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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): 18.0-999.0, Bladder Cancer Patients must have histologically confirmed MIBC (T2-T4a, N0-N1, M0 per American Joint Commission on Cancer [AJCC]) pure or mixed histology urothelial carcinoma. Clinical node-positive (N1) patients are eligible provided the lymph nodes (LNs) are confined to the true pelvis and are within the planned surgical LN dissection template The most recent TURBT that showed muscularis propria invasion should be within 10 weeks prior to beginning study therapy. Patients must have sufficient baseline tumor tissue from either initial or repeat TURBTs. The local site pathologist will be asked to estimate and record the rough approximate percentage of viable tumor in the TURBT sample (initial or repeat TURBT with highest tumor content) to document at least 20% viable tumor content prior to registration Patients must be ineligible for cisplatin-based chemotherapy due to any of the following below OR refused cisplatin-based chemotherapy Creatinine clearance(CrCl) <60 mL/min with Easter Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Creatinine clearance(CrCl) ≥ 60 mL/min with ECOG PS 2 (if patient fit for RC) Hearing impaired ≥ Grade 2 by CTCAE Neuropathy ≥ Grade 2 by CTCAE Patient refused cisplatin-based chemotherapy? Patients must be medically fit for TURBT and RC Age ≥ 18 years | 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): 1.0-999.0, Trauma;Pelvis The are: All patients with pelvic fracture and urethral distraction injury (PFUDDI) except patients with any of the The are: 1. Bladder neck injury 2. Rectal injury 3. Urethrorectal injury 4. Spinal cord injury 5. Associated anterior urethral strictures | 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, Infections, Bacterial Subject must be >=18 to <=65 years of age inclusive, at the time of signing the informed consent The subject has 2 or more of the following clinical signs and symptoms of acute cystitis with onset <=72 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain The subject has pyuria (>=10 white blood cells per cubic millimeters [WBC/mm^3] or the presence of leukocyte esterase) and/or nitrite from a pretreatment clean-catch midstream urine sample based on local laboratory procedures The subject is female. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance from the Baseline Visit through completion of the Test of Cure (TOC) Visit Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol The subject resides in a nursing home or dependent care-type facility The subject has a body mass index >=40.0 kilogram per square meter (kg/m^2) or a body mass index >=35.0 kg/m^2 with obesity-related health conditions such as high blood pressure or uncontrolled diabetes The subject has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation The subject is immunocompromised or has altered immune defenses that may predispose the subject to a higher risk of treatment failure and/or complications (e.g., renal transplant recipients, subjects with clinically significant persistent granulocytopenia [absolute neutrophil count <1000/microliter (µL)], and subjects receiving immunosuppressive therapy, including corticosteroid therapy [>40 mg/day prednisolone or equivalent for >1 week or >=20 milligrams per day (mg/day) prednisolone or equivalent for >6 weeks; or prednisolone or equivalent >=10 mg/day for >6 weeks]). Subjects with a known cluster of differentiation 4 (CD4) count of <200 cells/mm^3 should not be enrolled The subject has uncontrolled diabetes, defined as a non-fasting glucose value >300 milligrams per deciliter (mg/dL) or based on investigator judgment The subject has any of the following: A medical condition that requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: a) Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy; b) Acute severe pain, uncontrolled with conventional medical management; c) Active peptic ulcer disease; d) Parkinson disease; e) Myasthenia gravis; f) A history of seizure disorder requiring medications for control (this does not a history of childhood febrile seizures) OR Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug (e.g., ileostomy or malabsorption syndrome). Subjects who have had a gastric bypass or a cholecystectomy are excluded from the study OR Hemoglobin value <12 grams per deciliter (g/dL) or a known uncorrected iron deficiency The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period The subject has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacteriaceae (other than Escherichia coli [E. coli]) as the contributing pathogen The subject has symptoms known or suspected to be caused by another disease process such as asymptomatic bacteriuria or chronic interstitial cystitis | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture Surgery Urologic Diseases Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations) Male Age >= 18 years Fit for operation, based on the surgeon's expert opinion Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations Unique urethral stricture Urethral stricture =< 3 cm Urethral stricture at the bulbar segment Patient declares that it will be possible for him to attend the follow-up consultation Absence of signed written informed consent Age <18 years Female patients Transgender patients Patients unfit for operation Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Urethral strictures exceeding 3 cm A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Lichen Sclerosus related strictures Strictures after failed hypospadias repair | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-100.0, Lower Urinary Tract Symptoms Follow in neuro-urology for lower urinary tract symptoms Radical Prostatectomy Perineal Radiotherapy Surgery for stress urinary incontinence | 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, Neurogenic Bladder Multiple Sclerosis Voiding Dysfunction for subjects with neurogenic bladder Patients with clinical diagnosis of neurogenic bladder History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, Stroke, spina bifida, Parkinson's, major spine surgery) years or older Specifics for MS patients: Adult female patients with clinically stable MS [Expanded Disability Status Score (EDSS) ≤6.5], with bladder symptoms ≥3 months, will be screened. Patients will be considered to have VD if they have an increased Postvoid Residual (≥ 20% Maximum Cystometric Capacity). Patients who perform self-catheterization will be included in the VD category as well for subjects with neurogenic bladder Men (for aims 1 and 2 only), anatomical bladder outlet obstruction (anti-incontinence procedures, urethral strictures, or advanced pelvic organ prolapse). Severe debilitating MS, history of seizures, pregnancy or planning to become pregnant, contraindications to MRI, history of augmentation cystoplasty. Patients with active UTI can be treated and subsequently screened for the trial Positive urine pregnancy test at enrollment (There are no known risks to a subject's fetus. There is no known teratogenic risk associated with urodynamics or fMRI) - Cognitively impaired 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): 18.0-999.0, Peripheral Facial Paralysis Quality of Life Patient with peripheral facial palsy Age over 18 years old Subject wishing and able to give informed consent and to respect the requirements of the protocol Patient not being French Patient who can not read French Facial graduation Facial dysfunction other than PFP such as facial trauma Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to the subject or could compromise compliance with the study protocol Participation in other studies in the 30 days prior to in this study Legal incapacity or limited legal capacity | 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, BPH With Urinary Obstruction BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Male subjects ≥ 50 years of age who have symptomatic BPH. 2. International Prostate Symptom Score (IPSS) score ≥ 13. 3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml. 4. Post-void residual (PVR) ≤300 ml. 5. Prostate volume >80 cm3 to ≤150 cm3 Urology: 1. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate. 2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery. 3. Verified acute bacterial prostatitis within last 12 months documented by culture. 4. Active or history of epididymitis within the past 3 months. 5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device. 6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible. 7. Subject interested in maintaining fertility. 8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months): 1. Beta-blockers; 2. Anticonvulsants; 3. Antispasmodics; 4. Antihistamines; 5. Alpha blockers for BPH and anticholinergics or cholinergics; 6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia)); 7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)); 8. Estrogen, drug-producing androgen suppression, or anabolic steroids; 9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis) 9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible 10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment. 11. Visible hematuria with subject urine sample without a known contributing factor. 12. Presence of a penile implant or stent(s) in the urethra or prostate 13. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months. Gastroenterology: 14. Previous pelvic irradiation or radical pelvic surgery. 15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. Nephrology: 16. Compromised renal function defined as serum creatinine > 2.0 mg/dl. 17. Hydronephrosis (Grade 2 or higher). Oncology: 18. Prostate cancer testing: If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment Males 50-59 years PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25% Males 60+ years PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25% 19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable. 20. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of enrollment. Cardiology: 21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV). 22. Cardiac arrhythmias that are not controlled by medication and/or medical device. 23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. Pulmonology: 24. History of significant respiratory disease where hospitalization for the disease is required. Hematology: 25. Diagnosed or suspected bleeding disorder, or coagulopathies. 26. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment. Endocrinology: 27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed. Immunology: 28. History of immunosuppressive conditions (e.g., AIDS, post-transplant). Neurology: 29. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires. 30. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (< 25% of accepted and established nomograms). General: 31. Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.). 32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. 33. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 20.0-999.0, Interstitial Cystitis Adults with age of 20 years old or above 2. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes 3. Patients has received cystoscopy and ruled out other bladder lesion 4. Free of active urinary tract infection 5. Free of bladder outlet obstruction on enrollment 6. Free of overt neurogenic bladder dysfunction and limitation of ambulation 7. Patient or his/her legally acceptable representative has signed the written informed consent form Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up 2. Patients with bladder outlet obstruction on enrollment 3. Patients with PVR >100 ml 4. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection 5. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)> 3 x upper limit of normal range, and aspartate aminotransferase (AST) > 3 x upper limit of normal range 6. Patients have abnormal serum creatinine level > 2 x upper limit of normal range 7. Female patients who is pregnant, lactating, or with child-bearing potential without contraception 8. Patients with any other serious disease considered by the investigator not in the condition to enter the trial 9. Patients had received intravesical treatment for IC within recent 1 month 10. Patients had participated investigational drug trial within 1 month before entering this study 11. Patients with coagulopathy | 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 Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD) 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy Must have stable urinary management history: no significant changes in bladder management regimen within past 12 months OR Must have urodynamic profile suitable for C2P, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions) 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the C2P device, as specified in the investigational device instructions for use (IFU) Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (UTI) has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months) 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections) 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis) 7. Urinary tract inflammation or neoplasm 8. Urinary fistula 9. Bladder diverticulum (outpouching) > 5cm in size 10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) 11. Impaired kidney function or renal failure 12. Active gross hematuria 13. Active urethritis 14. Bladder stones 15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device 16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications 17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System | 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): 20.0-80.0, Overactive Bladder Syndrome Male patients with BPH and undergo TURP or TUIP. 2. Patients void smoothly after catheter removal. 3. No active urinary tract infection. 4. No gross hematuria or blood clot obstruction. 5. Patient or his care giver can complete voiding diary and report symptoms Patients have overt neurological diseases such as cerebrovascular disease, senile dementia or spinal cord injury. 2. Patients have severe medical disease and completely immobile. 3. Patients have PVR larger than 150ml. 4. Patients do not have OAB after TURP | 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, Urinary Tract Infections Recurrent UTI Antibiotic Resistant Infection Female, age 18-90 Ability to void spontaneously Suffers from recurrent multi-drug resistant or extensively drug resistant urinary tract infections caused by E.coli, Klebsiella, Enterococcus, Citrobacter, Proteus, Enterobacter, Serratia and Providencia Has staghorn renal calculi, chronic hydronephrosis, intermittent catherization, indwelling urinary catheters, urinary diversions, end stage renal disease on hemodialysis, transplantation, HIV, cirrhosis, pancreatitis, allergy to soy or milk/milk proteins or lactose intolerance Pregnant or breastfeeding Currently taking probiotics. 4 week washout | 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, Kidney Stone Patients with renal colic and non-obstructing renal calculi. No stone greater than 10 mm in longest diameter All other causes of pain have been eliminated (by clinical judgment; if the cause of pain is in doubt: assessment by a family doctor or medical specialist will be obtained) Patients older than 18 years old Moderate to severe pain (> or = 5 on BPI pain scale: pain at its worst in the last 24hrs) Patient's with anatomic abnormalities (calyceal diverticulum) Ureteral calculi Nephrocalcinosis RTA, medullary sponge kidney, sarcoidosis Hydronephrosis or hydrocalycosis Minimal pain (<5 on BPI pain scale: pain at its worst in the last 24 hrs) | 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, Prostatism Erectile Dysfunction requirements for all subjects 1. Men at least 40 years of age 2. Screening IPSS QoL must be 4-6: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6) 3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations 4. Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment Required for target efficacy subset Meets criterion for at least moderate ED: IIEF-5 (erectile function) score <13 or: Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20 Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil. 2. Current severe side effects from any drug 3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study. 4. Women | 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): 18.0-99.0, Prostate Cancer Adenocarcinoma of the Prostate Age ≥18 years Histologically confirmed adenocarcinoma of the prostate Previously undergone primary therapy for prostate cancer (radical prostatectomy (RP) or external beam radiation (XRT) or RP + XRT). Salvage XRT following RP ≥ 6 months prior to registration is allowed Rising PSA (two consecutive values ≥2.0 ng/mL above the PSA nadir taken ≥3 weeks apart). PSA level of 2-25 ng/mL (PSA up to 50 is allowed for patients undergoing pre- and on-treatment biopsies) For the biopsy sub-groups, subjects must be willing to undergo pre and on-treatment biopsies PSA Doubling Time (PSADT) ≤12 months Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky score ≥70 Adequate bone marrow, hepatic, and renal function Willingness to use barrier contraception during treatment Received any experimental immunotherapy on an experimental clinical trial ≤ 1 year prior to registration PSA > 25 at time of enrollment (or PSA >50 for patients receiving pre and on-treatment biopsies) Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors Received salvage XRT ≤ 6 months prior to registration Received ADT ≤ 6 months prior to registration Received any form of chemotherapy ≤ 90 days prior to registration Received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor (GM-CSF) ≤ 90 days prior to registration Any major surgery requiring general anesthesia ≤ 28 days prior to registration Any other concurrent or prior treatment for prostate cancer ≤ 28 days prior to registration | 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, Chronic Hepatitis c Vasculitis patients who primarily consults to a rheumatology department for vasculitis and agree to be evaluated through a questionaire to identify risk factors for hepatitis C and who also agree to be screened with a serological rapid test for hepatitis C patients who decline to participate | 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, Colorectal Cancer Cholangiocarcinoma History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent) Confirmation of diagnosis must be performed at MSKCC Patient may have completely resected hepatic metastases without current evidence of other metastatic disease Lab values ≤14 days prior to registration WBC ≥2.5 K/uL Platelets ≥100,000/uL Creatinine <1.7mg/dL HGB ≥ 8.5 gm/dL Total Bilirubin ≤1.5 mg/dl Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study] Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol) Active infection, ascites, hepatic encephalopathy Female patients who are pregnant or lactating or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start) If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis) Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded Serious or non-healing active wound, ulcer, or bone fracture History of other malignancy, except: 1. Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease 3. Adequately treated cervical carcinoma in situ without evidence of disease There is no of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population | 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 (UTI) Facility HCA hospitals admitting adults for UTI Facility use of as their electronic health record system Facility - Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Marginal Zone Lymphoma Nodal Marginal Zone Lymphoma Splenic Marginal Zone Lymphoma Chemotherapy and immunotherapy-naïve, symptomatic and in need of treatment patients, with histologically proven CD20-positive MZL, not eligible for local therapy, including: 1. EMZL (MALT Lymphoma) patients with MALT IPI score 1-2 in need of systemic therapy. Either de novo or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site with MALT-international prognostic index (IPI) score 1-2 at the time of study entry. 1.1.The following patients with gastric MALT Lymphoma can be entered: 1. H. pylori-negative cases, either de novo (non pretreated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics). 2. H. pylori-positive cases at diagnosis, who either first line antibiotics or further local treatment (surgery or radiotherapy), including patients with clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication clinical (endoscopic) and histological relapse (without H. pylori re-infection), after a remission patients persistent (stable) lymphoma at ≥ 1 year post H. pylori eradication. 1.2. Similar consideration may be applied to patients with ocular adnexal lymphoma treated with antibiotics. 2. SMZL patients in need of therapy. Either de novo or relapsed following local therapy [including surgery and antiviral therapy for Hepatitis C virus (HCV)]. Patient must have a symptomatic disease requiring treatment and be not eligible for splenectomy or not willing to undergo splenectomy. 2.1. Patients with SMZL can be entered if any of the following is present: 1. bulky progressive or painful splenomegaly; 2. enlarged lymph nodes or involvement of extranodal sites with or without cytopenias , i.e. involvement of ≥3 nodal sites, each with a diameter of ≥3 cm. Any nodal tumor mass with a diameter of ≥7 cm (GELG as adopted in follicular lymphoma); 3. one of the following symptomatic/progressive cytopenias Hgb < 10 g/dL ANC < 1000/μL PLT< 80 000/μL whatever the reason (autoimmune or hypersplenism or bone marrow infiltration). 2.2. Splenectomised patients with rapidly raising lymphocyte counts, lymphadenopathy or involvement of extranodal sites can be entered. 2.3. SMZL with concomitant HCV infection who have not responded to or are relapsed after antiviral therapy can be entered. 3. NMZL patients in need of therapy Either, de novo presenting with disseminated disease or relapsed after local radiotherapy or following antiviral therapy for HCV. Localized nodal MZL is not eligible Measurable or evaluable disease Ann Arbor II-IV. Stage I disease may be eligible only if not candidate to local therapy (surgery or radiotherapy) Any type of lymphoma other than MZL (including MZL with histologic transformation to high-grade lymphoma). 2. Localized (stage IE and IIE) MALT lymphoma, for example gastric, ocular and cutaneous lymphoma, that may benefit from local therapy only (surgery or radiotherapy). 3. Known CNS involvement of MZL. 4. Any previous systemic treatment with immunotherapy or chemotherapy or with BTK inhibitors. 5. Major surgery within 4 weeks prior to registration. 6. History of stroke or intracranial bleeding within 6 months. 7. Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia. 8. Concurrent use of warfarin of other vitamin K antagonists. 9. Concurrent use of strong cytochrome P450 (CYP)3A4/5 inhibitors (see http://medicine.iupui.edu/clinpharm/ddis/clinical-table/). 10. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk. 11. International normalized ratio (INR) or prothrombin time (PT) ≥1.5 ULN. Partial thromboplastin time (PTT) or activated PTT (aPTT) ≥1.5 ULN unless due to lupus anticoagulant. 12. Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization. 13. Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound of ibrutinib and/or rituximab themselves or to the excipients in their formulation). 14. Positive test results for chronic HBV infection (defined as positive HBsAg serology). 15. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing and taking specific antiviral prophylaxis, according to local policy. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination are eligible. 16. Positive test results for hepatitis C. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA. 17. HIV infection or immunodeficiency. 18. Active, severe infections 19. Pregnancy or breastfeeding. 20. Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. 21. Any serious medical or psychiatric illness likely to interfere with participation in this clinical study. 22. Prior history of malignancies other than MZL within 3 years,with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer. 23. Current enrolment or participation in another therapeutic clinical trial within 28 days prior to treatment start | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 3.0-999.0, Head Start Participation The Head Start programs participating in FACES 2014 were a probability sample selected from among 2,900 study-eligible programs on the 2012-2013 Head Start Program Information Report (PIR). To be eligible for the study, a program had to be In one of the 50 states or the District of Columbia Providing services directly to children ages 3 to 5 Not be in imminent danger of losing its grantee status. Within those classrooms, eligible classrooms needed to -have at least one Head Start child enrolled American Indian and Alaska Native Head Start programs (Region XI) or Migrant and Seasonal Worker Head Start programs (Region XII) were not eligible. Other ACF studies (AI/AN FACES-NCT03842111 and MSHS-NCT03116243) focus on those programs | 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, Complications; Urethral Catheter Ureteral Catheterization Ureteroscopy Lower Urinary Tract Symptoms Flank Pain adult patients Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines 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, Multiple Myeloma Amyloidosis Cryoglobulinemia Castleman's Disease Light Chain Deposition Disease Heavy Chain Deposition Disease Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes Smoldering Multiple Myeloma Plasma Cell Leukemia Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and/or monoclonal plasma cell population. Examples of PCDs but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and/or heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia Age ≥18 years Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points Must be able to read and speak English Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study There are no imaging or lab studies required to determine eligibility | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.083-18.0, Acute Lymphoblastic Leukemia Leukemia, Acute Myeloid (AML), Child Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Primary Immunodeficiency Anemia, Aplastic Hemoglobinopathies Cytopenia Fanconi Anemia Diamond Blackfan Anemia Thalassemia Anemia, Sickle Cell Signed written informed consent by the patient or the patient's guardian for children who are minors Enrolled on BP-004 protocol, received BPX-501 infusion, completed or discontinued from the study, and are beyond Day +180 Lack of parents'/guardian's informed consent for children who are minors Loss of allograft prior to 6 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): 18.0-999.0, Neurogenic Bladder Urinary Tract Infections >18 years of age 2. Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year) 3. Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism 4. >1 urinary tract infection in the last 12 months Intravesical botox in the last 6 months 2. Chronic antibiotic suppressive therapy 3. Active symptomatic UTI on day of randomization 4. Unable to understand written and spoken English 5. Prior/current utilization of the Uroshield device | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Complicated Urinary Tract Infection Acute Pyelonephritis Male and female subjects at least 18 years of age 2. Able to provide informed consent 3. Able to ingest oral tablets for the anticipated treatment duration 4. Have a diagnosis of cUTI or AP as defined below: a. cUTI definition: At least Two of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]) ii. Dysuria, urgency to void, or increased urinary frequency iii. Nausea or vomiting, as reported by the subject iv. Lower abdominal, suprapubic, or pelvic pain And at least One of the following risk factors for cUTI: i. Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents, or other urinary tract prosthetic material), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters that have been in place for >24 hours prior to Screening must be removed or replaced prior to collection of the Screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated) ii. Current known functional or anatomical abnormality of the urogenital tract, including anatomic abnormalities of the urinary tract, neurogenic bladder, or post-void residual urine volume of ≥ 100 mL within the past 6 months iii. Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to EOT) iv. Known intrinsic renal disease with blood urea nitrogen (BUN) >20 mg/deciliter (dL), or blood urea >42.8 mg/dL, or serum creatinine (Cr) >1.4 mg/dL v. Urinary retention, including urinary retention in men due to previously diagnosed benign prostatic hyperplasia (BPH) b. AP definition: Acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination. And at least One of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]) ii. Peripheral white blood cell count (WBC) >10,000/mm3 or bandemia (≥15% immature polymorphonuclear neutrophils (PMNs), regardless of WBC count) iii. Nausea or vomiting, as reported by the subject iv. Dysuria, urgency to void, or increased urinary frequency Note: Subjects who meet the definition for cUTI (Inclusion Criterion 4a) and also have flank pain or costovertebral tenderness should be randomized as cUTI rather than AP. 5. Have an adequate urine specimen for evaluation and culture obtained within 24 h prior to randomization with evidence of pyuria that includes at least one of the following: 1. At least 10 WBCs per high power field (hpf) in urine sediment 2. At least 10 WBCs per cubic millimeter (mm3) in unspun (non centrifuged) urine 3. Positive leukocyte esterase (LE) on urinalysis Note: Subjects may be randomized and administered investigational product (IP) prior to knowledge of urine culture results. 6. Expectation, in the judgment of the Investigator, that the subject will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study 7. Willing to comply with all the study activities and procedures throughout the duration of the study 8. Subjects must agree to use a highly-effective method of birth control; male subjects must agree to use an effective barrier method of contraception from Screening through late follow-up (LFU) and for 90 days following the last dose if sexually active with a female of childbearing potential (FOCP); female subjects must not be pregnant or nursing, and must commit to either sexual abstinence or use at least two medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from Screening through LFU and for 90 days following the last dose Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy, including but not limited to the following: 1. Perinephric or renal corticomedullary abscess 2. Uncomplicated urinary tract infection (uUTI) (acute cystitis that does not meet the cUTI disease definition, see Criterion 4a) 3. Polycystic kidney disease 4. Recent history of trauma to the pelvis or urinary tract 5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis 6. Chronic vesicoureteral reflux 7. Previous or planned renal transplantation 8. Previous or planned cystectomy or ileal loop surgery 9. Known or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia) 10. Confirmed or suspected infection that is caused by a pathogen that is resistant to either IP (e.g., carbapenem-resistant pathogen), including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis) 2. Gross hematuria requiring intervention other than administration of IP or removal/placement of urinary tract instrumentation 3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required relieving an obstruction or placing urinary tract instrumentation) 4. Creatinine clearance (CrCl) of <50 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL]) 5. Anticipated concomitant use of non-study antibacterial drug therapy between randomization and the LFU Visit that would potentially effect outcome evaluations of cUTI/ AP, including but not limited to antibacterials with potential activity versus uropathogens, antibacterial drug prophylaxis, and antibacterial bladder irrigation 6. Anticipated concomitant use of gastric acid-reducing medications between randomization and end-of-treatment (EOT), including proton pump inhibitors, histamine-2 receptor antagonists, and antacids 7. Receipt of more than a single dose of a short-acting potentially effective antibiotic within 72 h prior to randomization; no more than 25% of subjects will be enrolled who meet the above criterion Exception: Subjects who received more than a single dose of short-acting potentially effective antibiotic within 72 h prior to randomization may be eligible for enrollment if they meet all of the following 1. In the opinion of the Investigator they have failed the prior antibiotic therapy (e.g., have worsening signs and symptoms of cUTI/AP) 2. Have a documented uropathogen (growth in urine culture >105 CFU/mL) that is resistant to the prior antibiotic therapy 3. Have a documented uropathogen that is carbapenem-susceptible 4. Receives approval from the Medical Monitor to enroll the subject 8. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN) or total bilirubin >3x ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy) 9. Any signs of severe sepsis, including shock or profound hypotension defined as systolic blood pressure <90 mmHg or a decrease of >40 mmHg from baseline that is not responsive to fluid challenge 10. Pregnant or breastfeeding women 11. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures) 12. Receipt of any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to randomization 13. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-defining illness, or known cluster of differentiation 4 (CD4) count <200/mm3 within the past year 14. Presence of immunodeficiency or an immunocompromised condition including neutropenia (<1,000 neutrophils/mm3 obtained from the local laboratory at Screening), hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long term use of systemic corticosteroids (e.g., ≥20 mg/day of prednisone or systemic equivalent for at least 2 weeks) 15. A mean QT interval corrected using Fridericia's formula (QTcF) >480 msec based on triplicate ECGs at Screening 16. History of significant hypersensitivity or allergic reaction to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (Mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry) or any contraindication to the use of ertapenem 17. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia) 18. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT 19. Unable or unwilling to comply with the protocol 20. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator | 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, Ureteral Stricture Hydronephrosis Urothelial Carcinoma Urolithiasis > 18 years of age Participants meeting medical requirements to undergo ureteroscopy 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): 20.0-999.0, Hepatitis B Fibrosis and Cirrhosis of Liver Male or female, age ≥20 years 2. CHB diagnosis confirmed by positive HBsAg or HBV DNA for more than 6 months, or documented history of CHB in medical record before initiation of NUC therapy. 3. Currently maintained on nucleot(s)ide analogues (except TAF) therapy for more than one year, with detectable HBV DNA after 52 weeks of therapy, detectable HBV DNA within 3-6 months prior to screening, and remains detectable HBV DNA at screening. 4. Patients with liver fibrosis stage 3 (defined as Metavir fibrosis stage 3 by liver biopsy, or fibrosis-4 score 3.25 ~ 6.49, or ARFI 1.80 ~ 1.99 m/s, or Fibroscan 9.5~12.4 kPa), or cirrhosis (defined as Metavir fibrosis stage 4 by liver biopsy, or APRI >2, or fibrosis-4 score ≥ 6.5, or ARFI ≥ 2.0 m/s, or Fibroscan ≥12.5 kPa, or image diagnosis with splenomegaly or esophageal/gastric varices) at the initiation of prior NUC therapy or during the prior NUC therapy. The liver biopsy should be within 5 years, or during the prior NUC therapy and other non-invasive assessments should be within 6 months at the initiation of NUC therapy or during the prior NUC therapy. 5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) within 6 months prior to screening. (Note: multiply estimated rate by 0.85 for women). 6. Willing and able to provide informed consent 7. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study 2. Previous recipient of a liver transplant 3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV) 4. Severe or uncontrolled comorbidities, determined by the Investigator. 5. Known history of serum albumin level <3 g/dL, or total bilirubin level >3 mg/dL, or presence of ascites. 6. Known history of hepatic encephalopathy, and/or variceal bleeding. 7. Malignancy history including hepatocellular carcinoma, except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer within 5 yrs of screening). 8. On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening. 9. Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study. 10. Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance. 11. Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the 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): 18.0-999.0, Renal Cell Carcinoma Urothelial Carcinoma Cervical Cancer Ovarian Cancer Recurrent Endometrial Cancer Be willing and able to provide written informed consent/ for the trial. 2. Be at least 18 years of age on day of signing informed consent, male or female. 3. Patients with one of the following tumors Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (defined as more than 50% clear cell component) after failure of IL-2 and/or anti-VEGF TKI treatment. If patients didn't want to use anti-VEGF TKI medicine or couldn't stand anti-VEGF TKI medicine costs, they will also be considered Histologically or cytologically confirmed diagnosis of unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (defined as more than 50% transitional cell component) after failure of no more than two prior platinum-based chemotherapeutic regimen Histologically or cytologically confirmed diagnosis of advanced squamous cell carcinoma of the cervix after failure of first-line system treatment Histologically confirmed diagnosis of recurrent or refractory epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that are relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen Histologically confirmed diagnosis of recurrent or refractory endometrial cancer that are relapsed and resistant or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen. 4. At least one measurable lesion according to 1.1. 5. The patients can swallow pills. 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 7. Life expectancy of at least 12 weeks. 8. The results of patients' blood tests are as follows:-Neutrophils≥1.5E+9/L; - Plt≥90E+9/L; -Hb≥90g/L; -ALB≥30g/L ;-TSH≤1×ULN;-TBIL ≤ 1 ×ULN;-ALT and AST ≤ 3 ×ULN; AKP≤ 2.5×ULN; -Creatinine ≤ 1.5×ULN. 9. Male or Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. 2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. 3. Known history of hypersensitivity to other antibody formulation. 4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment. 5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg. 6. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to（1）Congestive heart failure (New York heart association (NYHA) class > 2)；（2）unstable or severe angina; （3）myocardial infarction within 12 months before enrollment；（4） ventricular arrhythmia which need medical intervention.（5）QTc>450ms（male）/QTc>470ms (female)； 7. Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. 8. Bleeding history, having bleeding event（≥3 Grade according CTCAE 4.0 ）within 4 weeks before screening. 9. Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators. 10. Previous Arterial/venous thrombosis events within 6 months. 11. Known hereditary or acquired bleeding and thrombosis tendency. 12. Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g. 13. Prior chemotherapy, radiotherapy, surgery therapy within 4 weeks or palliative radiotherapy within 2 weeks or target therapy within 5 half-life of the drug before the study drug administration, or any unresolved AEs > Common Terminology for Adverse Events (CTCAE) Grade 1. 14. Active infection or an unexplained fever > 38.5°C within 7 days before the study drug administration, or baseline WBC>15×E+9/L . 15. Has known history of Interstitial lung disease, or using steroids evidence of active, non-infectious pneumonitis, or would interfere with the detection and handling of suspicious drug-related pulmonary toxicity. 16. History of immunodeficiency or human immunodeficiency virus (HIV) infection. 17. HBV DNA>500 IU/ml，HCV RNA>1000copies/ml，HBsAg+ and anti-HCV+； 18. Has a known additional malignancy within the last 5 years, or that is progressing or requires active treatment. Exceptions basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or patients with recurrent ovarian cancer has a known additional breast cancer that has been radical mastectomy and doesn't relapse within 3 years. 19. Patients with treatment history of SHR-1210 or any other PD-L1 or PD-1 antagonists or famitinib. 20. Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks. 21. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early | 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, Lower Urinary Tract Symptoms patients with lower urinary tract symptoms patients with Suprapubic catheter History of radical prostatectomy or cystoprostatectomy Clinical evidence of urethral stricture, prostatitis Patients with bacterial growth on urine culture | 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 Retention Neurogenic Bladder Urologic Diseases Males age ≥ 18 with clinical diagnosis of significant urinary retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy Must have stable urinary management history as determined by the Investigator OR: Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions) 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU) Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after UTI has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia (AD) 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections) 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis) 1. Urinary tract inflammation or neoplasm 2. Urinary fistula 3. Bladder diverticulum (outpouching) > 5cm in size 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) 5. Impaired kidney function or renal failure 6. Active gross hematuria 7. Active urethritis 8. Bladder stones 7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device 8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications 9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System 10. Catheter Assessment Tool screening yields unacceptable results | 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, Marginal Zone Lymphoma Key 1. Age 18 years or older 2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes 3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented progressive disease (PD) after, the most recent systemic treatment 4. Current need for systemic therapy for MZL 5. Measurable disease by CT or MRI 6. Eastern Cooperative Oncology Group (ECOG) of 0-2 7. Life expectancy ≥ 6 months 8. Adequate bone marrow function 9. Adequate organ function 10. Male and female participants must use highly effective methods of contraception Key Known transformation to aggressive lymphoma, eg, large cell lymphoma. 2. Clinically significant cardiovascular disease 3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer 4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 5. History of stroke or intracranial hemorrhage 6. Severe or debilitating pulmonary disease 7. Active fungal, bacterial and/or viral infection requiring systemic therapy 8. Known central nervous system involvement by lymphoma 9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection 10. Major surgery within 4 weeks of the first dose of study drug 11. Prior treatment with a Bruton tyrosine kinase (BTK) inhibitor 12. Pregnant or lactating women 13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer 14. Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/ | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture Urethral Stricture, Anterior Lower Urinary Tract Symptoms Anterior Urethral Stricture Male subjects ≥ 18 years old 2. Visual confirmation of stricture via cystoscopy or retrograde urethrogram 3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm 4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs). 5. IPSS score of 13 or higher 6. Lumen diameter <12F by urethrogram 7. Able to complete validated questionnaire independently 8. Qmax <15 ml/sec 9. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long 2. Subjects with greater than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Previous urethroplasty within the anterior urethra 5. Stricture due to bacterial urethritis 6. Stricture due to untreated gonorrhea 7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO) 8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization) 9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult 10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 11. Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician 12. Prior diagnosis of overactive bladder (OAB) 13. Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician 14. Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence 15. Previous pelvic radiation 16. Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks 17. Diagnosed with chronic renal failure, at the discretion of the physician 18. A dependence on Botox (onabotulinumtoxinA) in the urinary system 19. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 20. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 21. Previous hypospadias repair 22. Diagnosis within the last 5 years of carcinoma of the bladder or prostate or suspicion of prostate cancer (e.g. abnormal DRE or high PSA) at the discretion of the physician 23. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires 24. Unwilling to use protected sex for ≥30 days post treatment 25. Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential. 26. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 27. Active infection in the urinary system 28. History of diabetes not controlled with a hemoglobin A1-C >7.0% 29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function. 30. Visible hematuria with subject urine sample without known contributing factor | 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, Patients With Urosepis and Received Ertapenem for Treatment >18 years of age Diagnosis of urosepsis They were pregnant Circulatory shock (defined as a systolic blood pressure of < 90 mmHg and pour tissue perfusion) Documented hypersensitivity to carbapenems Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of < 30 mL/min | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Recurrent Urinary Tract Infection Female 2. Pre-menopausal 3 episodes of cystitis in the last 12 months as defined by: 1. 3 symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria 2. Or less than 2 symptoms from the above list, but with cloudy urine 4 Normal flow studies with bladder residual <150ml 5 Normal renal tract on USS Anatomical anomalies of urinary tract 2 Neurological condition 3 Diabetes mellitus 4 Pregnancy 5 Use of Immunosuppressants 6 Symptomatic of UTI at time of treatment | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Catheter Infection Complications; Catheter Indwelling suprapubic Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study Catheter associated discomfort or difficulty with mucous plugging of the catheter Inability to provide informed consent No catheter associated discomfort or problems with mucous plugging | 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, Richter Syndrome Entry for randomised trial component (standard of care and experimental arms): for the randomised trial component Suitable for anthracycline-containing chemo-immunotherapy Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS ECOG performance status of 0, 1, 2 or 3 Age 16 years and over Signed written informed consent prior to performing any study-specific procedures for the randomised trial component Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation. (Please note that pre-treatment with prednisolone up to 2mg/kg is allowed for up to 14 days prior to the start of treatment) Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks of their last dose of ibrutinib. (Ibrutinib-exposed CLL patients who discontinue ibrutinib due to toxicity or progressive CLL and later (more than four weeks) develop RS are not excluded from the randomised trial component) Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted, with the exception of patients who have progressed on ibrutinib see criterion above) Known central nervous system (CNS) involvement of CLL or DLBCL Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin 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 Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HBV deoxyribonucleic acid (DNA) test will be performed and if positive the patient will be excluded 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): 50.0-999.0, BPH BOO - Bladder Outflow Obstruction Age 50 or older 2. Verified BPH with prostate size of at least 30 grams or of 25 mm. 3. Signed Informed Consent 4. Failure, intolerance or patient non-compliance of medical treatment 5. Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec) 6. Patient's voided volume of at least 125 ml in uroflow test 7. Patients not eligible for surgery or refusing surgery Known sensitivity to Nickel 2. Active Prostatitis 3. Urethral strictures 4. Prior surgery of prostate (simple or radical) 5. Currently active bladder tumor 6. Suspected neurogenic urinary bladder 7. Suspected a-contractile bladder 8. Enlarged median lobe of prostate. 9. Bladder Neck stricture or contracture 10. Urethral pathology: diverticula, strictures, tumors, fistula 11. Clinically Significant urinary tract infection 12. Uncontrolled bleeding disorders 13. Uncontrolled diabetes mellitus 14. Severe medical diseases precluding a minimally invasive procedure 15. Present active urinary stone disease 16. Patients who are under anticoagulants therapy | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Neurogenic Bladder Spinal Cord Injuries At least 18 years of age Non-progressive spinal cord injury Stable medical condition Bladder dysfunction as a result of spinal cord injury History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months) Signs or symptoms of serious UTI that requires the use of systemic antibiotics Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity Participants with known hearing loss and/or renal disease Pregnant at the time of enrollment or planning to become pregnant during the time 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 Tract Infections Prostatitis Interstitial Cystitis • Patient Informed Consent form completed Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's Including prostatitis, pyelonephritis, and/or interstitial cystitis Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0 • Do not provide written informed Consent with HIPAA authorization form Taking antibiotics for any reason other than UTI at the time of enrollment Patients with chronic (> 10 days) indwelling catheters Self-catheterized patients Patients with neobladders | 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, Spinal Cord Injuries Arm A & B Patients hospitalised at Royal Perth Hospital (RPH) in Western Australia following first acute traumatic SCI (with any degree of neurological impairment) Arm A & B Admitted to a hospital outside of Western Australia following SCI (prior to RPH) Unable to commence intervention within 10 days post-SCI Bladder or urethral trauma on admission Known history of bladder cancer or other bladder pathology Known hypersensitivity to hyaluronic acid, sodium salt or sodium chondroitin sulphate Diagnosis of a symptomatic urinary tract infection prior to commencing treatment Pregnancy Previous neurological disorder Inability to provide own consent due to intellectual, mental or cognitive impairment Arm C Previous traumatic or non-traumatic (sudden onset) SCI | 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, Polycystic Kidney Diseases Iinclusion Patients starting dialysis Patients included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF) patients without diagnosis of nephropathy | 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): 40.0-70.0, Prostatic Hyperplasia Male patients presenting with lower urinary tract symptoms to urology outpatient clinic 2. According to the European Association of Urology Guidelines: 1. International prostate symptom score> 8 2. Prostate volume> 40 ml 3. Q max <15 ml /sn 3. Patients who did not receive any treatment for lower urinary tract symptoms and applied for the first time 4. Patients who have not undergone lower urinary tract surgery Patients who had undergone medical and surgical treatment for lower urinary tract symptoms 2. Patients with accompanying urethral stricture 3. Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...) 4. Patients with spinal cord trauma 5. Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation) | 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, Pleural Effusion Pleural Diseases Malignant Pleural Effusion Age greater than or equal to 18 years old Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusion directly caused by malignancy with known thoracic involvement) Estimated life expectancy greater than 3 months Full lung re-expansion on chest x-ray after thoracentesis Age less than 18 years old Pregnant or lactating subject Any history of prior pleural talc administration History of an indwelling pleural catheter placed on the side of the active paramalignant pleural effusion Estimated life expectancy less than 3 months Active clinical heart failure Inability to return for frequent follow up appointments Current incarceration | 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 Neurogenic Bowel Bladder Dysfunction years old SCI of at least 3 months duration Neurogenic bowel dysfunction scores of >13 Pregnancy Inability to understand and respond to the provided questionnaires Carcinomas during the last 5 years Bowel surgery Crohn ́s disease or other bowel conditions | 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): 45.0-90.0, Voiding Disorders Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS IPSS (International prostate symptom score lower than 12) Nocturia equal or less than 2 on a two day bladder diary Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12 Improvement in IPSS in at least 3 points for storage symptoms Nocturia equal or less than 2 on a two day bladder diary Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure IPSS higher than 8 Nocturia more than 2 Delta change in IPSS score less than negative 3 points Men with Neurogenic bladder Urethral stricture Prior BOO procedures History of urinary retention with indwelling foley catheter or intermittent catheterization Additional for Group 1 and 2 (Subjects with BPH and LUTS) History of bladder cancer within 5 years History of treatment for prostate cancer other than active surveillance Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Bloodstream Infection Sepsis Pathogenesis Escherichia Coli Bacteremia E. coli bacteremic urinary tract infection Immunocompromised hosts: HIV/AIDS, Neutropenia, Solid neoplasia, Hematological neoplasia, patients receiving immunosuppressive therapy Systemic antibiotic therapy in the 2 months preceding the bloodstream infection Anatomical or functional urological abnormalities that require urological procedures in the previous 2 months | 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): 25.0-65.0, Healthy Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose) HbA1c ≥ 6.5% Use of glucose-lowering agents For female subjects: positive pregnancy test at the time of enrollment or study History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy Active systemic illness or malignancy Symptomatic macrovascular or microvascular disease Hormone replacement therapy >0.625 mg premarin daily | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Neurogenic Bladder Urinary Retention Urologic Diseases Males age ≥ 18 with clinical diagnosis of significant urinary retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy 1. Must have stable urinary management history as determined by the investigator OR: 2. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions) 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU) Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection) 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis) 1. Urinary tract inflammation or neoplasm 2. Urinary fistula 3. Bladder diverticulum (outpouching) > 5cm in size 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months) 5. Impaired kidney function or renal failure 6. Active gross hematuria 7. Active urethritis | 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, Multiple Sclerosis Lower Urinary Tract Symptoms Neurogenic Bladder Overactive Bladder Urinary Incontinence Urinary Urge Incontinence Diagnosis of Multiple Sclerosis Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence) Failed prior first and second line therapy (behavioral and pharmacotherapy) Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms Patients performing Intermittent Catheterization are Eligible Indwelling catheters (urethral or suprapubic) Currently pregnant or planning pregnancy Unable to attend weekly office visits for PTNS Urodynamic findings of bladder outlet obstruction History of: bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 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): 18.0-100.0, Colon Cancer Any patient who understands, agrees to participate and signs the informed consent older than 18 years-old electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened duration of the surgical act less than 180 minutes Prior anesthetic assessment of ASA I-III International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker) Open surgery or conversion to open surgery Performing periodic anesthesia or being ASA IV Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months) Moderate-severe prostate clinic (IPSS> 19) Presence of positive urine culture in men in preoperative tests Urinary infection clinic in women with positive urine culture Previous history of acute urine retention be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization men who underwent prostate surgery patients with a history of treatment for urological tumor | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-100.0, Renal Stone Cases older than 18 years with renal stone disease affecting no more than one major calyx and causing neither obstruction nor bothersome pain We define calyceal obstruction as calyceal dilatation with stone impaction at the calyceal neck If the stones are not impacted or are casting the calyx, they are not considered obstructing Gross or microscopic hematuria. 2. Patients who have difficulty to reach our tertiary center for follow-up. 3. Other pathology in the target uretero-renal unit that requires intervention, e.g., ureteropelvic junction obstruction, malignancies, ureteric stones, …etc. 4. History of recurrent 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): 30.0-88.0, Stroke, Complication Neurogenic Bladder Hemorrhagic or ischemic stroke No previous stroke history Disease duration > 6 months Patients with different stroke etiologies other than cerebrovascular events (such as traumatic and tumoral pathologies) Previous multiple stroke history Pre-stroke urinary complaints Previous urogenital surgery history Spinal Cord Injury (SCI) Prostate volume of > 35ml documented with urinary ultrasonography Bladder outlet obstruction Poorly controlled Diabetes Mellitus (DM) Concomitant neurological diseases such as Multiple Sclerosis and Parkinson's Disease Anticholinergic, alpha agonist-antagonist drug use | 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 Tract Infections ≥ 18 years of age 2. Chronic indwelling urethral catheter or supra-pubic tube for >6 months 3. Prior symptomatic UTI while catheter in place Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes) 2. Active infection (may be considered after treatment of active infection) 3. Prior urosepsis requiring ICU admission 4. Significant gross hematuria resulting from catheter exchanges 5. Supravesical urinary diversion 6. Upper urinary tract anatomical abnormality 7. Obstructing urolithiasis 8. Ongoing antibiotic therapy for non-urological infection 9. Indwelling nephrostomy tube or ureteral stent 10. Radiation cystitis 11. Pregnancy | 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, Knee Replacement, Total Knee Arthroplasty, Total Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic significant cognitive impairment neurological disorders affecting gait systemic rheumatic disease hospitalization for a cardiovascular condition the past six months psychosis substance abuse disorder lower extremity surgery in the past year any other health conditions determined to be contraindications to a home exercise program | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Recurrent Uti Can provide written consent and willingness to comply with all aspects of study treatment and study requirements Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception Free of a urinary tract infection at the time of trial inclusion History of bladder tumours including uterine, cervical, vaginal or urethral cancer Worrisome post-voiding residual (investigator's discretion) Infection related to urinary lithiasis Any immunological disease requiring active therapy Currently receiving Immunotherapy Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit Any known intolerance to the ingredients of the Uromune® Immunotherapy Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Atrial Fibrillation Chronic Eligible patients must be at least 18 years old at the time of enrollment Patient was referred to Johns Hopkins cardiac electrophysiology division for clinically indicated catheter ablation for persistent or long standing persistent AF either for index ablation or redo ablation Patient is currently on systemic anticoagulation or has no contraindication to initiate systemic anticoagulation Capable of undergoing informed consent A Pre-Op cardiac MRI including LGE in sinus rhythm must be performed prior to ablation and patient should be capable of undergoing cardioversion and cardiac MRI MRI scan should show evidence of left atrial scarring Patient is not a suitable candidate for AF ablation Patient is currently not on anticoagulation and has significant contraindications to initiate systemic anticoagulation Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in pregnancy Patient with Body weight more than 300 lbs as they cannot undergo MRI scans Patients with Glomerular Filtration Rate (GFR) < 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent No evidence of Left Arial fibrosis in MRI scan as these images are not suitable for simulation Inability to get MRI in sinus rhythm Long standing persistent AF more than 3 years of duration Prior surgical maze procedure | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 12.0-999.0, Stage IV Prostate Cancer Stage IV Colon Cancer Stage IV Breast Cancer Stage IV Cancer of the Cervix Age: Greater than 12 years Documented histologic evidence of cancer Staged as stage IV World Health Organization (WHO) Performance Status of between 0 and 2 Radiological confirmation of metastases with bone scan or X ray, CT and/or MRI scan Cancer stages less than stage 4 Pregnant women Children 0 years | 0 |
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): 1.0-99.0, Urinary Bladder, Neurogenic must have diagnosed neurogenic bladder None | 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, Constipation I 01. Adult subjects that self-medicate with occasional laxative no more than 4 times in the month before confirmation I 02. Meet Rome IV for Chronic Constipation. I 03. ≥18 years of age inclusive, at the time of signing the informed consent. I 04. Screening diary confirms they experience at least 2 days in the 7 day diary with either hard stools (Bristol Stool form Score 1 or 2) or no bowel movement I 05. BMI under or equal to 35 kg/m2 I 06. Female subjects of child bearing potential must have a negative urine pregnancy test at screening. Subjects of child bearing potential or with partners of child bearing potential must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, barrier methods, true abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners). I 07. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol E 01. Known hypersensitivity or other contraindications to bisacodyl use: such as ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting; and severe dehydration or rare hereditary conditions that may be incompatible with an excipient of the product (galactose intolerance, e.g. galactosaemia, fructose intolerance. E 02. Pregnancy and/or breast breast-feeding or positive urine pregnancy test History of known gastrointestinal organic disease (i.e. celiac disease, inflammatory bowel diseases). E 03. A positive diagnosis of irritable bowel syndrome based on the Rome IV questionnaire which requires the patient to experience abdominal pain at least weekly E 04. Reported history of previous major abdominal surgery (excluding appendectomy and cholecystectomy) E 05. Any medical condition making participation potentially compromising the participation in the study (e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products) as per investigator's judgment E 06. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury E 07. Any condition incompatible with the patient's participation to the study as per investigator's judgment. E 08. Not willing or able agree to dietary restrictions required in 24 hours before each MRI study day E 09. Anticipate need for antibiotics intake during the study. E 10. Unwilling to stop probiotics for the duration of the study period E 11. Unable/ not willing to stop drugs known to alter GI motility including, regular loperamide, antispasmodics, (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants (< 30mg amitriptyline or 50mg nortriptyline) will be recorded but provided dose is stable, will not be an ). E 12. Having taken part in a research study within 3 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): 18.0-999.0, Constipation I 01. Adult subjects that self-medicate with occasional laxative no more than 4 times in the month before confirmation I 02. Meet Rome IV for Chronic Constipation. I 03. ≥18 years of age inclusive, at the time of signing the informed consent. I 04. Screening diary confirms they experience at least 2 days in the 7 day diary with either hard stools (Bristol Stool form Score 1 or 2) or no bowel movement I 05. BMI under or equal to 35 kg/m2 I 06. Female subjects of child bearing potential must have a negative urine pregnancy test at screening. Subjects of child bearing potential or with partners of child bearing potential must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, barrier methods, true abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners). I 07. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol E 01. Known hypersensitivity or other contraindications to bisacodyl use: such as ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting; and severe dehydration or rare hereditary conditions that may be incompatible with an excipient of the product (galactose intolerance, e.g. galactosaemia, fructose intolerance. E 02. Pregnancy and/or breast breast-feeding or positive urine pregnancy test History of known gastrointestinal organic disease (i.e. celiac disease, inflammatory bowel diseases). E 03. A positive diagnosis of irritable bowel syndrome based on the Rome IV questionnaire which requires the patient to experience abdominal pain at least weekly E 04. Reported history of previous major abdominal surgery (excluding appendectomy and cholecystectomy) E 05. Any medical condition making participation potentially compromising the participation in the study (e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products) as per investigator's judgment E 06. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury E 07. Any condition incompatible with the patient's participation to the study as per investigator's judgment. E 08. Not willing or able agree to dietary restrictions required in 24 hours before each MRI study day E 09. Anticipate need for antibiotics intake during the study. E 10. Unwilling to stop probiotics for the duration of the study period E 11. Unable/ not willing to stop drugs known to alter GI motility including, regular loperamide, antispasmodics, (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants (< 30mg amitriptyline or 50mg nortriptyline) will be recorded but provided dose is stable, will not be an ). E 12. Having taken part in a research study within 3 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): 45.0-85.0, Bladder Cancer Males and females between the ages of 45 and 85 years of age Signed informed consent prior to initiation of any study-related procedures Minorities are included in this protocol Micro or macro-hematuria Persons incapable of providing informed consent Any person with a prior history of bladder cancer For continued enrollment in the validation of the miR SentinelMales and females between the ages of 45 and 85 years of age BCR Test, previous malignancies including bladder cancer, treatment with chemotherapeutic of immunotherapeutic agents Persons with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Hip Dysplasia Unilateral Crow IV hip dysplasia Bilateral Crow IV hip dysplasia without osteoarthritis on the other side Patients with serious medical disease Patients with lower extremity vascular disease; 3. Patients with severe mental illness | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-99.0, Urethral Stricture Fat Graft Urethral stricture that has re-occurred at least once Malignant etiology of urethral stricture | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urinary Tract Infections Chronic Urinary Tract Infection Recurrent Urinary Tract Infection Urinary Tract Infection Bacterial Bladder Infection Patients suffering recurrent urinary tract infections of diverse etiology Individuals being allergic to any of the ingredients of Pregnancy and breast feeding. There are neither specific studies nor a formal contraindication, the physician should value benefits/risk | 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, Non Hodgkin Lymphoma (NHL) Mantle Cell Lymphoma (MCL) FOR ALL 1. Patients must be aged ≥18 years with relapsed or refractory B-cell non-Hodgkin Lymphoma. 2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm3. 3. Magnetic resonance imaging (MRI) brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment. 4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 20 mm in the long axis or extranodal lesions >10 mm in long and short axis OR bone marrow involvement that is biopsy proven. 5. Karnofsky performance score ≥60. 6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease. 7. Adequate renal function, defined as creatinine clearance>40 ml/min. 8. Able to provide written informed consent. 9. Agree to practice birth control during the study. 10. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥35% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%. 11. Expected survival >12 weeks. 12. Negative urine or serum pregnancy test in females of child bearing potential at study entry. 13. Meet for regarding fertility and contraception. 14. No contraindication to central line access. Phase 1: 3+3 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and Diffuse large B-cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following criteria. 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant 3. Relapse post-allogeneic transplant 4. Patients not previously treated with CAR-T cell therapy PHASE 1b and 2 1: 6-9 patient expansion with 8-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 2: 6-9 patient expansion with 12-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-CD19 CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 3: Mantle Cell Lymphoma (Phase 2) 1. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously designed and have relapsed, refractory disease as defined as one of the following: 1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody. 2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor. 3. Relapse post-autologous transplant. 4. Relapse post-allogeneic transplant. 5. Relapse post anti-CD19 CAR-T cell therapy. i. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort (all patients) A potential subject who meets any of the following is ineligible to participate in the study. 1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per table 1. 2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. 3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily. 4. Presence of ≥grade 3 non-hematologic toxicities as per Common Terminology for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease. 5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis. 6. Refusal to participate in the long-term follow-up protocol. 7. Patients with active CNS involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis. 8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression. 9. Previous recipients of CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are <100 days post prior CAR-T cell treatment (does not re-enrollment). a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry. 10. Anti-CD20 antibody treatment within 4 weeks of cell infusion. 11. Anti-CD19 antibody treatment within 4 weeks of cell infusion. 12. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion (corticosteroids or targeted therapies for bridging allowable e.g. venetoclax, BTK inhibitors, lenalidomide, etc). 13. Cytotoxic chemotherapy treatment within 10 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells. 14. Patients post solid organ transplant who develop high grade lymphomas or leukemias. 15. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin | 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 Bladder Cancer Urologic Surgical Procedures Patients 18 years old of age Patients with a programmed TURB Absence of urinary tract infection (negative urine culture and no clinical manifestations for urinary tract infection) Patients with asymptomatic bacteriuria Patients with positive urine culture before procedure Patients with urinary catheterization | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Esophageal and Gastric Varices The 1. patients who were diagnosed with liver cirrhosis. 2. patients who underwent the abdominal contrast-enhanced CT examination. 3. patients who received endoscopic screening. 4. patients with written informed consent. The patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation. 2. patients with liver cancer. 3. patients with severe ascites or hepatic encephalopathy. 4. lacks abdominal contrast-enhanced CT within 1 month of endoscopy | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Marginal Zone Lymphoma Histologically documented marginal zone lymphoma, including splenic, nodal, and extranodal sub-types at the enrolling institution No prior systemic therapy for MZL with the exception of the following Prior antibiotic therapy for H. pylori, C. psittaci, and B. burgdorferi Prior antiviral therapy for HCV Note: Subjects are eligible if they had prior splenectomy or other local surgical treatment or local radiation therapy without systemic therapy and now require their first ever systemic therapy Men and women ≥18 years of age Patients with gastric MALT lymphoma must be H. pylori negative or have failed a trial of H. pylori eradication Patients with gastric MALT lymphoma who are H. pylori negative or who have relapsed/refractory disease after H. pylori eradication must be ineligible for, have refused or failed gastric radiation therapy Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 ≥1 measurable lesion on computed tomography (CT) scan (>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by magnetic resonance imaging (MRI) instead. Patients with splenomegaly without other measurable disease must have splenomegaly of >15 cm in the craniocaudal direction Life expectancy of >3 months, in the opinion of the investigator Medically apparent central nervous system lymphoma or leptomeningeal disease Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years Subject who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to first dose of ibrutinib/placebo or subject who requires continuous treatment with a strong CYP3A inhibitor Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of >20 mg/day of prednisone) within 28 days of the first dose of study drug Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmias or Class 3 or 4 congestive heart failure as defined by New York Heart Association Functional Classification; or a history of unstable angina, acute coronary syndrome, or myocardial infarction within 6 months of prior to screening Recent infection requiring systemic anti-infective treatment that was completed ≤14 days before the first dose of study drug Any uncontrolled active systemic infection Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia Hepatitis B (HBV): All subjects must be screened for hepatitis B and C. Subjects with a positive polymerase chain reaction for hepatitis B must be on entecavir or equivalent therapy as per institutional standard of care. (Hep C patients may be enrolled if other parameters precluding hepatic impairment are met. And they are not undergoing active therapy for hepatitis C | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 19.0-70.0, Aspirin Gastric Cancer Men and women aged 19-70 who underwent endoscopic resection for early gastric cancer Final pathological results after endoscopic resection met the absolute or expanded according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4) Patients who had negative H. pylori status or those who eradicated H. pylori status Willingness to sign an informed consent form Pateints who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases Regular aspirin uses (more than 3 times a week) with 2 months before screening visit Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose Previous gastrectomy history Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection) High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc) Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled) Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years Non-curative resection of early gastric cancer after endoscopic resection Aspirin allergy or contraindication of aspirin use | 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, Mantle Cell Lymphoma Follicular Lymphoma Splenic Marginal Zone Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Nodal Marginal Zone Lymphoma Indolent Non-hodgkin Lymphoma Note: During the period of cell procurement and CAR.κ.28 T cell production, subjects are allowed to receive additional standard of care chemotherapy to stabilize their disease if the treating physician feels it is in the subject's best interest. For subjects requiring bridging chemotherapy while awaiting manufacture of their CAR.κ.28 T-cells, details regarding treatment(s) administered including dose, frequency, number of cycles, etc. will be collected. for the Study Unless otherwise noted, subjects must meet all of the following to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Adults ≥18 years of age. 3. Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma OR histologically confirmed B-cell NHL, including the following types defined by WHO 2016: Aggressive Lymphomas DLBCL not otherwise specified (NOS) T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma Primary mediastinal (thymic) large B-cell lymphoma High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade B-cell lymphoma, NOS B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma Transformation of indolent lymphoma or CLL to DLBCL will also be included Burkitt lymphoma Indolent Lymphomas Follicular lymphoma grade 1-3b Splenic marginal zone lymphoma for the Study Subjects meeting any of the following will not be able to participate in this study (procurement, lymphodepletion and cell infusion): 1. A diagnosis of lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia or multiple myeloma. 2. A history of intolerance to bendamustine or fludarabine. Note: subjects with known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide and fludarabine at the discretion of the clinical investigator. 3. Subject is pregnant or lactating. 4. Tumor in a location where enlargement could cause airway obstruction. 5. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10 mg daily may be enrolled at discretion of investigator. 6. Active infection with HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy as well as no history of HIV. Subjects are required to have negative HIV antibody, negative HTLV1 and HTLV2 antibodies, negative hepatitis B surface antigen, and negative HCV antibody or viral load. 7. Subjects who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded. Subjects who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline (when tested during screening for procurement). Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. to be Met Prior to Procurement 1. Subject has signed a consent to undergo cell procurement. 2. Evidence of adequate organ function as defined by Hemoglobin ≥ 8.0 g/dL (transfusion independent for 2 weeks prior to enrollment) Total bilirubin <1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5 × ULN) AST and ALT < 5x ULN Pulse oximetry of >90% on room air Creatinine ≤1.5x ULN or Creatinine Clearance (CrCl) >60 mL/min per Cockcroft and Gault (see Appendix F). 3. Imaging results from within 120 days prior to procurement to assess presence of active disease. 4. Confirmed kappa-positive expression on lymphoma or CLL/SLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology. 5. Subject has adequate cardiac function, defined as No ECG evidence of acute ischemia No ECG evidence of active, clinically significant conduction system abnormalities Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant | 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, Bacterial Urinary Tract Infection Patients who have not submitted urine samples will not be included as the samples are required for both standard testing and research. This would patients who are being treated empirically by physicians Patient's who have not submitted urine samples for culture will not be included in study | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Facial Palsy Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure | 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, Non-small Cell Lung Cancer Gastric Carcinoma Gastroesophageal Junction Carcinoma Classical Hodgkin Lymphoma Diffuse Large B-cell Lymphoma Peripheral T-cell Lymphoma Cutaneous Melanoma Head and Neck Squamous Cell Carcinoma Bladder Cancer Ovarian Cancer Triple Negative Breast Cancer Monotherapy (Parts A and B) Histologically or cytologically-confirmed advanced or metastatic malignancy, defined as One of the following disease indications Unresectable locally-advanced or metastatic NSCLC, gastric/gastroesophageal (GE) junction carcinoma, cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC), bladder cancer, ovarian cancer, or triple negative breast cancer (TNBC) Lymphoma, including Classical Hodgkin lymphoma (cHL) Diffuse large B-cell lymphoma (DLBCL) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) Lymphoma: Participants should have disease progression on or after treatment with standard therapies expected to provide benefit in the judgement of the investigator (Parts A and B) History of another malignancy within 2 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not been completed before the first dose of study drug within the timeframe as follows Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks Palliative radiotherapy (≤2 weeks of radiotherapy to non-central nervous system [CNS] disease): ≤7 days prior to start of SEA-TGT Immune-checkpoint inhibitors: 4 weeks Monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates: 4 weeks (2 weeks with documented disease progression) T-cell or other cell-based therapies: 12 weeks Known CNS metastases Participants with a history of CNS metastases are allowed if they have undergone treatment for the CNS disease, symptoms have resolved, and steroids have been discontinued | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Marginal Zone Lymphoma Patients must have a proven pathological diagnosis of MZL, diagnosed by a reference pathology center. Patients must meet the following to be eligible for participation in this study Confirmed CD20 positive de novo or relapsed MALT Lymphoma in need of treatment following or being not eligible for local therapy (including surgery, radiotherapy and antibiotics e.g. for H. pylori-positive gastric lymphoma arisen at any extranodal site) OR Confirmed CD20 positive de novo or relapsed splenic MZL in need of treatment following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) OR Confirmed CD20 positive de novo or relapsed nodal MZL in need of treatment following or not being eligible for local therapy (radiotherapy). The need of treatment is applicable in the case of B symptoms, deterioration of peripheral blood counts due to lymphoma infiltration of the bone marrow, rapid enlargement of lymph nodes or compression of vital organs by bulky disease. For nodal MZL and extragastric MALT lymphoma: • At least one bi-dimensionally measurable lesion (>=1.5 cm in its largest dimension by CT/PET-CT scan or MRI) For splenic MZL (SMZL): In patients with splenic MZL, an enlarged spleen on CT scan and lymphoma cell infiltration has to be seen in bone marrow and/or peripheral blood. At least one of the following must be fulfilled Bulky progressive or painful splenomegaly one of the following symptomatic/progressive cytopenias: Hb < 10 g/dL, or Platelet count < 80.000 /µL, or neutropenia < 1000 /µL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration) splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites if not being eligible for local therapy SMZL with concomitant hepatitis C infection which has not responded to or has relapsed after Interferon and/or Ribavirin and/or direct antiviral agents (patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA) For gastric MALT Lymphoma: For gastric MALT lymphoma, the clinical evidence of the MZL as seen by gastroendoscopy is sufficient. There is no need to show a measurable lesion by CT scan or MRI. is possible for patients with H. pylori-negative cases following or being not eligible for local therapy (i.e., surgery, radiotherapy or antibiotics) or after systemic therapy H. pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy Others The presence of any of the following will a subject from enrolment ECOG performance status ≥ 2 History of a malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to study enrolment visit, other malignancy treated with a curative intent and currently in complete remission, for ≥ 3 years Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma Has had prior chemotherapy (systemic anti-cancer therapy), targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline value) from AEs due to a previously administered agent Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study Note: If a subject received major surgery, they must have recovered adequately from complications from the intervention prior to starting therapy Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrolment visit Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cholangitis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension Treatment with any other investigational agent or participating in another clinical trial with an investigational product within 4 weeks prior to entering this study or within 5 x the half-life (t1/2) of the investigational product, whichever is longer | 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, Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure，Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians Eligible patients will be those who are: 1) older than 80 years of age; or 2) 55 years of age or older who meet for serious illness. Serious illness encompasses acute illness (e.g. COVID-19) and chronic illnesses (e.g. those included in the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease) (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial Reasons for for any patient restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation) | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 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, Acute Adult T-Cell Leukemia/Lymphoma Adult T-Cell Leukemia/Lymphoma Chronic Adult T-Cell Leukemia/Lymphoma HTLV-1 Infection Patients must have histologically or cytologically confirmed CD2+, CD3+, or CD4+ acute, lymphoma or poor-risk chronic subtypes of ATLL including previously untreated or previously treated individuals who have received no more than 1 previous cycle of combination chemotherapy. If the patient has a cycle of EPOCH prior to entering on the study, doses of EPOCH during the first cycle with lenalidomide should be altered as described for cycle 2 EPOCH modifications below For patients who receive a cycle of EPOCH prior to enrollment on the protocol, cycle 2 (the first cycle on protocol) dose of EPOCH is altered according to toxicities in cycle 1 Patients previously treated with azidothymidine (AZT), interferon (IFN), bexarotene, or mogamulizumab are eligible. Patients with stable disease at high risk of relapse from prior non-combination chemotherapy containing treatment are eligible to participate Documentation of HTLV infection by enzyme-linked immunosorbent assay (ELISA) in individuals with confirmation of HTLV-1 infection (by immunoblot or polymerase chain reaction [PCR]) or a consistent clinical picture (including two of three of: 1) CD4+ leukemia or lymphoma, 2) hypercalcemia, and/or 3) Japanese, Caribbean, or South American birthplace) is required for enrollment. Confirmation of HTLV-1 infection is required to continue the subject on protocol after the first cycle of therapy. Patients will be enrolled based on reports from local or referral labs (e.g., Mayo Clinic or LabCorp). Confirmation will be performed by Ratner Lab at Washington University, retrospectively, but this is not a Clinical Laboratory Improvement Amendments (CLIA) assay and is not reimbursed by insurance Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,000/mm^3 unless decreased due to bone marrow (BM) involvement with lymphoma Platelets >= 75,000/mm^3 unless decreased due to BM involvement with lymphoma Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), if potentially due to lymphoma, in the dose-expansion cohort, the first cycle may be given without lenalidomide and if transaminitis and bilirubinemia improves to meet parameters, participant may be enrolled Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x institutional ULN, if potentially due to lymphoma, in the dose-expansion cohort, the first cycle may be given without lenalidomide and if transaminitis and bilirubinemia improve to meet parameters, participant may be enrolled Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal Patients that have received prior IMiDs for treatment of ATLL Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) within 14 days prior to enrollment, with the exception of alopecia Patients who are receiving any other investigational agents or have received them within 14 days prior to enrollment History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or other agents used in study. Anaphylactic reactions including death have been reported with cyclophosphamide. Possible cross-sensitivity with other alkylating agents can occur Patients unable to take aspirin or prophylactic doses of low molecular weight heparin or direct oral anticoagulants will not be eligible for maintenance treatment with lenalidomide, but may enroll and receive induction therapy with lenalidomide plus EPOCH Patients with urinary outflow obstruction (contraindication for cyclophosphamide) Patients with any form of demyelinating disease should not be given vincristine sulfate injection Patients with uncontrolled intercurrent illness Patients with psychiatric illness/social situations that would limit compliance with study requirements | 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, Benign Prostatic Hyperplasia Patient is able and willing to comply with all the assessments of the study 2. Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form 3. ≥ 45 years of age 4. Baseline IPSS score > 13 5. Prostate volume 25 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days 6. Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment 2. Urethral stricture, meatal stenosis, or bladder neck obstruction either current, or recurrent requiring 2 or more dilations as reported in the patient's history 3. Requiring self-catheterization to void. 4. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer 5. Any of the following, taken from a single uroflowmetry reading: 1. Post-void residual volume (PVR) > 250 ml 2. Peak urinary flow rate of > 15 ml/second 3. < 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required) 6. Other condition or disease that might cause urinary retention 7. History of other diseases causing voiding dysfunction 8. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months) 9. Concomitant bladder stones 10. Previous pelvic irradiation or radical pelvic surgery 11. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate 12. Chronic prostatitis, or recurring prostatitis within the past 12 months 13. Known allergy to nickel 14. Life expectancy less than 24 months 15. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function 16. Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (low dose aspirin therapy not prohibited). 17. Taking 5-alpha-reductase inhibitors within 3 months of pre-treatment (baseline) evaluation 18. Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation: 1. alpha-blockers, 2. imipramine, 3. anticholinergics, or 4. cholinergic medication gonadotropin releasing hormonal analogs 19. Taking androgens, unless evidence of eugonadal state for at least 6 months. 20. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation: 1. phenylephrine, or 2. pseudoephedrine 21. Future fertility concerns 22. Any concurrent medical condition or illness that might prevent study completion or would confound study results | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 21.0-70.0, MRSA Patients (Adult) with infections caused by S. aureus from the sites as follows: blood stream, skin or soft tissue, cerebrospinal fluid, bone and joint, genitourinary tract, infection of indwelling intravascular device, surgical wound, respiratory tract (organism grown from sputum and infiltrate on chest X-ray), peritoneal fluid or other otherwise sterile body fluids Patients with risk factors for nosocomial or medically related infections, and patients who have been decolonized (using mupirocin, chlorhexidine or bleach) in the past 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): 18.0-999.0, Neurogenic Bladder Dysfunction Informed consent Age >18 years Last urethro-cystoscopy and bladder washing cytology within 1 year before Last urodynamic investigation within 6 months and no change of bladder medication since then Refractory LUTD due to a neurological disorder: 1. Neurogenic OAB (i.e. urgency frequency syndrome with or without urgency incontinence) refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) 2. Neurogenic voiding dysfunction (i.e. incomplete bladder emptying/incomplete / complete urinary retention) refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks) 3. Combination of neurogenic OAB and neurogenic voiding dysfunction (i.e. urgency frequency syndrome with or without urgency incontinence and incomplete / complete urinary retention) refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha blocker for at least 4 weeks) Motor response by TTNS stimulation at least at one leg Willing not to change or start any new medications or treatments for the LUT during the entire study period (from screening till unblinding) Contraindications to the investigational product Known or suspected non-adherence, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia Participation in another study with investigational drug or product within the 30 days preceding and during the present study Neuromodulation treatment for urological indication in the last six months or ongoing Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six months Women who are pregnant or breast feeding Intention to become pregnant during the course of the study Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences [www.samw.ch/en/News/News.html] Enrolment of the investigator, his/her family members, employees and other dependent persons | 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, Neurogenic Bladder Neurogenic bladder for at least 6 months Utilizing indwelling catheterization for bladder management Women must be premenopausal and not currently menstruating Community dwelling physical disability Use of prophylactic antibiotics Instillation of intravesical antimicrobials to prevent UTI Psychologic or psychiatric conditions influencing the ability to follow instructions Use of oral or IV antibiotics within the past 2 weeks Sexual activity within the previous 72 hours Participation in another study with which results could be confounded | 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, Prostate Obstruction Prostatic Hyperplasia Prostatic Hypertrophy, Benign patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding 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, Marginal Zone Lymphoma One of the following subtypes of Histology confirmed Indolent non-follicular B-cell lymphoma Splenic MZL (bone marrow histology and/or splenic tissue) Extranodal MZL or MALT (tissue biopsy) Nodal MZL (lymph node biopsy). 2. Age over 18. 3. Availability of details on clinical presentation, treatment details and results, and on follow-up. 4. Execution of PET at diagnosis or/and at end of treatment or/and at relapse. 5. Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response. 6. Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Diagnosis based on tru-cut core-needle biopsies are permitted in the study. 7. Written informed consent Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL. 2. Scans images not available for whatever reason. 3. Cases diagnosed on fine needle aspiration cytology only | 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): 18.0-87.0, Detrusor Underactivity Patients underwent UDS from July 2016 to August 2019 Patients with neurogenic bladder (NB) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (CIC) | 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): 16.0-90.0, Ventilator Associated Pneumonia Antibiotic Resistant Infection Hospital-acquired pneumonia caused by extensively drug-resistant Pseudomonas aeruginosa ≥ 72 hours of targeted antibiotic therapy against Pseudomonas aeruginosa with either Colomycin or Ceftolozane-Tazobactam Participation in an interventional trial aiming nosocomial infections Treatment was not with the intent to cure the infection | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urethral Stricture patients who will be 2 years or more out of surgery patients with incomplete medical records or follow-up informations | 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, Colorectal Surgery Elective procedures involving total mesorectal excision, including low anterior resection and abdominoperineal resection for rectal cancer as well as proctectomy for inflammatory bowel disease All approaches (open, laparoscopic and robotic) will be included, as the approaches not differ in the total mesorectal excision technique Patients who received neoadjuvant chemotherapy and/or radiation treatments will be included Age ≥ 18 years American Society of Anesthesiologists (ASA) class I-III Ability to understand and the willingness to sign a written informed consent Patients undergoing emergent or urgent surgery Patients undergoing total mesorectal excision in combination with other major surgical procedures on the same day should be excluded from this study Patients sustaining genitourinary tract injury during the procedure should be excluded postoperatively History of urinary retention after previous procedure, surgery, or urinary catheter removal History of urinary retention not being actively treated Patients requiring prolonged duration or replacement of urinary catheter in the postoperative period for reasons other than urinary retention should be excluded History of neurogenic bladder Patients with chronic indwelling Foley catheterization or suprapubic catheterization History of cystectomy and/or any surgically created urinary conduit, including neobladder and ileal conduit Patients less than 18 years of age should be excluded from this study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 45.0-90.0, Urinary Retention All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study Large post void residual urine Simultaneous internal urethrotomy and TURP Uncontrolled Diabetes Mellitus (DM) Cerebrovascular accident accident (CVA) Spinal cord injury | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 12.0-999.0, Urinary Tract Infections Patients with a urinary tract infection in general practice Age > 12 years | 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, Enterococcal Bacteremia Hospitalized patient ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization bacterial isolate(s) is/are available for further characterization Repeat blood culture(s) within 7 days from the first positive culture Cultures obtained from patients not admitted to the hospital Isolate(s) not available for further studies | 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, Marginal Zone Lymphoma Age greater than or equal to 18 years Histologically confirmed Marginal Zone Lymphoma Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen >13 cm. °Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy Patients with gastric MALT lymphoma must be h. pylori negative °Patients who are h. pylori positive are allowed if they have failed a trial of h.pylori eradication Patients with gastric MALT lymphoma who are h. pylori negative or who have relapsed/refractory disease after h. pylori eradication must be ineligible for, have refused or failed gastric radiation therapy ECOG performance status ≤ 1 Life expectancy of greater than 2 years Patients must have normal organ function as defined below Platelet count ≥ 50,000 cells/mm^3 Hemoglobin ≥ 8.0 g/dL Patients who have had prior systemic therapy, including rituximab Patients who have had prior radiation therapy, with the following exception: °Palliative radiotherapy RT is allowed but must be completed at least 1 week prior to treatment on this study, and prior baseline imaging studies or biopsies. Patients must meet for measurable/assessable disease as outlined above after completion of RT Prior treatment with ibrutinib or other BTK inhibitor Patients with h. pylori-associated gastric MALT or stage I/II MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements °Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable Pregnant women or participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab are excluded from this study because of documented risks of rituximab on fetal immunologic development and unknown effects of venetoclax on embryonic development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued Received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax Received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax | 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, Lymphomas Person who has not opposed to their in the trial Confirmation of the diagnosis of one of the three lymphomas (DGLBL, LF or classic LH) according to the WHO 2016 international classification (Smerdlow et al, 2016) Patients not currently taking treatment for their haemopathy (or who have received corticosteroid therapy alone within 14 days prior to the 1st sampling, dose limited to 500mg total) Patients requiring systemic treatment within 30 days of screening PET images available for pre-therapy and follow-up (mid-treatment, end of treatment) Person subject to legal protection (curatorship, guardianship) Person under partial judicial control Pregnant, parturient or breastfeeding woman Adult incapable or incapable of giving consent Minor Localized lymphoma treated by surgery and/or localized 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): 20.0-999.0, Urinary Bladder, Overactive Sexual Behavior Sexual Activity Behavior Therapy Sexual Function Disturbances Sexually active men with OAB ≥ 20 years Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3) Patients can sign informed consent and record voiding diary Concurrent use of PDE5 inhibitor or testosterone therapy during study period History of stress urinary incontinence Neurologic conditions associated with OAB symptoms Evidence of active urinary tract infection or urinary tract stone at screening Confirmed or suspected genitourinary tract or pelvic malignancy Genitourinary tract operation during the 3-month period prior to baseline Postvoid residual urine volume (PVR) ≥ 100 mL History of uncontrolled hypertension (systolic >180 mmHg and/or diastolic >110 mmHg) History of intolerance to mirabegron History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study 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, Solid Tumor Melanoma Renal Cell Carcinoma Urothelial Carcinoma Lung Cancer Head and Neck Squamous Cell Carcinoma Esophageal Cancer Gastric Cancer Ovarian Cancer Prostate Cancer Triple Negative Breast Cancer Endometrial Cancer (General Phase 1 and Phase 1b): 1. Male or female patients aged ≥ 18 years 2. Histologically or cytologically proven locally advanced or metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate. 3. ECOG performance status of 0 or 1 4. Clinical or radiological evidence of disease 5. Adequate hematological, hepatic and renal function 6. Resolution of toxic effect(s) of prior anti-cancer therapy to ≤Grade 1 (Patients with ≤Grade 2 neuropathy, ≤Grade 2 endocrinopathy or ≤Grade 2 alopecia are exceptions) 7. Effective contraception for women of child-bearing potential as defined by World Health Organization guidelines for 1 "highly effective" method or 2 "effective" methods Additional Phase 1 Monotherapy and Phase 1b Combination With Nivolumab Expansion 1. Has one of the following tumor types: melanoma, non-small cell lung cancer, or triple negative breast cancer 2. Agrees to undergo a pre-treatment biopsy and another biopsy while on treatment Expansion specific to Melanoma: 1. Histologically confirmed, unresectable Stage III or Stage IV melanoma, as specified in the American Joint Committee on Cancer staging system. 2. Participants with ocular or uveal melanoma are ineligible. 3. PD-L1 status must be documented if available. 4. BRAF (V600) mutation status must be known. Both BRAF-mutated and wild type participants are permitted in this cohort. 5. BRAF-mutated participants must have been treated with approved targeted therapies. 6. Must have documented progressive or recurrent disease on or after discontinuation of anti-PD-(L)1 therapy (administered as monotherapy or as part of a combination) as per 1.1 7. Participants who received anti-PD-(L)1 in the adjuvant setting must have documented progressive or recurrent disease on or within 6 months of discontinuation of anti-PD-(L)1 therapy (administered as monotherapy or as part of a combination) as per 1.1 criteria. Expansion specific to NSCLC: 1. Histologically confirmed NSCLC meeting stage for stage IIIB, stage IV, or recurrent disease. 2. Participants must have recurrent or progressive disease during or after platinum doublet-based chemotherapy or at least two prior lines of systemic therapy for advanced or metastatic disease OR Must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy for local disease. 3. Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available. 4. Status for actionable mutations (e.g., EGFR, ALK, ROS1, RET, etc.) must be known (when testing is available as per country/region standard of care practices); participants with actionable mutations must have received and progressed on, have been intolerant to, or not be a candidate for, standard tyrosine kinase inhibitors (as available per country/region standard of care practices). Expansion specific to TNBC: 1. Histologically confirmed unresectable, locally advanced or metastatic triple negative breast cancer.PD-L1 status, HER2-negative, estrogen receptor-negative, and progesterone receptor-negative status must be evaluated by local institutions before enrolment per guidelines of the American Society of Clinical Oncology and the College of American Pathologists. 2. Patients must not have received an anti PD-1/PD-L1 for the treatment of the metastatic disease, but the administration of an anti PD-1/PD-L1 in the adjuvant setting is acceptable. 3. Patients must have received one line of chemotherapy for the treatment of their metastatic disease, and experience progression during or after that line of chemotherapy. 4. Patients must have not received more than one line of chemotherapy for the treatment of their unresectable, recurrent or metastatic disease. for Phase 2 (General) 1. Male or female patients aged ≥ 18 years. 2. ECOG performance status of 0 or 1 3. Clinical or radiological evidence of measurable disease. 4. Adequate hematological, hepatic and renal function. 5. Resolution of toxic effect(s) of prior anti-cancer therapy to ≤Grade 1. (Patients with ≤Grade 2 neuropathy, ≤Grade 2 endocrinopathy or ≤Grade 2 alopecia are exceptions.) 6. Participants must have received and progressed on or after anti-PD-(L)1 therapy. 7. Effective contraception for women of child-bearing potential as defined by World Health Organization guidelines for 1 "highly effective" method or 2 "effective" methods Additional for Phase 2 (Advanced Melanoma Patients) 1. Participants who received anti-PD-(L)1 in the advanced/metastatic setting, must have documented progressive or recurrent disease on or within 3 months of discontinuation of anti-PD-(L)1 therapy 2. Participants who received anti-PD-(L)1 in the adjuvant setting must have documented progressive or recurrent disease on or within 6 months of discontinuation of anti-PD-(L)1 therapy 3. Disease progression was confirmed at least 4 weeks after the initial diagnosis of disease progression while receiving an anti PD-1 antibody. 4. BRAF mutation status must be known and treated with approved targeted therapies. 5. Received a BRAF inhibitor if the tumor carries a BRAF activating mutation and progressed after the last line of treatment. 6. Participants with ocular or uveal melanoma are ineligible. 7. Confirmation of radiographic progression on prior anti-PD-(L)1 therapy is required with a scan confirming progression at least 4 weeks after the initial progression Additional for Phase 2 (Non-small Cell Lung Cancer) 1. Participants must have recurrent or progressive disease during or after platinum doublet-based chemotherapy or at least two prior lines of systemic therapy for advanced or metastatic disease OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy for local disease. 2. Status for actionable mutations must be known; participants with actionable mutations must have received and progressed on, have been intolerant to, or not be a candidate for, standard tyrosine kinase inhibitors for All Patients (All Phases) 1. Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety. 2. Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment. 3. Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ. 4. Rapidly progressive disease. 5. Any Grade 2 and higher neurological or pulmonary toxicity during a treatment with an anti-PD-1 or PD-L1 agent administered as a monotherapy. 6. Active or history of central nervous system (CNS) metastases unless all of the following are met: 1. CNS lesions are asymptomatic and previously treated. 2. Patient does not require ongoing steroid treatment daily for replacement for adrenal insufficiency. 3. Imaging demonstrates stability of disease 28 days from last treatment for CNS metastases. 7. Receipt of any organ transplantation, autologous or allogeneic stem-cell transplantation. 8. Significant acute or chronic infections, or active or latent hepatitis B or active hepatitis C. 9. Preexisting autoimmune disease needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years, clinically relevant immunodeficiencies, or fever within 7 days of Day 1. 10. Known severe hypersensitivity reactions to monoclonal antibodies and any history of anaphylaxis, or uncontrolled asthma 11. Serious cardiac illness or medical conditions. 12. History of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures | 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, Marginal Zone Lymphoma Age between 18 to 70 years old (including 18 and 70) 2. Diagnosed as marginal zone lymphoma 3. No receiving chemotherapy before enrollment 4. Indications for treatment: 1) symptoms related to tumor; 2) end-organ function damage; 3) large mass; 4) continuous or rapid progress of disease; 5) patient's willingness 5. Having at least one measurable lesions 6. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) 0-1 7. Life expectancy no less than 3 months 8. enough main organ function 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. Agreeing to sign the written informed consents Diagnosed as central nervous system lymphoma 2. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) ≥2 3. Other malignant tumor history or active malignant tumor need be treated 4. Serious surgery and trauma less than two weeks 5. Systemic therapy for serious acute/chronic infection 6. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 7. Active tuberculosis. Patients suspected of active TB need to be examined for chest X-ray, sputum and clinical symptoms and signs 8. HIV-positive, AIDS patients and untreated active hepatitis（HBV/HBV and HCV） 9. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 10. Patients with a history of mental illness 11. Researchers determine unsuited to participate in this 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): 50.0-999.0, Overactive Bladder Urinary Incontinence, Urge Urgency-frequency Syndrome Post Prostatectomy Patients have to fulfill all the following to be included in the study: 1. Ability to give informed consent and reply to questionnaires. 2. Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary. 3. Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy Patients who have any of the following will be excluded from the study: 1. Untreated UTI. 2. BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture. 3. Neurogenic lower urinary tract dysfunction (LUTD). 4. Uncontrolled diabetes mellitus. 5. Depression or any psychogenic disorders. 6. Prior radiation therapy to the pelvic area. 7. History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy. 8. Poor coagulopathy. 9. Severe cardiovascular disease | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Anterior Urethral Stricture, Male Age: 18 years or older Anterior urethral strictures (except for meatal strictures) Posterior urethral strictures Meatal strictures History of hypospadias repair History of phalloplasty | 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 Kidney Stone (all of the following) recurrent UTIs, defined as 3 positive urine cultures of specific organisms with symptoms within 12 months (or 2 positive cultures with symptoms within 6 months) prior to clinical assessment non-obstructing renal stone(s) on imaging within 6 months of initial visit age < 18 years pregnancy hydronephrosis or evidence of obstruction presence of a foreign body in urinary tract (e.g. Foley, ureteral stent, nephrostomy tube) at the time of UTI diagnosis concurrent bladder calculi Urinary diversion or previous surgery involving segments of bowel interposed into the urinary tract (ileal conduit, ileal ureter etc.) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Nephrolithiasis Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 8-20 mm is required Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines Must be 18 years or older Must be able to give consent Concomitant stones in the ureter Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture Prior radiotherapy to the abdomen or pelvis Neurogenic bladder or spinal cord injury Pregnancy Untreated UTI | 0 |
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