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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma 18 years of age and older 2. Diagnosis of multiple myeloma 3. In one of the following three treatment categories Transplant ineligible patients, currently in first line treatment Transplant eligible patients, sufficiently recovered from transplantation (>3 months following transplantation) Patients with relapsed/recurrent myeloma with either 1-3 prior lines of treatment or 4+ prior lines 4. Able to provide informed written consent in English 5. Approved for physical activity participation by their oncologist and cleared for physical activity by the Certified Exercise Physiologist on the PAR-Q+ Unstable cardiac/metabolic condition that would be deemed unsafe to exercise 2. Severe anemia 3. Spinal instability requiring surgical intervention 4. AL amyloidosis, solitary plasmacytoma, or Waldenstrom macroglobulinemia 5. Too frail to participate in home exercise, as determine by baseline physical assessment (i.e., unable to complete a single sit-to-stand or balance on one foot for ≥ 3 seconds). 6. Inability to provide consent 7. Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Ventricular Assist Device Psychosocial Factors Self-management Stable postoperative condition Outpatient treatment at the respective heart center years and older No contraindications (e.g. Cognitive, Language) Signed Informed Consent Not an outpatient at the respective heart center Underage Contraindications (e.g. Cognitive, Language) No signed Informed Consent Participation in other behavior-related studies
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-100.0, Amyloidosis Transthyretin Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement, and an increase of BNP >200 pg/mL and/or NT-proBNP >500 pg/mL Suspected cardiac ATTR amyloidosis Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm Patient signed consent Contraception method New York Heart Association (NYHA) functional class IV despite diuretic treatment Life expectancy <6 month due to the severity of cardiac amyloidosis and/or comorbidities Aortic valve surgical or percutaneous replacement within 30 days or planned within months Presence of primary (light chain) amyloidosis Contraindication to tafamidis Pregnancy and breast feeding ; pregnancy test in women of reproductive age irrespective of contraception method) Adults with protective measures
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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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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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 20.0-999.0, End Stage Renal Disease on Dialysis Aged greater than or equal to 20 years 2. Having end-stage kidney disease and having undergone maintenance PD for more than three months 3. Having adequate dialysis (weekly Kt/V greater than or equal to 1.7) 4. Serum albumin levels lower than 4.0 g/dL, measured by bromocresol green assay Untreated fluid overload 2. Uncorrected metabolic acidosis 3. Having active infection or inflammation 4. Hospitalization within the past 4 weeks 5. Having gastrointestinal bleeding 6. those who cannot cooperate with the dietary record 7. those who have poor adherence to whey protein consumption 8. History of psychiatric disorders 9. Having mental retardation
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Diagnosis of multiple myeloma per the International Myeloma Working Group (IMWG) Eligible for ASCT per institutional guidelines Within one year of start of myeloma therapy Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per institutional transplant guidelines Calculated creatinine clearance > 30 mL/min according to the Modification of Diet in Renal Disease (MDRD) formula Absolute neutrophil count > 1500 x106/L and platelets > 100,000 x106/L Ability to understand and the willingness to sign a written informed consent document Agreement to use an approved form of contraception for male patients or female patients of childbearing potential History of prior stem cell transplant for multiple myeloma or other indications Planned tandem stem cell transplant Prior history of failure to collect HSCs Liver function tests: Total bilirubin >1.5x upper limit of normal (ULN) in the absence of a documented history of Gilbert's syndrome and/or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3x ULN Known allergy to MGTA-145 or plerixafor Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6 cumulative months of treatment i.e more than six 28-day cycles or more than eight 21-day cycles Pregnant or lactating women
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Previously diagnosed with Multiple Myeloma (MM) based on standard criteria Dose Escalation Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator Dose Expansion Phase: Participants with r/r MM who have received at least three prior treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy Life expectancy of at least 12 weeks Agreement to provide protocol-specific biopsy material AEs from prior anti-cancer therapy resolved to Grade =<1 Measurable disease For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm Inability to comply with protocol-mandated hospitalization and activities restrictions Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study drug Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 2 weeks before first RO7425781 administration Prior treatment with systemic immunotherapeutic agents within 2 weeks before first RO7425781 administration Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks except for alkylating agents (e.g., melphalan) within 28 days, prior to first RO7425781 administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first RO7425781 administration and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication Prior solid organ transplantation Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Kidney Transplantation Organ Preservation Adult recipients older than 18 years; 2. Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation; 3. First single kidney transplantation; 4. The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent; 5. Ethics committee approved Patients less than 18 years old, or more than 65 years old; 2. Patients who receive multiple organ transplants; 3. Diagnosed with malignancy or had a history of malignancy in the past 5 years; 4. non-kidney transplantation history
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Chronic Myeloid Leukemia Chronic Myeloid Leukemia in Remission BCR-ABL Positive Chronic Myelogenous Leukemia CML in chronic phase. 2. TKI treatment for at least 3 years. 3. DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years 4. At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR 5. Written Informed Consent 6. CML patients with DMR for at least 1 years and MMR for at least 2 years after STOP TKI in anamnesis. For patients who are on the reduced dose TKI (1 stage) at the time of in the study 1. The duration of therapy at reduced doses of TKI phase I is at least 6 months. For patients on the reduced dose TKI (2 stage, before TFR phase) at the time of in the study 1. DMR (BCR-ABL≤0.01%) for at least 2 years 2. The duration of therapy at reduced doses of TKI phase 1 is for at least 6 months, the total duration of therapy at reduced doses is for at least 12 months Age under 18 2. ECOG >2 3. CML in accelerated phase or blast crisis at any time 4. Lack of Written Informed Consent 5. Pregnant or lactating women 6. Incapacity
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 2.0-18.0, Anemia Associated With Chronic Kidney Disease Important Clinically stable CKD in the opinion of the investigator Estimated glomerular filtration rate (Bedside Schwartz formula) of < 60 ml/min/1.73 m2 (stage 3, 4 and 5 CKD) for non-dialysis patients, or patients who are receiving chronic dialysis (hemodialysis or peritoneal dialysis) for ESRD For ESA-naïve patients (either NDD or DD; ESA-naïve is defined as those patients whose total duration of prior ESA exposure is ≤ 3 weeks within the preceding 12 weeks at the time informed consent is obtained), mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be < 11.0 g/dL. For patients currently receiving stable ESA dosing who will discontinue ESA and convert to roxadustat during study, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be ≥ 10.0 g/dL and ≤ 12.5 g/dL Ferritin >50 ng/mL and transferrin saturation >10% (obtained from screening visit) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5x ULN at randomization (obtained from screening visit) Serum folate and vitamin B12 > LLN (obtained from screening visit). Important Uncontrolled hypertension as judged by the principal investigator in the 2 weeks prior to screening Known hematologic disease other than anemia associated with CKD Known malignancy within the past 5 years before screening Any prior organ transplant or any planned organ transplant during the study period Any RBC transfusion during the past 8 weeks before screening Any condition leading to significant blood loss (e.g., gastrointestinal bleeding, surgical procedures) within 8 weeks before screening or during the screening period History of chronic liver disease Pure red cell aplasia (PRCA) or history of PRCA History of epileptic seizures History of hyperlipidemia or significant thrombotic/thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Relapse Multiple Myeloma Multiple Myeloma A prior diagnosis of multiple myeloma with documented disease progression after last line of therapy Double refractory to an immunomodulatory drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose Primary refractory disease (i.e. never responded with at least Minimal Response to any prior therapy for multiple myeloma) Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies Any medical condition that may interfere with safety or participation in this study Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance Known or suspected amyloidosis, plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) Known central nervous system (CNS) or meningeal involvement of myeloma Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease Prior treatment with melflufen
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 20.0-80.0, Multiple Myeloma (MM) Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at the time of consent Patients with a definitive diagnosis of active multiple myeloma Patients who have had 2 or more prior regimens (including all proteasome inhibitors, immunomodulators, and anti-CD38 antibody) Patients with relapsed and/or refractory Multiple Myeloma Patients who are positive for MMG49 antigen Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. Those with an ECOG-PS score of 2 due solely to MM bone lesions can be enrolled Patients who are expected to survive for at least 3 months Patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment Patients who have other active double/multiple cancers Patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents Patients with graft-versus-host disease that requires treatment Patients who underwent a highly invasive and extensive surgical procedure within 2 weeks Patients who previously underwent allogeneic stem cell transplantation or organ transplantation Patients who underwent autologous stem cell transplantation within 90 days Patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia Patients with prior or current central nerve involvement in MM Patients whose best ever response to MM treatment is PD
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Immunoglobulin Light-chain Amyloidosis Diagnosis of MM and/or AL amyloidosis according to the IMWG for MM and BSH guidelines for AL amyloidosis. MM diagnostic Smouldering MM Both must be met: 1. Serum M protein (Immunoglobulin G [IgG] or IgA greater than or equal to (>=) 30 gram per liter (g/L) or urinary monoclonal protein (M protein) >= 500 milligram per 24 hours (mg/24 h) and/or clonal bone marrow (BM) plasma cells (PCs) 1 percent (%) . 2. Absence of myeloma-defining events or amyloidosis Multiple myeloma Clonal BM plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events: 1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically Hypercalcemia: serum calcium greater than (>) 0.25 millimole per liter (mmol/L) (> 1 milligram per deciliter [mg/dL]) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL) Renal insufficiency: creatinine clearance (CrCl) less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micromole/liter (mcmol/L) (>2 mg/dL) Anemia: haemoglobin (Hb) value of >20 g/L below the lower limit of normal or a Hb value of <100 g/L Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT) or positron emission tomography-computed tomography (PET-CT). 2. Any one or more of the following biomarkers of malignancy Participants with planned cessation of treatment for MM or systemic AL amyloidosis from participation to the study (example, due to pregnancy). 2. Participating in blinded clinical trials, or in clinical trials with no possibility of obtaining information required in this study, or in clinical trials in which participation in other studies is not allowed
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Age ≥ 18 years. 2. Signed written informed consent prior to any study procedure. 3. Subject has a diagnosis of multiple myeloma with relapsed and/or refractory disease. Subjects must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for subjects with cellular therapy (eg, CAR T-cell therapy) as their last treatment, who may enroll beyond 12 months. 4. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without HSCT and with or without maintenance therapy is considered one regimen), including Autologous stem cell transplant A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination Anti-CD38 (eg, daratumumab), either alone or combination 5. Measurable disease 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ function Known active or history of central nervous system (CNS) involvement of MM 2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis 3. Uncontrolled or active infection 4. Active autoimmune disease requiring immunosuppressive therapy 5. History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-100.0, Multiple Myeloma Bortezomib exposure group: 1. Patients diagnosed with multiple myeloma. 2. Patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors Patients without complete clinical information. 2. Patients with malignant epidemic diseases. 3. Patients with alcohol abuse or special dietary habit . 4. Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function. 5. Patients with a history of gastrointestinal operation. 6. Patients with severe renal insufficiency without regular dialysis. 7. Patients with other possibilities who has severe liver or kidney function injury without intervention
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Waldenstrom Macroglobulinemia Patient over 18 years of age with the capacity to give express free and informed consent Patient followed in one of the services participating in the study and meeting the 2 following conditions 1. have myelodysplastic syndrome, or multiple myeloma, or monoclonal gammopathy of undetermined significance, or Schnitzler's syndrome. 2. have a fever of undetermined etiology associated with one of the following symptoms: rash, arthralgia or arthritis, serositis, abdominal pain Patient incapable of giving express free and informed consent Subject under guardianship, curatorship or safeguarding of justice Subject does not speak French Subject incapable of answering questions or expressing himself/herself Presence of a differential diagnosis that may explain the patient's symptoms
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Secondary Hyperparathyroidism Chronic Kidney Disease-Mineral and Bone Disorder Dialysis Hypocalcemia Hypoparathyroidism Age > 18 years; 2. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment > 3 months prior surgery; 3. Severe secondary hyperparathyroidism defined as iPTH level > 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT; 4. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue Emergency surgery; 2. Primary hyperparathyroidism as a cause of ESRD; 3. Scheduled (before surgery) blood transfusion; 4. Re-operative surgery; 5. Known allergy to the study drug. 6. Malignant neoplasms of bone tissue (primary or metastatic)
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, Cardiac Surgical Procedures * Adult cardiac surgery patients with a comprehensive TEE and TELUS examination pre CPB will be included Previous lung surgery Previous thoracic radiation therapy for cancer (lung, breast, lymphoma or other) Mitral valve surgery using a mini thoracotomy and video assistance Use of an ultrafiltration device during CPB Mechanical ventilation initiated before arrival in the OR
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 21.0-999.0, Cardiovascular Diseases End Stage Renal Disease Provision of informed consent prior to any study specific procedures Female or male aged ≥ 21 years Undergoing haemodialysis for end stage renal disease regardless of cause and previous cardiac events Diagnosis of Type 1 diabetes mellitus Pregnant or planning pregnancy or breast-feeding patients Any clinical condition that would jeopardize patient safety while participating in this clinical trial Intake of an investigational drug or participating in another clinical trial involving an investigational drug Life limiting disease other than ESRD with life expectancy estimated to be less than 12 month
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Autologous Stem Cell Transplant Age ≥ 18 years Patients with Multiple Myeloma within 6 months of their Autologous Stem Cell Transplant English Speaking Computer and internet access with video conferencing availability Evidence of disease relapse at the post-transplant follow up visit Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma for all subjects: 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age greater than or equal to 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of belantamab mafodotin as a single agent or in combination with KRd in subjects less than 18 years of age, children are excluded from this study. 3. ECOG Performance Status of less than or equal to 2 4. Demonstrate adequate organ function 5. Adequate cardiac function as defined by a greater than 40% left ventricular ejection fraction (LVEF) by ECHO, cardiac MRI or MUGA 1. Note for patients in phase II: if a cycle of pre-study induction therapy containing a PI or anthracycline was administered, assessment of the LVEF must be repeated. 6. For those with symptomatic pulmonary disease with Grade 2 or higher symptoms (e.g. COPD, asthma) or other signs / symptoms of pulmonary disease, adequate pulmonary function as defined by a FEV1 greater than or equal to 50% of predicted and DLCO/VA greater than or equal to 50% of predicted 7. Females of childbearing potential (FCBP) must have two negative serum pregnancy tests during screening: the first within 10-14 days prior to first dose of study treatment and the second within 24 hours prior to first dose of study treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are amenorrhoeic for less than 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation; or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). 8. FCBP must be willing to use 2 effective contraceptive methods or abstinence starting from the time of informed consent, while on belantamab mafodotin and lenalidomide. If either drug is discontinued, 2 effective forms of contraception should be continued until at least 4 weeks after the last dose of lenalidomide, and 1 form of effective contraception should be continued until 4 months post last dose of belantamab mafodotin. FCBP should use effective contraception or abstinence from consent until 30 days after last treatment with carfilzomib, and males with a partner of childbearing potential must use effective contraception or abstinence for at least 90 days post last dose of carfilzomib. 9. Male subjects must agree to the following from the first dose of study treatment until 6 months after the last dose of belantamab mafodotin, to allow for clearance of altered sperm: 1. Refrain from donating sperm PLUS either: 2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR 3. Must agree to use effective contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner of reproductive potential to use an additional highly effective contraceptive method with a failure rate of less than 1% per year 10. FCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the intervention period and for at least 4 months after the last dose of study intervention belantamab mafodotin, at least 30 days after the last dose of carfilzomib, and at least 4 weeks after the last dose of lenalidomide. 11. As determined by the enrolling physician, ability of the subject to understand and adhere with study procedures for the entire length of the study 12. Ability to swallow oral medications 13. Willing to refrain from using contact lenses while participating in this study Phase I treatment for Relapsed or Relapsed/Refractory MM: 1. Subjects with Relapsed or Relapsed/Refractory MM who have had 1-3 lines of prior therapy. 1. Refractory is defined as less than 25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment 2. A line of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. 2. Subjects must have measurable disease, at diagnosis, as defined by at least one of the following: 1. Serum monoclonal protein level greater than or equal to 0.5 g/dL 2. 24-hour urinary M-protein greater than or equal to 200 mg 3. Involved free light chain level greater than or equal to 10 mg/dL, along with an abnormal free light chain ratio. 3. Subject must have not progressed on full dose lenalidomide previously (25 mg on days 1-21 of a 28-day cycle or its dosing equivalent based on renal function at the time of progression) Phase II treatment for high-risk newly diagnosed MM: 1. Active, newly diagnosed multiple myeloma with CRAB features or a myeloma-defining event per the IMWG 2014 criteria. Note: It is acceptable to subjects who have had one cycle of emergent treatment for multiple myeloma. 2. High-risk disease: i. Del(1p) ii. Gain of 1q21 [greater than or equal to 3 copies] iii. Monosomy 13 or del(13q) by conventional karyotype iv. High risk IgH translocation [t(4;14), t(14;16) or t(14;20)] v. del(17p) 3. Measurable disease by 1 or more of the following: 1. Serum monoclonal protein level greater than or equal to 0.5 g/dL 2. 24-hour urinary M-protein greater than or equal to 200 mg 3. Involved free light chain level greater than or equal to 10 mg/dL (100 mg/L), along with an abnormal free light chain ratio. 4. Note: for subjects who have received a prior cycle of non-protocol therapy, measurable disease will be based on the serum and urine monoclonal protein and serum free light chain levels prior to the cycle of non-protocol therapy 4. No more than one prior cycle of non-protocol therapy will be allowed, recognizing that high-risk multiple myeloma subjects frequently require immediate therapy at initial diagnosis even before risk assessment is complete. For those subjects who receive a cycle of non-protocol induction therapy: a. There should be a washout period of ≥7 days from the last dose of pre-study therapy AND b. The subject must have adequate recovery from toxicity of pre-study therapy as defined by the following: i. Hematologic lab results within parameters ii. Non-hematologic toxicity resolved to grade 1 or baseline with the following exceptions: 1. Subjects who have started a course of antibiotic therapy for infection and symptoms have improved to baseline or grade 1, but remain on antibiotic therapy are eligible 2. Subjects with less than or equal to grade 2 fatigue are eligible 3. Subjects with less than or equal to grade 2 hyperglycemia are eligible, even if pharmacologic treatment was required 4. Subjects with less than or equal to grade 2 electrolyte abnormalities are eligible, even if pharmacologic treatment was required 5. Subjects with less than or equal to grade 2 nausea, constipation or diarrhea are eligible, even if pharmacologic treatment was required for all subjects: 1. Active infection requiring systemic therapy. NOTE: at the discretion of the treating investigator, subjects who have started antibiotic therapy for subjects who had symptoms present, symptoms must have improved to baseline or grade 1 in severity may start treatment prior to completion of their course of antibiotic therapy. 2. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.) 3. Subjects cannot have other prior or concomitant malignancies except for: 1. Curatively treated non-melanoma skin cancer 2. Other cancer for which the subject has been medically stable for at least 2 years and/or, in the opinion of the Site Principal Investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy 4. Active central nervous system (CNS) involvement 5. Concomitant AL amyloidosis or POEMS syndrome 6. Plasma cell leukemia 7. Treatment with any investigational drug within 14 days or five half-lives, whichever is shorter, prior to first dose of study treatment. 8. Medical, psychiatric, or other condition/disorder (including lab abnormalities) which, in the opinion of the treating physician, would make this protocol treatment unreasonably hazardous for the subject, or could interfere with obtaining informed consent or compliance to the study procedures 9. Significant cardiac disease, including any of the following: 1. Greater than or equal to Class 3 New York Heart Association (NYHA) congestive heart failure (see Appendix B) 2. ECG evidence of acute ischemia 3. Unstable angina 4. Myocardial infarction, Coronary angioplasty, stenting, or bypass grafting within three months prior to day 1 of treatment 5. Clinically significant uncontrolled and/or untreated arrhythmias or conduction block, including clinically significant ECG abnormalities such as 2nd degree Mobitz Type ll or 3rd degree atrioventricular (AV)block. However, PACs, PVCs, rate controlled atrial fibrillation, sinus arrhythmia, asymptomatic sinus bradycardia or sinus tachycardia and 1st degree heart block are not considered clinically significant. 6. Greater than or equal to Grade 2 QTcF prolongation (i.e. >480 msec) 10. Uncontrolled hypertension, defined as a systolic blood pressure of greater than or equal to 160 mmHg or a diastolic blood pressure of greater than or equal to 90 mmHg 11. Grade greater than or equal to 2 peripheral neuropathy 12. Psychiatric illness/social situation that would limit compliance with study requirements as determined by the investigator 13. Known immediate or delayed hypersensitivity or allergic reaction to any components of, or related to, protocol therapy (e.g. during exposure to carfilzomib, lenalidomide or dexamethasone as part of a pre-study cycle of therapy). 14. History of erythema multiforme to lenalidomide or other IMID 15. Discontinuation of prior carfilzomib, lenalidomide or dexamethasone due to treatment toxicity 16. Major surgery within 4 weeks prior to day 1 of treatment 17. Radiation within 14 days prior to day 1 of treatment. Note: palliative XRT to less than 5% of the total marrow volume as assessed by the treating investigator is allowed within 14 days prior to day 1 of treatment 18. Current corneal epithelial disease except mild changes in corneal epithelium 19. Positive hepatitis C antibody test result (this test preferable) or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment a. NOTE: Subjects with positive Hepatitis C antibody due to prior eradicated disease can be enrolled if a confirmatory negative Hepatitis C RNA test is obtained 20. A known diagnosis of HIV 21. Is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (i.e. subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Subjects who are PCR positive will be excluded. Subjects with Hepatitis B surface antibodies and previous Hepatitis B vaccination will be eligible. 22. Has current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry 23. Participant must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill 24. Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment 25. Any evidence of active mucosal or internal bleeding 26. Participant must not be simultaneously enrolled in any interventional clinical trial
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-99.0, AL Amyloidosis diagnosis of systemic AL amyloidosis; 2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part); 3. age ≥18 years; 4. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted); 5. planned (or ongoing) follow-up at participating center non-AL amyloidosis; 2. previous treatment for AL amyloidosis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Arrythmia Cardiac Amyloidosis Systemic AL Amyloidosis Sudden Cardiac Death Age over 18 years Diagnosed with cardiac AL amyloidosis using standard diagnostic techniques and at the NAC Willing and able to provide written informed consent Patient who already have a cardiac device inserted, such as a permanent pacemaker (PPM), implantable cardioverter-defibrillator (ICD) or implantable cardiac monitor (ILR) Other pre-existing cardiac or other pathology which, in the investigators opinion, would adverse affect primary outcome data collection Contraindication to CMR imaging
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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, Neoplastic Syndromes, Hereditary Urologic Neoplasms Category I: Individuals and family members with established diagnoses of hereditary malignancies where the disease gene is known, specifically von Hippel Lindau or HPRC. Category II: Individuals and family members with malignant disorders where the disease gene is not yet known, specifically hereditary forms of Type II papillary renal cancer, clear cell renal carcinoma, renal oncocytoma or chromophobe renal carcinoma or Birt Hogg Dube syndrome. Category III: Malignant diseases of suspected, but not proven genetic etiology, including families with more than one individual affected by the same or related cancers
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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 Participants must be men, aged 50 years or older with moderate-to-severe BPH Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Patient signed informed consent prior to the performance of any study procedures or discontinuation of any exclusionary medications Male at least 50 years of age AUA symptom severity score >= 10 Voided volume >= 100 ml Post-void residual < 350 ml Prostatic length 30-50 mm by cystoscopy (from bladder neck to verumontanum) or 35-60 mm by TRUS (from bladder neck to apex) Prostate volume 25-100 cc by TRUS Prostate transverse diameter 34-80 mm Patient able to complete the study protocol in the opinion of the investigator Any prior surgical intervention for BPH
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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, Benign Prostatic Hyperplasia Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are candidates for surgical or minimally invasive treatment will be enrolled in the study Subjects must have an AUA SI >13, Qmax between 5 and 15 mL/sec, and a urethral treatment length between 30 and 65 mm (defined as the length of the urethra between the bladder neck and the edge of the verumontanum distal to the bladder)
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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, Post-Traumatic Stress Disorder PTSD Samples: Twenty subjects (age 18-65) with current PTSD, as defined by DSM-IV of any ethnicity without other significant medical conditions will be selected. Healthy Control Samples: Twenty healthy subjects (age 18-65) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected. A control subject will be matched to each subject with PTSD for age, gender, and handedness, respectively. They must not be actively using illicit drugs or engaged in heavy consumption of alcohol, had no metallic implants that are ferromagnetic, and competent to sign consent forms to participate in the study Patients must not have taken antidepressant or other medications likely to alter SP-NK1 receptor system. Effective medications will not be discontinued for the purpose of this study. Subjects will be excluded if they have: 1. DSM-IV Axis I diagnostic other than PTSD and Major depression (All controls must not meet any of the Axis I diagnoses); 2. DSM-IV for psychoactive substance abuse/dependence within six months; 3. take psychotropic medication in last 3 weeks (8 weeks for fluoxetine); 4. abnormal MRI other than minor atrophy; 5. abnormal laboratory test, including HIV test; 6. are currently pregnant or breast feeding (as documented by pregnancy testing at screening or at days of the scanning); 7. prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits (A total effective dose 5.0 rem in a year and a 5 rad per year to the lens of the eyes, gonads and blood-forming organs; and 15 rad annually for all other organs); 8. are unable to lay on one's back for PET/MRI scans (PET and MRI scans take approximately 5 and 1 hour, respectively); 9. any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.); 10. individuals who recently donated blood; 11. serious suicidal ideation or behavior; 12. Xylocaine allergy; 13. positive HIV test. For healthy subjects b) through m) are same to those for PTSD subjects. As for item a), subjects will be excluded if they meet any current DSM-IV Axis I diagnostic criteria
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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, Breast Neoplasms Prostatic Neoplasms Laryngeal Neoplasms Cervix Neoplasms Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer Receiving palliative care Severe pain or symptoms causing distress Having cancer at other sites Having no spoken English Receiving treatment for psychological or psychiatric problems Visual or mental handicap Having case notes not available or ambiguous or illegible
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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, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Enlarged Prostate Patients of IU Health Physicians Urology in Indianapolis, Indiana Male patients over the age of 18 with benign prostatic hyperplasia requiring surgical intervention for symptomatic relief Patients unable or unwilling to provide informed consent
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Renal Calculi Male or female patients of Methodist Urology in Indianapolis, IN with kidney stones appropriate for percutaneous lithotripsy (PERC) Age greater than 18 years Inability to give informed consent Active infection Bleeding diathesis Pregnancy
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Ability to give informed consent Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia Maximum urinary flow rate < 15 ml/sec, voided volume ≥ 125 cc American Urological Association symptom score ≥ 9 Transrectal ultrasound determined prostate volume ≤ 60 cc Inability to give informed consent Maximum urinary flow rate ≥ 15 ml/sec Transrectal ultrasound determined prostate volume > 60cc AUA symptom score < 9 Active urinary tract infection Bleeding diathesis Neurological disease that is felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder Known prostate cancer Active bladder cancer (within the last 2 years) Prostate specific antigen (PSA) > 4.0 unless previous negative 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): 50.0-85.0, BPH Benign Prostatic Hyperplasia Symptomatic benign prostatic hyperplasia including patients with acute urinary retention Peak urinary flow rate < 12 ml/sec American Urological Association (AUA) symptom score > 12 Previous open or transurethral prostatic surgery History of urethral stricture Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery Patient interested in future fertility Patient with known neurogenic bladder dysfunction Untreated urinary tract infection American Society of Anesthesiologist (ASA) Class >III Patients requiring anticoagulation with Coumadin or Heparin Patient unable or unwilling to comply with follow-up schedule
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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) Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia Medical conditions that would confound the efficacy evaluation Medical conditions in which it would be unsafe to use an alpha-blocker The use of concomitant drugs that would confound the efficacy evaluation The use of concomitant drugs that would be unsafe with this alpha-blocker
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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 Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH Medical conditions that would confound the efficacy evaluation Medical conditions in which it would be unsafe to use an alpha-blocker The use of concomitant drugs that would confound the efficacy evaluation The use of concomitant drugs that would be unsafe with this alpha-blocker
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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, Pancreatic Cystadenoma Patients with a pancreatic cyst (1-5cm in diameter) Capable of safely undergoing endoscopy with conscious sedation Coagulopathy (INR>1.5, PTT>100, platelets of< 50k) Active infection of the cyst Unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema)
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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, Prostate Cancer Post-Brachytherapy Bladder Outlet Obstruction eligible for prostate seed implant years of age or older able to give informed consent presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter history of transurethral resection of prostate (TURP)procedure presence of urethral diverticuli presence of urethral strictures presence of bladder calculi or tumors prostatic urethra is less than 2.5 cm or greater than 6.5 cm inability to participate in study activities due to physical or mental limitations inability or unwillingness to return for all the required follow-up visits
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 21.0-999.0, Urethral Stricture Males > 21 years of age 2. Recurrent stricture of the bulbar urethra: 1. < 50 mm in length on urethrography; and which 2. has a segment unable to accommodate a 16Fr flexible cystoscope 3. Healthy tissue on both sides of stent 4. Urinary flow in the abnormal range of the Siroky nomogram. 5. Written informed consent obtained prior to participation in the study 6. Patients must be available for all follow-up visits Strictures: 1. outside the bulbous urethra 2. associated with, or suspected to be, urethral carcinoma 3. secondary to pelvic distraction injuries 2. Inability to enlarge the bulbar urethral stricture to > 26 Fr. 3. Presence of any other urologic implant 4. Presence of urethral diverticuli 5. History of hypospadias repair 6. Presence or prior history of balanitis xerotica obliterans. 7. Uncontrolled bleeding disorder 8. Active urinary tract infection 9. Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation. 10. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease 11. Concurrent participation in another clinical investigation 12. Current illness that might confound the results of this investigation 13. Inability to participate in all of the necessary study activities 14. Inability or unwillingness to return for all required follow-up visits 15. Inability or unwillingness to sign the patient informed consent document
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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, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization
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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, Prostatic Hyperplasia Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia) Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH Patients must only enter the study after the decision to prescribe dutasteride has been undertaken None specified
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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, Carcinoma of Urinary Bladder, Superficial (1) Patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis
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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 Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography Suffering for at least 6 months from lower urinary tract symptoms related to BPH An I-PSS total score ≥ 13 Out patient Patients previously treated with SL77.0499-10 Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology Isolated bladder neck disease Diagnosed carcinoma of the prostate Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH Patients having an indwelling catheter A residual urine > 200mL Patients with Moderate or sever hepatic insufficiency Known hypersensitivity to alpha1-blockers Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
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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, Sepsis Adrenal Insufficiency Males and non-pregnant females > 18 years of age Patients admitted and/or pending admission to the intensive care unit Positive corticotropin stimulation test (Basal cortisol level of ≤ 34 μg/dL with Δ ≤ 9 μg/dL after administration of 250 mg of cosyntropin) Patient satisfies for severe sepsis Infection one or more of the following Documented or Suspected positive culture results (from blood, sputum, urine, etc.) Anti-Infective Therapy patient is receiving antibiotic, antifungal, or other anti-infective therapy Pneumonia documentation of pneumonia (x-ray, etc.) Patients who respond to the short cosyntropin stimulation test(Δ > 9mg/dL) Pregnancy or breast-feeding mother Evidence of acute myocardial infarction, meningitis, pulmonary embolism AIDS (CD4 < 200 cells/mL) Contraindications for corticosteroids Formal indication for corticosteroids (specifically including patients with known adrenal insufficiency) Onset of shock > 24 hours Etomidate administration within the 6 hours preceding randomization Cardiac arrest prior to randomization
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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 patient is a male at least 50 years of age The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml Prostate volume must be greater than 30 grams The AUA-SI is greater than or equal to 9 Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP Patient must be able to complete the study requirements prior to the scheduled laser TURP The patient has signed the informed consent prior to the performance of any study procedures The patient has had any prior surgical intervention for BPH The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride The patient has taken an alpha-1 blocker within 1 month of randomization The patient has taken finasteride or dutasteride within 3 months of randomization The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids The patient has an inability to urinate The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg/dl or AST greater than 1.5 times the upper limit of normal) The patient has a PSA level greater than 10 ug/ml (Hybritech)
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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 years of age Radical Prostatectomy at William Beaumont Hospital Dementia
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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, Male Urinary Incontinence Male, with post-prostatectomy urinary incontinence (either after radical prostatectomy or prostatectomy of prostate adenoma, whatever the route used), and for whom there has been more than 6 months follow-up since the date of that procedure The patient should have been proposed urinary re-education, which was refused for personal reasons, or should still suffer from urinary incontinence despite the re-education Urinary incontinence is materialized in this population by a score between 4 and 16 (inclusive) for the three questions of the ICIQ questionnaire A urodynamic assessment including flow measurement and residue will have been carried out A urethroscopy or urethrography will have been carried out to eliminate cases of urethral stenosis is subject to obtaining informed written consent, after remittance of the information sheet, and having had a detailed medical examination carried out Medication for urinary incontinence and in particular anticholinergic drugs must have been stopped at least 15 days prior to initial assessment and for the duration of the trial. The same goes for urinary re-education Progressing prostatic neoplasia materialized by testing of PSA levels Prostate radiotherapy Neurological disorder which might lead to urinary incontinence or hinder assessment Urethral or anastomotic stenosis materialized by urethroscopy or urethrography Hyperactive detrusor muscle with leakage contemporaneous with uninhibited contractility Chronic retention of urine with leakage due to overflow Current urinary infection. This would be a temporary since assessment can take place after treatment and monitoring for sterility of urine
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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 All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study American Society of Anesthesiologists (ASA) classification of physical status > III An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods A myocardial infarction or coronary artery stent placement within 6 months of the treatment Neurogenic lower urinary dysfunction A post-void residual (PVR) volume ≥ 400 mL Pre-existing urinary incontinence Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function Pre-existing damage of external urinary sphincter Presence of cystolithiasis, urethral stricture, or bladder neck contracture Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
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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, Benign Prostatic Hyperplasia Males years old and up Suffer from BPH Candidate for radical prostatectomies According to the physician's decision
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Anesthesia Recovery Period Delirium, Dementia, Cognitive Disorders Neurobehavioural Manifestation Mental Competency Adult age patients undergoing general anesthesia Cerebral and cardiac surgery Surgical procedures required postoperative delayed extubation
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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 Prostatic Hyperplasia Clinical diagnosis of BPH AUA-SI >=12 [American Urological Association Symptom Index] Qmax > 5ml/sec and <=15ml/sec and minimum voided volume of >=125ml Prostate volume >=30cm(3) Post void residual volume >250ml History or evidence of prostate cancer Total serum PSA <1.5ng/ml or >10.0ng/ml (Prostate specific antigen) Previous prostatic surgery or other invasive procedures to treat BPH History of AUR (Acute Urinary Retention) within 3 months History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
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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, Urethral Stricture K/C/O Urethral Stricture of either sex and from all age groups With acute UTI Neoplasms of lower urinary tract BEP With impacted calculus in urethra and bladder neck
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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, Urinary Tract Infection Patients followed at the Require an indwelling bladder catheter (either transurethral or suprapubic) Have a history of at least 1 UTI in the past will be eligible for enrollment Have pre-existing bladder colonization obstructive urolithiasis percutaneous nephrostomy catheters supravesicular urinary diversion vesicoureteral reflux active malignancy uncontrolled diabetes mellitus AIDS requirement for immunosuppressive medication, expected survival < 6 months, creatinine clearance > 2.0 mg/dL, or current antibiotic therapy Latex allergy Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Prostate Cancer They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options Patients undergoing Open Radical Prostatectomy Patients with prior history of insulin dependent diabetes mellitus Patient who have received prior radiation therapy to the pelvis or prostate Patients requiring anticoagulation postoperatively Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria Patients with labile hypertension or history of prior priapism Patients with penile scarring or penile prosthesis Patients with an International Index of Erectile Function score < 24
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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 Diseases Patients with lower urinary tract dysfunction Controls with normal lower urinary tract function Age < 18 years old Pregnancy
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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): 50.0-999.0, Benign Prostatic Hyperplasia Men with symptomatic BPH requiring treatment IPSS score > 15 Age > 50 years Prostate size of 25 g or greater Prostatic urethra length between 2.0 cm and 5.5 cm Ability to understand and consent to participate in this investigation Willingness and ability to participate in all required follow-up evaluations Allergy towards Silicone Peak Urinary Flow > 15 mL/s Penile or urinary sphincter implant Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.) Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P) Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation Patients with confirmed or suspected bladder cancer Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 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): 40.0-999.0, Lumbar Spinal Stenosis neurogenic claudication or radicular leg pain with associated neurologic signs referring to the LSS syndrome moderate to severe spinal canal stenosis shown on cross-sectional imaging such as MRI or CT scan failure of conservative treatment for at least three months mechanical low back pain or segmental instability
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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, Urostomy In order to be enrolled in the clinical investigation, the subject must Be at least 18 years old Be mentally and physically capable of signing the written consent form Be able to fill in the Case Report Form (questionnaire) Have an urostomy with a size between 15-55 mm Have had the urostomy for 3 months or more Use a 1-piece bag normally Be able to handle the bag themselves (application and removal) Be willing to use Coloplast SenSura 1-piece bag Be willing to use Hollisters Moderma Flex, 1-piece bag In order to be enrolled in the clinical investigation, the subjects must not Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward) Need to use an ostomy belt Be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from Coloplast A/S) Being treated with chemo or radiation therapy Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or Be pregnant or breast-feeding
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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, Breastfeeding Term babies born to mothers by normal vaginal delivery in the study period Babies with major congenital malformation. 2. Multiple pregnancy 3. Babies requiring resuscitation beyond the initial steps 4. Babies requiring care in the neonatal intensive care unit. 5. Maternal problems requiring immediate care Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain Imminent eclampsia Severe bleeding Mother with significant surgical or medical illness requiring separation of the baby from the mother. 6. Small for dates and large for dates babies 7. Infants of diabetic mother 8. Maternal refusal 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): 0.0-999.0, Urodynamics Acute Urinary Retention Written informed consent Open kidney surgery with lumbotomy Thoracic epidural analgesia Significant renal dysfunction (creatinin >200mol/l) Contraindications to epidural anesthesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 Pregnancy
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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 Retention Urinary Catheterization Male patients Urinary retention defined as >150cc retained in bladder on post void residual Female patients Known urethral stricture Active symptomatic Urinary Tract Infection History of pelvic fracture or urethral disruption History of previous urethroplasty(urethral reconstructive surgery) Known Latex allergy Unable to physically perform CIC Unable to provide follow up Unable to give consent Currently taking chronic narcotic pain medication
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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, Unspecified Adult Solid Tumor, Protocol Specific Patients must be 18 years of age or older Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended Patients must clinically have been determined to be a candidate for the indicated surgical procedure Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens Patients must have a performance status of 0, 1 or 2 by ECOG standards Patients must give written informed consent, including consent to have IV line placed for 18F-FDG administration Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilization, or must give history of no menses in past twelve months Fasting blood sugar less than 200 mg/dl Any patient with active CNS tumor involvement Any patient who is pregnant or lactating Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised
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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): 0.083-18.0, Acute Respiratory Distress Syndrome Acute Lung Injury All intubated and mechanically ventilated patients on the Medical-Surgical Intensive Care Unit will be screened for the following 1. Age: 44 weeks post conceptual age to 18 years 2. Acute Lung Injury (ALI): American European Consensus Committee definition of ALI 1. PaO2/FiO2<300 on ABG within past 6 hours, 2. Acute onset of bilateral infiltrates on chest radiograph, and 3. No evidence of left atrial hypertension 3. Sedation: Must be receiving neuromuscular blockade or demonstrating apnea due to sedation 4. Arterial line must be present 5. Conventional mechanical ventilation 6. Current PEEP levels between 5 and 15 cm H2O Meets the above for ALI for > 72 hours 2. Active hemodynamic instability 3. Prematurity (birth at post-conceptual age <37 weeks) 4. Clinically recognized airways disease (including viral bronchiolitis) 5. Uncuffed endotracheal tube in place 6. Congenital heart disease 7. Hemodynamically significant heart disease 8. Congenital diaphragmatic hernia 9. Recent (past 2 months) history of intrathoracic instrumentation (e.g., orthopedic instrumentation, cardiac pacemaker, thoracostomy) 10. Pulmonary fibrosis 11. Restrictive lung disease (other than acute lung injury/ARDS) 12. Cystic fibrosis 13. Severe pulmonary hypertension 14. Severe brain injury with no intracranial pressure monitor or external ventricular drain in place 15. Extra-corporeal life support
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Spinal Anesthesia patients aged 18 years and older urologic elective ambulatory procedure. For example:cystoscopy, circumcision,transurethral bladder tumor resection, varicocele and hydrocele surgery gynecologic elective ambulatory procedure. For example: hysteroscopy, vulvar ou vaginal biopsy general surgery elective ambulatory procedure. For example:inguinal herniorraphy, short ano-rectal procedure INR > 1,3 platelet < 75 000 concomitant drugs: clopidogrel (last dose < 7 days), iv heparin, low molecular weight heparin (last dose < 24 hours) neurologic disease: spinal stenosis, symptomatic lumbar herniated disc, multiple sclerosis liquid restriction (cardiac or renal insufficiency) allergy or intolerance to chloroprocaine, bupivacaine or PABA atypical plasma cholinesterase or deficiency
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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, Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up) Control Group: No known evidence of bladder cancer-one urine sample > than 18 years of age < than 18 years of age
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Retention Neurogenic Bladder Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City Able to complete study measurements alone or with the help of a family member or caregiver Able to communicate with the study personnel in English Have access to a telephone for data collection Terminally ill Cognitively impaired No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Urinary Incontinence, Stress The subject has agreed to be implanted with the AMS Male Transobturator Sling System. 2. The subject is willing and able to give valid informed consent. 3. The subject is > 40 years of age. 4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management. 5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day. 6. Internal sphincter contractility confirmed by endoscopic view. 7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy 8. Pre-existing urological conditions, other than incontinence have been treated and are under control. 9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. 10. The subject is a good surgical candidate The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods. 2. The subject has an atonic bladder. 3. The subject has a post-void residual > 75 cc. 4. The subject has detrusor-external sphincter dyssynergia. 5. The subject has a urinary tract infection (UTI). 6. The subject was treated with pelvic radiation within the last 6 months. 7. The subject currently has an inflatable penile prosthesis. 8. The subject self-catheterizes. 9. The subject has symptomatic or unstable bladder neck stricture disease. 10. The subject has a history of urethral strictures that may require repetitive instrumentation. 11. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents). 12. The subject has a history of connective tissue or autoimmune conditions. 13. The subject has a compromised immune system. 14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. 15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials
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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, Urethral Stricture Male urethral stricture suitable for internal urethrotomy Stricture length less than 10 mm Stricture length over 10 mm Benign prostate enlargement
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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 Provide signed informed consent prior to enrolment in the study 2. IPSS ≥ 15 3. Prostate Volume ≥ 30 mL ≤ 70 mL 4. Qmax < 15 mL/sec based on a minimum void of 125 mL 5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study History of illness or condition that may interfere with study or endanger subject 2. Use of prescribed medications that may interfere with study or endanger subject 3. Presence of a median lobe of the prostate 4. Previous surgery or MIST for treatment of BPH 5. Post-void residual urine volume > 200 mL 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL 7. Participation in a study of any investigational drug or device within the previous 90 days 8. 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): 50.0-999.0, Benign Prostatic Hyperplasia Is male > 50 years of age at Screening Has a normal digital rectal exam with the exception of prostate enlargement Has suffered from symptoms of BPH for at least the 6 months before Screening Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound Has a serum PSA concentration > 1.5 ng/mL and ≤ 10 ng/mL at Screening Has an IPSS > 13 at Screening and Baseline Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable) Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug Neurogenic bladder dysfunction Has bladder neck contracture or urethral stricture Has acute or chronic prostatitis or urinary tract infection Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10 ng/mL; patients with a PSA concentration > 4 ng/mL and ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator Has a residual void volume > 250 mL Has any clinically significant unstable condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma) Has a history of smoking more than 5 cigarettes daily within the year before Screening Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening
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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, Thoracotomy Sternotomy Written informed consent Thoracic surgery including thoracotomy and sternotomy Thoracic epidural analgesia Contraindications to epidural anesthesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 Pregnancy
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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, Prostate Cancer Bladder Cancer Erectile Dysfunction Incontinence Duke Urology patients None
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2
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-90.0, Prostatic Hyperplasia Subjects that will be included must be consistent with the approved label indication of Doxazosin mesylate GITS in the Philippines, which includes adult male diagnosed with BPH, and who are prescribed with Doxazosin mesylate GITS Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines
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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): 2.0-999.0, Bladder Exstrophy Urinary Incontinence Group 1 Males and females at least 2 years of age with Classic bladder exstrophy with successful primary, secondary, or delayed primary closure and subsequent epispadias repair Cystography done with 90 days preceding participant identification and at least 12 months after successful bladder closure demonstrating a bladder capacity less than 100cc. 2. Group 2 Males and females greater than 5 years of age with Classic bladder exstrophy with successful primary, secondary, or delayed primary closure and subsequent epispadias repair Previous bladder neck reconstruction At the time of participant identification, urinary incontinence defined as leakage of urine at night or leakage of urine at an interval of less than 3 hours in the daytime persisting at least 2 years after bladder neck reconstruction. 3. Screening labs obtained less than 30 days prior to MDC injection meeting the following Urinalysis and urine culture demonstrating either no bacterial growth or growth of an organism that can be treated with an appropriate oral antibiotic for 7 days preoperatively. Participants with a positive urine culture should have the urinalysis and urine culture repeated after completion of antibiotics and prior to MDC injection. A negative urine culture must be demonstrated prior to MDC injection Serum creatinine in normal range for age (Infant: 0.2-0.4 mg/dl; Child 0.3-0.7 mg/dl; Adolescent 0.5-1.0 mg/dl) Urodynamic study demonstrating severe uninhibited bladder contractions. 2. Severe urethral or bladder neck stricture demonstrated during screening cystoscopy or cystogram 3. Cystography at the time of screening demonstrating Grade IV vesicoureteral reflux (high-grade reflux with dilation of the renal pelvis and blunting or the fornices) or Grade V vesicoureteral reflux (Grade IV findings plus loss of the papillary impression and ureteral tortuosity). 4. Any degree of renal scarring at the time of screening as demonstrated by DMSA or MAG3 renal scintigraphy in the presence of any grade of vesicoureteral reflux (VUR) 5. Renal ultrasound demonstrating Society of Fetal Urology Grade III hydronephrosis (widely split renal pelvis, renal calices uniformly dilated, no parenchymal thinning) or Grade IV hydronephrosis (Grade III dilation plus parenchymal thinning). See Appendix D. 6. Previous injection of bulking agents at the level of the bladder neck (bovine collagen or 7. Positive urine culture resistant to preoperative oral antibiotic therapy 8. Need for chronic or pulse steroids or history of other congenital or acquired condition that results in immunocompromise 9. Previous adverse reaction to anesthesia
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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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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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 Incontinence Subject is a male IC user able to self-catheterise 2. Subject has used hydrophilic-coated ICs for at least 1 month 3. Subject is at least 18 years old. 4. Subject has provided informed consent Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease). 2. Subject has known abnormalities in the lower urinary tract
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1
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 18.0-999.0, Urinary Tract Infections Urinary Tract; Accessory Inpatient with a permanent urinary catheter (balloon catheter) Urinary catheter placed in the hospitalization (previous day) or at admission Urinary tract infection diagnosis at time of the insertion Spinal cord injury or neurogenic bladder at admission
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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): 45.0-90.0, Benign Prostatic Hyperplasia BPH was diagnosed by DRE, Ultrasonography, CT or MR IPSS:>15 Qmax:≤10ml/s and volume of bladder >200ml The weight of prostate >45g Patient with other aggravating malignant tumor Total-PSA>20ng/ml, or 4<total-PSA<20ng/ml but the value of Free-PSA/total-PSA<0.16 The maximum press of detrusor muscle <15cmH2O Patient with urethral stricture Patient with urinary infection Patient with Nervous System Disease Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on
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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, Hemodialysis Catheter Blood Stream Infection Central Line Infection Dialysis Line Thrombosis Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids
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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): 16.0-120.0, Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Histologically confirmed transitional cell carcinoma of the urothelium Pure or mixed histology Upper or lower urinary tract Radiologically evaluable* locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy, meeting any 1 of the following T4b, any N, any M Any T, N2-3, any M Any T, any N, M1 NOTE: *Patients enrolled in the phase II portion of the trial must have radiologically measurable disease No transitional cell cancer for which subsequent radical treatment is being considered with a view to possibly cure the disease No history of CNS metastases
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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, Advanced Solid Tumors Adenocarcinoma of the Prostate Each participant must meet all of the following to be enrolled in the study years or older Histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment Measurable or evaluable disease is required. Participants must have clinical evidence of progressive disease or persistent disease Participants with castration-resistant prostate cancer (CRPC) are required to have Pathologically confirmed adenocarcinoma of the prostate Evidence of metastatic disease on bone scan or other imaging. Participants with prostate-specific antigen (PSA) elevation as the only manifestation of disease are not eligible Progressive disease after at least 1 hormonal treatment with documented testosterone levels less than 50 ng/dl Concurrent use of an agent for testosterone suppression (e.g., luteinizing hormone-releasing hormone [LHRH] agonist) is required if the participants has not been surgically castrated Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Participants meeting any of the following are not to be enrolled in the study Female participants who are lactating or pregnant Antineoplastic therapy or any experimental therapy within 21 days before the first dose of alisertib Prior or current investigational therapies within 4 weeks before the first dose of MLN8237 Concurrent investigational treatment of treatment with any investigational products within 28 days before the first dose of alisertib Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib Autologous stem cell transplant within 3 months before the first dose of alisetib, or prior allogeneic stem cell transplant at any time Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Present at screening with a history of benign prostatic hyperplasia (BPH) for >6 months Have an International Prostate Symptom Score (IPSS) greater than or equal to 13 at screening Have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (mL) at screening Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (mL/sec) (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening Have a prostate-specific antigen (PSA) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/mL) at screening Demonstrate a Post Void Residual less than or equal to 300 mL by ultrasound at screening Have not received the following treatments within the specified time period: 1. Finasteride or dutasteride for at least 6 months prior to screening. 2. Any alpha-adrenergic antagonists for at least 4 weeks prior to screening. 3. Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to screening. 4. Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening. 5. Any overactive bladder treatment for at least 4 weeks prior to screening. 6. Any Erectile Dysfunction treatment which may oral phosphodiesterase type 5 inhibitors or devices for at least 4 weeks prior to screening Have a morning fasting Total Testosterone concentration greater than or equal to 300 nanogram/deciliter (ng/dL) at screening If hyperlipidemic, based on history, be stable on statin treatment as determined by the investigator for at least 2 months prior to screening Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307 Have any history of BPH-related invasive procedures (for example, Transurethral Resection of the Prostate, open prostatectomy, and minimally invasive procedures that thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents) Have active cardiovascular disease as evidenced by the following: 1. Recent Myocardial infarction, unstable angina, stroke or Transient ischemic attack within 6 months of screening. 2. Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening. 3. Recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening. 4. Evidence of heart disease categorized as greater than or equal to Class III functional classification of New York Heart Association (NYHA) within 6 months of screening Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin) Have a history of deep venous thrombosis or pulmonary embolism disease Have moderate to severe renal insufficiency Have a hemoglobin A1c (HbA1c) greater than 9.0% Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis Are on pharmacological treatment other than statins for hyperlipidemia
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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, Alcoholism Be at least 18 years of age. 2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence. 3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking. 4. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 5. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. levonorgestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, 9. hormonal vaginal contraceptive ring, and/or 6. Be able to take oral medication and be willing to adhere to the medication regimen 7. Complete all assessments required at screening and baseline. 8. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 9. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study. 10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document. 11. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation
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0
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This is a 78 year-old male with h/o BPH s/p multiple urological procedures, including s/p Suprapubic prostatectomy. He was noted to have low urine output and bladder scan showed 360cc residual. It was impossible for staff to pass a foley. Urology was consulted, performed a flexible cystoscopy in the ICU and found severe 2cm bulbar urethral stricture. They were able to pass small catheter through and left in place. The patient leaked around the catheter, the catheter eventually came out but he continued to have good urine output and post-void bladder scans were performed q4h to ensure he did not have high residual volume. Urology suggested that when patient is stable he will have to be taken to the OR to have the stricture surgically fixed.
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eligible ages (years): 40.0-999.0, Overactive Bladder Lower Urinary Tract Symptoms Community-dwelling men 2. Age 40 years or older 3. Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary Urinary flow rate < 8.0 mL/sec on a void greater than 125 ml. 2. Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate). 3. Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture). Patients will be referred for treatment with antibiotics and may be enrolled if OAB symptoms persist after the infection is resolved. 4. Transurethral resection of the prostate (TURP), simple prostatectomy, or other benign prostatic hypertrophy (BPH) related surgery within the past 5 years. 5. Current active treatment for prostate cancer. 6. History of radical prostatectomy. 7. Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device. 8. Poorly controlled diabetes (glycosylated hemoglobin >9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately. 9. Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated. 10. Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam). 11. Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis. 12. Impaired mental status. Patients who screen as probable dementia on the Mini-Cog. 13. Contraindications to the study drugs (tolterodine and tamsulosin) including history of postural hypotension with syncope, history of acute urinary retention requiring catheterization, narrow angle glaucoma, or history of gastric retention. 14. Hypersensitivity to tolterodine or tamsulosin. 15. Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks. 16. Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks. 17. If on a diuretic, dose has not been stable for at least 4 weeks. 18. If taking dutasteride or finasteride, dose has not been stable for at least 6 months. 19. If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed. 20. Full course of behavioral training
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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, Colorectal Cancer All patients at Stanford Hospital undergoing anterior resection sigmoid colectomy low anterior resection abdomino-perineal resection total proctocolectomy with ileal pouch-analanastomosis coloanalanastomosis Patients with history of neurogenic bladder who had indwelling catheters or required intermittent straight catheterization prior to 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, Urethral Strictures Men over 18 years old with urethral stricture S/P urethral reconstruction Posterior urethral strictures Children
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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): 0.0-999.0, Prostatic Neoplasms, Prostatectomy Patients must have localized or locally advanced prostate cancer Patients must receive robot assisted laparoscopic radical prostatectomy Patients must be able to provide written informed consent Patients must not have a history of treatment with alpha blockers within 4 weeks Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate Patients must not have previously been diagnosed with neurogenic bladder Patients must not have hypersensitivity to trial drug or other alpha-blockers Patients must not have the participation of other clinical trial within the past 3 months
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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, Analgesia, Epidural Urodynamics Urinary Retention Written informed consent Open kidney surgery with lumbotomy Thoracic epidural analgesia International Prostate Symptom Score (IPSS) < 7 Preoperative residual urine volume < 100ml Contraindications to epidural analgesia or refusal Preoperative residual urine volume > 100ml International Prostate Symptom Score (IPSS) > 7 Pregnancy
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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): 55.0-85.0, Coxarthrosis Arthroplasties Hip Replacement Perioperative Blood Loss Indication for THA because of primary and secondary osteoarthritis of the hip male or female patients of the age of 55 years informed consent afer having been informed in detail about the clinical trial by the investigator negative pregnancy test (<= 2 days before inclusion) for women with child bearing potential (pre menopausal, <2 years menopausal, not surgically sterile), use of high security contraception methods as oral contraception agents or preservatives. The use of high security conception methods is also to obligatory for male patients Known hypersensitivity to one of the two investigational medical products or substaces of similar chemical structure or to any of the excipients Patients who have experienced bronchospasm, asthma, acute rhinitis, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors unexplained dysfunction of haematopoiesis treatment with NSAIDs or coxiben in the past 5 days before start of study Active peptic ulceration or active gastro-intestinal (GI) bleeding Pregnancy and lactation Congestive heart failure (NYHA II-IV) Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease clinically relevant disease of the cardiovascular system, severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10), severe renal dysfunction (estimated renal creatinine clearance <30 ml/min, clinical relevant disease of the nervous system, the endocrinium or another severe systematic disease Systemic lupus erythematodes or mixed connective tissue disease
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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): 0.0-24.0, Ductus Arteriosus, Patent Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support. - Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 μmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites. -
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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 Is at least 50 years old Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher Has a QoL score of 3 or higher Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec Has a PRV of below 100mL Voluntarily decides to participate in this trial and sign with informed consent form Has been administered silodosin Has been administered an α1A-adrenoceptor blocker within one month Has been prescribed antiandrogens except 5α-reductase inhibitors within a year Has had phytotherapy within 3 months Has had prostatectomy Has had intrapelvic radiation therapy Has had transurethral microwave hyperthermia of transurethral needle ablation Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI) Is conducting self-catherterization Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
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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, Portal Hypertension. Liver Cirrhosis Liver cirrhosis diagnosed by previous biopsy or by clinical, laboratory, ultrasound Portal hypertension gradient between6 mmHg and10 mmHg Absence of esophageal and gastric varices or small esophageal varices without red signs Absence previous episodes of gastrointestinal hemorrhage, ascites, encephalopathy or jaundice Written informed consent Age <18 and> 80 years Presence or history of ascites, clinical or ultrasound Previous decompensation of liver cirrhosis, ascites or SBP, bleeding varices, large varices, hepatic encephalopathy, jaundice Thrombosis splenoportal Hepatocellular carcinoma Child-Pugh >7 point Any comorbidity that leads to a restriction therapy and / or a life expectancy <12 months Absolute contraindication to treatment with statins or allergy Simvastatin Concomitant potent CYP3A4 inhibitors (eg., itraconazole, ketoconazole, protease inhibitors, HIV, erythromycin, clarithromycin, telithromycin and nefazodone) Pretreatment (<1 month) with simvastatin or other lipid-lowering
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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, Delayed Graft Function Males and females ≥ 18 years of age 2. Had renal transplantation due to end stage disease requiring chronic dialysis 3. Study drug can be administered within 36 hours after transplantation 4. Received kidney from healthy donor or donor with history of diabetes mellitus or hypertension 5. Donor terminal serum creatinine ≤ 2.2 mg/dL. 6. No urine output, OR average urine output of < 50 cc/H over 8 or more consecutive hours, OR normal urine output following transplantation that diminished to average of < 50 cc/H over 8 or more consecutive hours, OR creatinine reduction ratio at 24 hours after transplantation to pre-transplantation is < 30%. 7. Reason for low urine output is unlikely due to structural changes. If clinically indicated, an ultrasound will be performed 8. Dry weight to< 120kg and BMI <35 9. Women of child bearing potential have a negative serum pregnancy test prior to transplantation. 10. Women of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year) must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the 28-day study period. Men must agree to use condoms during the 28-day study period. 11. In the opinion of the investigator, the subject is capable of understanding and complying with the protocol. 12. Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure Subject with normal urine output and not requiring dialysis prior to renal transplantation (i.e., had pre-emptive renal transplantation). 2. Signs and symptoms of volume depletion. 3. Recipient of multiple organ transplantation or scheduled for multiple organ transplantation. 4. Recipient of pediatric en-bloc kidney transplantation. 5. Recipient of kidney with cold ischemia time > 40 hours 6. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy. 7. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment into this study. 8. Concurrent sepsis or active bacterial infection. 9. Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed. 10. Women of child bearing potential who are breast feeding. 11. History of positive HIV test. 12. History of rheumatoid arthritis. 13. Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®) 14. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel. 15. Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist
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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, Postoperative Retention of Urine Postoperative Urinary Tract Infection All general thoracic surgery patients with a thoracic epidural catheter Men > 65 years old History of urologic procedure Known benign prostatic hyperplasia Admission to intensive care units History of urinary retention Foreign speaking patient Pregnant women and those less than 18 years old
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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, Urinary Tract Infections Patients undergoing hip fracture surgery or hip replacement due to arthrosis Age 50 years and above Patients with an indwelling catheter in situ Cognitive impairment
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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, Prostatic Hyperplasia Male aged 50 years or older a diagnostic claim of BPH prescription claim for a 5ARI for at least 60 days during the observation period continuously eligible for 6 months prior to and at least 6 months after index date prostate cancer any prostate-related surgical procedure prior to index date
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1
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