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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, Robotic Surgical Procedures Prostatectomy Nephrectomy be aged between 18 years and 80 years laparoscopic surgery is required with one of the following surgical indications:(1)planning to perform radical prostatectomy(clinical stage is T1 or T2,and PSA≥ 0.2ng/mL) ;(2) planning to perform nephrectomy being able to cooperate and complete the follow-up and related examinations volunteer to participate in this study and sign the informed consent patients requiring emergency surgery have severe cardiovascular or circulatory disease and cannot tolerate surgery participated in other clinical trials in the last 3 months failure to understand study requirements
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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, Pain, Acute Conscious adult patients >= 2. Patient is scheduled for cystoscopy And BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity Diagnostic hydrodistention for painful bladder syndrome Biopsy or cauterization of bladder tumors Biopsy, cauterization and/or injection of Hunner's lesions Visual urethrotomy/bladder neck incision=/ injection of stricture Evaluation of the complex urinary tract problems 3. Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent 4. Patient is able to follow all study requirements and procedures and complete required questionnaires An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol 2. Clinically significant renal impairment 3. Women of child bearing potential who are pregnant or peri partum, including labour 4. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics 5. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene 6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives 7. Exacerbation of an underlying condition (i.e., chronic pain) 8. Clinically evident or potential hemodynamic instability as per the opinion of the investigator 9. Clinically evident respiratory impairment as per the opinion of the investigator 10. Prior treatment with within 3 months
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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, Cystoscopy Patients older than 18 years Being literate Having no hearing problems Patients who had allergies to anesthetic drugs 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): 18.0-999.0, Astrocytoma Brain Cancer Brain Metastases Bladder Cancer Breast Cancer Cervical Cancer Cholangiocarcinoma Colorectal Cancer Esophagus Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Liver Cancer Lung Cancer Melanoma Ovarian Cancer Pancreatic Cancer Pleural Mesothelioma Prostate Cancer Sarcoma Tongue Cancer Thymic Carcinoma Urinary Tract Cancer Male or female participants aged ≥18 years at the time of informed consent. 2. Adequate Bone Marrow Function 3. Adequate renal function 4. Adequate Liver Function 5. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 except for AEs not constituting a safety risk by Investigator judgment. 6. A histological or cytological diagnosis of a solid tumor that is advanced/metastatic, patients intolerant to standard treatment or, resistant to standard therapy* (per NCCN guidelines) or for which no curative therapy is available for the following tumor types Bladder, Brain, Breast, Cervical, Cholangiocarcinoma, Colorectal, Esophageal, Gastric, Head and Neck, Kidney, Liver, Lung, Melanoma, Ovarian, Pancreatic, Pleural mesothelioma, Prostate, Sarcoma, Tongue cancer, Thymic carcinomas, Urinary tract 7. At least one measurable lesion (as defined by version 1.1) that has not been previously irradiated. 8. An ECOG PS 0 to 2 Patients with tumor primarily localized to the brainstem or spinal cord. Presence of known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. 2. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement). 3. Patients with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. 4. Major surgery within 4 weeks prior to study entry. 5. Radiation therapy within 4 weeks prior to receiving the first QBS10072S dose (bone lesions requiring radiation may be treated with limited radiation therapy during this period). 6. Systemic anticancer therapy within 4 weeks prior to study entry 7. Bleeding esophageal or gastric varices <2 months prior to the date of informed consent. 8. Unmanageable ascites. 9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results 10. On therapeutic anticoagulation, except low molecular weight heparin, vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor. 11. Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsade de Pointes, clinically significant arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior hemiblock, bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinical significant episode of thromboembolic disease. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation). 12. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy) or requiring more than two medications for adequate control
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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): 18.0-49.0, Hypertension Women with singleton pregnancy Gestational age of 28 weeks and above Severe hypertension in pregnancy Patients who do not consent to the study Unconscious patients Complications of hypertension in pregnancy such as cerebrovascular accident, severe renal impairment and heart disease Multiple gestation Gestational ages below 28 weeks
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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, Cystoscopy Patients 18 years of age or older Patients undergoing routine office-based cystoscopy by a urology provider Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration Patients undergoing cystoscopy due to concern for urologic injury Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition Patients who perform clean intermittent catheterization Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy) Patients with a history of interstitial cystitis/chronic pelvic pain Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours Patients with a history of urethral stricture disease
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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, Anterior Urethral Stricture, Male Age: 18 years or older Anterior urethral strictures (except for meatal strictures) Posterior urethral strictures Meatal strictures History of hypospadias repair History of phalloplasty
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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): 18.0-75.0, Transgenderism Catheter Related Complication Female to male transgender men following penile reconstruction On waiting list for insertion of inflatable penile prosthesis Willing and able to provide written informed consent Transgender men prior to undergoing penile reconstruction Cisgender men or women Known urethral fistula or stricture that has not been treated Declines to be enrolled in trial Does not require a urethral catheter for clinical reasons Urinary tract 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): 55.0-999.0, Benign Prostatic Hyperplasia American Urological Association Symptom Score of eight or higher Maximum urinary flow rate of 10ml/s or less Post void residual urine volume of 50 ml or more And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS) A previous prostate or urethral surgery And non-BPH related voiding disorders Prostate cancer patients
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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, Musculoskeletal Pain Musculoskeletal Strain Fatigue; Muscle, Heart Cognitive Impairment Healthy surgeons with experience in performing procedures using LS and/or RALS Significant co-morbidities Significant musculoskeletal symptoms Procedures that major complications or requiring >50% more time than the mean average
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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, Family Members Post Intensive Care Unit Syndrome Post Traumatic Stress Disorder The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of Critically Ill Patients" (NCT03969810) and the patient had COVID-19 The patient has been discharged from the hospital None
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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): 0.0-60.0, Pelvi Ureteric Junction Obstruction or Ureteral Stricture any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture elderly patients unfit for general anaesthesia
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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, Bladder Dysfunction Neurogenic Bladder Dysfunction Urinary Incontinence Urinary Bladder, Overactive Urinary Incontinence, Urge Nocturia Urinary Frequency More Than Once at Night Lower Urinary Tract Symptoms Multiple Sclerosis Urinary Bladder, Neurogenic Self-reported diagnosis of any type of Multiple Sclerosis Male or female Aged ≥18 years old Ambulatory At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence) People with an indwelling urethral catheter or indwelling suprapubic catheter Urologic disease including bladder malignancy Diabetic mellitus Pregnant women or planning to be pregnant during the study time Recent pelvic related surgery <1 year Pacemaker or other metallic internal devices Urinary tract infections (UTIs) during recruitment phase
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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 Cancer Samples and images from men > =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy esla MRI with/without coil performed within 6 months preceding diagnostic biopsy Availability of diagnostic biopsy Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition Men with NCCN high risk or very high-risk prostate cancer Biopsy Gleason 8 No biopsy tissue available Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review Missing diagnostic PSA Missing clinical T stage Known lymph node positive or metastatic disease at time of diagnosis Missing MRI 6 months before diagnostic biopsy
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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, Surgery E-learning Second bachelor second master students enrolled in a University Previous experience on robotic surgery tasks
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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): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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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, Urethra Stenosis Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B) Age ≥ 18 years Male patient Fit for operation, based on the surgeon's expert opinion Isolated bulbar urethral stricture confirmed by imaging Preputium, penile shaft skin, buccal mucosa and lingual mucosa are allowed as free graft material in the executed dorsal onlay or ventral onlay FGU Patient is able and willing to attend the follow-up consultations Absence of signed written informed consent (Appendix B) Age < 18 years Female patients Transgender patients Patients unfit for operation Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Prior bulbar urethroplasty Lichen Sclerosus related strictures Strictures after failed hypospadias repair
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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): 18.0-80.0, SARS-CoV Infection SARS (Severe Acute Respiratory Syndrome) All patients of > 18 years of ages, males and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest Respiratory rate > 30/ min and not responding to non-rebreather masks COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP) Inability to provide consent Severe respiratory failure requiring invasive ventilatory support Indication of immediate tracheal intubation Significant acute progressive circulatory insufficiency Impaired alertness, confusion, restlessness Chest trauma or other contraindication to prone position Pneumothorax Nasal blockade Unable to tolerate high flow oxygen
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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 prostate volume less than 80 ml high IPSS more than 19 affecting quality of life recurrent urinary retention with failure of medical treatment recurrent urinary tract infection affection of upper urinary tract refractory hematuria bladder stones bladder diverticula patients with neurogenic bladder patients with previous prostate or urethral surgery associated urethral stricture prostate cancer diagnosed by TRUS biopsy prostate volume more than 80 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): 45.0-85.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Age ≥ 45 years and ≤ 85 years old Prostate volume ≥ 40 mL and ≤ 300 mL Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) Refractory or intolerant to medical management Ineligibility for or refusal of surgical management No evidence of prostate cancer History of pelvic cancer Neurogenic bladder disorder Bladder diverticula greater than 5 cm or bladder stones Acute urinary retention with Foley catheter dependence Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months Prior surgical prostate intervention Active participation in another clinical trial
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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): 45.0-99.0, Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia Patients to be included in the study will be either: 1. diagnosis of BPH based on abdominal ultrasound or digital rectal examination. 2. Moderate IPSS Score between 8 : 19. 3. severe IPSS Score between 20 : 35. 4. post void volume > 100 c. 5. prostate size 50 to 80 gm. 6. 2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment. 7. mental and physical capacity to understand and fill out the study questionnaires contraindications to Sildosin or Tadalafil. 2. diagnosis of prostate cancer. 3. possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention. 4. clinically significant cardiovascular, hepatic, or renal disorders. 5. cataract surgery planned during the study period
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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, Heart Failure With Preserved Ejection Fraction Amyloidosis Cardiac Patient is ≥ 60 years old or 50 y/o with carpal tunnel syndrome or spinal stenosis Patient has been diagnosed as HFpEF in their medical history or newly diagnosed as HFpEF. They have HF symptoms with NYHA Classification of I-IV when diagnosis. The of HFpEF is according to our previous studies More than 50% of them have LVPW ≥12mm (when diagnosis) Written informed consent could be obtained Patients unwilling to join this projects Patients with unstable coronary artery disease, plan to receive coronary intervention within months Patients has previous history of HFrEF with a LVEF <40%
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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, Anxiety Pain Male patient negative urine culture at least formal schooling (1-8 y of education) hearing or vision problems neurological deficits mental retardation history of chronic pelvic pain syndrome history of previous DC or USR procedures antidepressant use or analgesia use 24 h before the procedure decline to participate
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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): 18.0-90.0, BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms BPH Without Urinary Obstruction BPH Without Urinary Obstruction With Other Lower Urinary Tract Symptoms Lower Urinary Tract Symptoms Overactive Bladder Overactive Bladder Syndrome Urinary Obstruction Urinary Incontinence, Urge You have to be a male patient You must have a smartphone (iPhone or Android) For Group 1 (Symptomatic), you are at least 35 years old and have already been diagnosed with BPH or Overactive Bladder (OAB) condition OR you are presenting at least one of the following BPH / OAB symptoms: frequent or urgent need to urinate, increased frequency of urination at night (nocturia), difficulty starting urination, weak urine stream or a stream that stops and starts, dribbling at the end of urination, inability to completely empty the bladder, experience urge incontinence - the involuntary loss of urine immediately following an urgent need to urinate For Group 2 (Asymptomatic), you are at least 18 years old and have not been diagnosed with BPH or OAB, and you are not presenting any of the above symptoms Male younger than 18 or older than 90 Female
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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, Arthroplasty, Replacement, Knee Rehabilitation Hip Arthrosis The patient is aged 18 years or older, has a Belgian National Number, is insured by a Belgian sickness fund, and is not staying in a nursing home or long term rehabilitation centre. 2. The patient has sufficient knowledge of Dutch, French, German or English. 3. The patient has a planned date within the next 8 weeks for a primary unilateral unicompartmental knee arthroplasty (UKA); a bicompartmental knee arthroplasty, (BKA), consisting of either two UKA or a UKA and a patellar replacement; or a total knee arthroplasty (TKA) or a total hip arthroplasty (THA). 4. The patient is not planned to have a peri-operative procedure (e.g. intra-articular catheter) or postoperative procedure that is expected to significantly impact the rehabilitation in and out of hospital. 5. In the 6 months after arthroplasty the patient is not planned to have surgery that may impact the arthroplasty rehabilitation. 6. The patient is not suffering from a medical condition (e.g. Parkinson, multiple sclerosis, cerebrovascular accident) that is expected to significantly impact the rehabilitation or that constitutes a contra-indication for the use of the mobile application. 7. The patient confirms to have easy and daily access to the internet, a mobile phone, a personal email address and a computer, tablet or smartphone, now and over the next 8 months. 8. The patient does not upfront the possibility whereby part of the rehabilitation is performed without a physical therapist physically being present. 9. The patient is willing to complete online the patient reported outcomes and is aware that if he/she fails in this computer literacy test (performed before randomization) he/she will not be randomized and hence not included in the study. He/she will receive usual rehabilitation care
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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, Lower Ureteric Stones Patients aged ≥18 years Patient have a distal ureteric stone of 5-9 mm in greatest dimension Patient diagnosed by ultrasonography of the kidney, ureter, and bladder , X-ray KUB and noncontrast computed tomography scan Pregnant or lactating mothers Patients have UTI Patients have severe hydroureteronephrosis Patients have multiple ureteric stones Patients have solitary kidney Patients have acute or chronic renal failure Patients have previous therapies for the stone Patients with history of open surgery/endoscopic interventions Patients have ureteric strictures Patients take concomitant treatment with calcium antagonists, β-blockers, corticosteroids or nitrates
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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, Transforaminal Lumbar Interbody Fusion Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis) Patients able to provide informed consent Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post operative urinary retention protocol Lack of 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): 18.0-85.0, Endothelial Dysfunction We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital History of Coronary artery disease History of Peripheral Arterial Disease History of Heart failure History of Stroke hepatic failure renal failure active neoplasia poorly controlled DM, defined as Hba1C>7%
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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-Invasive Bladder Urothelial Carcinoma Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade Participant has a social security scheme Participant has signed a form of no objection to the use of the data Participant has had a transurethral resection of bladder tumor revealing non-invasive-muscle bladder tumor prior to within a maximum of 5 years from the date of diagnosis to the absence of recurrence since then Participant is seen for a follow-up cystoscopy on the day of the visit. Non-Inclusion Vulnerable persons (Article L 1121-6 of the Public Health Code) Adults subject to legal protection or unable to express their consent (Article 1121-8 of the Public Health Code) Persons with a bladder tumor other than a non-invasive bladder tumor (i.e., invasive bladder cancer) A person who has undergone bladder tumor resection or therapy with Calmette-Guerin bacilli or with Mitomycin C less than 6 weeks (42 days) prior to inclusion Participant no longer wishing to participate in the study, or in the course of the study with a refusal to use the data until exit from 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, Urethral Stricture, Male men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm patient with complete urethral stricture with a suprapubic catheter in place patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans
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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, Prone Position Severe Acute Respiratory Syndrome Coronavirus 2 Hypnotics and Sedatives Pulmonary Ventilation moderate to severe COVID-19 ARDS None
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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, Mitral Regurgitation clinically significant mitral insufficiency patient underwent screening for TMVI echocardiography data at baseline (and after TMVI, E2E and surgery) follow-up of at least 30 days age under 18 years
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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, Acute Respiratory Distress Syndrome Intensive Care Unit The study included patients who required invasive mechanical ventilation but was not initially diagnosed with ARDS 9, had a LIPS (Lung Injury Prediction Score) of > 7, and have been staying in the ICU for more than 24 hours pregnancy intracranial hypertension (suspected or confirmed by measurement with external ventricular drainage catheter) severe chronic obstructive pulmonary disease or type II respiratory failure confirmed bronchopleural fistula documented barotrauma history of pneumonectomy
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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): 75.0-999.0, Urinary Retention Aged patients aged 75 years or older with or without a urinary catheter admitted no more than 72 hours to an acute geriatric hospitalisation unit of the Leuven University Hospitals indwelling urinary catheter for another reason than acute urinary retention ascites dialysis uro or nephrostomy terminally ill postoperative refusal to participate unable to understand and carry out the instructions for the post-void residual volume measurement
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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, Urothelial Carcinoma Urinary Bladder Cancer Urinary Tract Cancer CASES Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the group of cases Bladder cancer Urethral tumor Renal Pelvis Tumor Ureteral tumor The will be Age under 18 Pregnancy Lack of informed consent Persons with indwelling catheter Presence of prostate cancer Presence and / or history of renal cancer, except tumors of the renal pelvis Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the control group Kidney, ureteral or bladder stones BPH The will be
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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): 18.0-80.0, Nephrolithiasis Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones Preoperative use of antihistamines, beta-3 agonists, anticholinergics, corticosteroids, and chronic opioid analgesic use Preoperative indwelling ureteral stent at the time of treatment Neurogenic bladder, ureteral stricture, interstitial cystitis, or chronic prostatitis Pregnancy or breastfeeding Planned bilateral ureteroscopy Solitary or transplanted kidney Hypersensitivity to antihistamines Severe renal disease (glomerular filtration rate (GFR) < 10 ml/min or on dialysis) Significant deviation in operative plan (ureteral stent not deemed necessary, incidental urologic malignancy, tandem ureteral stent placement, second-stage procedure required)
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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 ● The PUL and TURP/LASER cohorts male patient aged over 50 years patient who experienced a PUL or TURP/Laser surgery in first line of treatment for a symptomatic BPH, with an International Prostatic Symptom Score > 13, a Peak urine flow rate < 12ml/sec on a voided volume >150ml a Prostate volume >30cc to <80 cc per ultrasound patient affiliated to a French health insurance system Patient with current urinary retention, post void residual urine > 250ml Patient with active urinary tract infection at time of treatment Patient with previous Benign Prostatic Hyperplasia procedure Patient with urethral conditions that may prevent insertion and delivery of device system into bladder Patient with previous pelvic surgery or irradiation Patient with history of neurogenic or atonic bladder Patient with biopsy of the prostate within the past 6 weeks Patient with life expectancy estimated to be less than 1 year Patient with history of prostate or bladder cancer Patient with PSA>10ng/ml unless prostate biopsy is negative
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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): 18.0-85.0, Rectal Cancer Retention, Urinary Urinary Tract Infections Surgical Site Infection Anastomotic Leak Patients undergoing programmed rectal surgery Age ≥ 18 years and <85 years Any type of tumor, any T, N, M Consent signed by the patient and the researcher IPSS> 20 Transanal local resection Urinary catheterization in the 7 days prior to surgery Patients taking treatment for benign prostatic hyperplasia Urine infection in the month prior to surgery Patients with chronic kidney failure with Creatinine> 2 mg / dL Enterovesical fistula Neurogenic bladder Patients with a sacral nerve stimulator or artificial sphincter Inability to read or understand any of the languages of 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): 18.0-85.0, Acute Kidney Injury Pneumoperitoneum Kidney Patients diagnosed with kidney cancer at the department of Urology, Aalborg University Hospital, who are offered radical nephrectomy Speaks and understands Danish Patient diagnosed with kidney cancer but can be treated with partial nephrectomy Patients with severe to end stage chronic kidney disease (CKD stage 4-5) Inability to understand or comply with instructions
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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): 45.0-80.0, Benign Prostatic Hyperplasia (BPH) Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction 2. Subject is willing to be randomized 3. Subject is mentally capable and willing to sign a study-specific informed consent form 4. Subject is willing and able to comply with all study requirements 5. Age from 45 through 80 years 6. Subject has medical record documentation of a prostate volume up to 60mL (inclusive) by Transrectal Ultrasound (TRUS) (If TRUS testing documentation is available from less than 90 days prior to the informed consent date and the prostate volume is up to 60mL, it may be used for the inclusion/ ) 7. Subject has an IPSS urinary symptoms score greater than or equal to 13 measured at the baseline visit 8. Subject has medical record documentation of a maximum urinary flow rate (Qmax) ≤15mL/s and ≥5mL/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 120mL, and the Qmax is ≤15mL/s and ≥5mL/s, it may be used for the inclusion/ ) 9. Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery 10. History of inadequate response, contraindication, or refusal to medical therapy 11. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests 12. Normal Urinalysis and urine culture 13. Sexually active within 6 months before the index procedure 14. Sexual Health Inventory for Men score >6 15. Positive response to MSHQ-EjD (excluding the response ''Could not ejaculate'') 16. Incontinence Severity Index score >4 BMI ≥ 42 2. History of prostate cancer or current/suspected bladder cancer 3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds 4. Subjects with a history of actively treated bladder cancer within the past two (2) years 5. Neurogenic bladder as confirmed by urodynamics or other neurological disorder that affects bladder function 6. Diagnosis of polyneuropathy 7. Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size) 8. Active infection, including urinary tract infection 9. Prostatitis treated with antibiotics within 1 year of enrollment 10. Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g. nonbacterial chronic prostatitis) 11. Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture 12. Subject has damage to external urinary sphincter 13. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use 14. PVR > 250 mL 15. Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure 16. Subject has a history of intermittent self-catheterization 17. Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis 18. Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d) 19. Any severe illness that would prevent complete study participation or confound study results 20. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days prior to the date of informed consent, congestive heart failure NYHA IV), pulmonary disease or uncontrolled diabetes 21. Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent 22. Heart surgery, or cardiac arrest < 180 days prior to the date of informed consent 23. Participants using systemic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg) 24. Known illicit substance abuse 25. Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications 26. Dementia or psychiatric condition that prevents the participant from completing required follow up 27. Contraindication to general or spinal anesthesia 28. Previous pelvic radiotherapy 29. Participating in another investigational study that could affect responses to the study device 30. Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes 31. Subject is unwilling to accept a transfusion should one be required 32. Median lobe obstruction of the prostate as assessed by TRUS 33. Known allergy to nickel 34. Unwilling to report sexual function. Intraoperative Median lobe obstruction or any abnormal findings on cystoscopy at the time of implantation that can interfere with iTind implantation or TURP procedure
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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): 45.0-999.0, Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms Anyone with international prostate symptom score greater than or equal to 8 (moderate to severe lower urinary tract symptoms) Quality of life assessment greater than 3 Prostate volume greater than 40 cm3 Men >45 years old Indwelling urinary catheter secondary to benign prostatic hyperplasia or moderate-severe lower urinary tract symptoms Evidence of tortuous or severe atherosclerotic vessels on CT Neurogenic bladder <8 international prostate symptoms score Prostate volume less than 40cm3 History of prostate cancer
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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, Urethral Stricture, Male Hormone Deficiency Fibrosis Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department Patients not giving their informed consent Patients with urethral catheter at the moment of TUR P/B Patients with any type of urethral stricture at the moment of TUR P/B Patients under hormonal treatments (testosterone, thyroxine...) 1 year before the TUR P/B Patients with already known coagulation disorders or undergoing anticoagulation treatments at the moment of the blood test
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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, Urologic Cancer Thrombosis Embolism Surgery--Complications over 18 years of age scheduled for urological surgery (cystectomy and/or prostatectomy) signed basical declaration of consent absent or unsigned basical declaration of 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): 18.0-999.0, Pregnancy in Diabetics Placenta Fetal Growth Magnetic Resonance Imaging Age >18 years Singleton pregnancy Fetal malformation or abnormal karyotype Maternal height from spine to chest > 43 cm (for technical reasons) Sever claustrophobia or any other contradictions to MRI Women who do not read or understand Danish
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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, Urinary Bladder Neoplasm Transitional Cell Carcinoma Urogenital Neoplasms Circulating Tumor Cell Neoplasms female and male patients recurrent bladder tumor preoperative cystoscopy CT or MRI scan of abdomen not older than 30 days prior to surgery without suspicion of advanced disease (MIBC, metastasis) max. non-invasive papillary tumor (pTa) staging in prior histology max. low grade grading in prior histology max. 5 lesions in actual cystoscopy (all < 3cm) exophytic tumors transitional cell cancer of urinary bladder patient able to give consent initial tumor flat lesion > 3cm carcinoma in situ (CIS) in prior histology or suspicious CIS-finding in actual cystoscopy high grade grading in prior histology ≥ pT1 (tumor infiltration into subepithelial connective tissue) staging in prior histology > 5 lesions different entity from transitional cell carcinoma of urinary bladder prior radiation emergency surgery
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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, Kidney Transplant; Complications Kidney Transplant Infection Urinary Fistula Urinary Tract Infections Urinary Catheter Kidney transplant recipient Informed consent signed BMI under 18kg/m2 BMI over 40 kg/m2 Significant anatomical abnormalities of lower urinary tract Previous surgery on bladder or urinary tract Unusual urinary anastomosis (Leadbetter-Politano, Boari, conduit, psoas hitch, pyelo-ureteral or uretero-ureteral, double ureter) Severe vascular complications during surgery with blood loss >1000 ml Underwent haemodynamic shock or profund instability after surgery
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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, Anesthesia Anesthesia Complication Osa Syndrome Transurethral Resection of Prostate Sedation Complication Intraoperative Complications Snoring Airway Obstruction elective transurethral resection of bladder and prostate American Society of Anesthesiologists (ASA) physical status classification system: I, II, III regional anesthesia contraindications American Society of Anesthesiologists (ASA) physical status classification system: IV Atrioventricular cardiac block II and III degree Psychotic disorders Participants with tracheostomy Dementia Allergy on Dexmedetomidine or Midazolam
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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, Benign Prostatic Hyperplasia (BPH) The subjects will provide written informed consent form and agree to data collection The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study This is a retrospective study without any formal
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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, BPH Benign Prostatic Hyperplasia Patients must be 18 years of age or older 2. Patients must be diagnosed with benign prostatic hyperplasia 3. Patients must opt for surgical management of their BPH with laser enucleation Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy) 2. Patients with prostate glands greater or equal to 200 grams 3. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible
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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, Cystoscopy Ureteral Stent Adult (male or female), ≥18 years old 2. Patient undergoing routine flexible cystoscopy 3. Patient with a ureteral stent in the urinary system that is ready to be removed. 4. No active urinary tract infection 5. Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol History of prior bladder/urethral reconstructive surgery. 2. History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes. 3. Known unpassable urethral stricture 4. Febrile patient with active urinary tract infection (UTI) 5. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 6. Subject with severe coagulopathy 7. Patient is unable to read and/or understand study requirements 8. Patient is unable or unwilling to provide written consent to participate in the study. 9. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not
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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): 20.0-40.0, Urologic Injuries Urodynamic Changes Bladder Dysfunction Age 20-40 years Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment Bladder injury was diagnosed and repaired during surgery 6 months ago Patients with neurological problems Presence of congenital urinary system anomalies Urinary tract infections (UTIs) Previous urologic surgeries Patients with stone bladder or tumour Diabetic 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): 18.0-90.0, Recurrent Urinary Tract Infections Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine Failed previously treatments Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter Patients with neurogenic and non-neurogenic bladder dysfunction Patients with urostomy, kidney transplantation or another complicated genesis Written consent Malignancy in the urinary tract, kidney-, ureteral or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish
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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): 21.0-55.0, Major Depressive Disorder 55 years of age. MDD currently depressed subjects will meet DSM-V for MDD based on the Mini-International Neuropsychiatric Interview (MINI) (http://www.medicaloutcomes.com/index/mini7fororganizations) with a 17-item Hamilton Depression Rating Scale (HamD17) (Hamilton, 1960) score > 17 Subjects must have failed to enter remission with at least two prior antidepressant medications in the current episode (Vasavada et al., 2016) Must have been free of any medications known to significantly affect brain function for at least ten days prior to enrollment (except fluoxetine, which will require a five-week washout) No unstable medical illness that would prevent completion of participation in the trial (determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems) Clinically significant physical abnormalities as indicated by physical examination, hematological laboratory assay, or urinalysis, defined as: hematology and chemistry laboratory tests that are within normal (+/ ) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal A screening ECG that demonstrates anything other than normal sinus rhythm, normal conduction, and no clinically significant arrhythmias History of epilepsy, seizures, or severe head trauma Resting vital signs on any study visit outside of acceptable parameters (i.e., pulse of 60-100 bpm, blood pressures of 90-150 mm Hg systolic, 50 mm Hg diastolic) Any indication of suicidal ideation (e.g. as assessed by the suicidality question on the HamD17or the Columbia Suicide Severity Rating Scale Baseline QT prolongation (QTc> 450 ms): Given that citalopram has been found to be associated with a dose-dependent risk of ECG QT interval prolongation, in order to avoid the potential risk of causing ventricular arrhythmias including Torsades de Pointes, we will participants from the study who exhibit baseline QTc prolongation For women of childbearing age, a positive urine pregnancy test, as well as women who are currently breastfeeding or not using a medically acceptable method of birth control
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Arrhythmia Cardiovascular Diseases Heart Arrest Heart Diseases Myocardial Infarction Ventricular Fibrillation Cerebral Anoxia Men, women, and children in cardiac arrest for which CPR was initiated in ten minutes or less from the time of arrest
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Arrhythmia Cardiovascular Diseases Death, Sudden, Cardiac Heart Diseases Tachycardia, Ventricular Ventricular Fibrillation Men & women with VF, VT with syncope, or VT without syncope, but with ejection fraction less than or equal to .40 & systolic blood pressure less than 80 mm Hg, chest pain , or near syncope
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Cardiomyopathy, Hypertrophic Group 1: HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms. Group 2: HCM patients selected from Group 1 who at the follow-up cardiac catheterization are demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction (greater than 50% reduction in LVOT gradient). Patient who have developed a heart block will be excluded from group 2. Females must have a negative pregnancy test
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Hypertrophic Cardiomyopathy Patients of either gender, aged 18-80 years. NYHA functional class III/IV, or syncope, or greater than or equal to 2 presyncope despite verapamil and/or Beta-blocker therapy. LV outflow tract gradient greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than 100 bpm. No patients with mid-cavity obstructive HCM. No patients with LV septal wall thickness less than 15 mm estimated by echocardiography. No patients with greater than 50 percent luminal narrowing in a major coronary artery vessel. No patients with chronic atrial fibrillation. No patients with a positive pregnancy test
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Hypertrophic Cardiomyopathy Children of either gender, aged 4 to 18 years. Obstructive HCM defined as LV hypertrophy, and an LV intra-cavitary pressure gradient measured at cardiac catheterization of greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than or equal to 100 beats per minute. Cardiac symptoms (chest discomfort, dyspnea, lightheadedness or presyncope, syncope, cardio-respiratory arrest, palpitations, excessive fatigue); and/or exercise duration which is less than 10th percentile predicted for age/gender despite a trial of a beta-blocker therapy and a trial of verapamil therapy Other systemic diseases that prevent assessment by exercise tests and cardiac catheterization. Chronic atrial fibrillation. Positive pregnancy test: A negative urine pregnancy test will be required before each cardiac catheterization, electrophysiologic study and thallium study. Pregnant or lactating subjects may not participate in the study due to potential teratogenic effects of radiation
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-100.0, Cardiovascular Diseases Arrhythmia Death, Sudden, Cardiac Heart Diseases Syncope
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-100.0, Cardiovascular Diseases Arrhythmia Myocardial Infarction Heart Diseases
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Heart Diseases Ventricular Arrhythmia Ventricular Fibrillation Death, Sudden, Cardiac Heart Arrest Patients with left ventricular dusfunction 2. Patients with non-ischemic cardiomyopathy Patients not at high risk for sudden cardiac death (SCD)
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-75.0, Chronic Obstructive Pulmonary Disease Emphysema Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of >165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Atrial Fibrillation Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening Require the procedure of cardioversion (electric shock to correct abnormal rhythm) In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines Previously unsuccessful electrical cardioversions Failed to respond to any Class III antiarrhythmic drugs Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Atrial Fibrillation Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening Require the procedure of cardioversion (electric shock to correct heart rhythm) In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines Previously unsuccessful electrical cardioversions Failed to respond to any Class III antiarrhythmic drugs Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors: 1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism 2. hypertension requiring drug treatment 3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure) 4. age >75 years 5. age between 65-75 years plus diabetes mellitus, or 6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris) Written informed consent Legal lower age limitations (country specific) Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion Transient AF caused by a reversible disorder Active bleeding or high risk of bleeding Recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery Participation in another pharmacotherapeutic study within the prior 30 days Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg Pregnancy or childbearing potential without proper contraceptive measures Breastfeeding
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope Subjects are patients referred for neurocardiogenic syncope or presyncope, with or without postural tachycardia syndrome (POTS). Patients enter the trial after positive tilt table testing during the screening evaluation. Participation is offered to individuals 18 years old or older, independently of gender, race, advanced age, ethnicity, religion, or any other demographic or sociopolitical classifications Minors younger than 18 years old are excluded. Advanced age is not an criterion. Patients who have certain illnesses that would interfere or be contraindicated with the interventions or procedures in this study are excluded. These significant coronary artery disease, psychosis, or psychotic depression. A candidate is excluded if the subject is unwilling to experience hypnosis or to have hypnosis sessions recorded; holds religious or other beliefs that would prevent engagement in hypnosis; is not fluent in spoken English; or has physical or other disabilities that prevent adequate participation in hypnotic susceptibility testing. Certain herbal medicines or dietary supplements are known or suspected to interfere with the experimental results, and such herbal medicines or dietary supplements must be discontinued before enrollment in the study. For many herbal medicines or dietary supplements, the mechanisms of action and therefore the possible effects on the experimental results are unknown. In cases where the subjects wish to continue their herbal medicines or dietary supplements while on study, and search of the available medical literature fails to identify effects that are known or expected to interfere with the experimental results, then the subjects may participate. A candidate is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results. Patients who cannot discontinue medications in the following categories are excluded: certain anti-hypertensives including beta-blockers, anticoagulants, tricyclic antidepressants, barbiturates, and acetaminophen. Patients unable to discontinue nicotine, caffeine, or alcohol for 24 hours prior to tilt table testing are excluded. Patients with chronic alcohol intake are excluded. Patients are not to discontinue any medications before the patient or the patient's doctor discusses this with the Principal Investigator, Accountable Investigator, an Associate Investigator, or Research Nurse. If it is decided that discontinuing medications would be unsafe, then the patient is excluded. Patients who pose technical difficulties regarding the testing procedures are excluded. A candidate is excluded if, in the judgment of the Principal Investigator, Accountable Investigator, or Clinical Director, protocol participation would place the subject at substantially increased acute medical risk, or if the medical risk outweighs the potential scientific benefit
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 30.0-999.0, Syncope Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope syncope episodes in the last 2 years Severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator Age >30 years Patients have undergone carotid sinus massage, and ILR implantation ILR not implanted for any reason; in this case, the patients are still followed in the ILR-not implanted group Carotid sinus syndrome Suspected or certain cardiac syncope Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy) Steal syndrome Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator Patient compliance doubtful Patients who are geographically or otherwise inaccessible for follow-up Patient unwilling or unable to give informed consent
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Cardiovascular Diseases Diabetes Mellitus Hyperlipidemia Hypertension Obesity Is newly referred from a VA physician for nutritional counseling or has responded to an advertisement for the study Has one of the following diagnoses: diabetes, coronary artery disease, hypercholesterolemia, hypertension, obesity Is ambulatory and able to comfortably walk at least one block Has a body mass index (BMI) of 28 or greater Is not already regularly active (30 minutes a day, 5 days a week of moderate intensity physical activity) Is in the contemplation or preparation stage of readiness to become more physically active Is willing to try a walking program Can communicate comfortably in English Has attended a nutritional counseling session in the past 28 days May be at risk for adverse cardiovascular events with a walking program--specifically participants who have symptoms of cardiovascular disease (CVD) while walking have been told by a physician that walking might be dangerous; or have a stress test scheduled in the next two months
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-75.0, Heart Failure Ventricular Arrhythmias All subjects must have a nonthoracotomy insertion Have a primary cardiac etiology of their ventricular arrhythmia (coronary artery disease, cardiomyopathy, valve dysfunction, or combination) Be fluent in English Live within a 75 mile radius of the coordinating center Be accessible by telephone Only those receiving their first ICD, not replacement generators, will be entered Being evaluated or on a waiting list for heart transplantation Congenital disease or long QT syndrome Disorientation documented in the pre-implantation hospitalization period History of psychiatric disorder or progressively debilitating comorbidity that would confound outcome measures
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Ventricular Fibrillation ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention) Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF Patient's life expectancy less than 1 year due to a non-cardiac chronic disease Patient on heart transplant list which is expected in < 1 year Patient's age less than 18 years ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD) Unwillingness or inability to provide written informed consent Enrollment in, or intention to participate in, another clinical study during the course of this study Inaccessibility for follow-up at the study center Ventricular tachyarrhythmias associated with reversible causes Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients Other electrical implantable devices (neurostimulators, etc.)
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Acute Myocardial Infarction Duration of painless than 6 hours ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more precordial leads The patient is getting thrombolysis Time to reach an invasive center is more than 1 hour Age 18-75 years Known serious renal failure (creatinin > 250 mmol/l) Pregnancy Cardiogenic chock Life threatening arrythmias Other serious diseases with life expectancy less than 1 year Inability to perform an informed consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-85.0, Syncope Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes Indication for the implantation of a pacemaker Indication for the implantation of an implantable cardioverter defibrillator Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular [LV] outflow stenosis, decompensated heart failure) Contraindication for a diagnostic procedure requested by the study protocol Enrollment in another study Circumstances or comorbidities which do not allow enrollment
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Chronic Kidney Disease Secondary Hyperparathyroidism Left Ventricular Hypertrophy Chronic kidney disease (S-creatinin > 150 and < 600 mikroM) Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay) Stable blood pressure during the last 6 months (less than (160/95) B-hemoglobin > 6 mmol/l EKG with sinus rhythm and no sign of Q-wave infarction Expected follow up 6 month Pregnancy Kidney transplantation Malignant disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Fibrillation Ventricular Tachycardia Age > 18 years Positive agreement EPS for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia primary prophylaxis: Brugada syndrome, long QT syndrome, cardiomyopathy, short QT syndrome secondary prophylaxis: Multicenter Automatic Defibrillator Implantation Trial (MADIT) syncope, documented ventricular tachycardia Severe neurological deficit Cardiopulmonary resuscitation
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Cardiac Arrest structural heart disease and survived cardiac arrest or hemodynamically unstable VT (bpm > 200/min) conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber ICD; co-morbidity, prior ICD PM, or EPS
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death Congestive Heart Failure I. DAVID I patients enrolled in the VVI-40 who are hemodynamically stable. II. Patients with an LVEF 0.40 considered for ICD therapy because of one of the following primary, spontaneously occurring, sustained events within the last 6 weeks prior to enrollment VF arrest (ACC/AHA indication Class 1-1) VT with syncope (ACC/AHA indication Class 1-1 or 1-2) Non-syncopal sustained VT with significant cardiac symptoms or BP < 80 (ACC/AHA indication Class 1-2, IIb-4), OR III. Patients considered for ICD therapy because of one of the following LVEF < 0.40 with inducible VT or VF within 6 weeks prior to randomization (with or without spontaneous arrhythmia), or LVEF < 0.30 with coronary artery disease, > 1 month from a myocardial infarction, and > 3 months from bypass surgery or percutaneous coronary intervention. If the ICD was already implanted at time of consideration for enrollment, the device must have been programmed in the VVI mode since implant NYHA CHF Class III unless on optimal heart failure therapy for at least 3 months prior to enrollment NYHA CHF Class IV Reversible causes of the VT/VF event Permanent pacemaker First degree AV block with PR interval of more than 240 ms d or 3rd or advanced degree heart block Symptomatic bradycardia Pre-existing endocardial pacing leads Permanent atrial fibrillation (>= 6 months or unknown duration) Patient awaiting a cardiac transplant
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ischemic Cardiomyopathy LV Dysfunction Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following may be enrolled in the study: 1. Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease 2. LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment. 3. Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy for the trial. 4. The patient is 18 years of age or older. 5. In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm. 6. The patient has signed the latest IRB approved informed consent form Patients meeting any of the following will not be eligible for enrollment: 1. The patient is unable to give informed consent. 2. The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication). 3. The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial. 4. The patient has unstable coronary artery disease. 5. The patient has contraindications to ICD implantation. 6. A submaximal exercise test is contraindicated. 7. The patient has persistent atrial fibrillation or flutter. 8. The patient is less than 28 days post MI, post CABG, or post coronary angioplasty. 9. The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1. 10. The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment. 11. The patient is on any class 1 or 3 antiarrhythmic drug. 12. The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini. 13. The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation. 14. The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia. 15. The patient has a life expectancy of less than one year from any cause. 16. The patient has a positive pregnancy test. 17. The patient is not geographically stable or is unable to comply with the follow up schedule
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Long QT Syndrome Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Dysplasia Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease Patients with long QT syndrome Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals Patients with Brugada syndrome Patients with hypertrophic cardiomyopathy Patients with arrhythmogenic right ventricular dysplasia Inability to understand study protocol
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Angina, Unstable Age >21 years old Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) Presentation with ECG diagnostic for STEMI
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Atrial Fibrillation Patients with persistent Atrial Fibrillation on Warfarin paroxysmal atrial fibrillation with self terminating episodes left atrial size>6.0cm myocardial infarction in the previous 6 months contraindications to amiodarone use cardiac surgery in the previous 3 months an acute reversible illness contributing to the development of af a QTc interval > 480ms pregnancy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months MAIN (non-exhaustive list) Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Sick Sinus Syndrome General: A. Undergoing primary pacemaker implantation B. Able to appear for outpatient follow-up C. Age > 18 years Symptoms: D. Syncope or E. Dizzy spells or F. Congestive heart failure Electrocardiographic: G. Sinus bradycardia <40/minute for at least 1 minute in a conscious awake state or H. Sinus arrest/sinoatrial block >2 seconds or I. Bradycardia/tachycardia with sinus-pauses >2 seconds Clinical: A. Malignant disease. B. Severe psychogenic disease including severe decrepitude and dementia. C. Impending larger operation expected to influence the major end point. D. Cardiac disorder expected to need cardiac surgery during the follow-up period. E. Need for other device implantation: ICD (implantable cardioverter defibrillator) or implantable DC converter (for atrial fibrillation). F. Carotid sinus syndrome (positive carotid sinus massage with pauses >3 seconds). Electrocardiographic: G. Atrioventricular block. H. Bundle-branch block (complete RBBB, LBBB, bifascicular bundle-branch block or non-specific intraventricular block with QRS >0.12 seconds). I. Chronic atrial fibrillation. J. Atrial fibrillation/atrial flutter with QRS pauses >3 seconds during atrial fibrillation. K. Atrial fibrillation/atrial flutter with QRS frequency <40/minute for 1 minute
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Arrhythmias Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II) Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD) Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias) Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD) Fibrillation, Ventricular Syncope Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time Patient has history of spontaneous sustained symptomatic ventricular arrhythmias. If patient has had an electrophysiology test in the past, and has sustained inducible VT <180 bpm
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 2.0-999.0, Cardiac Arrest Long QT Syndrome Brugada Syndrome Catecholaminergi Polymorphic Ventricular Tachycardia Idiopathic VentricularFibrillation Early Repolarization Syndrome Arrhythmogenic Right Ventricular Cardiomyopathy Cardiac arrest requiring cardioversion or defibrillation Syncope with documented polymorphic ventricular tachycardia felt to be responsible for the index event First degree relative of an index case of UCA undergoing clinical testing First degree relative of a family member with UCA or sudden death before age 35 with a negative autopsy for cause of death, presumed arrhythmic First degree relative of a family member with UCA or sudden death with objective evidence of primary electrical disease, such as a diagnostic electrocardiogram (ECG), exercise test, drug infusion, or genetic testing Coronary artery disease (stenosis > 50%) Reduced left ventricular function (left ventricular ejection fraction [LVEF] < 50%) Event managed without an implantable cardioverter defibrillator [ICD] (for follow-up portion) Unwilling or unable to provide clinical follow-up (for follow-up portion) Comorbidity making survival of > 1 year unlikely Persistent resting QTc > 460 msec for males and 480 msec for females Reversible cause of cardiac arrest such as marked hypokalemia (< 2.8 mmol/l) or drug overdose sufficient in gravity without other cause to explain the cardiac arrest Hemodynamically stable sustained monomorphic ventricular tachycardia with a QRS morphology consistent with recognized forms of idiopathic ventricular tachycardia (outflow tract or apical septal) Brugada's sign with e2 mm ST elevation in V1 and/or V2 Unwilling or unable to provide consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 25.0-999.0, Vasovagal Syncope A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment A positive tilt-table test of other causes for syncope by a complete diagnostic work-up allowing only minor cardiac abnormalities Syncope for >= 2 years Number of syncopal episodes >= 3 At least 1 instance of syncope within the last 6 months A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response Vasovagal Syncope International Study (VASIS) type 1 with bradycardia < 40 bpm, or VASIS type 2A, or VASIS type 2B Conventional indication for pacemaker (i.e. atrioventricular [AV] block) Indication for cardiac resynchronisation therapy (i.e. left bundle branch block [LBBB]) Documented atrial fibrillation or flutter Epilepsy Congestive heart failure History of myocardial infarction (MI) or angina pectoris Serious chronic disease, life expectancy < 3 years Age < 25 years Pregnant and lactating women Participating in other investigation
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope Pre-Syncope Palpitations syncope, pre-syncope or palpitations less frequently than every 24 hours Pre-syncope without loss of consciousness defined as transient dizziness, leghtheadedness, unsteadiness or weak spells: syncopal events with or without warning: palpitations Subjects with non-diagnostic 24 hours of monitoring related to symptoms within 45 days of enrollment into study Subject able to understand, assent to , and willing to sign the Informed Consent Form Class IV heart failure Post Myocardial infarction less than or equal to 3 months Unstable angina defined as chest pain at rest, new onset of angina, or a change in existing patterns of angina. Subjects who are candidatees for or have had recent (less than or equal to 3 monthr) heart valve surgery History of sustained ventricualr tachycardia or ventricular fibrillation documented EF 35% or less with complex ectopy defined as PVC's 10 or greater per hour. Subject is less than 18 years old at the time of signing informed consent. Any condition which may prohibit the completion of or compliance with the protocol
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 21.0-999.0, Syncope Near Syncope Acute syncope or near syncope as a reason for the ED visit Altered mental status, alcohol or illicit drug-related loss of consciousness, Definite seizure, Transient loss of consciousness caused by head trauma
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2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 19.0-999.0, Congenital Disorder Congenital heart disease diagnosis Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005 Age 18 to 80, inclusive Those who do not meet
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0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Arrhythmia Patient has an indication for implantation of a dual-chamber pacemaker Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature Patient has persistent or permanent AF/AFl Patient has permanent AV Block Patient has a pacemaker replacement Patient is in NYHA class IV Patient is unable to attend the follow-up visits Patient is pregnant Patient is less than 18 years of age
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2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Death, Sudden, Cardiac Ventricular Fibrillation Tachycardia, Ventricular All patients admitted to telemetry ward and emergency department Age > 18 years Pregnant women Patients with R wave less than 0.5 millivolts Patients with functioning Internal Cardiac Device Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double counting of pacer spikes) Patients with visible chest lesions that would prevent AECD pad placement Patients who are designated Do Not Resuscitate Right bundle branch block Patients with Parkinson's disease Patients with seizure disorders
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2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-999.0, Ventricular Tachycardia Wide QRS Tachycardia Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina Age > 18 years Written inform consent obtained Treatment with iv amiodarone or iv procainamide during the previous 24 hours QRS tachycardia <120 ms Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination Irregular tachycardia Tachycardia that is considered as supraventricular due to physician (adenosine and/or vagal manoeuvres response) Patient that do not want to cooperate
|
2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-999.0, Ventricular Tachycardia Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one) 1. For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study. 2. For patients without ICDs: Documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ECGs and hospitalization records. 3. Incessant VT due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion). 2. Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention. 3. Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days. 4. Age eighteen (18) years or older. 5. Signed Patient Informed consent form. 6. Able and willing to comply with all pre-, post-, and follow-up testing requirements Definite protruding left ventricular thrombus on pre-ablation echocardiogram. 2. Myocardial infarction within the preceding two (2) months. Patients with incessant VT (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their MI is at least three (3) weeks old. 3. Patients with idiopathic VT. 4. Other disease process likely to limit survival to less than twelve (12) months. 5. Class IV heart failure. 6. Serum creatinine of > 2.5 mg/dl. 7. Thrombocytopenia (defined as platelet count <80,000) or coagulopathy. 8. Contraindication to heparin. 9. Women who are pregnant. 10. Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (2) months. Patients with incessant VT (present 50% of the time with intervention for a period >12 h) may be enrolled if their surgery is at least three (3) weeks old. 11. Acute illness or active systemic infection. 12. Unstable angina. 13. Severe aortic stenosis or flail mitral valve. 14. Uncontrolled heart failure. 15. Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study. 16. Enrolled in an investigational study evaluating another device or drug
|
2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Hypertension; Hypertrophy, Left Ventricular Caucasian; male or female outpatients and age between 18-80 years of age, inclusive Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg Patients with Left Ventricular Hypertrophy Severe hypertension Symptomatic heart failure History of stroke, heart attack, coronary bypass surgery etc Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus. Other protocol-defined inclusion/
|
0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-999.0, Arrhythmia Eligible subjects were male or female subjects, age >18 years, with clinically documented coronary artery disease and life-threatening ventricular arrhythmias who met the following Were scheduled for an ICD implantation or had an ICD implantation within 1 month, according to the class I American College of Cardiology/American Heart Association (ACC/AHA) practice guidelines for ICD therapy OR Were already treated with an ICD for a class I ACC/AHA indication for more than one month, provided they received at least one appropriate ICD intervention (shock or antitachycardia pacing (ATP) for ventricular tachycardia or ventricular fibrillation) during the preceding six months Patients with ventricular arrhythmias in the acute phase of myocardial infarction (first 48 hours) Patients with incessant ventricular tachycardia Patients with ventricular arrhythmias without underlying coronary artery disease Patients with a transient or reversible cause of ventricular arrhythmias (including significant electrolyte disturbances or drug induced proarrhythmia)
|
2
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-75.0, Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County. Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG) Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, …) Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies
|
0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-999.0, Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death Randomized Arm 1. Evidence of Coronary Artery Disease (CAD)a. 2. Evidence of prior Myocardial Infarction defined by either: A. Clinical history of prior myocardial infarction OR B. Mild-moderate systolic LV dysfunction with an EF ≤50% 3. LVEF>35% by any current standard evaluation technique (e.g., echocardiogram, MUGA, angiography). • Patients who have an EF between 30-35% and NYHA Class I heart failure who do not have a history of ventricular tachyarrhythmias, or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled (Target Population). 4. CE-MRI measure of infarct mass > 10% of LV mass (as measured by the MRI core lab) • If CE-MRI performed ≤ 40 days after myocardial infarction infarct mass must be ≥ 15% of the LV mass. 5. Patients aged 18 years or above 1. CAD will be confirmed by evidence of one of the following three (3) 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. Patients may not be randomized until 90 days after revascularization. 2. MI should be documented by the presence of two (2) of the following three (3) 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients may not be randomized until 40 days after myocardial infarction History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater)* 2. Unexplained syncope 3. Need for revascularization based on investigator's clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization) 4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead 5. Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder) 6. Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome 7. Current or planned renal or liver transplant 8. End stage renal disease on hemodialysis or peritoneal dialysis 9. Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye 10. Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain, body piercing 11. Recent MI (<40 days) or revascularization (<90 days) 12. CVA within 90 days 13. Antiarrhythmic drug therapy for ventricular arrhythmias 14. New York Heart Association CHF functional class IV at enrollment Non-Investigational Registry Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction Evidence of LV dysfunction (ejection fraction) as measured by any current standard screening technique (e.g., echocardiogram, MUGA, angiography).c Clinical CE-MRI within the past 12 months (scheduled or completed) Patients aged 18 years or above CAD will be confirmed by evidence of one of the following three (3) 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery MI should be documented by the presence of two (2) of the following three (3) 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab) Patients can be enrolled in the registry even if they have received or are about to receive an ICD for primary prevention History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120BPM or greater)* Contraindication to CE-MRI or history of allergy to gadolinium-based contrast
|
1
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-90.0, Diabetes Diabetic Nephropathy Renal Protection Diagnosis of Diabetes Mellitus Type II 2. Treatment With Oral hypoglycemics 3. Availability of Baseline and follow up clinical data Insulin Therapy at baseline 2. Malignancy
|
0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 18.0-80.0, Atrial Fibrillation Thromboembolism Male or female, 18 to 80 years old. 2. Able to provide written informed consent. 3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG) 4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2 Subjects with mitral valve disease or previous valvular heart surgery 2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin 3. Known or suspected hereditary or acquired bleeding or coagulation disorder
|
0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
|
eligible ages (years): 14.0-999.0, Penile Cancer Written informed consent must be obtained from each patient prior to study entry. 2. Age >/= 14 years of age. Life expectancy greater than or equal to 6 months. PS </= 2 (ECOG). 3. Patients with histologically confirmed squamous cell carcinoma of the penis who present with clinical stage (T(subscript)xN(subscript)2-3M(subscript)0) disease based on the 1987-1992 TNM Staging System and meeting the additional clinicopathologic as defined in the protocol (section 3.1). 4. Patients must have adequate physiologic reserve as evidenced by: absolute neutrophil count (ANC) >/= 1,500/mm3(superscript) and platelet count >/= 100,000/mm3. Transaminases </= 2 times the upper limit of normal. Conjugated bilirubin </= 1.5mg/dL. Creatinine clearance (either calculated or measured) of >/= 40ml/minute. 5. No evidence of active ischemia on the EKG and, for patients with significant prior coronary artery disease history, an ejection fraction of more than 40%. No evidence of severe conduction abnormalities on EKG Patients with uncontrolled infection or CNS disease. 2. Distant metastasis (TNM stage M1, i.e., lung, bone, other visceral sites, lymph node metastasis above the aortic bifurcation). 3. Patients with clinically negative inguinal examinations or those with palpable adenopathy not meeting pathological or clinical (i.e., minimal nodal metastasis or false positive inguinal examination). 4. Prior systemic chemotherapy for penile carcinoma. 5. Prior radiation therapy to inguinal or pelvic lymph nodes
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0
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