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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Urinary Incontinence Chinese Physically able to complete the pad test Prior bladder surgery Prior urinary incontinence Neurogenic dysfunction of the lower urinary tract Pre-operative history of overactive bladder Impaired mental status Allergic to latex
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pancreas Cancer Patients 18 or above will be included in the study. 2. Patients suspected of pancreatic mass or with a known pancreatic mass would be enrolled in the study. 3. Patients with suspected pancreatic pathology and scheduled for imaging study (CT vs. MRI) will be included if they had obstructive jaundice, with either a stricture in the lower common bile duct on magnetic resonance cholangiopancreatography (MRCP) or a pancreatic mass on ultrasound or other imaging study Patients with known advanced pancreatic tumors and those with previous pancreatic resection will be excluded. 2. Patients with renal insufficiency: increase Cr level or glomerular filteration rate (GFR) of less than 45 ml/min/1.73. 3. Patients who demonstrate increase in Cr level or patients with acute renal injury. 4. Claustrophobic or patients who are not able to tolerate MRI. 5. Patients with previous history of contrast allergies. 6. Pregnant patients
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer Prostatic Neoplasms Men greater than 18 years of age Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging Prostate cancer is diagnosed by transrectal ultrasound guided standard 12 core biopsy or MR image guided biopsies Gleason Score less than or equal to 7 (3+4), less than or equal to 3 cores positive in a standard 12 core biopsy or less than or equal to 4 cores positive on MR image guided biopsy where in 2 cores are taken from each of the two MRI target lesions If the standard biopsy cores are positive, they must be from the same location in the prostate as MR Lesion was biopsied and proven to be cancer. (Left / Right, Base, Mid Gland, Apex) MRI obtained within 6 months of ablation Metastatic Disease work up as per NCCN guidelines (www.nccn.org) Bone scan indicated to r/o metastatic disease if [clinical T1 and PSA > 20 or T2 and PSA > 10] PSA less than or equal to 15 ng/ml or PSA density less than or equal to 0.15 ng/ml(2) in patients with a PSA > 15 ng/ml The patient has given written informed consent after the nature of the study and alternative treatment options have been explained Patients who present with local recurrence or residual tumor after prostate cancer treatment which is visible on MRI The presence of 3 or more MR Visible lesions positive on biopsy The presence of extra capsular, seminal vesical invasion or metastatic disease Patient is unable to tolerate MRI (foreign body, i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc ) Patient with inability to follow up Acute urinary tract infection Lower urinary tract symptoms defined by a International Prostate symptom score (IPSS) >20 Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, due to they will not be able to undergo gadolinium enhance MRI Patients with Uncontrolled Coagulopathies who are at increased risk of bleeding Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS, renal or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Outlet Obstruction clinical diagnosis of benign prostatic hyperplasia (BPH) has indication for urodynamic evaluation
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Prostate Cancer Patients do not have to be eligible for both modifications to be included in the study. Lymphadenectomy vs no lymphadenectomy Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC Port site closure technique Patients 21 years or older scheduled for minimally-invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC Lymphadenectomy vs no lymphadenectomy Presence of positive/suspicious pelvic nodes on MRI or CT (positive/suspicious defined as a pelvic node >15mm in short axis or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum Any prior pelvic radiation therapy used to treat prostate cancer Port site closure technique There are no for any of the modifications
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer Open Phase 1. Has the patient given written informed consent and is the patient willing and able to abide by the protocol? 2. Is the patient 18 years old or above? 3. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 4. Does the female patient of childbearing potential have a negative serum pregnancy test at screening? 5. Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have multiple tumors (2-7) No single Tumor > 3 cm No history / evidence of Tis Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have A single tumor that is ≤ 3 cm No history / evidence of Tis 6. Is the patient able to retain bladder instillations for a minimum of 60 minutes? 7. Did the patient have upper urinary tract evaluation to urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening? 8. Is patient's urethra (including prostatic urethra in men) endoscopically free of any visible TCC? 9. For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening? 10. Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator? Double-Blind Phase 1. Was all visible tumor resected at the initial TURBT? 2. Does Central Pathology review of the patient's bladder tumor confirm Low grade Ta disease for multiple tumors (2 High Grade Ta disease for single tumor No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli Open Phase Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)? 2. Has the patient ever received apaziquone? 3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago? 4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT? 5. Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)? 6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma? 8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past? 9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years? 10. Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L? 11. Does the patient have a screening hemoglobin < 10 mg/dL? 12. Does the male patient have a serum PSA > 10 ng/mL? 13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive? 14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study? 15. Has the patient participated in an investigational protocol within the past 90 days? 16. Is the patient pregnant or breast feeding? 17. Does the patient have a life expectancy of <3 years? 18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except non-melanoma skin tumors stage 0 (in situ) cervical carcinoma undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer? 19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent? 20. Does the patient have tumor in a bladder diverticulum? 21. Does the patient have a known allergy to red color food dye?
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Kidney Neoplasms any person who is being treated for kidney cancer with partial nephrectomy those from whom we cannot obtain adequate informed consent those that are converted from partial to radical nephrectomy intraoperatively
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Male Age 50 or older at the index date (the date of the first filled prescription for an AB or 5ARI during the enrollment period) At least one claim with an ICD-9 diagnosis code for BPH (222.2 or 600.xx) in any position and at least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) or at least one fill for a 5ARI (dutasteride or finasteride) (with or without a diagnosis for BPH) Continuous enrollment with medical and pharmacy benefits for 6 months prior to the index date (i.e., baseline period) and 12 months after the index date (follow-up period) At least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) any time during the pre-index period prior to the index date At least one fill for a 5ARI (dutasteride or finasteride) any time during the pre-index period prior to the index date A diagnosis code for prostate cancer (ICD-9 = 185, 198.82, 233.4, 236.5, 239.5, V10.46) or bladder cancer (ICD-9 =188, 198.1, 223.3, 233.7, 239.4, V10.51) in any position during the pre-index or follow-up period A pharmacy claim for finasteride 1 mg tablets (i.e., treatment of male-pattern baldness) during the pre-index or follow-up period Prostate surgery anytime during the pre-index period or 5 months after the index date
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-90.0, Uremic Pruritus Hemodialysis patients which have treated at least 3 months Dermatologic diseases
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Ureteral Calculi Renal Calculi Patient undergoing URS for treatment of a urinary calculus who requires placement of ureteral stent on a string Able to undergo a general anaesthetic At least 18 years old Willing and able to complete patient symptom questionnaires Solitary Kidney Renal failure Anatomic bladder or ureteral abnormality Uncorrected coagulopathy Previous cystectomy or urinary diversion Neurogenic bladder Interstitial cystitis Transplanted kidney Pregnancy Requires an indwelling catheter
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pain Catheter Complications Adenocarcinoma of the prostate Subjects treated by conventional or robotic assisted laparoscopic prostatectomy Be willing/able to adhere to follow up visits Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer Contraindications for anticholinergic drugs Waist measurement > 100 cm No written informed consent Age < 18 years Subjects with known narrow-angle glaucoma
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer (for Open Label): 1. Has the patient given written informed consent and is the patient willing and able to abide by the protocol? 2. Is the patient 18 years old or above? 3. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 4. Does the female patient of childbearing potential have a negative serum pregnancy test at screening? 5. Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have multiple tumors (2-7) No single Tumor > 3 cm No history / evidence of Tis Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have A single tumor that is ≤ 3 cm No history / evidence of Tis 6. Is the patient able to retain bladder instillations for a minimum of 60 minutes (± 6 minutes)? 7. Did the patient have upper urinary tract evaluation to urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening? 8. Is patient's urethra (including prostatic urethra in men) endoscopically free of any visible TCC? 9. For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening? 10. Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator? (for Open Label): 1. Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)? 2. Has the patient ever received apaziquone? 3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago? 4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT? 5. Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)? 6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma? 8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past? 9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years? 10. Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L? 11. Does the patient have a screening hemoglobin < 10 g/dL? 12. Does the male patient have a screening serum PSA > 10 ng/mL? 13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive? 14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study? 15. Has the patient participated in an investigational protocol within the past 90 days? 16. Is the patient pregnant or breast feeding? 17. Does the patient have a life expectancy of <3 years? 18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except non-melanoma skin tumors stage 0 (in situ) cervical carcinoma undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer? 19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent? 20. Does the patient have tumor in a bladder diverticulum? 21. Does the patient have a known allergy to red color food dye? Double-Blind Phase 1. Was all visible tumor resected at the initial TURBT? 2. Does Central Pathology review of the patient's bladder tumor confirm Low grade Ta disease for multiple tumors (2 High Grade Ta disease for single tumor No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia (BPH) male over the age of 18 years present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention subjects must read, understand and sign the Informed Consent AUA ≥ 15 Qmax < 15mL/sec Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months Prostate volume ≥ 30g PVR > 300ml Current urine retention Previous surgical or invasive treatments (TURP, TUMT, TUNA) PSA ≥ 4 (must have negative biopsy within last 12 months) Neurogenic bladder Obstruction due to urethral stricture Any disorder or condition of the subject that the investigator believes will counter indicate their in the study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Pain, Postoperative ASA I,II,III status Who were scheduled to have elective transurethral resection of the prostate Chronic renal failure coagulopathy active anorectal disease active urinary tract infection uncontrolled diabetes
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention Age > 18 Competent to consent to participate in trial Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection) Receiving epidural analgesia post-operatively If male, international prostate symptom score <20 Previous lower urinary tract surgery Chronic lower urinary tract disease Intermittent self-catheterisation Neurogenic bladder Urethral catheter inserted >24 hours pre-operatively Presence of pelvic sepsis/abscess at surgery Previous trans-abdominal pelvic surgery Urethral catheter required for urine output monitoring beyond 24 hours post-operatively Presence of enterovesical fistula Pre-operative use of medications which alter detrusor function
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Fractured Neck of Femur Fractured neck of femur surgical fixation performed under spinal anaesthesia ASA I to III Patient refusal Coagulation disorders Head injury or other associated injuries Previous vascular surgery in the femoral area Loss of consciousness and signs of acute coronary syndrome Mini-Mental Score < 25 (see appendix 3) Allergy to lignocaine Skin lesions/infection at site of injection Sepsis
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Bladder Cancer The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes Age 18 years or above Patients with known tumors in the prostatic urethra or distal urethra Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy) Patient with porphyria Hypersensitivity to the active substance or to any of the excipients of the solvent Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included Patients who have received BCG or chemotherapy within three months prior to study inclusion Conditions associated with a risk of poor protocol compliance Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-80.0, Prostate Cancer Robotic Prostatectomy Foley Catheter Discomfort age 40 years and above diagnosis of prostate cancer electing to undergo robot-assisted radical prostatectomy allergy to bupivacaine or amide-type local anesthetics chronic pain condition recently or currently on narcotics genital abnormalities
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia (BPH) Benign Prostatic Enlargement (BPE) Moderate-to-severe LUTS as determined by the International Prostate Symptom Score Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 6.0-14.0, Nocturnal Enuresis Monosymptomatic nocturnal enuresis Age 6-14 years Clinical examination normal ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output Constipation (by ROME III criteria) Day incontinence Overactive bladder (ICCS 2008 classification of symptoms) Current or past history of clinical or laboratory findings that can be related to diseases or conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder Clinical signs of urinary tract infection Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff Set treatment with one or more drugs
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, Uremia Dialysis patients aged 18-80 years thrice-weekly HD or HDF for at least 6 months body weight less or equal to 90 Kg stable clinical condition written consent infections malignancies active systemic diseases active hepatitis or cirrhosis unstable diabetes diuresis higher than 200 ml/24h dysfunction of vascular access blood flow rate less than 300 ml/min
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-85.0, Pancreatic Pseudocyst Adults with ages from 18-80 years old. 2. The pseudocysts were formed more than 3 months. 3. The size of pseudocyst is more than 5 cm. 4. The patient has the symptoms related with the pseudocyst. 5. The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image. 6. The consent form has been signed The patient can't accept the endoscopic procedure. 2. The patient has blood coagulation dysfunction. 3. The patient has mental disorders. 4. The patient has mild or severe cardiorespiratory insufficiency. 5. The patient has hypertension and can't be controlled to safe level. 6. Diabetics whose blood sugar level can't be controlled to safe level. 7. Patients with alcohol dependence 8. Pregnant and lactating women. 9. The patients the investigator don't think suitable for this study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Anesthesia Pain Urinary Retention Nulliparous Term (≥37 week gestation) Healthy ASA class 1-2 Who are being induced for labor who request labor analgesia and who successfully receive standard combined spinal epidural analgesia (verbal rating score for pain ≤ 1 after 10 min) Women with ASA 3 or greater BMI ≥40 kg/m2 Prior history of urge or stress incontinence or urinary retention before pregnancy Women with a history of nephrolithiasis Chronic urinary tract infections Women whose post-void residual volume as assessed by ultrasonography is found to be >100ml before epidural placement will be excluded Women with an absolute or relative contraindication to the usual combined spinal epidural technique Failed analgesia will be excluded Women for whom the anesthesiologist selects an analgesic technique other than combined spinal epidural technique or fail to obtain CSF for CSE will be excluded Women with fetal heart rate decelerations before request for analgesia will be excluded due to increased risk of cesarean delivery
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-80.0, Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia yrs or greater International prostatic symptom score >= 12 Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20) Patients with urologic malignancies such as prostate cancer and bladder cancer Patients underwent urethral, prostate surgery Patients with urethral stricture or bladder diverticulum or bladder neck contracture
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-85.0, Benign Prostatic Hyperplasia (BPH) Male patient Between 45 and 85 years old Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2) Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2) I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary) Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2) Serum total PSA at randomisation visit (visit 2) ng/mL Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2) Urological history Urethral stricture disease and/or bladder neck disease Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection Indication of BPH surgery Stone in bladder or urethra Acute or chronic (documented) prostatitis Prostate and cancer cancer treated or untreated Interstitial cystitis (documented by symptoms and/or biopsy) Active upper tract stone disease causing symptoms
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-79.0, Malfunction; Catheter Thrombosis Mechanical Complication of Hemodialysis Catheter End-stage kidney disease patients with newly inserted temporary untunnelled dual-lumen catheter Naive to study but not naive to catheters (both virgin and non-virgin catheters will be included) Expected to use catheter, and to dialyze at study centre, for at least six months Frequency of HD 3 times per week If indication for catheter was replacement for catheter related infection patients will be eligible after the infection has been treated and the patient has been off antibiotics for 3 HD sessions Patient or legal representative able to provide written consent Eighteen years of age or older Baseline INR ≤ 1.3 (no anticoagulation allowed outside the HD session) Baseline platelet count ≥ 60 x 109/L Use of systemic anticoagulation (if indication for anticoagulation is catheter patency patients may be eligible if the systemic anticoagulation is discontinued and baseline INR is ≤ 1.3) Insertion of a new catheter into the femoral vein Current use of antibiotics for catheter-related bacteraemia (see above) Major haemorrhage in the prior 4 weeks, defined as bleeding resulting in a drop in haemoglobin of greater than 20 g/L or bleeding requiring transfusion of packed red blood cells with other clinical evidence or suspicion of bleeding History of intra-cranial bleed in the prior 4 weeks Intra-cranial or intra-spinal neoplasm (current) Allergy or intolerance to rt-PA or heparin or its constituents Active pericarditis defined by the presence of a pericardial rub Weight ≤ 30 kg or > 130 kg
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Severe Aortic Stenosis Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days Subjects must meet all of the under at least one of the sub-groups 2a-c: a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions: 1. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography 2. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography 3. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification) or creatinine clearance <20cc/min but not requiring renal replacement therapy AND ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%) AND iii. an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND/OR b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization AND ii. an initial aortic valve area of ≤0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND iii. radiographic evidence of severe aortic valve calcification AND/OR c. Failed bioprosthetic surgical aortic valve Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Clinical Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy Untreated clinically significant coronary artery disease requiring revascularization Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support Need for emergency surgery for any reason Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Active Gastrointestinal (GI) bleeding that would preclude anticoagulation
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Subject capable of understanding & complying with protocol requirements & signed the informed consent form 2. Minimum age 18 years 3. Histologically confirmed adenocarcinoma of the prostate with tumour tissue available for molecular analyses 4. At least one but no more than two previous taxane-based chemotherapy regimens. If docetaxel chemotherapy is used more than once, this will be considered as one regime. Patients may have had prior exposure to cabazitaxel treatment 5. At least 28 days since the completion of prior therapy, including major surgery, chemotherapy & other investigational agents. Clinically relevant sequelae should have resolved to grade 1 or less prior to recommencing treatment. For hormonal treatment & radiotherapy refer to the protocol guidelines 6. Documented prostate cancer progression as described in the protocol. 7. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists this must have been initiated at least 4 weeks prior to Cycle 1 Day 1 & must be continued throughout the study. 8. Eastern Cooperative Oncology Group Performance Status of 0, 1, 2 9. Life expectancy > 12 weeks 10. Able to swallow a whole tablet 11. Patient & the patient's partner of childbearing potential, must agree to use medically accepted methods of contraception during the course of the study & for 3 months after the last dose of study drug 12. Agreeable to have all the biomarker studies including the paired fresh tumour biopsies. 13. CTC count of 5 cells/7.5mls blood or more at screening. Note: For Part B, CTC count >5 cells/7.5mls blood is not mandatory if patient has measurable disease by modified and a lesion >2cm and PSA greater than or equal to 2ng/ml at screening. 14. Adequate bone marrow, hepatic & renal function as defined in the protocol 15. For Part B only, patients must have genomic defects associated with olaparib sensitivity identified by NGS by the central lab Surgery, or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1 2. Less than 28 days from any active anticancer therapy or investigational agents. For hormonal treatment & radiotherapy refer to the guidelines outlined in the 3. Prior treatment with a PARP inhibitor, platinum, cyclophosphamide or mitoxantrone chemotherapy 4. Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements 5. Any acute toxicities due to prior chemotherapy & / or radiotherapy that have not resolved to a NCI-CTCAE v4.02 grade 0 or 1 with the exception of chemotherapy induced alopecia & grade 2 peripheral neuropathy 6. Malignancy within the previous 2-years with a > 30% probability of recurrence within 12 months with the exception of non-melanoma skin cancer, in-situ or superficial bladder cancer 7. Patients with myelodysplastic syndrome/acute myeloid leukaemia 8. Patients with known symptomatic brain metastasis are not suitable for enrollment. Patients with asymptomatic, stable, treated brain metastases are eligible for study entry 9. Patients with symptomatic or impending cord compression unless appropriately treated beforehand & clinically stable & asymptomatic 10. Patients who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures 11. Patients receiving any of the following classes of inhibitors of CYP3A4 (see protocol for guidelines & wash out periods) 12. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication 13. Initiating bisphosphonate therapy or adjusting bisphosphonate dose/regimen within 30 days prior to Cycle 1 Day 1. Patients on a stable bisphosphonate regimen are eligible & may continue 14. Presence of a condition or situation, which, may put the patient at significant risk, confound the study results, or interfere significantly with participation in the study
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer Histologically confirmed, non-metastatic adenocarcinoma of the prostate, previously untreated (other than by neoadjuvant hormonal treatment) 2. National Collaborative Cancer Network locally advanced disease (T3b± or T4)43 or: • Estimated risk of pelvic lymph node involvement ≥30% * and either Gleason 9 or 10 or Gleason 8 and one other high risk feature (T3± disease or PSA >20) or Gleason 7 and 2 high risk features (T3± disease and PSA ≥30) 3. WHO performance status 0 or 1 4. Normal blood count (Hb > 11g/dl, WBC >4000/mm3, platelets >100,000/mm3) 5. LHRH analogue therapy for 6-9 months duration prior to proposed radiotherapy treatment and PSA < 4ng/ml prior to randomisation. 6. Age ≥ 18 years 7. Patients must be prepared to attend follow up. All patients participating in the Patient Reported Outcomes (PRO) Study must have adequate cognitive ability to complete the PRO questionnaires. 8. Written informed consent T3a disease should be demonstrated convincingly, either clinically or by MRI. T3b disease (seminal vesicle involvement) must be convincingly demonstrated on MR Risk of pelvic lymph node involvement = (Gleason score x 10 + 2/3 PSA Prior pelvic radiotherapy 2. Prior major pelvic surgery (e.g. colectomy, colostomy, cystectomy, prostatectomy)* 3. Radiologically suspicious (short axis diameter ≥1.0cm unless biopsied and negative) or pathologically confirmed lymph node involvement 4. Life expectancy < 5 years 5. Castrate resistant prostate cancer (rising PSA after LHRHa and anti-androgen) 6. Previous active malignancy within the last 5 years other than basal cell carcinoma 7. Co-morbid conditions likely to impact on the decision to treat with radiotherapy (e.g. previous inflammatory bowel disease, previous colo-rectal surgery, significant bladder instability or urinary incontinence) 8. Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration Patients who have undergone minor pelvic surgery will be eligible (eg appendicectomy, trans urethral resection of prostate (TURP), exploratory laparoscopy, haemorrhoidectomy, inguinal/femoral hernia repair)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-85.0, Prostatic Obstruction Acute Urinary retention due to Prostatic Obstruction Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral or bladder surgery, or if they were at high risk of developing bladder or kidney stones
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 20.0-65.0, Dysfunctional Voiding Adults with age of 20 years old or above Free of active urinary tract infection Free of bladder outlet obstruction on enrollment Patients should have severe dysuria or urinary retention, large residual urine and have been treated with medication or other therapeutic modality for over 3 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up Patients with bladder outlet obstruction on enrollment Patients with uncontrolled confirmed diagnosis of acute urinary tract infection Patients have laboratory abnormalities at screening including: Alanine aminotransferase (ALT) > 3 x upper limit of normal range aspartate aminotransferase (AST) > 3 x upper limit of normal range Patients have abnormal serum creatinine level > 2 x upper limit of normal range Patients with any contraindication to be urethral catheterization during treatment Female patients who is pregnant, lactating, or with child-bearing potential without contraception Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial Patients participated investigational drug trial within 1 month before entering this study Written informed consent has been obtained
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 60.0-999.0, Benign Prostatic Hyperplasia Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist Male subjects aged 60 years or older IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline) Able to comply with protocol procedures Written informed consent obtained before beginning any investigational procedures Hypersensitivity to the active substance or to any of the excipients Patients for whom cataract surgery is scheduled History of orthostatic hypotension or syncope Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula) Severe hepatic impairment Concomitant use of other α-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto serenoa serrulate/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline) Concomitant use with potent cytochrome P450 3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible pharmacokinetic interaction) Prostate cancer History of prostate or bladder neck surgery, including transurethral prostatectomy, TUNA, laser or other minimally invasive therapy
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-89.0, Spinal Cord Injury For All Groups Age 18-65 years (18-89 years for Non-Invasive Only SCI Subjects) Stable health for > 6 months Non-smoker o Subjects with SCI Level of injury C1-S4 Duration of injury ≥ 1 year AIS classification A, B, C For Main Study SCI Group Tachycardia (resting HR ≥ 100 bpm) Bradycardia (resting HR ≤ 40 bpm) Hypertension KNOWN: Coronary artery disease, Chronic heart failure, Cardiac arrhythmias, Diabetes mellitus, Thyroid disease, Renal insufficiency, Hepatic disease, Autonomic neuropathy, Ulcerative colitis, Benign prostatic hyperplasia, Hiatal hernia, Glaucoma, Parkinson's disease, Stroke, other neuromuscular diseases, Known sulfite allergy or hypersensitivity, Asthma, Active illness or infection, For Non-invasives Only SCI Group Diabetes mellitus Autonomic neuropathy Parkinson's disease Active illness or infection
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Spinal Cord Injury (SCI) Chronic Urinary Retention Urinary Incontinence Age 18 and older that have spinal cord injury and/or chronic, irreversible neuropathic bladder dysfunction from other progressive neurological syndromes including Stroke, multiple sclerosis and Parkinsonism Candidates must have a minimum duration of injury and bladder dysfunction of 2 years Candidates shall be those who utilize an indwelling Foley catheter an indwelling suprapubic catheter diapers or external (condom) catheter drainage or intermittent self-catheterization but finds the current alternative to be socially unsatisfactory Candidates need to recognize the investigational nature of the "tissue bonding cystostomy" device and must be willing to return for periodic follow-up Candidates also need to recognize that a minor surgical procedure may be needed to remove the device if it proves unsatisfactory Patients must be willing and capable of signing the Informed Consent Document (ICD) have a reversible spinal cord injury or a reversible neurological illness have been injured less than two years have acceptable forms of urological management utilizing intermittent self-catheterization, or spontaneous voiding with the use of an external collecting appliance have no advanced neuropathic bladder dysfunction of less than 2 years duration have advanced neuropathic bladder dysfunction and are happy with intermittent self-catheterization or more traditional forms of tube drainage are non-candidates This feasibility study will females of child-bearing age. In subsequent expanded clinical trials it may be appropriate [depending on the outcome of the feasibility study] to females of child-bearing age
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture Disease Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists Transsexual patients Patients with perineostomy
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Noninvasive Ventilation NAVA Catheter Hypercapnic Exacerbation COPD Informed consent COPD Hypercapnic respiratory acidosis Clinical need of NIV ventilation on the intensive care NAVA catheter in situ Pre-existent muscle disease (congenital or acquired) or diseases / disorders known to be associated with myopathy including auto-immune diseases Diabetes Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) Recent (< 1 month) nasal bleeding Allergic to xylocaïne
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Study personnel will evaluate participant using a checklist of and as outlined below. Clinical information will be obtained from subjects by interview and from the medical record. At the screening visit, potential participants will be included if Age greater than or equal to 18 years Have RA, as defined by the 1987 revised American College of Rheumatology In sustained clinical remission for the last 6 months while receiving treatment with either etanercept, infliximab, or adalimumab, and greater than or equal to 1 DMARD (methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, minocycline, cyclosporine, azathioprine, gold, penicillamine). DAS28 should be less than 2.6 on each visit over the preceding 6 months, with at least one visit 2-4 months before enrollment. If there is no visit 6 months before enrollment, the nearest visit in the 6-12 month period before enrollment should be considered and have a DAS28 less than 2.6. Potential participants will be excluded if Had dose increase of anti-TNF agent or DMARD in the last 6 months Had change of anti-TNF agent or DMARD in the last 6 months Treated currently with golimumab or certolizumab Treated with greater than 10 mg of prednisone (or equivalent) daily in the last 6 months Treated with greater than 5 mg of prednisone (or equivalent) daily in the last 3 months Treated with intramuscular or intravenous corticosteroids in the last 6 months for RA activity
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Tract Infection Male or female patients with traumatic or medical spinal cord injury Age of 18 years or above Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian) Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector Patients with urinary tract infection at the moment of Current antibiotic use or use within 7 days prior to Outpatients with sporadic medical examinations (less than one per month) Known allergy to latex, silver salts or hydrogels Patients with surgical interventions in the urinary tract that may interfere, at the investigator with the study results Pregnant or breastfeeding woman
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Sexual Functions and Problems in the Adult Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH. 2. Failed medical treatment of BPH. 3. International prostate symptom score (IPSS) >9. 4. Peak urinary flow rate (Qmax) <10 ml/sec. 5. Patients in retention secondary to BPH. 6. Total prostate size not less than 30 gm by TRUS (transrectal ultrasound) - Patient who have a neurological disorder as neurogenic bladder, cerebrovascular stroke or Parkinson disease. 2. Non BPH causes of LUTS as cystitis. 3. Infravesical causes of LUTS other than BPH as urethral stricture. 4. Presence of active bladder cancer (within the last 2 years). 5. Known cancer prostate patients on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary. -
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Pain Hematuria Lower Urinary Tract Symptoms All male patients aged 18 and above Visiting for evaluation of Haematuria or Lower urinary tract symptoms (which poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence) For removal of double J ureteral stent will be included in the study Patients with clinical evidence of urethral stricture and/or prostatitis Patients in which biopsy will be taken those having psychiatric illness Asthmatics Kidney, liver disease Those allergic to NSAIDs (non-steroidal anti-inflammatory drugs) Those who refuse to participate Having history of chronic analgesia use or Having language barrier will be excluded
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer Men with biopsy-proven histologic diagnosis of prostate adenocarcinoma Low risk for seminal vesicle invasions defined by: Clinical stage T1c/tumor 2-node 0-metastasis 0, Gleason score ≤ 6, PSA ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage T1c/T2N0M0, Gleason ≤ 7, PSA ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%) Sexually potent, defined as International Index of Erectile Function score ≥ 21, prior to randomization and surgery Competent to provide informed consent Able to read and write English Candidate for bilateral nerve-sparing Willing to be followed for 12 months post-surgery Intermediate or high risk for seminal vesicle invasion Unwilling to be randomized to either treatment arm Pre-operative treatment with radiation and/or hormone therapy Planned adjuvant radiation and/or hormonal therapy
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Men ≥ 18 years of age Histological documentation of adenocarcinoma of the prostate, with available biopsy pathology. Biopsy material must be available for pathologic review All patients must meet one or more of the following disease features: clinical stage greater than or equal to T3; Primary Gleason score of 4 OR Gleason score of 8, 9 or 10; serum prostate-specific antigen (PSA) ≥ 20 ng/mL; Prostate MRI findings consistent with T3 disease; Any clinical stage and PSA (prostate-specific antigen) >10 and Gleason score 7; A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60% Patients must have a PSA (prostate-specific antigen) ≥ 2 ng/mL at the time of diagnosis of prostate cancer or later No prior radiation or chemotherapy for prostate cancer treatment Scheduled for radical prostatectomy surgery Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Patients may have been treated with up to 4 months of androgen deprivation therapy No clinical evidence of metastatic prostate cancer, or enlarged pelvic lymph nodes in the imaging studies Resected lymph nodes must be provided for all subjects for biomarker analysis immediately (same day) after surgery (radical prostatectomy) Clinical evidence of metastatic prostate cancer Prior malignancy. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: Active peptic ulcer disease Known intraluminal metastatic lesion/s with risk of bleeding Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to Malabsorption syndrome or Major resection of the stomach or small bowel Corrected QT interval (QTc) > 480 msecs Note: Correction method should be reported History of any one or more of the following cardiovascular conditions within the past 6 months Cardiac angioplasty or stenting Myocardial infarction
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-90.0, Benign Prostatic Hyperplasia You must have symptoms from BPH for at least 6 months 2. Your symptoms must meet the entrance as determined by a short questionnaire you will be asked to complete. 3. You must have urinary flow rates that meet entrance as measured by a simple urination test. 4. Enlargement of the prostate, as measured by the urologist, with a volume of between 50 and 100 cc. 5. You must be at least 50 years of age, but not more than 90 Prostate Cancer 2. Blockage of major arteries in your pelvis or other arterial abnormalities that prevent embolization or that might increase risks of injury. You will be screened for these conditions if you consent to participate. 3. Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery. 5. Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate. 6. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression. 7. History of clotting disorders. 8. Current medications (use of alpha-blockers within two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics within one week of treatment unless you have been on the same drug with a stable urination pattern. 9. Active urinary tract infection 10. Allergy to iodinated contrast agents, collagen or gelatin products 11. Acute urinary retention that has NOT been treated by a urinary catheter. 12. Significant retained urine after voiding as measured by ultrasound. In this case, significant means more than 250 ml (about 1 cup). 13. Bladder stones or blood in urine within three months 14. Previous rectal surgery, excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease 15. Prior pelvic irradiation or radical pelvic surgery 16. If you are interested in future fertility 17. Unable to speak and read English
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-85.0, Benign Prostatic Hyperplasia Patients with a urinary retention due to obstructive benign prostatic hyperplasia (BPH) confirmed by endoscopy Patients aged 50-85 years Patients with indwelling urinary catheter for at least 1 month Patients with at least one failure of a trial without catheter despite alpha-blocker treatment for at least 72 hours Patients informed about alternative treatment (transurethral resection of the prostate, laser prostatectomy, prostatic adenomectomy) Patients signed an informed consent form Prostate cancer (evaluated by PSA, physical examination, in all patients and by prostatic biopsy in suspicious cases) History of relevant neurological disease (e.g. multiple sclerosis, spinal cord injury, parkinson's disease) Patients who have on urodynamic investigation evidence of an atonic bladder Urethral stricture Chronic persistent local pathology that may cause urinary symptoms (e.g. interstitial cystitis, tumor, bladder stone) Renal insufficiency stade 3 or 4 (creatinine clearance < 35 mL/min) Any allergy or contraindication to ciprofloxacin or drugs used in this protocole (xylocaine, Atarax, paracetamol, and nonsteroidal anti-inflammatory drug) Any allergy to intravenous contrast agent or iodine Thyrotoxicosis Concomitant use of tizanidine
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Refractory Cancer The patients who agreed and written consent to participate in this research 2. The patients who are scheduled for collection such as the patient tissue, pleural fluid, cerebro spinal fluid, blood samples for the purpose of surgery and diagnostics 3. The patients who diagnosed with cancer as below GBM, Colon Cancer, Ovarian Cancer, Lung Cancer, Breast Cancer, Brain metastases, Lymphoma, Bone Metastatic Cancer , Gastric Cancer, Pancreatic Cancer, Gall bladder Cancer, Prostate Cancer, Kidney Cancer, Bladder cancer, Osteosarcoma, Soft tissue sarcoma, Head and neck cancer, 기타 Brain tumor Those who do not agree in writing to participate in research
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-70.0, Benign Prostate Hyperplasia •Qmax < 12 mL/s, IPSS >19 Age between 50 and 70 years Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 60.0-999.0, Transurethral Resection of Prostate Artery Embolization Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms Refractory to medical treatment for at least 6 months Qmax (maximum urinary flow) less than 10 mL/second Patients not candidates for transurethral resection of the prostate (TURP) Advanced atherosclerosis and tortuosity of the iliac arteries No visualization of the prostatic artery CT angiography study Urethral stenosis, detrusor failure or neurogenic bladder Glomerular filtration < 30 mL/min Presence of malignant tumor History of allergy to iodinated contrast Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Acute Heart Failure Age: more than 18 years Heart failure Left heart failure: as evidenced by 2 out of 3 Left ventricular ejection fraction (LVEF) ≤ 40% and cardiac index ≤ 2.5 L/min/m2 Acute pulmonary oedema of cardiac origin or mechanical ventilation (including CPAP/BIPAP) for respiratory failure of predominantly cardiac origin Need for inotropes/vasopressors for cardiac pump failure OR Right heart failure: as evidenced by 1 out of 2 Bilateral leg oedema above ankles RV failure (low tricuspid annular plane systolic excursion (TAPSE), dilated floppy RV) Poor peripheral perfusion as evidenced by 2 out of 3: Cold mottled skin Low urine output Acutely clouded sensorium/poor mentation Consent obtained from patient or patient's next of kin Hypernatremia: [Na] >145 mmol/L Diagnosed hypertrophic obstructive cardiomyopathy Uncorrected severe valvular heart disease Documented third degree heart block, sustained ventricular tachycardia Documented cardiac tamponade Septic shock Acute respiratory distress syndrome (ARDS) Moribund patients likely to die before 24h Patients with major diseases of limited prognosis such as end stage cancer,end-stage liver failure, end stage dialysis dependent renal failure Patients with absolute indication for acute hemodialysis/hemofiltration (pH, K, urea > 35 mmol/L, severe fluid overload in the presence of oliguria < 200 mL/6h
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urethral Stricture male urethral stricture surgery informed consent loss of follow-up not willing to participate
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 19.0-80.0, Pain Blood Pressure Nausea Vomiting Arrhythmia Patients scheduled for transurethral bladder resection ASA I-III Patient who disagrees to participate this investigation Patient with severe cardiovascular disease Patient with small-sized foley catheter (less than 18 Fr.) Patinets with any urinary tract obstructions Patient with hyperactive or neurogenic bladder Patients with chronic renal failure Patient with morbidly obese Patients with neurogenic disorder Patient with medications for chronic pain
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-95.0, Benign Prostate Hyperplasia Urinary Retention Male subjects, over 50 years of age at the time of enrollment. 2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates 3. Written informed consent to participate in the study. 4. Ability to comply with the requirements of the study procedures Previous surgical treatment for BPH 2. Presence of bladder stones 3. History of prostate cancer 4. Prostate size > 150 g 5. History of urethral stenosis or its management 6. Known of suspected neurogenic bladder 7. History of recent hematochezia in the last 3 months 8. Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure 9. Uncorrected coagulopathy 10. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. 11. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. 12. Subjects who are uncooperative or cannot follow instructions. 13. Mental state that may preclude completion of the study procedure or obtention of informed consent
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-90.0, BPH (Benign Prostatic Hyperplasia) Men undergoing surgery for BPH Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-75.0, Prostatic Diseases Men who be referred a new urological outpatient and satisfy the following Wanted examined because of elevated PSA Not strong family history of prostate cancer It is taken biopsy as part of routine investigation. 2. Control group: Men referred to urological outpatient clinic, and who satisfy the following urination complaints Normal PSA examination shows prostate size> 40cc 3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following - symptoms that might indicate cancer suspicion in colorectum 4. Age> 40 years and <75 years known prostate cancer 2. Reduced consent 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Adenocarcinoma Informed consent obtained Men >18 years Histologically confirmed prostate adenocarcinoma (centrally reviewed) Low and intermediate risk prostate cancer, defined as clinical stage T1-2b, Gleason Score less than/equal to 7, and PSA less than 20 ng/mL (low risk patients will have refused or felt to be inappropriate for active surveillance) Androgen deprivation therapy (LHRH-agonists or antiandrogens)>6 mo Prior pelvic radiotherapy Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Large prostate (>90cm3) on imaging Immunosuppressive medications Inflammatory bowel disease Presence of a hip prosthesis
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Bladder Outlet Obstruction Pressure Flow Study Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12) 2. Patients scheduled to have pressure flow study. 3. Able to give fully informed consent Patients with urologic malignancies such as prostate cancer and bladder cancer 2. Patients underwent urethral, prostate surgery 3. Patients with urethral stricture or bladder diverticulum or bladder neck contracture 4. seems not to be appropriate to this study by the decision of investigators because of any other reasons
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Hydrocephalus. Age: 18 years or older Indication for a ventricular drainage (such as hydrocephalus, slit ventricles, pseudotumor cerebri) Pregnancy Concurrent participation in another interventional trial (participation in an observational trial is not an postoperative imaging not to be performed frontal burr hole not available
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Liver Transplant Kidney Transplant Participated in one of the selected Astellas sponsored clinical trials PMR-EC-1106 PMR-EC-1211 PMR-EC-1212 Or, any potential new Astellas-sponsored Advagraf trial Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical trials and received a kidney or liver organ transplant. NOTE: The primary objective is to study long-term graft survival in patients currently or previously treated with Advagraf. Therefore patients do not have to be currently receiving Advagraf to be included, nor do they have to have completed a previous Astellas clinical trial
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Benign Genital Diseases, Male Lower Urinary Tract Symptoms Prostatic Diseases Male patients ≥ 45 years-old Diagnosis of BPH based on clinical history, digital rectal examination, urine sediment, transrectal prostate ultrasound and PSA Use of a marketed alpha-blocker for LUTS/BPH in the previous 6 months Severe lower urinary tract symptoms at screening and baseline defined by all the following: IPSS (7 items) ≥ 20, QoL ≥ 3, Qmax < 12 mL/s and prostate volume ≥ 40 mL CTA shows that prostatic arteries are feasible for PAE Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment Written informed consent Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months History of prostate or bladder cancer or pelvic irradiation Active or recurrent urinary tract infections (more than 1 episode in the last 12 months) History of neurogenic bladder or LUTS secondary to neurological disease Advanced atherosclerosis and tortuosity of iliac and prostatic arteries Secondary renal insufficiency (due to prostatic obstruction) Large bladder diverticula or stones Detrusor failure Previous history of acute urinary retention
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Relapsed or Refractory Acute Myeloid Leukemia (AML) Untreated AML Other IDH1-mutated Positive Hematologic Malignancies Myelodysplastic Syndromes Key Subject must be ≥18 years of age Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study Subjects must have ECOG PS of 0 to 2 Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed) Subjects must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic disease Subjects must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance >40mL/min based on Cockroft-Gault glomerular filtration rate (GFR) Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration. Key Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted.) Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120) Subjects who received an investigational agent <14 days prior to their first day of study drug administration Subjects who are pregnant or breastfeeding Subjects with an active severe infection or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled) Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1 Subjects with a history of myocardial infarction within the last 6 months of screening Subjects with a known unstable or uncontrolled angina pectoris Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias Subjects with known unstable or uncontrolled angina pectoris
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Chronic Total Occlusion of Coronary Artery Subject shows the presence of at least one coronary chronic total occlusion (CTO), either with or without the presence of one or more other diseased coronary arteries. This CTO must be located in a native coronary artery and have a visually estimated stenosis of 100%, corresponding with Thrombolysis in Myocardial Infarction (TIMI) flow 0. Following the operators judgment, this occlusion is present for more then 3 months Subject will be/is treated percutaneously for one or more CTOs via the hybrid techniques Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after PCI procedure to assess any complications and clinical status) The occlusion is considered to be less than 3 months present Subject is treated via PCI without application of the hybrid algorithm and/or use of the CrossBoss™ and Stingray™ technology (Bridgepoint Medical, Inc.) Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Carcinoma, Non-small Cell Lung For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC) For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC Have either measureable or nonmeasurable disease as defined by the Response Evaluation in Solid Tumors (RECIST v1.1) Have adequate organ function including Hematologic: Absolute neutrophil count (ANC) 1.5 x 109/liter (L), platelets 100 x 109/L, and hemoglobin 8 gram/deciliter (g/dL) Hepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment are eligible Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 3 to 4 months after the last dose of trial treatment (as appropriate) Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG. Additional For Part C History or evidence of cardiovascular risk including any of the following History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Transitional Cell Carcinoma of the Bladder Patients: Urothelial (transitional cell) carcinoma. Early and advanced stages of with transitional cell carcinoma of the bladder before transurethral resection of bladder Tumor (TURBT) Controls: Healthy volunteer's adults matched with age Urinary tract infection (UTI) patients Cardiac patients
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer Minimum age of 18 Years 2. Voluntarily agreement to participate in this study 3. Written informed-consent 4. Release of medical records for regulatory or research purposes 5. Clinically organ-confined prostate cancer BMI >40 2. History of catheterization 3. History of radiation 4. History of chemotherapy 5. Person's participating in any other research 6. Unable to provide informed consent
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-80.0, URINATION DISORDERS MEN THAT STUDY 6/2011 TO 9/2013 NONE -
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention English-speaking Women over the age of 18 Patients with stress urinary incontinence planning to undergo midurethral sling placement Prior incontinence surgery Concomitant surgery for pelvic organ prolapse except for anterior repair Intraoperative cystotomy Patients taking anticholinergic medication
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 2.0-999.0, Posttraumatic Stress Disorder Pseudopheochromocytoma Healthy Volunteers Neurocardiogenic Syncope Postural Tachycardia Syndrome Patients may be included if they are at least 18 years old and are known or suspected to have failure of one or more components of the autonomic nervous system, small fiber neuropathy, inherited dysautonomia, orthostatic intolerance, neurocardiogenic syncope, status post endoscopic thoracic sympathectomy, or disorders of catecholamine synthesis or fate. Children greater than two years old may be enrolled in this Protocol if they might personally benefit from the tests in the Protocol through the establishment of a diagnosis There are no for the study as a whole Healthy adult Volunteers (at least 18 years old) may be included, pending normal or medically insignificant results of history and physical examination. A repeat history and physical examination is required if more than 6 months have gone by from a previous workup A candidate Healthy Volunteer will be excluded if the person has any of the following: symptoms of autonomic dysfunction, including lightheadedness, fainting, abnormalities of sweating, frequent nausea, vomiting, constipation, or diarrhea, or urinary frequency or retention. If the Volunteer has a condition requiring medication that in the judgment of the Investigators will affect results of the pupillometric tests under this Protocol, the Volunteer may be included for training purposes
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Benign Prostatic Hyperplasia Male Age > 40 Prostate gland measures between 80 and 150 grams Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects Moderate to severe LUTS as defined by IPSS score >18 Peak urine flow rate (Qmax) <12 ml/sec Capable of giving informed consent Life expectancy greater than 1 year Severe cardiac or pulmonary disease Uncontrolled diabetes mellitus Immunosuppression Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc Acute urinary retention Glomerular filtration rate less than 45 as approximated using using serum creatinine levels Confirmed or suspected bladder cancer Recent (within 3 months) cystolithiasis or gross hematuria Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology Active urinary tract infection
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-85.0, Pelvic Organ Prolapse Urinary Tract Infections Urinary Retention Women undergoing minimally invasive sacrocolpopexy Sacrocolpopexy with or without concomitant procedures Patients having the first start surgery of the day to standardize hospital time Elevated post void residual (PVR) Mobility problems Neurological conditions Intra-operative cystotomy or urinary tract injury
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Voiding Dysfunction Benign Prostate Obstruction Detrusor Underactivity "UPSTREAM Phase I" Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may surgery unable to pass urine without a catheter (urinary retention) relevant neurological disease, such as a stroke undergoing treatment for prostate or bladder cancer previously had prostate surgery not medically fit for surgery, or are unable to complete outcome assessments do not consent to be assigned at random to one of the pathways "UPSTREAM Phase II": PROMS (questionnaire) study component: Men randomised (enrolled) to the trial (Phase I) who were willing to be contacted for long term follow up, as indicated on their original (Phase I) consent form. NHS Digital data extraction study component: Men randomised (enrolled) to the trial (Phase I) PROMS (questionnaire) study component: 1. Patients who are not already randomised (enrolled) to the trial (Phase I) 2. (Phase I) participants who: 2.1. are not willing to be contacted about long term follow up 2.2. have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3. do not consent and/or are not willing or able to comply with essential study procedures of this further follow up (UPSTREAM Phase II) NHS Digital data extraction study component: 1. Patients who are not already randomised (enrolled) to the trial (Phase I) 2. (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their 18-month timepoint
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Urinary Tract Infection Veteran Hospitalized in one of the two participating Spinal Cord Injury Units Require a size 14, 16, or 18 French catheter Sign and date the written informed consent document acknowledging his/her desire to participate in the study, or if unable to sign due to spinal cord injury give verbal consent in front of two impartial witnesses who sign and date the informed consent document in the presence of the participant Be able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions Require insertion or exchange of a Foley catheter for no longer than 15 days Unable to provide informed consent Has a current symptomatic urinary tract infection Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter insertion Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy Has periurethral inflammation or infection Has a known urethral anatomical anomaly which makes catheterization difficult Has a known silicone allergy or sensitivity Cannot accommodate a size 14,16 or 18 French Foley catheter
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Benign Prostatic Hyperplasia male adults > 40 years old severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention no improvement after or intolerance of medical treatment for at least six months prostatic volume > 30 cm³ female less than 40 years old eGFR < 45 ml/min * m² suspicion of prostatic malignancy prostatic malignancy acute prostatitis or cystitis hydronephrosis bladder stone or bladder diverticulum urethral stenosis major surgery within 4 weeks prior to the screening visit
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-90.0, Prostatic Hyperplasia patients in whom 12-month follow-up data were available a previous diagnosis of urethral stricture prostate or bladder carcinoma neurogenic bladder disease a previous history of urological surgery
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Prostatic Hyperplasia Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information is defined, prescribing information is to be considered
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Prostatic Hyperplasia Patients suffering from BPH symptoms Preceding treatment with a phytotherapeutic for at least 4 weeks IPSS sum score ≥ 8 points prior to treatment start with ALNA® Indication for a switch to treatment with ALNA® for a minimum period of 2 months Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Prostatic Hyperplasia Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information Patients with known hypersensitivity to Tamsulosin, or any other component of the product Patients with a history of orthostatic hypotension or severe liver failure
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Prostatic Hyperplasia Patients older than 21 years old diagnosed with benign prostatic hyperplasia (BPH), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. The study will naïve patients and patients not responding to previous therapy who receive Secotex as alternative or complementary treatment. The decision to treat a patient with Tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following Secotex (Tamsulosin) prescription information Patients with known hypersensitivity to Tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.083-999.0, Pulmonary Arterial Hypertension of Congenital Heart Disease The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for in the study must be signed by parents or legal guardians for minors, by the patient for adults The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-999.0, Diabetes Lipodystrophy Hyperlipidemia Age greater than or equal to 6 months Partial lipodystrophy (either genetic or acquired) Previously or currently treated with metreleptin under NIH study 02-DK-0022 and/or NIH study 13-DK-0057 Documented metabolic benefit from prior or current metreleptin treatment, defined as one or more of the following TG reduction greater than or equal to 30% OR HbA1c reduction greater than or equal to 1% OR Decrease in insulin requirements greater than or equal to 40% OR Decrease in episodes of pancreatitis OR Improvement in steatohepatitis OR Withdrawal of metreleptin led to marked worsening of metabolic parameters Availability of metreleptin to the patient either as an approved drug, or through local compassionate use or expanded access programs Known HIV infection or HIV-associated lipodystrophy Psychiatric disorder impeding competence or compliance Any medical condition or medication that will increase risk to the subject Current alcohol or substance abuse Subjects who have a known hypersensitivity to E. coli derived proteins
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Post Thrombotic Syndrome Chronic Thromboembolic Pulmonary Hypertension Venous Thrombosis Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B years of age Signed informed written consent Patients who refuse to consent Patients who have been treated with other anticoagulants than thoose included in the study Patients who can not participate due to logistic reasons
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Male Stress Urinary Incontinence Males > 21 years 2. Willing/able to sign informed consent 3. Has undergone radical prostatectomy or transurethral resection of the prostate or other prostate surgery prior to 6 months of the time of enrollment 4. Primary stress urinary incontinence confirmed urodynamically as dominant form of UI 5. Failed conservative incontinence treatment (see list below) for at least 6 months 1. Pelvic exercises and bladder training 2. Drug Therapy 3. Biofeedback 4. Electrical stimulation 5. Behavioral therapy 6. Subject has severe urinary incontinence defined by: a. One 24-hour pad weight test ≥300 gm 7. Max urethral closure pressure < 30 cm H2O 8. Bladder capacity > 250 ml 9. Post void residual urine < 50 ml 10. Abnormal/poor compliance bladder defined by <30-40cm H2O. 11. Willing/able to comply with follow-up activities 12. Is an appropriate surgical candidate as determined by the investigator 13. Negative urine culture prior to surgery 14. Cognitive/manual capability to operate device Subjects considered to be vulnerable 2. Refuses or unable to sign the informed consent 3. Cannot comply with study requirements, follow-up visits and tests 4. Currently enrolled or plans to enroll in another investigational device or drug clinical trial or has completed an investigational study within 2 weeks 5. Estimated life span < 5 years 6. Recent or planned surgeries within 3 months before or 12 weeks after the implant procedure 7. Primary urge incontinence, mixed incontinence with a predominant urgency component, or urinary incontinence due to or complicated by bladder outlet obstruction 8. Has had implantation of artificial urinary sphincter prosthesis, sling, or other urogenital implant 9. Has had ProACT device explanted and the urethra is compromised as assessed by the investigator 10. Demonstrated bladder outlet obstruction (BOO) as measured by the pressure flow cystometry 11. Neurogenic bladder dysfunction not treatable/controllable by pharmacological or alternative methods 12. Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of >12mmol/l (216. mg/dl) and a glycosylated hemoglobin (HbA1C) of >9% (75mmol/mol) over the preceding 3 months 13. Active abscess or infection 14. Bladder neck or urethral stricture disease requiring > 2 regular instrumentation or dilation proximal to or at the level of the urethral sheath 15. Bladder cancer or transitional cell carcinoma requiring regular cystoscopy and/or rapidly progressive prostatic or testicular cancer 16. Needs self-intermittent catheterization 17. Diagnosed disease precluding subject from being able to recall or summarize urinary status 18. Diagnosed disease or medical condition (e.g., Parkinson's) precluding subject from being physically capable of manipulating the device 19. History of bleeding diathesis or cannot stop usage of an anti-coagulant until the International Normalized Ratio (INR) is below 1.5 or quick value >70 20. Uses an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use for study assessments 21. Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms no signs of local recurrence 22. Known allergy to device material 23. Active or recurrent urinary tract infections (UTIs) . Recurrent defined as > 4 times over the past year 24. Urodynamic testing shows significant incontinence caused by factors other than stress incontinence 25. No anatomic abnormalities of the urethra, scrotum or penis judged to prevent implantation
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Scarring Spinal Stenosis Herniated Disc Are 18 (eighteen) years of age or older at the time of surgery. 2. Patients with single or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy 3. Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled. 4. Are willing and able to sign study specific informed consent Non-English speaking patients 2. Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc. 3. Allergic to aminoglycoside antibiotics 4. Is a prisoner 5. Is involved in worker's compensation or other litigation relative to the spine injury 6. Has a history of drug or alcohol abuse within the last 12 months 7. Is currently participating in another drug or device clinical trial 8. Previous spinal surgery 9. History of deformity, mechanical instability, or spinal fusion requirement 10. History of hard or soft-tissue spinal infection 11. Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past 12. Patients unable to undergo a MRI
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Non-muscle Invasive Bladder Cancer Clinical diagnosis of NMIBC based on cystoscopic appearance ECOG 0-2 No intravesical therapy within 6 weeks of study entry No prior radiation to the pelvis ANC >1500/mm³; Hb >9.0 g/dL; Platelet >100000/mm³ Serum creatinine ≤ 1.5 mg/dL Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence of liver metastasis INR < 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8 Candidate for TUR and planning to undergo TUR Negative pregnancy test within 7 days of treatment start Prior local or systemic treatments for NMIBC Concurrent treatment with any chemotherapeutic agent Patients not deemed acceptable for general anaesthesia Women who are pregnant or lactating History of vesicoureteric reflux or an indwelling urinary stent Administration of an investigational agent within 3 months of study entry Active cardiac disease Known infection with HIV, hepatitis B or C Active uncontrolled infection
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Undernutrition Renal Insufficiency, Chronic Obesity all dialysis patients receiving dialysis therapy at Roskilde Hospital, Denmark < 3 months dialysis fever antibiotic treatment major surgery within 2 weeks disseminated cancer age below 18 psychosis pregnancy physical or mental disability where participation was not feasible language barriers
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-70.0, Urethral Stricture Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm Patient is able and willing to sign informed consent Patient is able and willing to complete all study requirements Previous open urethroplasty Previous hypospadia surgery Previous surgery for congenital curvature or Mb Peyronie Previous pelvic irradiation therapy Known grave psychiatric disorder Haemophilia or other clotting disorders that cause bleeding diathesis Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Transitional Cell Carcinoma of Urinary Tract Candidate for diagnostic or therapeutic ureterorenoscopy Signed informed consent No signed informed consent
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 2.0-999.0, Lysosomal Acid Lipase Deficiency Non-obese** patients with elevated low-density lipoprotein (LDL) 2. Non-obese** patients with low high-density lipoprotein (HDL) 3. Non-obese** patients with unexplained and persistently elevated liver transaminases, 4. Non-obese** patients with hepatomegaly 5. Patients with cryptogenic cirrhosis 6. Patients with biopsy-proven microvesicular or mixed micro/macrovesicular steatosis without a known etiology 7. Patients with presumed Familial Hypercholesterolemia (FH) in which genetic analysis was performed for the genes encoding the low-density lipoprotein receptor (LDLR), Apo-B and PCSK9 genes and no disease-causing mutations were identified 8. Patients with presumed FH with unclear family history 9. Patients with autosomal recessive hypercholesterolemia (other than homozygous FH) 10. Patients with autosomal recessive low HDL of unknown etiology Also, patient must meet the following Patient or patient's parent or legal guardian (if applicable) consents to participate in the study and provides informed consent prior to any study procedures being performed. If the patient is of minor age; he/she is willing to provide assent where required per local regulations, and if deemed able to do so Patient is willing and able to comply with protocol requirements Patients who do not fall into one of the aforementioned categories (cohorts) but are considered highly suspicious for LAL D should be tested to rule out the disorder outside of the study at the discretion of the Investigator Active viral hepatitis Other confirmed genetic liver diseases (e.g., Wilson's disease, hemochromatosis, alpha 1-antitrypsin)
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-85.0, Benign Prostatic Hyperplasia patients between the ages of 40 and 85 patients with BPH patients scheduled for PVP patients with known prostate cancer patients with bleeding problems patients with previous rectal surgery patients with anal stenosis patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk patients with previous pelvic irradiation patients with penile implants patients with artificial urinary or rectal sphincters patients who are unwilling or unable to sign informed consent
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Obstruction; Catheter, Infusion Catheter (Vascular) Catheter; Complications (Indwelling Catheter) Able to read and understand English Has an implanted port in place less than one (1) year Evidence of a patent (unobstructed) port catheter prior to enrollment in the study Is receiving active treatment (i.e., receiving a therapeutic drug through the implanted port) Current treatment protocol projected to continue for a minimum of three (3) months Anticipates receiving care at the identified centers for 12 months following enrollment in the study Does not receive care of implanted port at any other facility Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin) Does not have a BioFlo port (heparinized port) Does not meet one or more of the
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 3.0-35.0, Neurofibroma, Plexiform Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Prolymphocytic, Acute Sarcoma Diagnosis Phase I: Patients must have recurrent or refractory solid tumors or acute leukemia (limited to AML or ALL) or have been intolerant of prior therapies, confirmed by the Laboratory of Pathology, NCI, e.g., solid tumors including rhabdomyosarcoma, Ewing sarcoma, soft tissue sarcomas. These may primary neoplasms of the central nervous system, such as high-grade (WHO grade III-IV) glioma. Patients with diffuse intrinsic pontine glioma (DIPG) or optic pathway glioma are exempt from histologic verification. For DIPG typical MRI findings must be present which hypo or isointense on T1-weighted imaging, hyperintense on FLAIR or T2-weighted imaging, epicenter in the pons in the face of a typical clinical presentation. Optic pathway glioma are located in the optic pathway and are typically hypo or iso-intense on T1 and hyperintense on T2-weighted images In addition, patients with NF1 and with malignant peripheral nerve sheath tumor (MPNST) Phase II: inoperable PN causing morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or significant cosmetic problems, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions in patients with NF1 Histologic confirmation of PN tumor is not necessary in the presence of consistent clinical and radiographic findings but should be considered if malignant degeneration of a PN is clinically suspected A PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches. A spinal PN involves two or more levels with connection between the levels or extending laterally along the nerve. In addition to PN, all study subjects must have either positive genetic testing for NF1 confirmed in a CLIA certified laboratory or have at least one other diagnostic criterion for NF1 listed below (NIH Consensus conference) Six or more cafe-au-lait macules (greater than or equal to 0.5cm in prepubertal subjects or greater than or equal to 1.5 cm in post pubertal subjects) Freckling in axilla or groin Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial will be excluded from participation, due to the unknown effects of PLX3397 on a growing fetus or newborn child Individuals with malignant peripheral nerve sheath tumors will not be eligible to participate in the phase II portion of the trial Ongoing treatment with any other cancer therapy or investigational agent, with the exception of IT chemotherapy for leukemia, when indicated Individuals who require therapy with warfarin 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 Active untreated infection Known chronic Hepatitis B or C, or HIV infection History of allergic reactions attributed to compounds of similar chemical or biologic composition to PLX3397 or other agents used in study Patients with PT and/or INR higher than or equal to 1.5 time upper limit of normal, unless patients have lupus anticoagulant in which case they are eligible if cleared by hematology Drugs that strongly inhibit or potentiate CYP3A4
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Benign Prostate Hyperplasia age>=45, male, diagnosed on BPH, Total IPSS>=13 Hypersensitivity to investigational products or components PSA>=4ng/ml
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-80.0, Benign Prostatic Hypertrophy patients with lower urinary tract symptoms (LUTS ) 2. IPSS≥ 15 despite medical treatment > 1 month if monotherapy or > 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin 3. prostate volume > 30 cc by transrectal ultrasonography ; 4. IPSS Qol ≥ 3 has at ; 5. PSA ≤ 4 ng / ml ; 6. if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP <6 months . 7. Accommodation <50 km; 8. company available for the return at home and monitoring first post operative night . 9. patient sign the informed consent 10. patient covered by social security or other health insurance post voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days 2. prostate volume > 100 cc by transrectal ultrasound not older than 45 days 3. urological antecedents : o urethral stenosis or cervical disease UTI in progress SAD patient or self-catheterization obstructive hydronephrosis + / renal failure vesical calculi cancer of the prostate treated or untreated bladder tumor associated Interstitial cystitis ( symptom or biopsy) 4. antecedent of the prostate surgery 5. neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome ) 6. related concomitant medications that can not be stopped at least < 48 hours before PVP with GL XPS 180 W 7. contra indication for outpatient care for medical reason 8. contra indication of a product analgesic according to protocol 9. patient inability to understand and sign the informed consent as well as completing the questionnaires 10. ASA Score > 3
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 0.0-18.0, Post-Operative Complication Pediatric Urology Children aged 0-17 years who have undergone urological surgery Children within the immediate post-operative period (0-14 days) Children with concerns directly related to operative site including, but not limited to catheters, stents, rashes and urine output Surgical patients outside the immediate post-operative period Those families who are unwilling or unable to email digital photographs Concerns related to issues other than the operative site (medications, follow up appointments, return to activities) Inability to understand written consent due to language barrier
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women Prisoners
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