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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Male gender Diagnosis of symptomatic BPH Age ≥ 45 years International Prostate Symptom Score (IPSS) ≥ 13 Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml Prostate volume ≤ 80 cc per ultrasound Current urinary retention Post void residual (PVR) urine > 250 ml Have an obstructive or protruding median lobe of the prostate Active urinary tract infection at time of treatment Current gross hematuria Previous BPH surgical procedure Previous pelvic surgery or irradiation History of neurogenic or atonic bladder Stress urinary incontinence Biopsy of the prostate within the past 6 weeks
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 35.0-65.0, Stroke, Subacute Hemiplegic affected side spastic <3 on the Ashworth scale History of stroke should be > 6 weeks and <12 weeks Individuals with the other neurological deficit Diabetic ulcer, infection or amputation of limb Serious cardiovascular disease or unstable angina Serious orthopedic problem Chronic medical problems
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Hemodialysis Complication Acute Kidney Injury Anticoagulant Toxicity All patients with acute kidney injury admitted to the intensive care unit and candidates for extended dialysis (renal replacement therapy) Age over 18 years Acute liver failure Hemorrhagic stroke in the last 30 days Patients with platelet levels below 20,000/mm3 Active bleeding requiring transfusion (two or more red blood cell packs within 24 hours)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 25.0-45.0, Urinary Incontinence,Stress stress urinary incontinence (confirmed by a medical examination) female age between 25 and 45 years old gynecological, spinal, and abdominal surgery (excluding cesarean delivery) menopause spinal and pelvis injuries chronic diseases of the circulatory and respiratory system neurlogical accidance
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Peripheral Artery Thrombosis Embolism Limb Ischemia Deep Vein Thrombosis Hemodialysis Access Thrombosis Peripheral Vascular Disease Patient has been treated for acute/sub-acute thrombosis in the peripheral vascular system with any of the JETi® Peripheral Thrombectomy System Catheters Patient has provided appropriate consent/authorization per the site's institutional policy and procedure Age ≥ 18 years Patient has previously been enrolled in JETi Registry in the last 12 months Current participation in another drug or device trial
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Gastric Cancer Colorectal Cancer Bladder Cancer Patients who are scheduled for gastric tumor, colorectal tumor or bladder tumor resection Signed informed consent the vital signs are not stable unconscious unwilling to cooperate
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Males over 50 years of age at the time of enrollment 2. Referred to urology for refractory LUTS secondary to BPH 3. Prostate size on preoperative TRUS of 40-80 ml 4. IPSS >15, QOL score ≥3 and Qmax <15 ml/sec 5. Written informed consent to participate in the study 6. Ability to comply with the requirements of the study procedures Previous surgical treatment for BPH 2. Presence of bladder stones 3. History of prostate cancer 4. Prostate size > 80 mL or <40 mL 5. History of urethral stenosis or its management 6. Known or suspected neurogenic bladder 7. Participants with active urinary tract infection until appropriately treated 8. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. 9. Participants who are uncooperative or cannot follow instructions. 10. Participants who lack the capacity to provide free and informed written consent
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer PSA Patients with elevated PSA (>3 ng/mL) Signed informed consent Patients that have a cystitis (bladder infection) Patients under chemotherapy Patients using 5-alpha reductase inhibitors History or presence of cancers, or non-prostate urological disorders
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 12.0-999.0, Urinary Tract Infections Patients with a urinary tract infection in general practice Age > 12 years
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 30.0-55.0, Lower Urinary Tract Symptoms male between the ages of 30 and 55 when signing the informed consent form the subject was diagnosed with mild to severe non-neurogenic lower urinary tract symptoms and planed to receive Tamsulosin therapy the sum of International Prostate Symptom Score (IPSS) on questions 1 to 7 was 10 points or higher the subject can take medication via oral or nasogastric tube confirmed with the function of absorption by the principal investigator or co-principal investigators the subject was willing to corporate study-related procedures and sign the informed consent form post-void residual urine volume greater than 200 mL or peak of maximum urine flow rate less than 5 mL/s total serum prostate-specific antigen higher than 10 ng/mL bladder outlet obstruction caused by reasons other than benign prostatic hyperplasia lower urinary tract symptoms caused by neurological disease such as Cerebrovascular Diseases, Parkinson's, dementia, Multiple Sclerosis (MS), spinal cord injuries (SCI), cauda equina syndrome, and Peripheral Neuropathy history or evidence of prostate cancer, male reproductive cancers, bladder cancer, and cancer of the ureter and urethra history or evidence of acute urinary retention (AUR) history or evidence of acute orthostatic hypotension with the urinary catheter or intermittent catheter stone in the urinary system Interstitial cystitis (IC), neurogenic bladder, overactive bladder (OAB) and Inflammatory Bowel Disease (IBD) within 3 mo prior to study entry
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Acute Heart Failure Hospitalized with worsening HF or de novo diagnosis of HF LVEF < 50% Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics Cardiogenic shock Systolic Blood Pressure <85 mmHg Acute myocardial infarction other than type II <5 days prior to randomization * Severe uncorrected cardiac valve disease Expected or possible need for hemodialysis as judged by the investigator Ongoing inotropic treatment Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator Ongoing, severe infection Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated) Atrial Fibrillation with heart >120 beats per minute
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Age>18 years COVID-19 confirmed with RT-PCER and/or chest CT-scan Acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke age<18 Other neurovascular diseases
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-80.0, Urine Detectable Acute and Chronic Diseases Men and women 18-80 years of age Subjects who are healthy or pregnant; or Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite Subject is capable and willing to provide informed consent Subject has facility with both hands Subject is capable and willing to adhere to the study procedures
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-80.0, Stroke first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory early subacute phase of stroke (between 1 and 4 weeks after stroke onset) electroencephagraphy feature is not usable Fugl-Meyer Assessment of Upper Extremity score is over 50 ataxia global aphasia concomitant neurological diseases psychiatric diseases participating in other interventional research during this period other conditions might interfere with experiment
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-80.0, Urine Detectable Acute and Chronic Diseases Men and women 18-80 years of age Subjects who are healthy or pregnant; or Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite Subject is capable and willing to provide informed consent Subject has facility with both hands Subject is capable and willing to adhere to the study procedures
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 55.0-999.0, Benign Prostatic Hyperplasia American Urological Association Symptom Score of eight or higher Maximum urinary flow rate of 10ml/s or less Post void residual urine volume of 50 ml or more And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS) A previous prostate or urethral surgery And non-BPH related voiding disorders Prostate cancer patients
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Vitamin D Deficiency Age between 18 and 70 years HD level is no more than 16 ng/ml Postmenopausal state or adequate contraception in female patients Willing and able to give legal informed consent for study entry Severe endocrine or metabolic disease, significant metabolic bone disease (except primary age-related osteoporosis) significant obesity (BMI >36 kg/m2) hypercalcemia at screening or within one year (seCa > 2.60 mmol/l) long standing hypercalciuria, kidney stones within 2 years sever kidney injury (KDIGO CKD 3 or more) chronic disease which significantly affects bone metabolism, vitamin D metabolism or calcium absorption significant malabsorption that affects calcium metabolism heart failure or angina pectoris alcohol or drug abuse daily vitamin D intake is more than 1000 IU within 2 months
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Covid19 Normal, healthy adults aged 18 to 65 years Allergy to Heparin Currently taking any prescription blood thinners or anti-coagulants, or currently taking any intranasal medication Known history of anemia, thrombocytopenia, or other blood disorder Autoimmune disorders Known history of Neurologic/Psychiatric disorders Report of an active infection Subject is pregnant or breast-feeding, or is expecting to conceive during the study. NOTE: Subjects will be instructed to abstain from alcohol for the duration of the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-90.0, Prostate Hyperplasia Prostatic Hypertrophy Surgery Bladder Outlet Obstruction Quality of Life Complication of Surgical Procedure Selection Men over 50 Patients receiving HoLEP due to an enlarged prostate Patients who fully understood and agreed to the study Patients with neuropathy that may adversely affect the urination function (Parkinson's disease, dementia, etc.) Patients with acute urinary lung disease within the last month Patients with symptomatic urinary tract infection In case there are other factors that can significantly affect treatment results at the discretion of the researcher
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-100.0, Prostatic Neoplasms age between 40 and 100 years old PSA >0.4 ng/mL for primary PCa with biopsy proven or RP diagnosis of prostate cancer PSA >0.2 ng/mL after RP, PSA ≥2 ng/mL above the nadir after EBRT) or persisting PSA after radical treatment with rising PSA values complete clinical, pathological, imaging and biochemical information lack of histological examinationproven diagnosis of PCa 18F-PSMA PET/CT being performed after pharmacotherapy since PSMA-targeted imaging can be disturbed by previous therapie
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-100.0, Benign Prostatic Hyperplasia Adult males (18-year-old and more) Suffering bothersome LUTS or urinary retention secondary to BPH Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder) Not competent to give consent and/or inability to provide answers to the questionnaire Patient who refuse to participate in the study Patients without a median lobe Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound prostate sizing) Patients who have renal impairment secondary to BPH Patients with proven or suspicion of prostate cancer based on clinical examination and/or PSA level Patients with refractory hematuria secondary to BPH Patients with urethral strictures Patients with bladder cancer
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Lymphoblastic Leukemia, Acute, Adult Ph Negative ALL Newly Diagnosed Age 18-65 years Lymphoblasts positive for CD19 Eligible to intensive chemotherapy, due to general health status With newly diagnosed B-precursor-ALL Without BCR-ABL fusion by FISH analysis and/or RT-PCR Blasts expressing the CD19 antigen by flow cytometry Previously untreated ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 Diagnostic sample of bone marrow (or peripheral blood with >50% of blasts) available for central MRD assessment Written informed consent obtained prior to any screening procedures History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for Malignancy treated with curative intent and with no known active disease present for 5 years before enrollment and felt to be at low risk for recurrence by the treating physician Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated cervical carcinoma in situ without evidence of disease Adequately treated breast ductal carcinoma in situ without evidence of disease Prostatic intraepithelial neoplasia without evidence of prostate cancer History or presence of central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis Persisting ALL in the CNS at the end of run-in period; patients with initial cerebrospinal fluid (CSF) infiltration arriving into CSF negativity after up to 4 intrathecal applications of chemotherapy within the first 10 days of therapy are allowed for the study Current autoimmune disease or history of autoimmune disease with potential CNS involvement Active known hepatitis B virus (HBV) or hepatitis C virus (HCV) or positive HIV serology
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-99.0, Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia Patients to be included in the study will be either: 1. diagnosis of BPH based on abdominal ultrasound or digital rectal examination. 2. Moderate IPSS Score between 8 : 19. 3. severe IPSS Score between 20 : 35. 4. post void volume > 100 c. 5. prostate size 50 to 80 gm. 6. 2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment. 7. mental and physical capacity to understand and fill out the study questionnaires contraindications to Sildosin or Tadalafil. 2. diagnosis of prostate cancer. 3. possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention. 4. clinically significant cardiovascular, hepatic, or renal disorders. 5. cataract surgery planned during the study period
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Hyperplasia Patients superior or equal to 18 years old Benign Prostate Hypertrophy ( more than 30cc.) Indication to surgical treatment No contraindication for surgery No opposition to participating in the study Evidence of urethral stenosis Evidence of a bladder tumour Evidence of prostate cancer known or confirmed by prostate biopsies if suspected Known neurological bladder Refusal to participate
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-64.0, Healthy Aged between 45 and 64 Generally Healthy BMI between 18.5 and 27 All drugs taken on a daily basis Diabetes or pre-diabetes Digestive dysfunction Pregnancy or lactation Allergy to the supplement Participate in an intensive physical exercise training (more than three times a week) Being on a ketogenic diet or consumption of ketogenic supplement More than 2 alcoholic beverages each day Any clinically significant anomaly in the blood profile Smoking
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours ≥18 Years Old prior episode of DVT contraindication to standard therapeutic anticoagulation
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Spinal Cord Injuries Neurogenic Bladder Neurogenic Bowel Spinal Cord Stimulation Sexual Dysfunction, Physiological A participant must meet all of the following in order to be eligible for 1. Resident of British Columbia, Canada with active provincial medical services plan 2. Male or female, 18-65 years of age 3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment. 4. >1-year post injury, at least 6 months from any spinal surgery. 5. Documented presence of bladder dysfunction (NDO during UDS) 6. Documented presence of bowel or sexual dysfunction. 7. American Spinal Injury Association Impairment Scale (AIS) A, B. 8. Greater than or equal to antigravity strength in deltoids and biceps bilaterally 9. Hand function sufficient to perform Clean Intermittent Catheterization (CIC) or a committed caregiver to provide CIC for management of urinary bladder drainage. 10. Participants must have documented three days of bladder and bowel history prior to their baseline visit. 11. Willing and able to comply with all clinic visits and study-related procedures. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator). 12. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities. 13. Stable management of spinal cord related clinical issues (i.e., spasticity management). 14. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: 15. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events. Women of childbearing potential must agree to use adequate contraception*~2~* during the period of the trial and for at least 28 days after completion of treatment. 16. Effective contraception includes abstinence. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment. 17. Must provide informed consent A participant who meets any of the following will be ineligible to participate: 1. Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications [tricyclics]; or unstable diabetes. The following conditions apply: 1. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min) 2. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin [total]; GGT) as judged by the investigator. 2. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit) 3. Ventilator dependent 4. Clinically significant depression or ongoing drug abuse 5. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study. 6. Intrathecal baclofen pump. 7. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones. 8. Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive TCSCS. 9. Severe anemia (Hgb<8 g/dl) or hypovolemia 10. Participant is a member of the investigational team or his /her immediate family. 11. Participant has undergone electrode implantation surgery
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Colon Cancer Stage I UICC stage 1 colon cancer ASA score min. 3 and/or WHO PS score min. 1 CELS eligible resection Biopsy show adenocarcinoma or suspicious lesion No preop chemo or radiotherapy Accept Hereditary cancer Rectal cancer Radiation downstaging
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Oligometastatic Prostate Cancer Able to provide informed consent European Cooperative Oncology Group performance status 0 to 2 Medically fit for all protocol treatment and follow-up Histologically confirmed adenocarcinoma of the prostate Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases No prior therapy for prostate cancer apart from androgen deprivation Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization If used, anti-androgens must have started within 26 weeks of randomization Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA, Transrectal ultrasound-guided biopsy, CT or MRI abdomen and pelvis, Bone scan) Planned for long-term androgen deprivation therapy High metastatic burden defined as 5 or more bone metastases or visceral metastases Abnormal liver function Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation Medically unfit for anesthesia International Prostate Symptom Score (IPSS) greater than 20 Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available) Prostate volume greater than 60cc after maximal cytoreduction Pubic arch interference Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Gram Negative Infections more than or equal to 18 years of age 2. Admitted to hospital with documented gram negative infection 3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management The patient is enrolled in any clinical trial of an investigational product 2. Age <18 years 3. Received Ceftazidime avibactam for less than 48 hours. 4. Patient with documented Acinetobacter infection. 5. Patient was a part of named access program or any other interventional study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer Patients aged ≥ 18 years. 2. Histologically or cytologically confirmed prostate adenocarcinoma. 3. Prior radical prostatectomy or definitive radiation. 4. Biochemically recurrent prostate cancer with PSA doubling time ≤ 12 months at the time of study entry (calculated per Memorial Sloan Kettering Cancer Center (MSKCC) prostate nomogram: https://www.mskcc.org/nomograms/prostate/psa_doubling_time). Calculation of PSA doubling time should the use of all available PSA values obtained within the past 12 months prior to randomization, with a minimum of three values separated by at least two weeks apart. The PSA values used to calculate the PSA doubling time must all be ≥ 0.1 ng/mL and should be measured in the same laboratory whenever feasible. 5. Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient comorbidities. (N/A for patients who underwent definitive radiation therapy). 6. Screening PSA > 0.5 ng/mL. 7. No definitive evidence of metastases on screening computerized tomography scan (CT) or magnetic resonance imaging (MRI) of abdomen/pelvis and radionuclide whole-body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 1.5 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. prostate specific membrane antigen (PSMA) or choline positron emission tomography (PET)) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated. 8. Screening serum testosterone > 150 ng/dL. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 or Karnofsky Performance Status ≥ 70. 10. No prior Janus Kinase 2 (JAK2) inhibitor treatment. 11. Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent 12. Ability to understand a written informed consent document, and the willingness to sign it. 13. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan. 14. Willing to provide blood and tissue for research analysis. (encouraged but not necessary for in trial). 15. Adequate organ function as defined by the following laboratory values at screening Serum aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) < 2.5 x upper limit of normal (ULN) Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, the subject may be eligible) Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed Estimated glomerular filtration rate (GFR) > 45 ml/min using Cockroft-Gault equation Platelets ≥ 100,000/mL independent of transfusion and/or growth factors within three months prior to randomization Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within three months prior to randomization Absolute neutrophil count ≥500/µL Serum albumin ≥ 3.0 g/dL Adequate coagulation defined by prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1x.5 ULN Previously treated with pacritinib. 2. Prior systemic treatment with androgen deprivation therapy and/or first-generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior androgen deprivation therapy (ADT) and/or first-generation anti-androgen in the (neo)adjuvant, definitive and/or salvage setting in conjunction with radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to the date of randomization and the total duration of prior therapy is ≤ 36 months. 3. Prior treatment with 17α-hydroxy / 17,20-lyase (CYP17) inhibitor (e.g., ketoconazole, abiraterone acetate, galeterone) or next-generation androgen receptor antagonist including apalutamide or enzalutamide. 4. Prior chemotherapy for prostate cancer except if administered in the neoadjuvant or adjuvant setting and last dose <= 6 months from randomization. 5. Use of 5-alpha reductase inhibitor within 42 days prior to randomization. 6. Use of investigational agents within 28 days prior to randomization. 7. Use of other prohibited medications within seven days prior to Cycle 1 Day 1 on study (see Appendix 3 and 4 for list of prohibited medications). 8. Systemic treatment with a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or a strong cytochromes P450 (CYP450) inducer within 14 days prior to treatment Day 1 (Appendix 3 and Appendix 4, respectively) 9. Prior bilateral orchiectomy. 10. Uncontrolled hypertension. 11. Baseline severe hepatic impairment (Child-Pugh Class B & C). 12. An intercurrent illness that is not controlled, such as active infection, psychiatric illness/social situations that would limit compliance with study requirements. 13. Any chronic medical condition requiring a higher dose of corticosteroid than an equivalent of 10 mg prednisone/prednisolone per day. 14. Significant recent bleeding history, as defined as National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) grade≥2 within three months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury) 15. Systemic treatment with medications that increase the risk of bleeding, including anticoagulants (warfarin, direct oral anticoagulant, etc.), antiplatelet agents (except for aspirin dosages of ≤ 100mg/day), vascular endothelial growth factor (anti-VEGF) agents, and daily use of COX-1 inhibiting nonsteroidal anti-inflammatory agents (NSAIDs) within 14 days prior to treatment Day 1. 16. Systemic treatment with medications that can prolong the time from the start of the Q wave to the end of the T wave (QT interval) within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with the approval of the principal incestigator, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1. 17. Any history of CTCAE grade ≥2 cardiac conditions within six months before treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for with the approval of the PI, if stable and unlikely to affect patient safety. 18. QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction]), or history of long QT interval syndrome. 19. New York Heart Association Class II, III, or IV congestive heart failure (Appendix 7). 20. Any active gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication. 21. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation. 22. Other malignancy within three years prior to treatment Day 1, other than curatively treated basal cell or squamous cell skin or corneal cancer; curatively treated carcinoma in situ of the cervix; or in situ breast carcinoma after complete surgical resection. 23. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements. 24. Known seropositivity for human immunodeficiency virus. 25. Known active hepatitis A, B, or C virus infection
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Prostate Cancer Histologically confirmed diagnosis of adenocarcinoma of the prostate Favorable risk disease defined as either Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50% Prostate volume < 60 cc as determined by US, CT or MRI Ability to undergo MR imaging Provide written informed consent Documented nodal or distant metastases Previous pelvic radiotherapy Previous transurethral resection of prostate, previous prostatectomy or HIFU Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15 Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Significant medical co-morbidity rendering patient unsuitable for general anaesthesia
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolism Patient hospitalized for more than 48 hours in a cardiology department with a discharge prescription for curative anticoagulation Indication for a direct oral anticoagulant for atrial fibrillation, deep vein thrombosis or pulmonary embolism Patients treated for the prevention of venous thromboembolic disease who have undergone scheduled total hip replacement or total knee replacement surgery Patient with cognitive impairment Patients with a previous prescription for a direct oral anticoagulant
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) Overactive Bladder willing to provide written informed consent men over 50 years with lower urinary tract symptoms and overactive bladder and benign prostatic hyperplasia persistence of overactive bladder despite 4 weeks of silodosin treatment symptoms of overactive bladder (urinary frequency and urgency with or without urinary incontinence) for ≥3 months prior to visit 1 willing and able to complete the 3-day voiding diary and questionnaires International Prostate Symptom Score (IPSS) score ≥8 experience an average of 8 or more micturition's per day over the 3-day diary period experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period willing to provide written informed consent men over 50 years with lower urinary tract symptoms and overactive bladder and benign prostatic hyperplasia persistence of overactive bladder despite 4 weeks of silodosin treatment symptoms of overactive bladder (urinary frequency and urgency with or without urinary incontinence) for ≥3 months prior to visit 1 willing and able to complete the 3-day voiding diary and questionnaires International Prostate Symptom Score (IPSS) score ≥8 experience an average of 8 or more micturition's per day over the 3-day diary period experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period post-void residual volume (PVR) >200 mL evidence of Urinary Tract Infection and haematuria
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Carcinoma Patients suspected with prostate cancer and planned to undergo prostate needle biopsy Patient with serum PSA test result Patient willing to provide morning urine sample before biopsy, and willing to provide patient information Participants without any tumor disease and willing to attend the study by providing morning urine Male patients aged >= 18 years Participants signed informed consent form Age under 18 years Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record Patient already received urethral catheterization Patient with late-stage uremia and need regular dialysis Patient with urothelial carcinoma or suspected urothelial carcinoma Suspected PC patient with endocrine therapy without histological results of the prostate PC patient after any related therapy: endocrine therapy, radiotherapy, radical operation, immunotherapy, chemotherapy, transurethral prostate surgery, cryoablation or other local therapy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma Urinary Bladder Cancer Urinary Tract Cancer CASES Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the group of cases Bladder cancer Urethral tumor Renal Pelvis Tumor Ureteral tumor The will be Age under 18 Pregnancy Lack of informed consent Persons with indwelling catheter Presence of prostate cancer Presence and / or history of renal cancer, except tumors of the renal pelvis Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the control group Kidney, ureteral or bladder stones BPH The will be
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-85.0, Lower Urinary Tract Symptoms Urinary Incontinence Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read Patients above 18 years old
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-60.0, Spinal Cord Injuries Neurogenic Bladder Neurogenic Bowel A participant must meet all of the following in order to be eligible for Resident of British Columbia, Canada with active provincial medical services plan Male or female, 18-60 years of age Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment At least 1-year post injury, at least 6 months from any spinal surgery American Spinal Injury Association Impairment Scale (AIS) A, B Able to tolerate an upright posture for 30 minutes (with or without breaks) Willing and able to comply with all clinic visits and study-related procedures Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator) No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-85.0, Rectal Cancer Retention, Urinary Urinary Tract Infections Surgical Site Infection Anastomotic Leak Patients undergoing programmed rectal surgery Age ≥ 18 years and <85 years Any type of tumor, any T, N, M Consent signed by the patient and the researcher IPSS> 20 Transanal local resection Urinary catheterization in the 7 days prior to surgery Patients taking treatment for benign prostatic hyperplasia Urine infection in the month prior to surgery Patients with chronic kidney failure with Creatinine> 2 mg / dL Enterovesical fistula Neurogenic bladder Patients with a sacral nerve stimulator or artificial sphincter Inability to read or understand any of the languages of informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-80.0, Benign Prostatic Hyperplasia (BPH) Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction 2. Subject is willing to be randomized 3. Subject is mentally capable and willing to sign a study-specific informed consent form 4. Subject is willing and able to comply with all study requirements 5. Age from 45 through 80 years 6. Subject has medical record documentation of a prostate volume up to 60mL (inclusive) by Transrectal Ultrasound (TRUS) (If TRUS testing documentation is available from less than 90 days prior to the informed consent date and the prostate volume is up to 60mL, it may be used for the inclusion/ ) 7. Subject has an IPSS urinary symptoms score greater than or equal to 13 measured at the baseline visit 8. Subject has medical record documentation of a maximum urinary flow rate (Qmax) ≤15mL/s and ≥5mL/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 120mL, and the Qmax is ≤15mL/s and ≥5mL/s, it may be used for the inclusion/ ) 9. Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery 10. History of inadequate response, contraindication, or refusal to medical therapy 11. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests 12. Normal Urinalysis and urine culture 13. Sexually active within 6 months before the index procedure 14. Sexual Health Inventory for Men score >6 15. Positive response to MSHQ-EjD (excluding the response ''Could not ejaculate'') 16. Incontinence Severity Index score >4 BMI ≥ 42 2. History of prostate cancer or current/suspected bladder cancer 3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds 4. Subjects with a history of actively treated bladder cancer within the past two (2) years 5. Neurogenic bladder as confirmed by urodynamics or other neurological disorder that affects bladder function 6. Diagnosis of polyneuropathy 7. Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size) 8. Active infection, including urinary tract infection 9. Prostatitis treated with antibiotics within 1 year of enrollment 10. Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g. nonbacterial chronic prostatitis) 11. Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture 12. Subject has damage to external urinary sphincter 13. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use 14. PVR > 250 mL 15. Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure 16. Subject has a history of intermittent self-catheterization 17. Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis 18. Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d) 19. Any severe illness that would prevent complete study participation or confound study results 20. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days prior to the date of informed consent, congestive heart failure NYHA IV), pulmonary disease or uncontrolled diabetes 21. Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent 22. Heart surgery, or cardiac arrest < 180 days prior to the date of informed consent 23. Participants using systemic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg) 24. Known illicit substance abuse 25. Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications 26. Dementia or psychiatric condition that prevents the participant from completing required follow up 27. Contraindication to general or spinal anesthesia 28. Previous pelvic radiotherapy 29. Participating in another investigational study that could affect responses to the study device 30. Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes 31. Subject is unwilling to accept a transfusion should one be required 32. Median lobe obstruction of the prostate as assessed by TRUS 33. Known allergy to nickel 34. Unwilling to report sexual function. Intraoperative Median lobe obstruction or any abnormal findings on cystoscopy at the time of implantation that can interfere with iTind implantation or TURP procedure
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-85.0, Male Urogenital Diseases Genital Diseases, Male Prostatic Disease Prostatic Hyperplasia Presence of Lower Urinary Tract Symptoms (LUTS) measure by International Prostate Symptom Scores (IPSS) greater than 9 Serum creatinine levels <1.5 ng/dl and GFR > 55 Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry, pressure flow studies or urodynamic investigation Post-void residual (PVR): ≤ 250 mL Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound Signed informed consent Previous invasive prostate intervention (TURP, laser, ablation, etc.) History of prostate or bladder cancer Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury Evidence of neurogenic bladder Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy Other conditions / status listed in full protocol
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Urologic Diseases All patients treated at the study sites, signed informed consent No consent to record medical history
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 35.0-90.0, Lower Urinary Tract Symptoms Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms Anyone with international prostate symptom score greater than or equal to 8 (moderate to severe lower urinary tract symptoms) Quality of life assessment greater than 3 Prostate volume greater than 40 cm3 Men >45 years old Indwelling urinary catheter secondary to benign prostatic hyperplasia or moderate-severe lower urinary tract symptoms Evidence of tortuous or severe atherosclerotic vessels on CT Neurogenic bladder <8 international prostate symptoms score Prostate volume less than 40cm3 History of prostate cancer
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, End Stage Renal Disease Over 18 years Anuric patients (residual urinary volume ≤ 100 mL/24 h) Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each) Without modification of their prescription in the last three months Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both Letter of acceptance to enter the protocol and a signed informed consent Under 18 years Active intake or intake in the last six months of immunosuppressants or systemic steroids Active autoimmune disease Evidence of active systemic infectious event at the time of or two weeks prior Diagnosis of neoplasia or active oncological disease Hypoalbuminemia (< 3.2 g/dL) Pregnancy or lactation Refusal to participate in the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-999.0, CKD PAD I: Patients 1. Age > 20 years old on the day of screening. 2. CKD patients with eGFR 15 < eGFR < 60 ml/min/1.73m2 in a stable status, creatinine elevated less than 0.3 mg/dL in at least 30 days before enrollment. 3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI < 0.9 (or documented by CT-angio, vascular duplex, etc.). II: Controls 1. Age > 20 years old on the day of screening. 2. With eGFR > 60 ml/min/1.73m2 3. No clinical PAD Baseline estimated glomerular filtration rates (eGFR) < 15 ml/min/1.73m2 according to MDRD equation. 2. Patients in severe malnutrition status, albumin less than 2.0 g/dL 3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin < 8 g/dL. 4. Peptic ulcer, esophageal varices, ileus or under fasting status 5. Previous gastrointestinal operation. 6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded. 7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission. 8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C. 9. Solid organ or hematological transplantation recipients. 10. Patients with oliguric kidney injury, as defined with less than 500 cc/day. 11. Evidence of obstructive kidney injury or polycystic kidney disease. 12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-100.0, Questionnaire Side Effects Antimuscarinics Overactive Bladder OAB symptoms according to ICS definition neurogenic bladder antimuscarinic treatment Treatment change between first evaluation and second evaluation (Test retest validity)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Idiopathic Normal Pressure Hydrocephalus for patients iNPH-diagnosis according to the international guidelines (2005) Planed for shunt surgery for patients Cognitive impairment that makes it impossible to participate Not able to walk 20 meters without walking aids (part 1) for healthy individuals > 60 years of age Subjectively healthy without any serious disease healthy individuals Visible gait or balance disturbance Dementia diagnosis
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-90.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused International Prostate Symptom Score (I-PSS) score 14 or greater Quality of Life (QoL) score ≥ 3 Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months Able to provide written consent Not participating in any other investigational drug or device studies • History of biopsy-proven prostate cancer Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis) Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure Allergy to iodinated contrast agents unless pre-treated by corticosteroids
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 25.0-75.0, Bladder Hypersensitivity Age > 18 years; 2. Signed informed consent; 3. The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant). 2. Convulsive attacks in the anamnesis; 3. Taking medications that may trigger the risk of seizures; 4. The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.) 5. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.) 6. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram); 7. The postvoid residual volume (more than 50 ml); 8. The concentration of prostate specific antigen (PSA) in the blood is more than 4.0 ng / ml; 9. The presence of urinary tract infection; 10. A history of cancer of the pelvic floor organs
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-85.0, Benign Prostatic Hyperplasia Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information Patient who does not meet the for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Intensive Care Unit Acquired Weakness Sepsis, Severe Being in the Intensive Care Unit Over the age of 18 Diagnosed with sepsis/ septic shock Under the age of 18 Pregnancy Having a cardiac pacemaker Amputated lower limbs Having severe venous insufficiency or major injuries to their lower extremities Having neuromuscular disease Malignancy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Prostate Hyperplasia Patients with benign prostatic hyperplasia with prostate size (60-100) grams Lower urinary tract symptoms (LUTS) not responding to medical treatment Recurrent prostatic bleeding Recurrent acute urinary retention Chronic urinary retention Patients with coagulation disorders Previous prostatic surgery Previous finasteride administration Bladder pathology (urinary bladder stones bladder mass) Suspected or proved cancer prostate Hepatic or renal impairment Patients unfit for operation eg. Decompensated heart failure, poor chest condition
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Patient Engagement Patient Preference men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease) have moderate-to-severe LUTS and/or poor quality of life (QOL) as assessed by the validated International Prostate Symptom Score (IPSS) of eight or more and/or its individual QOL score of three or more men of any local Asian ethnicity and were willing to provide written consent can communicate with their allocated PCP in either of the three main local languages; English, Mandarin or Malay have indwelling catheters urinary incontinence requiring diapers anuria due to any renal pathology gross hematuria acute urinary retention symptoms consistent with an acute urinary tract infection existing treatment of LUTS or other prostate pathology visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent men unwilling to discuss their LUTS treatment options with their PCP
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Neoplasm Neoplasm Metastasis Women of any age with clinical stage II breast cancer who met the following Patients with stage II breast cancer will primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]). Patients will be staged according to the 1986 AJCC TMM classification. Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III. Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin. Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI. Patients must be mentally competent to understand and give informed consent for the protocol. Estrogen receptor (ER) status can ER positive, negative, or unknown. Patients with prior cancers may be eligible as long as they have received curative therapy and have had no evidence of recurrence for greater than or equal to 10 years Patients will be excluded from this protocol for the following reasons: Advanced local disease or distant metastases (stage III or IV). Previous therapy to the breast other than excisional biopsy. Pregnancy. Unwillingness to use birth control during chemotherapy. Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Breast Neoplasms Women and men at increased risk for the development of breast cancer by at least one of the following Histologically documented ductal carcinoma in situ (DCIS), including DCIS with minimal invasion or microinvasion. Histologically documented lobular neoplasia, including lobular hyperplasia and lobular carcinoma in situ (LCIS). Histologically documented atypical ductal hyperplasia in postmenopausal women. Histologically documented atypical ductal hyperplasia in premenopausal women with 1 first-degree relative (mother or sister) diagnosed with breast cancer. Histologically documented atypical ductal hyperplasia in premenopausal women with 3 or more relatives diagnosed with breast cancer provided at least 1 is a second-degree relative. 3 or more first or second-degree relatives diagnosed with breast or ovarian cancer with at least 1 diagnosed with breast cancer. 2 or more premenopausal (under age 50) first-degree relatives diagnosed with breast cancer. 1 or more first-degree relatives diagnosed with breast cancer if at least 1 relative in the extended pedigree had ovarian cancer. 3 or more relatives with breast cancer with at least 1 first-degree relative diagnosed with premenopausal breast cancer. Previously diagnosed Stage I breast cancer with surgery and/or radiotherapy only (without prior adjuvant chemo or hormonal therapy). Positive for the BRCA1/BRCA2 gene. No history of other invasive breast cancer. No evidence of malignancy on breast and gynecologic exams. Participants with a family history of breast cancer will be seen in consultation by the Family Studies Branch, NCI. PRIOR/CONCURRENT Mastectomy or lumpectomy plus radiotherapy required prior to entry for patients with DCIS. Patients with DCIS who have participated in protocol NCI-MB-348 eligible. No participation in any other breast cancer prevention study involving pharmacologic intervention. No prior chemotherapy or hormonal therapy for invasive breast cancer. At least 3 months since estrogen or progesterone replacement therapy or hormonal contraceptives. Age: 35 and over. Performance status: Ambulatory. Life expectancy: At least 10 years. Hematopoietic: Complete blood count normal. Hepatic: Bilirubin normal. Alkaline phosphate normal. AST normal. PT, PTT normal. No history of bleeding disorder. No history of chronic hepatitis or cirrhosis. Renal:Creatinine less than 1.5 mg/dL. Cardiovascular: No history of deep venous thrombosis. No history of pulmonary embolus. Other: No allergy to any study medication. Capable of tolerating multiple diagnostic procedures. No history of abnormal vaginal bleeding. Hysterectomy for vaginal bleeding of benign etiology allowed. No history of retinal disease, macular degeneration, or night blindness. No medical or psychiatric risk due to nonmalignant systemic disease that would preclude study participation. No history of malignancy except: Curatively treated nonmelanomatous skin cancer. Curatively treated in situ cervical carcinoma. Hodgkin's disease treated more than 5 years ago. No pregnant women. Adequate contraception required of fertile patients during and for 12 months after fenretinide and for 2 months after tamoxifen
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 60.0-999.0, Breast Cancer Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable No prior axillary clearance or biopsy Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy) Hormone receptor status Not specified Age and over Sex Female Menopausal status Postmenopausal Performance status
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-120.0, Breast Cancer Adenocarcinoma of the breast with 1 or more histologically proven positive axillary nodes OR Adenocarcinoma of the breast with negative axillary nodes or adverse prognostic factors such that the patient is at high risk for recurrence and node negative lesion is characterized by the following features: Tumor at least 1 cm Poorly differentiated, SBR grade III, or MSBR grade V and/or lymphatic/vascular invasion Pathologic review by experienced breast pathologist recommended if grade is unspecified and lymphatic/vascular invasion is absent Disease considered potentially curable and treated by 1 of the following: Complete surgical removal of the breast plus axillary node dissection Partial surgical removal of the breast plus axillary node dissection, with the intention of giving breast irradiation following completion of an adjuvant chemotherapy regimen Regional nodal or chest wall irradiation not prohibited but strongly discouraged No evidence of residual tumor in the axilla following dissection No microscopic evidence of residual tumor at the resection margins following total mastectomy Further excision highly recommended if there is microscopic residual disease present at partial mastectomy margins If further excision is not undertaken, a radiotherapy boost to the tumor bed is required in addition to breast irradiation given following protocol chemotherapy Disease clinically staged prior to surgery as T1-T3a, N0-2, M0 No clinical T4 disease, i.e.: No extension to the chest wall No edema (including peau d'orange) No skin ulceration No satellite skin nodules confined to the same breast No inflammatory carcinoma Disease pathologically staged following surgery as TNM stage I, II, or III (T0-4; N0-2; M0) T4 allowed only with dermal involvement on pathology assessment No evidence of metastatic disease beyond the homolateral axillary nodes on pre-chemotherapy chest x-ray, bone scan (with radiographs of suspicious areas), and abdominal ultrasound (required only if bilirubin, alkaline phosphatase, or AST/ALT are elevated) Simultaneous bilateral breast carcinoma allowed Complete tumor resection on both breasts required Axillary dissection on both sides must meet as above if both sides are clinically node-positive Axillary dissection on the second side optional if the axilla is clinically negative at the time of surgery and the other side is node-positive Adjuvant chemotherapy must begin within 14 weeks of initial pathologic diagnosis Hormone receptor status: Any receptor level allowed (values must be available if biochemical method used; immunocytochemical assay permitted) Age: Not specified Sex: Female Menopausal status: Pre or perimenopausal, i.e., meeting at least 1 of the following Normal menstruation Amenorrhea for less than 1 year (up to 3 years in patients under age 52) Biochemical evidence of ovarian function Hysterectomy without bilateral oophorectomy in patients under age 56 Premenopausal women no greater than age 50 who were started on replacement hormone therapy before amenorrhea are eligible Performance status: ECOG 0-2 prior to chemotherapy Hematopoietic: WBC at least 3,000/mm3 Polymorphs and bands at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: (unless abdominal ultrasound indicates liver metastasis) Alkaline phosphatase no greater than 2 times normal AST and/or ALT no greater than 2 times normal Renal: Not specified Other: No history of serious underlying medical illness or psychiatric or addictive disorder No second malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer Curatively treated endometrium, colon, or thyroid cancer or carcinoma in situ of the cervix No plan for pregnancy during the 5-year study period Fertile women must use effective contraception (other than oral contraception) Accessible for treatment and follow-up PRIOR Biologic therapy: Colony-stimulating factors allowed (use must be documented) Chemotherapy: No prior chemotherapy No concurrent other cytotoxic therapy Endocrine therapy: Adjuvant tamoxifen (20 mg po daily) allowed up to 2 weeks before or during adjuvant chemotherapy provided drug is discontinued at randomization No long-term prednisone or other hormones Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Required Tumor Parameters 1.1 Patients with operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. Node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by immunohistochemistry or histology. This includes any patient with one or more positive lymph nodes whose tumors are T0, T1, 2 or 3 and N1, N2, MO. Patients with metaplastic carcinoma are eligible. Bilateral disease does not patients from entry. 1.2 Tumors that are locally advanced at diagnosis are not eligible. This is left to investigator judgment. Patients with tumors fixed to the chest wall, peau d'orange skin changes, skin ulcerations, or clinical inflammatory changes (T4 disease) are excluded from this study. Dermal lymphatic involvement noted on pathology without clinical inflammatory changes will not a patient from this study. 1.3 Patients with any ERP/PgR status are eligible. 2. Prior treatment: 2.1 <84 days from mastectomy or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure. 2.2 Surgical resection margins All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy. Node dissection: patients may have had either an axillary node dissection or sentinel lymph node biopsy before beginning treatment on protocol Mastectomy: There should be no evidence of gross or microscopic tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible. 2.3 No prior chemotherapy. 2.4 No prior radiation therapy for this malignancy. Patients who received radiation to the breast for DCIS are eligible. Patients who have had segmental mastectomy will be treated with radiotherapy according to standard procedures in the treating physician's institution after completion of all chemotherapy. Patients who have had modified radical mastectomy may also receive radiotherapy at the discretion of the treating physician according to institutional guidelines. 2.5 Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen therapy should be discontinued before the patient is enrolled on this study. 3. Age > 18. There is no upper age limit for enrollment on this study. 4. Required initial laboratory data Granulocyte count > 1000/mm3 Platelet count > 100,000/mm3 Bilirubin within upper limits of normal
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed invasive adenocarcinoma of the breast Confined to the breast and ipsilateral axilla on clinical exam Stage I, II, or IIIA (cT1-3, N0-1, M0) At least one axillary lymph node with evidence of tumor on histologic exam Sentinel node biopsy allowed if followed by axillary dissection No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR Prior lumpectomy and axillary dissection Patients must receive radiotherapy after randomization (not before) AND after chemotherapy
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following Histologically confirmed by core or open biopsy Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography Clinically negative lymph nodes No positive ipsilateral axillary lymph nodes No prior removal of ipsilateral axillary lymph nodes No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude Tethering or dimpling of the skin or nipple inversion allowed No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 35.0-999.0, Breast Cancer Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following At least 12 months since spontaneous menstrual bleeding Prior documented hysterectomy and bilateral salpingo-oophorectomy At least 55 years of age with prior hysterectomy with or without oophorectomy Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range Histologically confirmed lobular carcinoma in situ treated by local excision only OR a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, using Breast Cancer Risk Assessment Profile No clinical evidence of malignancy on physical exam within the past 180 days No evidence of suspicious or malignant disease on bilateral mammogram within the past year No bilateral or unilateral prophylactic mastectomy No prior invasive breast cancer or intraductal carcinoma in situ
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women with a diagnosis of breast cancer established by tissue obtained by needle biopsy or incisional biopsy There must be a residual measurable breast and/or axillary mass after biopsy Clinical stage T1, N1-3, Mo or T2-4, N0-3, Mo. T2N0 lesions < 4cm in maximum dimension are eligible only if breast conservation is not feasible or practical without preoperative tumor shrinkage Patients must be willing to undergo a mastectomy or breast sparing procedure plus axillary lymph node dissection There must be no evidence of systemic metastases No prior chemotherapy. Patients may have received up to 14 days of tamoxifen. 3.1.7 Patients > 18years are eligible ECOG performance status 0-1 Normal hematologic function defined as white blood cell count > 3500/111 or neutrophil count > 1500411 and platelets >100,000/4 Normal renal function defined as serum creatinine <1.5 mg/di Adequate hepatic function. Bilirubin must be < institutional upper limit of normal (ULN). Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional ULN if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are < ULN. However, patients who have both transaminase elevation > 1.5 X ULN and alkaline phosphatase > 2.5 X ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity) Patients with a prior history of malignancy other than those mentioned in section 3.1.12 are ineligible Patients must not have severe concurrent medical or psychiatric illness (i.e. no severe diabetes mellitus, poorly controlled ischemic heart disease or congestive heart failure, or severe chronic obstructive or restrictive pulmonary disease) The interval between initial diagnosis of breast cancer and the start of treatment must not be greater than 8 weeks Due to anticipated toxicities to an unborn fetus, and excretion of chemotherapy in breast milk, patients must not be pregnant or lactating and must use effective contraception during treatment No history of hypersensitivity reaction to preparation containing polysorbate 80, 3.2.6 Patients must not have peripheral neuropathy grade 2 or higher Patients must not have had prior radiation to >25% of bone marrow
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 15.0-999.0, Cystic Fibrosis ENTRY --Disease Characteristics-- Diagnosis of cystic fibrosis (CF) with mild to moderate lung disease; FVC at least 60% predicted; Schwachman-Kulczycki score at least 65; Sweat chloride greater than 60 mEq/L All CF genotypes allowed No sputum colonization with Burkholderia cepacia or another multiply resistant organism No recurrent or intermittent hemoptysis; At least 1 year since significant hemoptysis requiring transfusion or embolization OR Coughing of greater than 30 mL of blood more often than once a week --Prior/Concurrent Therapy-- At least 30 days since hospitalization or home intravenous antibiotic therapy for pulmonary exacerbation No concurrent investigational drugs or therapy --Patient Characteristics-- Other: No concurrent cigarette smoking; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 1.0-120.0, Breast Cancer Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast Fine needle aspiration, core needle biopsy, or incisional biopsy allowed No excisional biopsy Any of the following Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0) Any T with N2 (including axillary lymph nodes matted to one another) or N3 Any T4, including inflammatory breast cancer Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor Supraclavicular or infraclavicular positive lymph nodes without distant metastases Distant metastases with measurable disease in breast or lymph nodes
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-100.0, Breast Cancer Annual Follow-up Study: To participate in the Annual Follow-up Study, a woman must: Be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 56 years of age. Must be: A known BRCA1 or BRCA2 deleterious mutation carrier OR A first or second degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation OR A first or second degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation. Have undergone genetic counseling and risk assessment. Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making. Have an ECOG performance status of 0-1. Be able to provide informed consent. Have at least one non-irradiated breast Annual Follow-up Study: Any of the following will result in from the Annual Follow-up Study: Pregnancy or lactation within 6 months of enrollment. Abnormal CA-125 level. Bilateral breast cancer, ovarian (any stage) or breast cancer (Stage IIB or worse) unless relapse free for 5 years prior to the time of enrollment. Patients with DCIS, Stage I and Stage II breast cancer are eligible provided that it has been at least 6 months from the completion of primary therapy (surgery, radiation, and chemotherapy as applicable). Tamoxifen and aromatase inhibitor adjuvant therapy is allowed. Patients with DCIS, Stage I and Stage II breast cancer who have had a local relapse after primary treatment are not eligible unless they have been relapse free for 5 years prior to the time of enrollment. History of other invasive cancer unless relapse free for 5 years prior to the time of enrollment. Non-Melanoma skin cancer or cervical carcinoma in situ are excepted. Previous bilateral mastectomy or bilateral radiation therapy. Weigh over 136 kilograms. Allergy to gadolinium. Allergy to lidocaine or Marcaine (bupivacaine). (excluded from breast duct lavage only). Subareolar or other surgery of the breast to be studied which might disrupt the ductal systems. For example, papilloma resection, biopsy or fine needle aspirations (FNAs) within 2 cm of the nipple might disrupt the ductal systems. Biopsies or FNAs greater than 2 cm from the nipple are acceptable. (Excluded from ductal lavage only) A breast implant or prior silicone injections in the breast to be studied. (Exclude from breast ductal lavage only) Active infections or inflammation in a breast to be studied. (breast ductal lavage only) Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-100.0, Breast Cancer Menstrual Cycle Study: To participate in the Menstrual Cycle Pilot Study, a woman must: Must be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 46 years of age. Must be premenopausal as determined by menstrual history (no change in menstrual pattern in prior 6 months) and an FSH level less than 15 mIU/ml obtained on the third day of the menstrual cycle. Have undergone genetic counseling and risk assessment. Must be a known mutation carrier or be a first or second-degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation. Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making. Be willing to use non-hormonal methods of contraception until completion of the 3 month follow-up studies. Have an ECOG performance status of 0-1. Be able to provide informed consent Menstrual Cycle Study: Any of the following will result in from the Menstrual Cycle Pilot Study: A history of menstrual cycle irregularities over the previous 6 months, including history of cycles less than 26 days or more than 35 days. Steroid therapy, use of selective estrogen receptor modulators (SERMs) or hormonal agents (including tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, depoprovera, progestin IUD, oral progestins, norplant, or drugs to induce ovulation) within 6 months prior to study entry and must agree not to use these compounds until completion of the three-month follow-up study. Pregnancy or lactation within 12 months of enrollment. History of infertility with a suspected ovarian etiology or persistent ovarian cyst. Abnormal CA-125 level. History of invasive cancer except for non-melanoma skin cancer or cervical carcinoma in situ. Creatinine greater than 2. Previous bilateral mastectomy, bilateral radiation therapy to the breast, or oophorectomy. History of DCIS or LCIS . Weight over 136 kilograms. Allergy to gadolinium. Allergy to lidocaine or Marcaine (bupivacaine) (excluded from breast duct lavage only). Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research Training Cohort: To participate in the Training Cohort a volunteer must Be female and at least 18 years and less than 51 years of age Have at least one breast considered eligible for study Provide evidence (either films or radiologist's report) of a mammogram done within the 12 months prior to enrollment showing low or no suspicion of carcinoma in at least one breast. (Mammograms will not be provided to participants as part of the training cohort.) Have a physical examination of the breast to be studied consistent with low or no suspicion of carcinoma at the time of enrollment Provide the name of a primary care physician to whom the results of breast duct lavage cytologies can be sent Have signed the informed consent for breast duct lavage Training Cohort: Any of the following will a potential participant from the Training Cohort Pregnancy or lactation within the past 12 prior to enrollment
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. If any sentinel node is histologically positive by H & E, or histologically suspicious on H & E and confirmed positive by immunohistochemistry (IHC), then the patient must have a completion axillary dissection The tumor must be invasive adenocarcinoma on histologic examination with clinical assessment T1-3, N0-1, M0 Patients must not be participating in any other clinical trials of systemic therapy for early-stage breast cancer. Patients may participate in the following radiation therapy trials Node-positive patients may participate in the National Cancer Institute of Canada Clinical Trials Group protocol MA.20, provided the requirements of the B-34 protocol continue to be met. (Node-negative B-34 patients may not participate in MA.20.) Node-positive mastectomy patients may participate in Southwest Oncology Group protocol S9927, provided the requirements of the B-34 protocol continue to be met Patients must have an analysis of both estrogen and progesterone receptors on the primary tumor performed prior to randomization. Tumors will be defined as ER or progesterone receptor (PgR) positive if: 1) the Dextran-coated charcoal or sucrose-density gradient method shows them to have greater than or equal to 10 fmol/mg cytosol protein, or 2) if using individual laboratory they can be shown to be positive by the enzyme immunoassay method (EIA) or immunocytochemical assay. "Marginal or borderline," results (i.e., those not definitively negative) will also be considered positive At the time of randomization, the patient must have had the following within the past 3 months: history and physical exam, a bone scan, thoracic and lumbar spine x-rays, and a chest x-ray. Within the past 12 months patients must have had a gynecologic exam (for women who have a uterus and who will be taking tamoxifen) and a bilateral mammogram At the time of randomization the postoperative absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3 (or less than 1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal) the postoperative platelet count must be greater than or equal to 100,000
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA) No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis Prior surgical resection, including 1 of the following Total mastectomy and axillary dissection (modified radical mastectomy) OR Lumpectomy and axillary dissection Prior post-lumpectomy breast radiotherapy required Prior sentinel node biopsy allowed with the exception of the following If any sentinel node is histologically positive by hematoxylin and eosin (H & E) OR histologically suspicious on H & E and confirmed positive by immunohistochemistry then the patient must have a complete axillary dissection Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Neoplasms Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up Accessible for treatment and follow-up at participating centers Histologically proven breast cancer with an interval between definitive surgery that included axillary lymph node involvement assessment and registration of less than or equal to 60 days. A central pathology review might be performed post randomization for confirmation of diagnosis and molecular studies. The same block used for HER2neu determination prior to randomization might be used for the central pathology review Definitive surgical treatment must be either mastectomy with axillary lymph node involvement assessment, or breast conserving surgery with axillary lymph node involvement assessment for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and/or ductal carcinoma in situ (DCIS) Participants must be either lymph node positive or high risk node negative. Lymph node positive participants were to be defined as participants having invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes. High risk lymph node negative participants were to be defined as participants having invasive adenocarcinoma with either 0 (pNo) among a minimum of 6 resected lymph nodes or negative sentinel node biopsy (pNo) and at least one of the following factors: tumor size > 2 cm, estrogen receptor (ER) and/or progesteron receptor (PR) status was negative, histologic and/or nuclear grade 2-3, or age < 35 years Tumor must show the presence of the HER2neu gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) by a designated central laboratory Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization Karnofsky Performance status index ≥ 80% Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) (multiple-gated acquisition [MUGA] scan) and electrocardiogram (ECG) within 3 months prior to registration. The result of the MUGA must be equal to or above the lower limit of normal for the institution Laboratory requirements: (within 14 days prior to registration) a) Hematology: i) Neutrophils ≥ 2.0 109/L ii) Platelets ≥ 100 109/L iii) Hemoglobin ≥ 10 g/Dl b) Hepatic function: i) Total bilirubin ≤ 1 UNL ii) Aspartate aminotransferase (ASAT) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine amino transferase (ALAT) (Serum glutamic-pyruvic transaminase [SGPT]) ≤ 2.5 UNL iii) Alkaline phosphatase ≤ 5 UNL iv) Participants with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study. c) Renal function: i) Creatinine ≤ 175 µmol/L (2 mg/dL) ii) If creatinine was 140 - 175 μmol/L, the calculated creatinine clearance should be ≥ 60 mL/min Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy) Prior anthracycline therapy, taxoids (paclitaxel, docetaxel) or platinum salts for any malignancy Prior radiation therapy for breast cancer Bilateral invasive breast cancer Pregnant, or lactating participants. Participants of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must had negative urine or serum pregnancy test within 7 days prior to registration Any T4 or N2 or known N3 or M1 breast cancer Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by National Cancer Institute (NCI) criteria Cardiac disease that would preclude the use of doxorubicin, docetaxel and Herceptin: 1. any documented myocardial infarction 2. angina pectoris that required the use of antianginal medication 3. any history of documented congestive heart failure 4. Grade 3 or Grade 4 cardiac arrhythmia (NCI Common Terminology [CTC], version 2.0) 5. clinically significant valvular heart disease 6. participants with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF was ≥ the lower limit of normal for the radiology facility; 7. participants with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Participants who were well controlled on medication were eligible for entry) 8. participants who currently received medications (digitalis, beta-blockers, calcium channel-blockers, etc) that altered cardiac conduction, if these medications were administered for cardiac arrhythmia, angina or congestive heart failure. If these medications were administered for other reasons (ie hypertension), the participant was eligible Other serious illness or medical condition: 1. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent 2. active uncontrolled infection 3. active peptic ulcer, unstable diabetes mellitus 4. impaired hearing (only for those participants treated at centers who had selected cisplatin as their platinum salt of choice) Past or current history of neoplasm other than breast carcinoma, except for: 1. curatively treated non-melanoma skin cancer 2. in situ carcinoma of the cervix 3. other cancer curatively treated and with no evidence of disease for at least 10 years 4. ipsilateral DCIS of the breast 5. lobular carcinoma in-situ (LCIS) of the breast
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-74.0, Breast Cancer for Breast Cancer and High-Risk Patients Age greater than or equal to 18 years and less than or equal to 74 years Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age and race-matched general population risk Women known to be BRCA1/2 or other hereditary genes mutation carriers Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or LCISl Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status Breast cancer may be invasive or noninvasive, and in the past or the present for Breast Cancer Patients Contralateral breast prosthesis Pregnancy History of radiation therapy to the contralateral breast Lactating breasts Chemotherapy within the past 1 month Current antiestrogen therapy Current hormonal replacement therapy or oral contraceptives Concurrent infection Previous contralateral major duct excision
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Vestibular Neuronitis Vestibulopathy Main vestibulopathy and locomotor unsteadiness Main diseases/impairments that prevent rehab participation
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients must have histologically confirmed invasive carcinoma of the female breast, with 0-3 positive axillary lymph nodes Patients must have 0-3 positive axillary lymph nodes to be eligible for this study; patients with node-negative breast cancer should have sufficiently "high risk" disease to warrant chemotherapy; as general guidelines, node-negative patients with tumors of >= 1 cm or estrogen or progesterone receptor negative tumors of any size may be eligible; ultimately though, the definition of "high risk" may be determined by the treating physician, and if the treating physician feels the patient warrants chemotherapy, the patient is eligible; for patients with 1-3 positive axillary nodes, the patient is eligible regardless of primary breast tumor characteristics, if in the opinion of the treating physician, chemotherapy is deemed potentially beneficial to the patient If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative; if an axillary dissection, without a sentinel node biopsy, is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed and negative for the patient to be considered node-negative; axillary nodes with single cells or tumor clusters =< 0.2 mm by either hematoxylin and eosin stain (H&E) or immunohistochemistry (IHC), will be considered node-negative; lymph nodes positive for polymerase chain reaction (PCR) with tumor cells/clusters =< 0.2 mm will be considered node-negative; any axillary lymph node with tumor clusters > 0.2 mm will be considered positive If the patient has a sentinel node biopsy and one of the sentinel nodes is positive, as defined by tumor clusters > 0.2 mm, an axillary dissection must be performed; a total of at least 6 axillary lymph nodes, including sentinel nodes plus the subsequent dissection, must be removed for the patient to be eligible; of all the lymph nodes removed from both the sentinel node procedure and the axillary dissection, 1-3 must be positive for the patient to be eligible as a node-positive patient; if an axillary dissection is done without a sentinel node procedure, at least 6 lymph nodes must be removed and a 1-3 nodes must be positive for the patient to be considered node-positive and eligible for this study Determination of involvement of axillary nodes with metastatic cancer will follow the revised tumor-node-metastasis (TNM) staging system: axillary nodes with single cells with tumor clusters =< 0.2 mm, by either H&E or immunohistochemistry (IHC), will be considered negative axillary node; lymph nodes positive for PCR with tumor cells/clusters < 0.2 mm will be considered negative axillary node; any axillary lymph node with clusters > 0.2 mm will be considered to be positive Patients with estrogen-receptor and/or progesterone receptor negative, positive, or unknown tumors are eligible; estrogen-receptor (ER) and progesterone receptor (PgR) assays should be performed by immunohistochemical methods according to the local institution's standard protocol Patients with human epidermal growth factor receptor 2 (HER2) positive, negative or unknown disease are eligible for this trial; patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by fluorescence in situ hybridization (FISH) may receive trastuzumab There must be negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS) in the case of mastectomy or lumpectomy; lobular carcinoma in situ (LCIS) is acceptable at the margin Patients with multi-centric breast cancer are eligible as long as all known disease is resected with negative margins, and have 0-3 positive axillary lymph nodes Patients must be registered within 84 days of the last breast surgery; patients must have undergone either modified radical mastectomy or lumpectomy; for patients undergoing sentinel node sampling or axillary dissection a simple mastectomy is acceptable; lumpectomy patients must receive radiation therapy; for patients treated with radiation therapy prior to chemotherapy, the patients should be registered on this study after the conclusion of radiation, with chemotherapy administration beginning within 7 days of registration * All primary breast and axillary node surgery must be completed prior to enrollment on study
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Histologically confirmed ductal carcinoma in situ (DCIS) of the breast Mixed DCIS and lobular carcinoma in situ (LCIS) allowed Must have undergone lumpectomy Margins must be histologically free of disease Re-excision to obtain tumor-free margins allowed No more than 84 days since prior lumpectomy or re-excision More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied No prior invasive breast cancer or DCIS Patients with a history of LCIS are eligible
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast Primary tumor classified as T1, T2, or T3 Candidate for breast-conserving surgery Must have undergone lumpectomy with negative margins or minimal margin involvement Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection No evidence of metastatic disease Hormone receptor status Not specified Age Adult Sex Female Menopausal status
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-70.0, Neoplasms, Breast Patient must have a previous diagnosis of HER2/neu-positive breast cancer: FISH positive test (for HercepTest 2+ patients), or, HercepTest 3+ patients. 2. Patients must be Stage II with at least one positive node or Stage III in remission. Patients must have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment. 3. Patient must have completed at least one course of standard adjuvant treatment within 5 years of study entry. 4. Patient may be on concurrent hormonal therapy. 5. Patient must be free of recurrent breast cancer as shown by standard diagnostic tests at entry onto study. 6. Patient must have a chest X-ray showing no evidence of disease. 7. Patient should have an expected survival of at least 12 months. 8. Written informed consent must be obtained prior to any protocol-specific procedures being performed. 9. Patient must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0. 10. Patient must not be pregnant and must use adequate contraception throughout the study and must plan to not bear children in the future. 11. Patient must not be lactating. 12. Patient must have a negative pregnancy test prior to enrollment. Pregnancy testing need not be done for patients who are > 55 years of age, post-menopausal or surgically sterile. 13. Patient must be 40 to 70 years of age inclusive. Patients younger than 40 years of age may be enrolled if they are sterile and incapable of childbearing. Chemotherapy-induced amenorrhea is not considered to be a sign of sterility. 14. Patient must have adequate bone marrow reserve as indicated by: WBC ≥3000/mm3, neutrophils ≥1500/ mm3, platelets ≥100,000 mm3, lymphocytes ≥1000/mm3, and hemoglobin ≥10.0 g/dL. 15. Patient must have an absolute CD4 cell count of >200 cells/mm3. 16. Patient must have adequate renal function. 17. Patient must have adequate hepatic function as indicated by: serum bilirubin within normal limits, aspartate aminotransferase <1.5 times the upper limit of normal and an alkaline phosphatase <1.2 times the upper limit of normal. Patients with an alkaline phosphatase above normal must have negative bone scans and abdominal CT scans prior to entry onto protocol. 18. Patient must have a baseline left ventricular ejection fraction (LVEF) measured by multi-gated acquisition (MUGA) scan equal to or greater than the lower limit of normal for the radiology facility. The serial MUGA scans for each individual must also be performed at the same radiology facility, using the same equipment in the same manner, for consistency of method. 19. Patients who had an earlier baseline MUGA scan at the radiological facility of the investigator's site to be used in the study, such as a MUGA scan done prior to adjuvant treatment, must meet the above for LVEF AND must also not have had a decrease in LVEF of above 15 percentage points from the original baseline MUGA scan. Patients who have not had a MUGA scan done at this radiological facility prior to adjuvant treatment must have a normal MUGA scan at screening. 20. Patient must not be known to be HIV positive. Results of virology screening must indicate that the patient has negative serology for HCV (hepatitis C virus) and is negative for HBsAg (hepatitis B surface antigen). (HBV testing indicating positive serology (antibodies) is allowed.) Patients who are presently being treated with Herceptin or have been treated with Herceptin in the past. 2. Patients who have received surgery or chemotherapy treatments within 8 weeks prior to enrollment. Patients who have received radiation therapy within 12 weeks prior to enrollment. 3. Patients who have received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose). 4. Patients with any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or prothrombotic disorder. 5. Patients with auto-immune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease, Graves' disease and Hashimoto's disease. 6. Patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens. 7. Patients with previous splenectomy or radiation to the spleen. 8. Patients who have received a major organ graft (including bone-marrow transplantation). 9. Patients who require chronic oral treatment (defined as more than 14 days) with immunosuppressive agents including glucocorticosteroids or other immune-modifying drugs. 10. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for > 2 years and highly likely to have been cured. 11. Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to unacceptable risk. 12. Patients with previous congestive heart failure or difficult-to-control hypertension. Patients with known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on electrocardiogram (EKG) or previous myocardial infarction. 13. Patients with psychiatric or addictive disorders that may compromise the ability to give informed consent, or comply with the trial procedures. 14. Patients who have received any investigational or non-registered drug or non-registered vaccine other than the study product within the 30 days preceding the first dose of study product, or who plan to receive such a drug during the study period. 15. Patients who have received any immunoglobulins and/or blood products within the 3 weeks prior to study product administration. 16. Patients who have received any commercial vaccine within one week before the first dose of the study product
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Histologically confirmed invasive breast cancer pT1-3; pNX, pN0-2 or pN3*; M0 Neoadjuvant patients are eligible no earlier than 3 weeks or later than 3 months after excisional surgery, provided both the clinical-diagnostic staging of cancer and postsurgical resection-pathologic staging of cancer meet the requirements for primary tumor, regional lymph nodes, and distant metastasis classification NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes Completely resected disease Primary surgery performed at least 3 weeks but no more than 3 months before study entry (if no chemotherapy was given) Primary surgery is defined as the last surgery at which histologic evidence of invasive or in situ disease was present in the pathology specimen Patients with positive sentinel lymph node biopsy are eligible provided they have had a subsequent axillary lymph node dissection No metachronous breast cancer Bilateral mammogram within the past 12 months unless initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required No metastases confirmed by 1 of the following methods
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Estrogen Receptor Positive Breast Cancer Progesterone Receptor Positive Tumor Recurrent Breast Carcinoma Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Premenopausal women (estradiol [E2] in the premenopausal range [according to institution parameters]) who meet the following Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for timing determination Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible; (please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion); in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to recheck their estradiol level at a later timepoint within 8 months of completing chemotherapy, even in the absence of return of menses Histologically proven, resected breast cancer; pathology material should be available for submission for central review as part of the quality control measures for this protocol Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; hormone receptors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure; patients who received neoadjuvant therapy must have had operable disease prior to neoadjuvant treatment to be eligible; patients who had a pathological evaluation with tru cut or core biopsy of invasive breast cancer prior to neoadjuvant therapy and were found to have no invasive tumor in the pathological specimen from definitive surgery are eligible; for these patients, pre-neoadjuvant tumor characteristics will be used for defining eligibility; in case of persistent disease, pathology findings from the definitive surgery should be used Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease A total mastectomy; radiotherapy is optional after mastectomy OR Patients who are postmenopausal (i.e., do not have an estradiol [E2] level in the premenopausal range) after surgery or after chemotherapy, whichever is later Patients with distant metastatic disease Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible; patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible Patients with positive final margins (referring to only DCIS and invasive cancer, not lobular breast carcinoma in situ [LCIS]), except as noted; DCIS at a margin is permitted if a complete mastectomy has been performed Patients with clinically detectable residual axillary disease Patients with a history of prior ipsilateral or contralateral invasive breast cancer; patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other Patients with previous or concomitant invasive malignancy are not eligible; the exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated Basal or squamous cell carcinoma of the skin In situ non-breast carcinoma without invasion Contra
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed invasive breast cancer Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1) Unifocal disease (single focus that can be encompassed by one lumpectomy) The following histologies are eligible Invasive ductal Medullary Papillary Colloid (mucinous) Tubular No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer Diagnosis of carcinoma of the cervix of 1 of the following cellular types Squamous cell carcinoma Adenocarcinoma Adenosquamous cell carcinoma Stage IB1 disease (no greater than 4 cm) No unequivocal evidence of metastases Adequate surgical candidate No known allergy to triphenylmethane compounds No prior pelvic irradiation No prior retroperitoneal surgery
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma Largest tumor lesion ≤ 5 cm Palpable or nonpalpable breast lesion Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions Prior (preoperative) or planned (intraoperative) sentinel node biopsy required At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension No clinical evidence of distant metastases No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following Skeletal pain of unknown cause Elevated alkaline phosphatase
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Neoplasms Postmenopausal female. Postmenopausal defined as no menses for at least 12 months or bilateral oophorectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with follicle stimulating hormone (FSH) greater than 35 U/L. Elevated risk for developing invasive breast cancer by virtue of one of the following Gail Model risk of greater than or equal to 1.7% over 5 years from study entry. (This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial). Lobular neoplasia. Atypical ductal hyperplasia. DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/ tamoxifen. Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet criteria. Prior stage I or II breast cancer at least 2 years out from treatment for invasive disease and no prior use of aromatase inhibitors. Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing intrauterine devices (IUDs). E-string is acceptable). Venlafaxine will be offered as supportive care for women with menopausal symptoms. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Subject has been counseled regarding her options and has signed the informed consent document. Baseline dual-emission x-ray absorptiometry (DEXA) scan with bone mineral density (BMD) T-score greater than or equal to 2.5 at antero posterior (AP) spine. Hemoglobin greater than or equal to 11 g/dl. Creatinine less than 1.5 times the upper limits of normal. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times upper limit of normal. No investigational agent for the past 30 days. If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment Current or recent chronic use (within 3 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. (Subjects on chronic topical or inhaled steroids will be eligible for the study.) Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism. History of clotting or bleeding disorder. History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane). Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 35.0-999.0, Breast Cancer Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS No invasive disease Not completely excised Epidermal growth factor receptor (EGFR) positive (> 10% of cells stained) Planned lumpectomy or mastectomy within the next 2-4 weeks Hormone receptor status Estrogen receptor status known Age and over Sex Female Menopausal status Not specified Performance status
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients must be greater than or equal to 18 years of age The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions and performance status should be taken into consideration, but not the diagnosis of breast cancer.) The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, sentinel lymph node biopsy, axillary surgery, or re-excision of lumpectomy margins) and randomization must be no more than 84 days The tumor must be invasive adenocarcinoma on histologic examination. (Patients with tumors that are pure tubular or mucinous adenocarcinomas are not eligible.) The primary tumor must be T1-3 by clinical and pathologic evaluation Lymph nodes obtained from all axillary staging procedures must be pN0 according to pathologic staging of the 6th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Patients must have undergone axillary nodal staging procedures, for example sentinel node (SN) biopsy alone, SN biopsy followed by axillary sampling or completion dissection, or axillary node dissection to obtain lymph nodes for pathologic evaluation. If the patient has palpable nodes, axillary dissection is required Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER is negative, then progesterone receptor (PgR) analysis must be performed. If ER is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.) Patients must have had either a lumpectomy or total mastectomy Patients must have no clinical or radiologic evidence of metastatic disease
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed infiltrating carcinoma of the breast Unresected disease High-risk (> 50% risk of relapse) disease, including any of the following high-risk markers Estrogen receptor and progesterone receptor negative Palpable axillary lymph nodes Grade 3 histology S phase fraction > 10% Ki67 > 30%
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast Stage 0, I, or II disease Stage II tumors must be ≤ 3 cm Gross disease must be unifocal Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006 Prior axillary staging required for patients with invasive breast cancer, including 1 of the following Sentinel node biopsy alone (if sentinel node is negative) Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive)
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (< 1 mm) by core biopsy or excisional biopsy HER2/neu positive tumor, defined as > 10% of the tumor population expressing HER2/neu by immunohistochemical staining No evidence of invasive disease by MRI (performed within the past month) Hormone receptor status Not specified Age Over 18 Sex Not specified Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Neoplasms Written informed consent Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk according to St. Gallen consensus criteria Histologically proven breast cancer. Interval between surgery and registration is less than 60 days Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin Patients without proven metastatic disease Estrogen and progesterone receptors performed on the primary tumour prior to randomization Age between 18 years and 70 years Karnofsky performance status index > 80 % Adequate hepatic, renal and heart functions Adequate hematology levels Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy) Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy Prior radiation therapy for breast cancer Bilateral invasive breast cancer Pregnant, or lactating patients Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment Any T4 or N1-3 or M1 breast cancer Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria Other serious illness or medical condition Past or current history of neoplasm other than breast carcinoma
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Histologically confirmed ductal carcinoma in situ (DCIS) of the breast T0 disease Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool [mammotome] or an equivalent method) Biopsy tissue available for molecular marker analysis Baseline mammography performed within the past 8 weeks Hormone receptor status Not specified Age Postmenopausal Sex Female Menopausal status Postmenopausal, as defined by 1 of the following
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Cancer of the Breast Clinically node negative operable breast cancer No prior incision or excision biopsy Palpable axillary lymph nodes Contraindications for injecting radiocolloid
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Asphyxia Neonatorum Live births with a weight ≥ 1500 grams (community minimum) Infants born in participating communities Stillbirths Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left-sided congenital heart disease that will not be repaired) Any infant who is transported/brought to the center after delivery
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 20.0-999.0, Breast Neoplasms Women 20 years of age or older Imaging abnormality necessitating a core needle biopsy Core needle biopsy revealing ALH or LCIS Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS) A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS Received tamoxifen in the past
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients with stage II or III breast cancer HER-2 positive tumors Older than 18 years of age Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1 ANC > 1,500/mm3 Hemoglobin > 9gm/dl Platelets > 100,000mm3 Creatinine < 2mg/dl Glucose < 200mg/dl Bilirubin < 1.5 x ULN Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy Pregnant or breast-feeding women Serious illness, or medical or psychiatric condition Uncontrolled infections Active or severe cardiovascular or pulmonary disease Patients with left ventricular ejection fraction < 50% Peripheral neuropathy of any etiology that exceeds grade 1 Prior history of malignancy Uncontrolled diabetes
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Stage II Breast Cancer Stage III Breast Cancer EGOG performance status of 0-1 HER2 overexpressing (IHC 3+ or FISH +) Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible years of age or older Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine Pregnant or lactating women Uncontrolled infections, including AIDS History or symptoms diagnostic of systemic connective tissue or inflammatory disease Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma Left ventricular ejection fraction < 50% Peripheral neuropathy of any etiology that exceeds grade 1 Prior history of malignancy treated without curative intent Uncontrolled diabetes
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 60.0-999.0, Breast Cancer Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T4 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors. Patients with inflammatory breast cancer will not be included (Stage IIIb). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice (see Appendix B consent form) Females 60 years of age (postmenopausal) Be ambulatory (outpatient) and have an ECOG PS <2 (Appendix F) Patients must have measurable disease by mammogram and/or breast ultrasound. The target lesion must not have been previously irradiated No prior chemotherapy Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, total bilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, Transaminases (AST, ALT) may be up to 2.0 x institutional upper limit of normal. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0 No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy Hypertension must be controlled (<150/100 mmHg) Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this sponsor-investigator Bevacizumab cancer study Uncontrolled high blood pressure (150/100 mmHg) Unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure see Appendix G) History of myocardial infarction within 6 months History of stroke within 6 months Clinically significant peripheral vascular disease History of a bleeding disorder Presence of central nervous system or brain metastases Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 19.0-999.0, Breast Cancer Lumpectomy Mastectomy Plus Axillary Lymph Node Dissection Lymphatic Leakage Written informed consent has been obtained from the subject prior to FS VH S/D administration Female subjects >= 19 years of age Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I and II axillary lymphadenectomy with two separate incisions Subjects with known hypersensitivity to aprotinin or other components of the product Subjects with immunodeficiency Subjects with increased red cell production (e.g., in hemolytic anemia) Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes Subjects having previously had axillary surgery Subjects having undergone irradiation therapy to the axillary tissue Subjects having ever received chemotherapy before the surgery
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Primary Breast Cancer Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection Evidence of minimal residual disease (disseminated tumor cells in bone marrow) Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy Prior stem cell rescue/bone marrow transplant History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix Additional protocol-defined /
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Neoplasms Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. A representative sample of the primary tumor (either blocks or slides) must be sent to the operational office, for central pathology reviews, after patients randomization Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection (not sampling) for operable breast cancer (clinical T1-3, N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4) will not be eligible. Patients who have a breast conserving procedure with a positive margin may become eligible if they subsequently undergo adequate resection or mastectomy with clear margins Histologic examination of the tumor: invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of eight resected lymph nodes. All nodes must be examined by the pathologist. The determination of ER (estrogen receptor) and PgR (progesterone receptor) is mandatory and results must be known by the end of chemotherapy in order to decide whether hormonal therapy is indicated (Biochemical or immunohistochemical methods required ; ER and/or PgR positivity should be in accordance with the policy in use at each participating center. Each center will specify its own policy) Age > or = 18 years and age < or = 70 years. The upper age limit is not meant to be exclusionary but rather is based on the lack of safety data for women > 70 years of age Karnofsky Performance status index > or = 70 % Normal cardiac function must be confirmed by LVEF (MUGA scan or echocardiography). The result must be above the lower limit of normal for the institution Laboratory requirements: (within 14 days prior to registration) Hematology Neutrophils > or = 2.0 x 109/L Platelets > or =100 x 109/L Prior systemic anticancer therapy for breast cancer (chemo-immuno-hormonotherapy) Prior radiation therapy for breast cancer Pregnant, or lactating patients Any locally advanced (clinical or pathological T4 and/or N2-known N3) or metastatic(M1) breast cancer.Patients with inoperable residual axillary nodal disease or with supraclavicular nodes Pre-existing motor or sensory neurotoxicity of a severity ³ grade 2 by NCI criteria Other serious illness or medical condition congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent active uncontrolled infection active peptic ulcer, unstable diabetes mellitus
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