2. The subject has an atonic bladder. 3. The subject has a post-void residual > 75 cc. 4. The subject has detrusor-external sphincter dyssynergia. 5. The subject has a urinary tract infection (UTI). 6. The subject was treated with pelvic radiation within the last 6 months. 7. The subject currently has an inflatable penile prosthesis. 8. The subject self-catheterizes. 9. The subject has symptomatic or unstable bladder neck stricture disease. 10. The subject has a history of urethral strictures that may require repetitive instrumentation. 11. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents). 12. The subject has a history of connective tissue or autoimmune conditions. 13. The subject has a compromised immune system. 14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. 15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials | 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): 18.0-90.0, Complicated Urinary Tract Infection Males and females 18 to 90 years of age, inclusive. 2. Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power field in spun urine) 3. Clinical signs and/or symptoms of cUTI, either of: a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness; OR b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms Dysuria Frequency Suprapubic pain Urgency ii. At least one of the following complicating factors Male gender Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration Urogenital surgery within 7 days preceding administration of the first dose of study drug Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial 2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed 3. Complete, permanent obstruction of the urinary tract 4. Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL) 5. Suspected or confirmed perinephric or intrarenal abscess 6. Suspected or confirmed prostatitis 7. Known ileal loop or vesico-ureteral reflux 8. Women who are pregnant or nursing | 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): 18.0-90.0, Aortic Valve Disorder Patients planned for aortic valve/root replacement or repair will be selected for the study Patients with known chronic obstructive pulmonary disease emphysema previous thoracic or cardiac surgery history of CVA or stroke and evidence of intraoperative pleural adhesions will be excluded from the study Patients requiring internal mammary artery coronary bypass 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): 18.0-65.0, Hepatitis C, Chronic Liver Diseases Virus Diseases proven chronic hepatitis C aged between 18 and 65 male patients high grade liver fibrosis (Grade 3 renal disease hyperparathyroidism hypogonadism malignant disease use of any other drug known to effect bone mineral metabolism use of alcohol organ transplant any form of thyroid disease any medical condition known to be associated with bone loss | 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): 20.0-999.0, Urinary Bladder, Overactive Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself Patient with an average frequency of micturition of 8 or more times per 24-hour period Written informed consent has been obtained Patients without experience of urge incontinence before informed consent Patients given a clear diagnosis of stress incontinence Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc) Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis Patients with a previous history of recurrent urinary tract infection Patients complicated with or with a history of bladder tumor or prostatic tumor Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period Patients with an indwelling catheter or practicing intermittent self-catheterization Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia | 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): 50.0-999.0, Benign Prostatic Hyperplasia Prostatic Hyperplasia Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment Is withdrawn from the dose finding study Has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study Has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study Has the post void residual volume > 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound) Has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study Has acute urinary retention in the dose finding study Has a history or current evidence of drug or alcohol abuse during the dose finding study Has been treated with any investigational product including post-marketing clinical trials during the dose finding study Has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study Has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of GI198745 in this study and that might poses additional risk to the patient | 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, Thoracotomy Sternotomy Written informed consent Thoracic surgery including thoracotomy and sternotomy Thoracic epidural analgesia Contraindications to epidural anesthesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 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): 18.0-120.0, Bladder Cancer Pathologically (histologically or cytologically) diagnosis of carcinoma of the bladder within 105 days prior to registration Patients with operable tumors that are primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis Patients with disease involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate. If the patient's initial tumor was a high grade Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment (transurethral resection bladder tumor [TURBT] and intravesical bacillus Calmette-Guerin [BCG] immunotherapy) or have presented to a participating urologist who judged BCG therapy is contraindicated because this patient may be immuno-compromised or because the patients refuses BCG therapy No confirmed tumor-related hydronephrosis No pN+ or > T1 disease No histologically or cytologically confirmed node metastases If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy No evidence of distant metastases Patients for whom radical cystectomy is the standard next therapy per urologic guidelines, in the judgement of the participating urologist, are eligible | 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, Cystitis, Interstitial Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome Body mass index (BMI) of >39 kg/m2 History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein Patients with peripheral neuropathy Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0% | 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 Adult patients with a suspected or documented complicated urinary tract infection Female patients must test negative for pregnancy and agree to use adequate birth control measures Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy Patients with complete obstruction of any portion of the urinary tract Patients with rapidly progressive or terminal illness Renal transplant patients | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
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 Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
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, Bleeding Marginal Ulcer patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer bleeding marginal ulcers after other bariatric procedures staple-line bleeding after RYGB iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage missing records and/or unreachable patients with scant information for analysis | 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 Hyperplasia Male, 50 years of age or older. 2. American Society of Anesthesiology (ASA) classification of physical status, class 1-3 3. Signed an informed consent at the beginning of the study. 4. Patients presenting with LUTS associated to benign prostatic enlargement for more than 3 months, needing a surgical management, with at least one of the following situations: disability score ≥3, I-PSS ≥12, or full urinary retention 5. Qmax ≤12ml /s for no drained patients with voided volume> 125 ml. 6. Estimated prostate weight between 25g and 80g 7. Patient free of catheter with PVR ≤ 300cc 8. Patient without renal disorders. 9. No prostate cancer suspicion at clinical examination, including DRE. 10. PSA ≤ 10 ng/ml, with negative prostate biopsies of PSA is between 4 and 10 ng/mL if patient is 75 years or younger or has a life expectancy of more than 10 years. 11. In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery. 12. In case of current BPH medical management, alpha blockers and herbal medicines should be stopped one week before surgery and 5-alpha-reductase-inhibitors should be stopped one month before surgery. 13. Patient must be affiliated to the French social healthcare or equivalent Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods 2. Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease. 3. History of pelvic lesions with abdominal sphincter injury. 4. Urinary tract infection without antibiotics. 5. Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation. 6. Subject with neurogenic bladder and/or sphincter abnormalities 7. Subject with confirmed or suspected malignancy of the prostate or the bladder. 8. Previous prostatic surgery. 9. History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis. 10. Patient having a prosthesis in the procedure area 11. Patient with an active anorectal disease 12. Treatment emergency 13. Individual unable to respect timing and visits determined by the protocol. 14. Constitutional hemostasis and coagulation abnormalities not linked to oral medications 15. Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator | 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, Waldenstrom's Macroglobulinemia Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstrom's macroglobulinemia.1 All patients with the diagnosis of WM will be evaluable for response according to the response (section 8.1) No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed. In that case baseline monoclonal protein levels for assessment of response will be the levels prior to plasmapheresis, if this is the higher value prior to treatment initiation Patients must have at least one of the following indications to initiate treatment as defined by "Consensus Panel Two" recommendations from the Second International Workshop on Waldenstrom's Macroglobulinemia41. 1. Recurrent fever, night sweats, weight loss, fatigue 2. Hyperviscosity 3. Lymphadenopathy which is either symptomatic or bulky (≥5cm in maximum diameter) 4. Symptomatic hepatomegaly and/or splenomegaly 5. Symptomatic organomegaly and/or organ or tissue infiltration 6. Peripheral neuropathy due to WM 7. Symptomatic cryoglobulinemia 8. Cold agglutinin anemia 9. Immune hemolytic anemia and/or thrombocytopenia 10. Nephropathy related to WM 11. Amyloidosis related to WM 12. Hemoglobin ≤10g/dL 13. Platelet count <100x109/L 14. Serum monoclonal protein >5g/dL even with no symptoms CD20 positive disease based on any previous bone marrow immunohistochemistry or flow cytometric analysis performed up to 3 months prior to enrollment Karnofsky performance status >=60 Life-expectancy >3 months Baseline platelet count >=50 10^9/L, and absolute neutrophil count >= 0.75 10^9/L Meet the following pretreatment laboratory at the Screening visit conducted within 28 days of study enrollment AST (SGOT): >3 times the upper limit of institutional laboratory normal ALT (SGPT): >3 times the upper limit of institutional laboratory normal Prior systemic treatment with WM (plasmapheresis is allowed) Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Cardiac amyloidosis Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3 Women who are pregnant. Women who are breast-feeding and do not consent to discontinue breast-feeding. Women of childbearing age who are not willing to use effective anti-conceptive methods for the duration of the study and 6 months thereafter. Men who do not consent not to father a child during the treatment period and six months thereafter | 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, Overactive Bladder male or female, aged 18 to 80 years old, weighing 110 pounds or more 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 must have a stable neurological injury occurring at least 6 months or more has detrusor overactivity demonstrated during the screening period or within 1 year of screening has a negative pregnancy result if female and of childbearing potential. The following are also required for entry into the study at Randomization/Day 1 experiences at least 14 episodes or more of urinary incontinence per week with no more than 2 incontinent-free days currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted) Volunteers with a negative urine culture result must take an antibiotic medication for 3 days immediately prior to Randomization/Day 1 and agree to continue antibiotic medication for at least 3 days following treatment. Volunteers with a positive urine culture result indicating urinary tract infection (UTI), must take an antibiotic to which the identified organism is sensitive for at least 3 days immediately prior to Randomization/Day 1, on Randomization/Day 1, and continue for 3 days following the procedure (or longer as needed) has history or evidence of any pelvic or urological abnormalities including but not limited to the following: 1. elevated serum creatinine more than 2 times the upper limit of normal (reference range) 2. current or history of hematuria, 1) if the hematuria is determined to be a pathologic condition or 2) is uninvestigated 3. interstitial cystitis in the opinion of the investigator bladder stones within 6 months of screening 4. surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries for bladder stones (more than 6 months) and stress incontinence, uterine prolapse, rectocele, or cystocele (more than1year) from screening has had previous or current botulinum toxin therapy within 9 months has been immunized for any botulinum toxin serotype discontinued anticholinergic medication for overactive bladder less than 14 days prior to Randomization/Day 1 has a history or current diagnosis of bladder cancer male with previous or current diagnosis of prostate cancer or has a Prostate Specific Antigen (PSA) level greater than 10.0 ng/mL has 24 hour total volume voided more than 3000 mL of urine has a post void residual volume above 200 mL has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening uses any anti-platelet or anticoagulant therapy or is using medications with anticoagulative effects within 3 days prior to treatment | 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 Infection Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture Positive blood cultures or no blood cultures taken | 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): 20.0-90.0, Healthy Obesity Subject giving his written informed consent Male from 20 to 35 years old and more than 60 Affiliated to the French National Health Insurance Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm Complete blood count (CBC)-platelet, normal liver function and normal coagulation Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative normal Thyroid Stimulating Hormone(TSH) Previous medical and/or surgery judged by the investigator as incompatible with this study Glaucoma C-reactive protein > 10 mg/l people over 120 kg People with triglyceridemia > 3 g/L or with familial hypercholesterolemia Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test Dietary habits judged by the dietitian as incompatible with the study aim Vegetarians Nutritional allergies or xylocaïn allergy People with eating disorders | 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 Urinary Tract; Accessory Inpatient with a permanent urinary catheter (balloon catheter) Urinary catheter placed in the hospitalization (previous day) or at admission Urinary tract infection diagnosis at time of the insertion Spinal cord injury or neurogenic bladder at admission | 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, Infection Osteoarthritis of the Knee patients with osteoarthritis of the knee patients who are undergoing primary knee replacement patients who are able to provide informed consent patients with a prior joint infection patients who have a known allergy to tobramycin, and patients who have no fixed address | 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, Osteoarthritis in the Knee Joint Osteoarthritis in the Hip Joint patients who have had a primary total hip or total knee arthroplasty patients with osteolysis, or previous complications from their joint replacement | 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): 18.0-69.0, Urothelial Carcinoma T2 clinical stage (no palpable mass under anesthesia after TURB) Absence of diffuse Cis (Cis on random bladder biopsies) Patients above 18, and below 70 years of age PS status ≤ 2 No previous treatment for a bladder muscle infiltrative carcinoma. Previous endovesical instillations for non muscle infiltrative lesions (pTa, pT1, Cis) are allowed. No metastases on tauraco-abdomina-pelvic CT scan (no node > 1 cm) and bone scan. Normal biological values: neutrophils > 1,5.109 /l, platelets > 100. 109 /l, Alkaline Phosphatases < 2 x N, bilirubin < 1,5 N, Transaminases < 1,5 x N, Creatinine clearance ≥ 60 ml/min Signed inform consent Patient belonging to a social security system All other histology than urothelial carcinoma primitive adenocarcinoma epidermoid carcinoma little cells carcinoma In situ diffuse carcinoma associated with urothelial carcinoma muscular infiltrating Tumor stade > T2, T3 or T4 or pT4a (prostatitis) Serious cardiac, pulmonary, hepatitic, renal, digestive or neurological pathology which is non equilibrating or potential aggravating risk by treatment Cancer history or other actual cancer (except skin cancer) not remission or with an end of treatment inferior to 2 years Participation to another clinical trial in a delay inferior to 30 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, Bladder Cancer Diagnosis of non-muscle invasive bladder cancer Recurrent disease after undergoing induction or maintenance therapy with bacillus Calmette-Guérin (BCG), meeting any 1 of the following Stage Ta or T1 disease (grade 2 or 3) Carcinoma in situ with stage Ta or T1 disease (grade 1, 2, or 3) Carcinoma in situ alone Has undergone a second resection of all T1 disease to muscle invasive disease No urothelial cell carcinoma (UCC) ≥ T2 No recurrence of grade 1 UCC following BCG induction therapy No UCC involving the prostatic urethra or upper urinary tract WHO performance status 0-4 | 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): 0.0-40.0, Carcinomas Amyloidosis Anal Cancer Anemia Cholangiocarcinoma of the Extrahepatic Bile Duct Transitional Cell Carcinoma of Bladder Bone Marrow Transplant Failure Bone Cancer Cancer of Brain and Nervous System Breast Cancer Carcinoma of the Large Intestine Endocrine Cancer Esophageal Cancer Eye Cancer Gall Bladder Cancer Gastric (Stomach) Cancer Gastrooesophageal Cancer Gastrointestinal Stromal Tumor (GIST) Gynecologic Cancers Head and Neck Cancers Hepatobiliary Neoplasm Kidney (Renal Cell) Cancer Leukemia Lung Cancer Hodgkin Disease Lymphoma, Non-Hodgkin Mesothelioma Multiple Myeloma Myelodysplastic Syndromes (MDS) Neuroendocrine Tumors Myeloproliferative Disorders Pancreatic Cancer Prostate Cancer Skin Cancer Soft Tissue Sarcoma Testicular Cancer Thymus Cancer Thyroid Cancer Criteria:1.) Past exposure to anthracycline chemotherapy for cancer 2.) Echocardiogram at least six months after exposure to anthracyclines (in patients over the age of 40, the echocardiogram must be obtained within 6 months of anthracycline exposure) 3.) Ability to understand and the willingness to sign a written informed consent document. We have no age, gender, or ethnic background limitations. Due to the increased frequency of cardiovascular disease from other causes in adults over 40 years, we will limit enrollment to those patients with an echocardiogram 6 months after the completion of anthracycline exposure. Children will be included and will be eligible if they have an echocardiogram at least 6 months after completion of anthracycline treatment ) Congenital heart disease (other than patent foramen ovale) 2.) Pre-existing cardiomyopathy before anthracycline administration 3.) Patients with Down syndrome 4.) Patients receiving B-blocker therapy at the time of anthracycline exposure 5.) Pregnant patients (if their echocardiogram was obtained either during pregnancy or within three months of pregnancy) All participants will be cancer survivors. To minimize bias from post-partum cardiomyopathy, pregnant patients will be excluded if their echocardiogram was obtained during pregnancy or within three months of pregnancy. HIV-positive persons will not be excluded from the study. Of note, some patients receive a MUGA (multigated acquisition) study to evaluate left ventricular ejection fraction. Patients who receive only a MUGA scan will NOT be included in the study an echocardiogram is necessary | 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): 0.167-2.0, Vesicoureteral Reflux Infants admitted to the inpatient ward at Children's National Medical Center for the treatment of a febrile urinary tract infection (see definitions) will be screened for into the research protocol UTIF: A UTIF will require the presence of (1) fever and/or symptoms consistent with UTI (2) pyuria based on urinalysis, and (3) culture-proven infection with a single organism. Specifically, the study definition of UTIF will require Fever: A documented temperature of at least 100.4 °F or 38°C, measured anywhere on the body either at home or at doctor's office. Positive dipstick analysis: Pyuria on urinalysis (>10 WBC/mm3 (uncentrifuged specimen) OR >5 WBC/hpf (centrifuged specimen), OR >1+ leukocyte esterase on dipstick) Culture documentation of UTI: Evidence of bacteria (>5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen). Bag collected specimens will not be acceptable Infants who do not conform to the above and who have co-morbidities such as duplication abnormalities, diabetes mellitus, over weight status, anatomical defects of the urinary tract and neuropathic bladder dysfunction | 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 Adult patients who admitted to the Taipei Veterans General Hospital with the diagnosis of community-onset UTI caused by Enterobacteriaceae will be eligible for in this study if hospitalization for parental antimicrobial therapy is required pregnancy or lactation in women history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled) complete obstruction of the urinary tract peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy a baseline pathogen resistant to study drug treatment with a systemic antimicrobial agent for >24 h within 72 h prior to enrolment, or absolute neutrophil count <1000/mm3 Men with a history or physical findings suggestive of acute or chronic prostatitis will also 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): 18.0-999.0, Prostate Cancer Male, over 18 years of age Karnofsky Performance Scale (KPS) greater or = to 70% Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC) A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three Soft tissue progression defined by 1.0 Bone disease progression defined by PCWG2 with two or more new lesions on bone scan Post-hormonal therapy rising PSA values from a hormone therapy nadir on greater or = to 3 successive determinations at least two weeks apart, where the increase above the nadir is the greater of greater or = to 2.0 ng/mL or a greater or = to 10% change (Subjects with a rise in PSA but no evidence of metastases at any time by imaging studies will NOT be eligible.) For subjects who have discontinued anti-androgen therapy, PSA rise as defined above must be documented Within two weeks after discontinuation if used following surgical or medical castration (second line therapy) After four weeks discontinuation if used as first line therapy History of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five years History of splenectomy Autoimmune or Ab-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease Radiation therapy within four weeks prior to start of study treatment (Day -1) Patients may not have received more than one prior chemotherapy The following medications within four weeks prior to start of study treatment (Week 1): systemically administered radiopharmaceuticals such as bone seeking isotopes (e.g., samarium-153 Lexidronam); hematopoietic growth factors other than erythropoietin; medroxyprogesterone as an appetite stimulant; or alternative medicine treatments for prostate cancer, including Prostasol (formerly: PC-Plus), saw palmetto, or Zyflamend® Active central nervous system (CNS) or symptomatic epidural metastatic disease An infection requiring antibiotic treatment within seven days of starting study treatment (Day -1) | 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, Healthy Healthy, non-smoking male subjects, 18 years of age or older BMI greater than or equal to 19 and less than or equal to 30 Negative for HIV Hepatitis B surface antigen and Hepatitis C antibody Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone) Urine cotinine test No significant diseases or clinically significant findings in a physical examination No clinically significant abnormal laboratory values No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG) Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration Known or suspected carcinoma Known history or presence of Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity Alcoholism within the last 12 months Drug dependence and/or substance abuse Use of tobacco or nicotine-containing products within the last 6 months Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet) | 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, Healthy Healthy, non-smoking male subjects, 18 years of age or older BMI greater than or equal to 19 and less than or equal to 30 Negative for HIV Hepatitis B surface antigen and Hepatitis C antibody Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone) Urine cotinine test No significant diseases or clinically significant findings in a physical examination No clinically significant abnormal laboratory values No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG) Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration Known or suspected carcinoma Known history or presence of Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity Alcoholism within the last 12 months Drug dependence and/or substance abuse Use of tobacco or nicotine-containing products within the last 6 months Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet) | 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): 18.0-79.0, Postoperative Pain Knee Replacement Arthroplasty Unilateral primary total knee replacement Weight 50-125 kg Age 18-79 years Intact neurological exam to the surgical lower extremity Cognitively intact with ability to sign informed consent Renal insufficiency with creatinine >1.5 mg/dL Allergy to medication used in the study Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.) Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management | 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, Richter's Syndrome Signed written informed consent prior to performing any study-specific procedures Patients with B-CLL and newly diagnosed not previously treated and biopsy proven DLBCL Richter's transformation Computerized tomography (CT) scan performed within 6 weeks prior to starting treatment ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2 or 3 Age 18 years and over CHOP or CHOP-like anthracycline containing treatment for DLBCL within 6 months prior to registration Known central nervous system (CNS) involvement of B-CLL Any malignancy that requires active treatment with the exception of basal cell carcinoma and non-invasive squamous cell carcinoma Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis Subjects meeting any of the following must not be enrolled in the study Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg (the surface antigen of the Hepatitis-B-Virus). In addition, if negative for HBsAg but HBcAb (Hepatitis B core Antibody) positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. Consent will be sought prior to any test being performed Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease History of significant cerebrovascular disease in last 6 months Known Human immunodeficiency virus (HIV) positive | 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 Strictures Men over 18 years old with urethral stricture S/P urethral reconstruction Posterior urethral strictures Children | 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 (Induction) Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months Bone marrow biopsy alone not acceptable Stage II, III, or IV AND grade 1, 2, or 3a disease Must meet for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) OR the follicular lymphoma international prognostic index (FLIPI) as defined below Patient must meet ≥ 1 of the following GELF Nodal or extranodal mass ≥ 7 cm At least 3 nodal masses > 3.0 cm in diameter (Induction) Prior chemotherapy, radiotherapy, or immunotherapy for lymphoma Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy A prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed Recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years Pregnant or nursing Active, uncontrolled infections (afebrile for > 48 hours off antibiotics) ≥ grade 2 neuropathy Myocardial infarction within the past 6 months NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities | 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, Analgesia, Epidural Urodynamics Urinary Retention Written informed consent Open kidney surgery with lumbotomy Thoracic epidural analgesia International Prostate Symptom Score (IPSS) < 7 Preoperative residual urine volume < 100ml Contraindications to epidural analgesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 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, Benign Biliary Strictures Subject is 18 years or older 2. Subject has benign biliary stricture 3. Subject must be able to give informed consent Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP) 2. The subject is unable to give 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): 18.0-999.0, Urinary Catheter Blockage and Encrustation Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation Screening within 30 days of first treatment Systemic antibiotics within 7 days of first treatment Investigational drug or device within 30 days of enrollment Current infection that requires treatment with systemic antibiotics Recent history of significant autonomic dysreflexia (requiring intervention or 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): 40.0-999.0, Knee Osteoarthritis Age 40 years and older American College of Rheumatology for symptomatic Knee OA: Pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101 WOMAC pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each) Clinical examination confirming knee pain or discomfort or instability referable to the knee joint Physically able to participate in both the Tai Chi and Standard PT programs Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen. 2. willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee Any intra-articular Synvisc or Hyalgan injections in the previous 6 months Inability to pass the Mini-Mental Status examination (with a score below 24)102 Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments Enrollment in any other clinical trial within the last 30 days Plan to permanently relocate from the region during the trial period Positive pregnancy test or planning pregnancy within the study period Not 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): 0.25-18.0, Neurogenic Bladder Spina Bifida Healthy Child with spina bifida who requires clean intermittent catheterization (CIC) for ongoing bladder management Child either self catheterizes or receives catheterization by a consistent person Child/parent/caregiver able to read and understand English in order to consent to participation in the study and to respond to verbal questions about the experience and satisfaction with the catheter Urethral deformities (i.e. stricture, false passage) Antibiotic prophylaxis Allergy to PVC product Diabetes Mellitus Unwilling to reuse catheters History of bladder pathology (ie. tumours, calculus) Surgical history of augmentation (cystoplasty, continent diversion) | 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, Spinal Cord Injuries years of age or above with motoric complete Spinal cord injury medullary level C4-L4 Preserved Hamstring reflex (L5) Participation acceptance in verbal and writing Respiratory dependent patient Baclofen pump Malignancy in the urinary tract, surgery on the urinary tract, urethral strictures Ileostomy, Colostomy or radiation towards the area Pregnancy, for men planning a pregnancy with their partner | 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): 18.0-90.0, Neurogenic Bladder Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation No antibiotic treatment Written informed consent Pregnancy and breastfeeding Current antibiotic 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, Diverticulum, Colon Colorectal Neoplasms Crohn Disease Colitis, Ulcerative Colostomy Ileostomy - Stoma Rectal Prolapse Intestinal Polyposis Lymphoma Endometriosis Intestinal Volvulus Patient was > 18 years old at time of procedure Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™ Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use Patient underwent his/her first follow-up visit within two months post-surgery have been defined for this data collection | 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 Prostate Cancer Cancer of the Prostate Prostate Cancer Patients with measurable or evaluable metastatic adenocarcinoma of the prostate. Either histologic or cytologic diagnosis is acceptable 2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix A.) 3. Age 18 years old or above 4. Laboratory values (performed within 28 days prior to enrollment) as follows WBC ≥ 2000/microlitre Serum creatinine < 1.5 X upper limit of laboratory normal Hgb > 8g/dl (patients may be transfused to reach this level) Platelets > 100,000 cells/mm3 Total bilirubin < 1.5 X upper limit of laboratory normal, unless due to Gilbert's disease AST (SGOT) and ALT (SGPT) < 2.5 X upper limit of laboratory normal Alkaline phosphatase < 2.5 X upper limit of laboratory normal (If alkaline phosphatase > 2.5 X upper limit of laboratory normal due to bone metastases, then patient is eligible.) HIV 1 and 2 antibody Negative Hepatitis B surface antigen Negative Active infection. 2. Active autoimmune disease. 3. Previous treatment with mouse monoclonal antibodies 4. Need for chronic maintenance oral steroids. 5. Active brain metastatic disease. Patients with treated brain metastases with surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and off steroids are eligible. 6. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures | 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): 0.0-35.0, Neurogenic Bladder Urinary Retention Patients who perform clean intermittent catheterization on a regular basis Patients on daily continuous antibiotic 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, Prostate Cancer I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was resistant to hormone therapy and previously treated with a docetaxel-containing regimen. I 02. Participant must had either measurable or non-measurable disease. I 03. Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents. I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours). I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 18 years) E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must had elapsed prior to first study drug administration. E 03. Adverse events (excluding alopecia and those listed in the specific criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology [NCI CTCAE] v4.03) at the time of randomization. E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study. E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had been disease-free for ≥ 5 years. E 06. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months was also not allowed. E 10. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or to comply with the study procedures or interfere with interpretation of study results. E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study. E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum. E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E 16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03). The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial | 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 Untreated, histological diagnosis of CD20-positive diffuse large B-cell lymphoma Stage II-IV (Ann Arbor Staging) Measurable or assessable disease defined as at least one of the following A lymph node or tumor mass that is ≥ 2.0 cm in at least one dimension by CT portion of PET/CT scan, CT scan, or MRI Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease Diagnostic tissue slides and paraffin-embedded block must be available No CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells ECOG performance status 0-2 Absolute neutrophil count (ANC) ≥ 1,500/mm³ Peripheral platelet count ≥ 100,000/mm³ | 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 Associated With Catheter Urinary Tract Infection patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, Burch colposuspension, with or without mid-urethral sling Known UTI at time of surgery Unable to provide informed consent Use of chronic intermittent self-catheterization pre-operatively Use of chronic prophylactic antibiotics Use of antibiotics for any indication other than UTI during peri-operative and 6-week post-operative period Presence of fistula involving urogenital tract Use of chronic steroids or immunosuppressant Immunocompromised patient | 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 Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL) Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible Patients must have non-bulky stage I or II disease by Ann Arbor classification This staging excludes FDG-PET evaluation Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable | 0 |
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