topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 19.0-999.0, Allergic Rhinitis Patient over the age of 18 2. Positive allergy skin prick test that diagnose AR 3. Persistent and Moderate-to-Severe AR (Persistent symptoms for more than 6 weeks and suffers from abnormal sleep, impairment of daily activities, work-school problems, or has troublesome symptoms; TNSS of at least 8/12) 4. Negative CT sinus Non-Allergic Rhinitis patients will be excluded from this study. 2. Participants who are pregnant or lactating 3. Hypersensitivity to FP, MP-AzeFlu, or Rupatadine 4. Superficial or moderate nasal erosion, nasal mucosal ulceration or nasal septum perforation, who had nasal surgery within the last year, had significant pulmonary disease (excluding intermittent asthma) 5. Participants who had inferior turbinate reduction surgery 6. Participants who smoke 7. Not able to read and understand the consent form 8. Patients suffering from nonallergic rhinitis (eg. vasomotor, infectious, or drug-induced rhinitis) or with a negative skin prick test will not be included
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Heart Failure, Systolic Heart Failure; With Decompensation Pulmonary Congestion Hospital admission for primary diagnosis of acutely decompensated heart failure, regardless of etiology, according to the of the American College of Cardiology Diagnosis on echocardiography of heart failure with reduced ejection fraction (<40%) Presence of pulmonary congestion defined as at least 2 pulmonary fields with more than 3 B lines in each field on pulmonary ultrasound at the time of hospital discharge Pulmonary fibrosis or other severe disease that changes the image acquisition (significant pleural effusion, severe pulmonary emphysema, previous pneumectomy or lobectomy, primary or metastatic lung cancer, breast implants) Pregnancy Dialysis renal failure patient Factors that could hinder follow-up (not returning to the outpatient clinic of Hospital de Clínicas) Disability or refusing to understand and adhere to the protocol Refusal to sign consent form
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Heart Failure Patients included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients included in the PRADO program Patients not included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients not included in the PRADO program Patient under guardianship or guardianship Patient living in EHPAD Patient transferred to another establishment on discharge from hospital (surgery, follow-up care, EPHAD, etc.) Patient who died during hospitalization Patient objecting to the use of their data
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 20.0-45.0, Asthma Individuals with clinical diagnosis of asthma Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax Participants with pleura disorder and chest trauma & rib fracture
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Low Back Pain Acute Pain patients aged>18 years old initiation of acute low back pain in the 10 days prior to study entry and functionally impairing low back pain, which we defined as a score of > 5 on the Roland-Morris Disability Questionnaire (RMDQ) aged>65 years old history of trauma radicular pain, which we defined as pain radiating below the gluteal folds history of vertebral tumor or metastasis patients who were pregnant or lactating unavailable for follow-up with allergy or contraindication to the investigational medications chronic analgesic use autoimmune diseases or inflammatory rheumatic disorders cardiopulmonary restrictions
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 6.0-999.0, Asthma Dyspnea; Asthmatic Diagnoses Disease Presence of respiratory symptoms that can be signed to asthma last month or Only doctor diagnosed asthma last five years Daily intake of asthma control medication Use of oral corticosteroids Pregnancy, breast feeding Inability to perform spirometry A contraindication of a severe a medical condition, i.e. heart failure or aorta or cerebral aneurysm or history of myocardial infarction or stroke within three months Smoking history greater than ten pack-years (possible COPD)
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 10.0-40.0, Scoliosis Idiopathic adolescence/adult idiopathic scoliosis severe and rigid scoliosis (defined as Cobb angle more than 80° and flexibility index less than 25%) either skull tongs-femoral traction or Cotrel longitudinal traction used in the preoperative time period other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.) intradural abnormalities (diastomatomyelia, tethered cord, etc) history of previous spine surgery
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Bronchial Asthma Eosinophilic Asthma Signed Informed Consent Form; 2. Male and female non-smokers of 18 to 65 years of age (inclusive); 3. The diagnosis of asthma not earlier than 12 months prior to screening; 4. Steps 2 and 3 according to Global Initiative for Asthma (GINA, 2019) recommendations; 5. Patients receiving stable ICS doses with or without long-acting β2-agonists; 6. Еosinophil blood level measured twice at a 1 week interval, of ≥ 300 cells/µl ; 7. Signs of partially controlled BA within 4 weeks prior to screening according to GINA 2019 recommendations; 8. FEV1 value prior to the use of bronchodilators in the range of 55 to 85% of the proper value (inclusive); 9. Consent of patients to use adequate contraception methods throughout the study; 10. Ability to comply with all the study protocol requirements Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of child-bearing potential (including those without history of surgical sterilization and women with <2 years post-menopause) not using adequate contraception methods; 2. Smoking for 1 year prior to screening or previous smoking history of more than 10 packs/year; 3. Severe exacerbations or uncontrolled BA within 3 months prior to screening; 4. Chronic obstructive pulmonary disease (COPD) or other serious lung diseases other than asthma; 5. Inflammatory diseases of the oral cavity at screening; 6. An acute infectious disease within 30 days prior to screening; 7. Participation in any clinical study or any study drug administration within 30 days prior to screening; 8. Taking or indications for taking of prohibited drugs (including anti-leukotriene preparations, modified-release theophylline, etc.); 9. Indications for long-term use of systemic steroids or nonsteroidal anti-inflammatory drugs or drugs affecting on the immune system; 10. The need for periodical intake of antihistamines during the study (stable doses of antihistamines for at least 1 month prior to screening and throughout the study is allowed); 11. Immunosuppressant therapy within 3 months prior to screening; 12. Anaphylaxis, generalized urticaria, or angioedema within 1 year prior to screening; 13. Known allergies, hypersensitivity or contraindications for XC8 or its ingredients; 14. A history of systemic autoimmune diseases or vascular collagenosis; 15. Malignancies within the last 5 years (except for the cured basal cell carcinoma); 16. Significant cardiovascular diseases diagnosed at present or within 12 months prior to screening; uncontrolled hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg; pulmonary embolism or deep vein thrombosis; 17. Nephrotic syndrome, moderate to severe chronic renal failure or significant renal impairment with creatinine level >1.5 mg/dL (132 μM/l) in males and > 1.4 mg/dL (123 μM/l) in females or glomerular filtration rate < 60 mL/min; 18. HIV, hepatitis B or C, history of cirrhosis; 3-fold increased serum aspartate aminotransferase or alanine aminotransferase > above the Upper Limit of Normal; 2-fold increased total bilirubin level > above at screening; 19. Anemia (hemoglobin level ≤ 10.5 g/dL in females or ≤ 11.5 g/dL in males); significant blood loss or collection of at least one volumetric unit of donated blood (> 500 mL), or blood transfusion within 12 weeks prior to screening; 20. Any concomitant disease, other than asthma, not controlled by a stable therapy regimen; 21. Drugs or alcohol abuse at screening or in the past, which, in the Investigator's opinion, makes the patient not eligible for participation in the study; 22. Inability to read or write; unwillingness to understand and comply with the protocol procedures; non-compliance with the drug dosing regimen or procedures which, in the Investigator's opinion, may affect study results or the patient's safety and prevent the patient's participation in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible for participation in the study, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-30.0, Hamstring Tightness Asymptomatic 70 degrees active knee extension loss with hip in 90 degrees flexion in dominant limb Volunteers involved in recreational or flexibility sport activities History of previous lower limb injury from past one year History of fracture or surgery of back, pelvis, hip or knee Spinal deformity
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 15.0-45.0, Asthma respiratory symptoms suggestive for asthma - COPD -
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Chest Pain Acute Coronary Syndrome Age ≥ 18 years of age The patient agrees and signs an informed consent form One of the following 2 1. Acute chest pain (last episode of pain beginning <6 hours after inclusion) or 2. Syncope, dyspnea or epigastric pain without an obvious cause at the initial assessment (last episode of one of these symptoms beginning <6 hours after inclusion) associated with at least one of the following factors: Age ≥ 65 years, history of arterial disease, history of diabetes mellitus Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation Dialysis patients Patients with trauma Myocardial revascularization or acute myocardial infarction in the last month Pregnant and breastfeeding women Patient unable to be followed for 30 days
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-75.0, Chronic Cough Eosinophilic Bronchitis Asthma Aged ≥18-75 2. Subjects with a history of chronic cough (cough lasting for >8 weeks) 3. Evidence of airway eosinophilia (sputum eosinophilia>2%) 4. Forced expiratory volume-1 ≥ 70% of predicted 5. Normal chest x-ray (within the last 6 months) Symptoms of upper respiratory tract infection in the last 1 month which have not resolved. 2. Lower respiratory tract infection or pneumonia in the last 1 month. 3. Subjects with a positive covid-19 test within 2 weeks of screening 4. Subjects with seasonal allergic rhinitis that affects their asthma control 5. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months 6. Symptoms of uncontrolled asthma at screening defined as: Asthma Control Questionnaire-5 >1.5, or use of 3 or more puffs of a short acting beta-2 agonist per week, or an exacerbation in the previous month requiring oral prednisone or antibiotics. 7. Use of regular maintenance oral corticosteroids or long-acting muscarinic antagonist within 4 weeks prior to enrolment into the study. 8. A previous asthma exacerbation requiring Intensive Care Unit admission. 9. Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis. 10. Any history or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure. 11. Any history or symptoms of significant neurologic disease, including transient ischemic attack, stroke, seizure disorder, or behavioural disturbances 12. Clinically significant abnormalities in laboratory test results during the screening period (including complete blood count, coagulation, electrolytes, liver function tests) unless deemed not significant by the investigator. 13. Any history or symptoms of clinically significant autoimmune disease 14. History of anaphylaxis to any biologic therapy or vaccine 15. History of Guillain-Barre Syndrome 16. A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy. 17. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B can enroll. 18. A history of immunodeficiency disorders including a positive human immunodeficiency virus test 19. Pregnancy or breast-feeding. 20. Women of childbearing potential must not be actively seeking pregnancy, and must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/ intrauterine system levonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. Women of childbearing potential must agree to use an effective method of birth control, as defined above, from enrolment, throughout the study duration and within the 8 treatment weeks. They must demonstrate a negative serum pregnancy test at screening and demonstrate a negative urine pregnancy test immediately before each dose of study drug or placebo. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: i. Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range. ii. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. 21. Male patients not using an acceptable method of contraception. All male patients who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from the first dose of study drug until their last dose. 22. Use of angiotensin-converting-enzyme inhibitors 23. Use of immunosuppressive medication (including but not limited to: methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, oral corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained 24. Use of any other biological within 4 months or 5 half-lives prior to randomization, whichever is longer. 25. Any centrally acting medication within the last 2 weeks which in the view of the investigator could influence the coughing (Any participant who is taking amitriptyline, dextromethorphan, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication for the duration of the study. The reason for this is that centrally acting medications may influence coughing rates.) 26. History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-40.0, Covid19 Influenza Individuals with a confirmed COVID-19/influenza viral infection, as determined by a qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19 or rapid flu test from nasal swab for influenza. 2. Individuals who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent contraception, during the entire course of the study Viral infections other than COVID-19 or influenza. 2. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina 3. Pregnancy 4. Females of child bearing potential age not on adequate contraception or lactating 5. Subjects receiving systemic corticosteroid treatment within one month of Screening Visit 6. Subjects Less than 18 years of age 7. Hospitalization within last 6 months due to acute exacerbation of airway disease 8. Subjects with a clinically significant abnormal chest x-ray within past 12 months 9. Medication changes within one month of study entry 10. Subjects who have participated in another investigation drug treatment study within the previous month. 11. Subjects with a current history of alcohol or recreational drug abuse. 12. Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit. of Women and Minorities Every attempt will be made to all genders, and minorities that present with an active COVID-19 or flu infection that are not exempted due to
|
0
|
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
|
eligible ages (years): 0.0-999.0, Fibrosis Radiation Injuries Regional advanced postradiation fibrosis of the neck, chest wall, pelvis, or extremities causing measurable impairment of specific function, i.e.: Decreased range of motion, Weakness, Sensory deficit, Pain requiring narcotics, Significantly altered activities of daily living. None of these conditions present either before or during radiotherapy or attributed to surgery or chemotherapy. Patients with prostate cancer allowed if prostate-specific antigen (PSA) is less than 4.0 ng/mL and the last 3 PSA values were stable or decreasing. Abnormal bone scan or film acceptable if consistent with degenerative disease. No recurrent or metastatic cancer. No concurrent second cancer. PRIOR/CONCURRENT At least 3 months since pentoxifylline. Age: 18 and over. Performance status: Karnofsky 70%-100% (unrelated to postradiation fibrosis). No symptomatic coronary artery disease with frequent anginal episodes necessitating any of the following during past 6 months: Coronary artery bypass, Angioplasty, Pacemaker placement, Thrombolytic treatment. No chronic cardiac failure with persistent hemodynamic abnormality and ejection fraction less than 40%. No coagulation, platelet, or vascular disorder that threatens to cause bleeding. OTHER: No intolerance to pentoxifylline or other xanthines (e.g., caffeine, theophylline, theobromine). No seizure disorder. No peptic ulcer disease. Willing to undergo serial evaluations (excluding biopsies, laser Doppler, MRI) by NCI rehabilitation specialist for documentation and grading of functional disability. No pregnant or nursing women. Adequate contraception encouraged in fertile women
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years PRIOR Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer patients must have prostate specific antigen (PSA) only androgen dependent adenocarcinoma of the prostate. All patients must have failed definitive therapy (radical prostatectomy, radiation therapy with external beam or brachytherapy,or cryosurgery) Patients must have a negative Computerized Tomography (CT) scan and Bone Scan for metastatic prostate cancer Patients must have histopathological documentation of prostate cancer. Every attempt should be made to have slides and blocks reviewed at National Cancer Institute (NCI) Pathology laboratory. The review of pathology by the NCI will not delay enrollment Patients must have progressive prostate cancer. Two consecutively rising PSAs above the nadir post-definitive therapy and an absolute value greater than 1.0 ng/ml separated by at least 2 weeks Patients must have a life expectancy of more than 12 months Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria Hematological parameters (within 2 weeks of starting therapy): Granulocyte count greater than or equal to 1,000/mm^3. Platelet count greater than or equal to 75,000/mm^3 Biochemical parameters (within 2 weeks of starting therapy): If the creatinine is greater than 2.0 mg/dL obtain a 24 hour urine collection. Creatinine clearance must be greater than 40 mL/min. Hepatic function: bilirubin (total) less than or equal to 1 mg/dL upper limit of normal; Alanine aminotransferase (ALT) less than 2.5 times upper limit of normal Exception: Patients with Clinical Gilbert's Syndrome may have total bilirubin less than or equal to 2.5 mg/dL Patients must not have other concurrent malignancies (within the past 2 years) with the exception of nonmelanoma skin cancer and Rai Stage 0 chronic lymphoma leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning thalidomide) Patients that have received leuprolide, diethylstilbestrol (DES), flutamide, bicalutamide, PC stands for prostate cancer and SPES is the Latin word for hope)PC-SPES, goserelin, cytotoxic chemotherapy, finasteride and/or nilutamide within the past year (or currently) are not eligible. Patients that received these agents for adjuvant or neoadjuvant therapy at the time of definitive therapy are eligible. Exception: Patients enrolled under late entry who have received leuprolide/goserelin within 3 months of starting study are eligible Patients with National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) grade 2 or greater peripheral neuropathy of any cause that is clinically detectable, patients receiving anti-convulsive medications, and patients with a history of seizures within the past 10 years will not be eligible for this study Patients who are receiving sedative/hypnotic agents (i.e. benzodiazepines) which cannot be discontinued, will not be eligible for this study. Patients who have had a surgical orchiectomy will not be eligible for this study Patients who received a systemic chemotherapy for prostate cancer will not be eligible Patients with a confirmed psychiatric history of a major depression consistent with American Psychiatric Association Diagnostic and Statistical Manual (DSM IIIR criteria), confirmed by a psychiatrist will not be eligible
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Histologically proven locally recurrent organ-confined prostate cancer after external beam radiotherapy, radiation seed implants, or cryosurgery. Gleason score of at least 6. Prostate specific antigen values (PSA) of at least 1.0 ng/mL with 2 consecutive rises in PSA at least 2 weeks apart, of which the second increase is greater than the first, after achieving a nadir. Must have at least 3 recorded PSA values over a minimum of the last 3 months to determine the slope. Patients must have declined additional conventional treatment or be ineligible for conventional treatment of their prostate cancer. No metastasis by bone scan. No significant central nervous system (CNS) disease. Age: 18 and over. Performance status: Karnofsky 80-100% OR Eastern Cooperative Oncology Group (ECOG) 0 or 1. Life expectancy: Not specified. Hematopoietic: White blood cell count (WBC) greater than 3,000/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 9.0 g/dL. Hepatic: Bilirubin normal. Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal. Albumin greater than 3 g/dL. Prothrombin time (PT) and partial thromboplastin time (PTT) normal. Hepatitis B surface antigen negative. Renal: Creatinine normal. Cardiovascular: No uncontrolled hypertension. No significant cardiovascular disease, e.g.: History of ventricular dysfunction; Congestive heart failure; Symptoms of coronary artery disease; History of any ventricular arrhythmia; Prior myocardial infarction. Other: HIV negative. Fertile patients must use effective double-barrier contraception during and for 3 months after study participation. No active autoimmune disease. No active infection requiring IV antibiotics. No uncontrolled diabetes mellitus. No significant psychiatric disorder that would preclude study. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer. PRIOR Biologic therapy: No prior Leuvectin. Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or hydroxyurea). Endocrine therapy: No prior hormonal therapy for prostate cancer. Radiotherapy: See Disease Characteristics. At least 3 weeks since prior radiotherapy. Surgery: At least 1 month since prior intrathoracic or intra-abdominal surgery. At least 2 weeks since other prior major surgery. Other: At least 10 days since prior anticoagulants or non-steroidal anti-inflammatory agents. No neoadjuvant or other concurrent anticancer drug therapy. No concurrent immunosuppressive drugs. No other concurrent experimental therapy
|
0
|
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
|
eligible ages (years): 0.0-70.0, Prostate Cancer Histologically confirmed adenocarcinoma of the prostate Unilateral cT3a, cN0, M0 Well or moderately differentiated tumor Gleason score no greater than 7 (4 plus 3 or 3 plus 4) Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent) Age and under Performance status WHO 0-1 Life expectancy Not specified Hematopoietic WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3
|
0
|
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
|
eligible ages (years): 18.0-120.0, Prostate Cancer Histologically confirmed adenocarcinoma of the prostate T1c-T2b, N0, M0 Intermediate-risk disease, as defined by 1 of the following Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL Gleason score 7 AND PSA < 10 ng/mL No evidence of distant metastases Prostate volume ≤ 60 cc by transrectal ultrasonography American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) Age and over Performance status Zubrod 0-1 Life expectancy
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostatic Neoplasms Androgen-independent metastatic adenocarcinoma of the prostate defined as progressive metastatic disease while on gonadotropin releasing hormone (GnRH) agonists or post surgical castration Histopathological documentation of prostate cancer confirmed in the National Cancer Institute (NCI) Laboratory of Pathology at the National Institutes of Health, the Pathology Department at Walter Reed Medical Center or the Pathology Department at National Naval Medical Center, prior to starting this study. In addition, patients whose slides are lost or unavailable will be eligible for the study if they provide documentation of prostate cancer and if they meet of clinically progressive prostate cancer as outlined in section 3.1.1.3. Clinically progressive prostate cancer documented prior to entry. Progression must be documented by at least one of the following parameters Two consecutively rising prostate-specific antigen (PSA) levels. The first rising PSA must be a minimum of one week from a reference value. It is recognized that PSA fluctuations are such that the confirmatory PSA value might be less than the previous one. In these cases, that patient would still be eligible provided the next PSA was greater than the first rising PSA value. Patients must have PSA greater than or equal to 5.0 At least one new lesion on bone scan Progressive measurable disease. Patients must have undergone bilateral surgical castration or must continue on GNRH agonist. Those patients receiving an anti-androgen agent and are entering the trial due to a rise in PSA must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide. Patients may not have received any chemotherapy for metastatic prostate cancer Age greater than or equal to 18 years Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Life expectancy of greater than 3 months Patients must have adequate organ and marrow function as defined below: Leukocytes greater than or equal to 3,000/microliter Absolute neutrophil count greater than or equal to 1,500/microliter Platelets greater than or equal to 100,000/microliter Hemoglobin greater than or equal to 8.0g/L transfusions acceptable Total bilirubin less than or equal to 1.5 times the institutional upper limits of normal Aspartate aminotransferase (AST)serum glutamic oxaloacetic transaminase(SGOT) and alanine aminotransferase (ALT)serum glutamic pyruvic transaminase(SGPT) Present clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) brain scan. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Persistent systolic blood pressure greater than or equal to 170 mmHg or diastolic blood pressure greater than or equal to 100 mmHg. Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel, bevacizumab, and/or the combination. Proteinuria, as demonstrated by a urine, protein, creatinine (UPC) ratio greater than or equal to 1.0 at screening, required to be assessed if urine dipstick is greater than or equal to 1+. Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment. Note: UPC ratio of spot urine is an estimation of the 24 urine protein excretion a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formula [urine protein]/[urine creatinine] if both protein and creatinine are reported in mg/dL [(urine protein) x 0.088]/[urine creatinine] if urine creatinine is reported in mmol/L Therapeutic anticoagulation with coumadin, heparins, or heparinoids. Greater than Grade 2 peripheral neuropathy at baseline. History of transient ischemic attacks (TIA) or cerebrovascular accident (CVA) within the past 2 years. History of allergic reaction to docetaxel, prednisone, thalidomide and/or bevacizumab or related products. Patients who are on concurrent investigational agent(s) Patients who are unable to ingest oral medication. OF WOMEN AND Men of all races and ethnic groups are eligible for this trial. Every effort will be made to recruit minorities in this study. Women are ineligible for this study
|
0
|
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
|
eligible ages (years): 55.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms International Prostate Symptom Score > 7 Age > 55 years Heart failure Diabetes type I Psychiatric disorder/cognitive dysfunction History of prostate surgery Active treatment for lower urinary tract symptoms
|
2
|
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
|
eligible ages (years): 60.0-75.0, Healthy Volunteers Healthy men age 60 to 75 History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease, current alcohol or illicit drug abuse, or major psychiatric disorders Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), or anti-convulsants Cognitive or intellectual impairment that precludes complete understanding of the study protocol History of deep vein thrombosis, pulmonary embolism, or clotting disorders Serum 25-hydroxyvitamin D < 15 ng/mL Serum parathyroid hormone (PTH) < 10 or > 65 pg/mL Serum thyroid stimulating hormone (TSH) < 0.5 or > 5.0 U/L Serum calcium > 10.6 mg/dL Serum creatinine > 2 mg/dL
|
1
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention Is a male patient aged 18 years or over Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL Has an ECOG (Eastern Cooperative Oncology Group) score of 2 Has a PSA value of 2 ng/mL Has a life expectancy of at least 13 months Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin Has a known or suspected hepatic or symptomatic biliary disease Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator Has a mental incapacity or language barriers precluding adequate understanding or cooperation Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study
|
0
|
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
|
eligible ages (years): 18.0-999.0, Anemia Subjects with nonmyeloid malignancy(ies) Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS) Unstable cardiac disease or anemia due to other causes
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Histologically confirmed adenocarcinoma of the prostate, previously untreated 2. Males ≥ 18 years of age. 3. Potential candidate for radical prostatectomy 4. Any of the following (minimum of 2 positive biopsies) Clinical stage T3 Serum PSA > 10 ng/ml Gleason score 7-10 Gleason score 6 and > 3 positive biopsies 5. ECOG performance status 0-1 6. WBC ≥ 3.0 x 10^9/L 7. Hemoglobin ≥ 100 g/L 8. Platelets ≥ 100 x 10^9/L 9. PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits 10. Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations [CFR]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment Prior hormone, radiation, or chemotherapy for prostate cancer 2. Evidence of active infection 3. Patients receiving therapeutic doses of warfarin or heparin 4. Severe end organ disease 5. Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors 6. Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence. 7. Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol
|
0
|
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
|
eligible ages (years): 45.0-999.0, Impotence clinical diagnosis of erectile dysfunction (ED) lower urinary tract symptoms (LUTS) previous prostate surgery or invasive intervention for BPH active urinary tract disease
|
0
|
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
|
eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism) Who have no contraindications to standard treatment with heparin and/or warfarin, and Who provide informed consent to participate Contraindication to compression stockings Limited lifespan (estimated < 6 months) Geographic inaccessibility preventing return for follow-up visits Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily Treatment of acute DVT with thrombolytic agents
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Patients must have documented adenocarcinoma of the prostate, treated with androgen suppression, and now present with a rising PSA Prior therapy with hydrocortisone is allowed (must have discontinued > 4 weeks prior to study treatment). Prior use of ketoconazole for prostate cancer treatment is allowed (must have discontinued > 4 weeks prior to study treatment) Prior therapy with chemotherapy is allowed if it was administered as neoadjuvant or adjuvant therapy related to primary treatment and was completed > 6 months prior to starting study treatment Testosterone level < 50 ng/dl within 4 weeks prior to study treatment. Patients who have not undergone surgical castration must continue primary androgen suppression therapy (luteinizing hormone-releasing hormone [LHRH] agonist) while on protocol therapy Patients may be receiving oral bisphosphonate therapy prior to study treatment and continue while receiving treatment, but must not begin treatment with bisphosphonate while receiving study treatment. Patients on oral bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to study treatment Patients must have adequate major organ function. All values must be obtained within 4 weeks prior to study treatment Creatinine < 1.7 mg/dL or a creatinine clearance > 50 mL/min SGOT (AST), SGPT (ALT) < 2X the institution's upper limit of normal Bilirubin < 1.5 mg/dL ANC > 1500/mm3 No previous palliative radiation. Prior radiation to the primary site is allowed HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib Patients with gastrointestinal tract disease resulting in an inability to take oral medication are ineligible Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements Patients must not have received prior targeted therapy, including no prior EGFR inhibitor Patients must not have evidence of metastatic disease
|
0
|
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
|
eligible ages (years): 40.0-999.0, BPH Male subjects aged 40 or older with no pathologically-proven prostate cancer or other cancers. Patients who have had a negative prostate biopsy are still acceptable Subjects with a PSA between 2.5 and 20.0 ng/ml Subjects understand the study procedures and agree to participate in the study by providing a written informed consent and scheduled blood or urine samples Subjects whose liver function and renal function tests are within normal range Subjects who may have fluctuated serum PSAs, such as urinary tract infection, prostatitis, acute urinary retention, receiving radiotherapy to the pelvis, etc Subjects who have received a prostate surgery or biopsy within 6 weeks before the initiation of lycopene supplementation Subjects who may or will receive a prostate surgery or biopsy within 12 weeks of the initiation of lycopene supplementation Subjects who have known allergic reaction to carotenoids including lycopene Subjects who are participating or will participate in other clinical trials Subjects who are taking medications that may alter serum PSA levels, such as 5-alpha reductase inhibitor (eg. finasteride), sex steroids or hormonal agents (eg. luteinizing hormone releasing hormone agonists, cyproterone acetate, flutamide, bicalutamide, megesterol acetate, etc.) Subjects who may require increased dosage of medications for lower urinary tract symptoms (LUTS) during the 12 weeks of protocol treatment. Subjects who have been put on medications for LUTS before entry and have a stabilized disease are still acceptable. These medications but note limited to, selective or non-selective alpha-blockers and anti-cholinergics Subjects who have or have had clinical gastrointestinal malabsorption regardless of the etiology
|
2
|
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
|
eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Ability to give informed consent Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia Maximum urinary flow rate < 15 ml/sec, voided volume ≥ 125 cc American Urological Association symptom score ≥ 9 Transrectal ultrasound determined prostate volume ≤ 60 cc Inability to give informed consent Maximum urinary flow rate ≥ 15 ml/sec Transrectal ultrasound determined prostate volume > 60cc AUA symptom score < 9 Active urinary tract infection Bleeding diathesis Neurological disease that is felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder Known prostate cancer Active bladder cancer (within the last 2 years) Prostate specific antigen (PSA) > 4.0 unless previous negative biopsy
|
2
|
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
|
eligible ages (years): 21.0-999.0, Prostate Cancer Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate Clinical stage A2, B, C, D1 Age: older than 21 years old Performance status of 0 or 1 Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency) If less than 30 months since completion of radiation therapy, biopsy of prostate suggested within 6 months of study entry. If more than or equal to 30 months since completion of radiation therapy, biopsy of prostate suggested within 1 year Written informed consent Abnormal bone scan suggestive of metastatic osseous disease Previous hormonal manipulation including orchiectomy or any medication with significant antiandrogenic activity (combined androgen suppression over 9 months, monotherapy antiandrogens, estrogens, ketoconazole). *Neoadjuvant androgen suppression therapy of less than or equal to 3 months is allowed, if this androgen suppression therapy was completed more than or equal to 1 year prior to study enrollment AND if the Testosterone level is within the normal ranges Any systemic chemotherapy or curative radiotherapy within 6 months Hepatic dysfunction Total bilirubin greater than 2.0 mg/dl Aspartate transaminase (AST; SGOT) greater than 3 times the upper limit of normal range Lactate dehydrogenase (LDH) greater than 3 times the upper limit of normal range) Renal dysfunction Blood urea nitrogen (BUN) greater than 40 mg/dl Serum Creatinine greater than 2.0 mg/dl
|
0
|
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
|
eligible ages (years): 40.0-999.0, Uncomplicated Lower Urinary Tract Symptoms new patients with uncomplicated LUTS (I-PSS score 0-35) aged 40 years and over referred for the first time by their family doctor (general practitioner) to one of a participating urological outpatient departments lower urinary tract symptoms due to any urological malignancy previous prostatic surgery within the last 10 years or pelvic radiotherapy complications of urinary obstruction (acute or chronic urinary retention post micturition volumes over 300ml, bladder stones, renal failure, recurrent urinary tract infection or haematuria) uncontrolled diabetes, dementia and end stage cardiac or respiratory failure inability to speak or understand the English language severe symptoms where drug therapy or surgical management is indicated or requested by the patient medical therapy for lower urinary tract symptoms in the previous 3 months, including alpha-blockers, 5-alpha reductase inhibitors (finasteride) or anti-cholinergics
|
2
|
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
|
eligible ages (years): 20.0-40.0, Healthy Healthy volunteer age between 20 and 40 years Healthy according to medical history and physical examination Informed consent given Phenotyped or genotyped as extensive or poor metabolizer of sparteine Female: Use of safe contraception (IUD, gestagen injectiones or oral contraceptive) or negative u-HCG test Any known allergy or intolerance to oxycodone Regularly drug therapy or medication (except contraceptives) Alcohol or medicine abuse
|
0
|
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
|
eligible ages (years): 0.0-999.0, Prostatic Hyperplasia Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months Patients previously not improved by an alpha 1-blocker treatment Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI) Known hypersensitivity to alfuzosin History of postural hypotension or syncope Combination with other alpha 1-blockers Hepatic insufficiency Unstable angina pectoris Severe concomitant condition threatening life
|
2
|
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
|
eligible ages (years): 0.0-70.0, Lymphoma Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age <70. 6. Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen -
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostate Cancer Histologically documented adenocarcinoma of the prostate Progressive, systemic (metastatic) disease despite castrate levels of testosterone due to orchiectomy or luteinizing-hormone releasing hormone (LHRH) agonist, meeting 1 of the following Measurable disease, defined as any lesion that can be accurately measured in at least 1 dimension ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan or MRI Nonmeasurable disease with PSA ≥ 5 ng/mL Bone lesions Pleural or pericardial effusions, ascites CNS lesions, leptomeningeal disease Irradiated lesions, unless progression documented after radiotherapy No PSA ≥ 5 ng/mL as only evidence of disease PSA evidence for progressive prostate cancer consists of a PSA level ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart
|
0
|
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
|
eligible ages (years): 18.0-77.0, Atrial Fibrillation Diet Therapy Prostate Cancer Blood samples available from Bordeaux Blood samples not received from Bordeaux
|
0
|
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
|
eligible ages (years): 16.0-999.0, Cystic Fibrosis Male or female between 16 years and 65 years of age. 2. Confirmed diagnosis of CF based on the following i. positive sweat chloride 60 mEq/liter (by pilocarpine iontophoresis) and/or ii. a genotype with two identifiable mutations consistent with CF, and iii. accompanied by one or more clinical features consistent with the CF phenotype 3. FEV1 50% predicted value (subjects 16 <18 years of age) or 40% predicted value (subjects 18 years of age) 4. Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0) 5. Ability to reproducibly perform spirometry and peak flow measurements 6. Ability to understand and sign a written informed consent or assent and comply with the requirements of the study Use of an investigational agent within the 4-week period prior to Visit 1 2. Chronic daily use of ibuprofen or other NSAIDs, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to Visit 1 or acute usage within 72 hours prior to Visit 1 3. History of hypersensitivity to beta-agonists 4. History of hypersensitivity to hydroxychloroquine or chloroquine 5. Oxygen saturation < 92% on room air at Visit 1 6. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 7. History of hemoptysis 30 cc per episode during the 30 days prior to Visit 1 8. Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
|
0
|
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
|
eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization
|
0
|
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
|
eligible ages (years): 18.0-999.0, HIV Infections Confirmed first-time incomplete virologic suppression during treatment with at least 12 weeks of an ARV regimen consisting of TDF or ABC + FTC or 3TC + NNRTI or PI (TDF as Truvada or individually with FTC, and ABC as Epzicom or individually with 3TC). Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times. 2. Screening HIV-1 RNA < 20,000 copies/mL obtained within 30 days prior to study entry. 3. Screening CD4 cell count ≥ 200 cells/mL. 4. Screening HIV-1 genotype with M184V or at least one treatment-related primary mutation. 5. Routine labs as demonstrated by last available lab panel to be Hemoglobin > 8.0 g/dL Platelet count > 50,000/mm3 AST (SGOT) < 210 U/L ALT (SGPT) < 240 U/L Alkaline phosphatase < 625 U/L Total bilirubin < 3.25 mg/dL; and Calculated creatinine clearance ≥ 50 as estimated by the Cockcroft-Gault equation. 6. If participating in sexual activity that could lead to pregnancy, female study subjects must use two forms of contraception, one of which must be a barrier method. 7. Men and women aged ≥ 18 years. 8. Ability and willingness of subjects to give written informed consent Subjects with screening HIV-1 genotype that is wild-type or contains the resistance mutations K65R/x or L74V/x. 2. Prior or current treatment with ARV regimen consisting of only NRTIs, ZDV or d4T, more than 2 NRTIs, ritonavir-boosted or dual PI regimen. 3. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. For non-serious illnesses, treatment of less than 21 days with larger doses of corticosteroids is permitted. 4. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 5. Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restrictions. 6. Unable to discontinue contraindicated current medications
|
0
|
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
|
eligible ages (years): 45.0-999.0, Urination Disorders Diagnosis of lower urinary tract symptoms with urgency and frequency with or without urge incontinence have had at least 4 weeks of 0.4 mg/day tamsulosin therapy an International Prostate Symptom Score (I-PSS) >=13 irritative component I-PSS score >= 8 max flow >= 8ml/sec with voided volume >= 125 ml, post-void residual volume <= 150 ml on two occasions Clinically significant medical problems or other organ abnormality or pathology Prostate-Specific Antigen (PSA) >= 4 ng/ml history of inability to empty bladder completely or not at all uncontrolled narrow angle glaucoma history of any prostate surgery or treatment history of significant gastrointestinal problems
|
1
|
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
|
eligible ages (years): 18.0-100.0, Prostate Subjects must be over age 18. Subjects must have a newly diagnosed prostate disease or condition. Subjects must not currently take hormones
|
0
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography Suffering for at least 6 months from lower urinary tract symptoms related to BPH An I-PSS total score ≥ 13 Out patient Patients previously treated with SL77.0499-10 Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology Isolated bladder neck disease Diagnosed carcinoma of the prostate Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH Patients having an indwelling catheter A residual urine > 200mL Patients with Moderate or sever hepatic insufficiency Known hypersensitivity to alpha1-blockers Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
|
2
|
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
|
eligible ages (years): 18.0-90.0, Cold Agglutinin Disease CAD diagnosis defined by the combination of Chronic haemolysis Cold agglutinin titre > 64 Positive direct antiglobulin test when performed with polyspecific antiserum, negative (or only weakly positive) with anti-IgG, and strongly positive with anti-C3d 2. The presence of a clonal B-cell lymphoproliferative disorder defined by Monoclonal IgMκ band by serum electrophoresis and immunofixation, and Lymphocyte phenotype with κ/λ-ratio > 3.5 and CD20+,κ+ co-expression, using flowcytometric immunophenotyping of bone marrow aspirates 3. Clinical symptoms requiring treatment, such as anaemia or Raynaud-like symptoms 4. Informed consent An aggressive lymphoma 2. Blood lymphocyte count > 50 . 109/L 3. Non-lymphatic malignant disease other than basal cell carcinoma 4. Contra-indications to rituximab or fludarabine therapy 5. Inability to cooperate
|
0
|
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
|
eligible ages (years): 18.0-999.0, Cystic Fibrosis Mucoviscidosis Age >= 18 years Patient suffering from cystic fibrosis Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed Affiliation to French social security Capacity to consent Pregnant women Contraindication to application of magnetic field Pacemaker History of neurosurgical intervention Presence of metallic particles near the stimulation site
|
0
|
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
|
eligible ages (years): 40.0-999.0, Prostatic Hyperplasia Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 Clinical diagnosis of BPH Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml Urodynamically defined bladder outlet obstruction prostate cancer Post-void residual urine volume >200 ml Documented UTI History of relevant urological surgery
|
1
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia suffering from LUTS related to BPH for at least 6 months having an IPSS >13 having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL having a residual urine volume < or = 200 mL
|
1
|
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
|
eligible ages (years): 35.0-75.0, Prostate Cancer Elevated prostate-specific antigen (PSA), meeting 1 of the following PSA > 4.0 ng/mL for patients at any age PSA > 2.0 ng/mL for patients 35 to 49 years of age PSA rise (velocity) of > 0.75 ng/mL over the past year Has undergone a prostate biopsy* (following findings of elevated PSA) within the past 180 days that failed to reveal prostate cancer Prostate intraepithelial neoplasia allowed NOTE: *At least 4 core biopsies are considered acceptable Karnofsky performance status 80-100% Bilirubin ≤ 2.0 mg/dL AST and ALT ≤ 2 times upper limit of normal Creatinine ≤ 2.0 mg/dL
|
0
|
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
|
eligible ages (years): 18.0-999.0, Locally Confined Adenocarcinoma of the Prostate Histologically confirmed, locally confined adenocarcinoma of the prostate PSA of less than 10 ngmL Combined Gleason score 6 or less, with no individual Gleason score of 4 or 5 The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer Karnofsky Performance Status greater than 70 Prostate volume by TRUS less than 50 cc International Prostate symptom score must be 18 or less Signed study-specific consent form prior to registration Clinical or Pathological Lymph node involvement Evidence of distant metastases Radical surgery for carcinoma of the prostate Chemotherapy or pelvic radiation therapy Previous transurethral resection of the prostate Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease free for at least 5 years Significant obstructive symptoms Major medical or psychiatric illness which, in the investigator's opinion, Hip prosthesis Anatomic or medical condition (such as prior abdominal perineal resection or anal stricture) which would preclude the use of TRUS Implanted device or apparatus which might obstruct visibility of the implanted sources on fluoroscopy
|
0
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy All of the following questions must be answered "Yes" at Visit 1 in order for the patient to participate in the study Is the patient at least 50 years old? Does the patient have clinical signs and symptoms consistent with BPH? Does the patient have an IPSS ³13 at screening (prior to placebo run in)? Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec established on a voided volume of at least 125 mL? Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? All of the following questions must be answered "No" at Visit 1 in order for the patient to participate in the study Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL? Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL? Does the patient have a residual urine volume > 350 mL by ultrasound? Has the patient taken or is currently taking any of the following
|
2
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia The patient is a male at least 50 years of age The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml Prostate volume must be greater than 30 grams The AUA-SI is greater than or equal to 9 Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP Patient must be able to complete the study requirements prior to the scheduled laser TURP The patient has signed the informed consent prior to the performance of any study procedures The patient has had any prior surgical intervention for BPH The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride The patient has taken an alpha-1 blocker within 1 month of randomization The patient has taken finasteride or dutasteride within 3 months of randomization The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids The patient has an inability to urinate The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg/dl or AST greater than 1.5 times the upper limit of normal) The patient has a PSA level greater than 10 ug/ml (Hybritech)
|
2
|
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
|
eligible ages (years): 0.0-999.0, Differentiated Thyroid Carcinoma Hiostologically proved DTC (M0) Preoperative metastasis
|
0
|
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
|
eligible ages (years): 18.0-999.0, Recurrent Prostate Cancer Histologically or cytologically confirmed prostate cancer Stage D0 Must have undergone some definitive local therapy for prostate cancer Must be free of macrometastatic disease, as evidenced by computed tomography (CT) scan and bone scan, if serum PSA ≥ 10 ng/mL prior to GnRH agonist therapy Progressive disease meeting the following NOTE: Patients who have undergone a prostatectomy and have two detectable, rising serum PSA levels are eligible Two consecutive rises in PSA above nadir recorded after definite local therapy Serum PSA concentrations must have absolute value of > 0.5 ng/mL (separated by ≥ 2 weeks) prior to beginning GnRH agonist therapy PSA < 0.5 ng/mL Testosterone < 30 ng/mL No measurable disease
|
0
|
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
|
eligible ages (years): 18.0-70.0, Hepatocellular Carcinoma Histologically proven hepatocellular carcinoma. 2. HCC underwent curative resection within 6 weeks before registration. 3. Grossly, the resection margin should be > 1 cm. 4. Tumors, either single, < 5 cm in size or no more than 3 for size < 3 cm. 5. Patients must have a performance status of ECOG score < 2. 6. Patients must have adequate liver reservation and adequate hemogram Pugh-Child's Score < 7 The serum total bilirubin level are < 2 mg/dl The prothrombin times are < 3 sec above normal control The platelet are > 7.5 x 104 / mm3 The WBC are > 3,000 / mm3. 7. Patient must have serum creatinine < 1.5 mg/dl 8. Cardiac function with NYHA classification < Grade II 9. HBsAg (+) . 10. Signed informed consent Patients who have non-curative resection are not eligible. 2. Resected HCCs with histologically positive margins are not eligible. 3. HCCs with radiological evidence of portal vein thrombus are not eligible. 4. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. 5. Patients with advanced second primary malignancy are not eligible. 6. Patients with pregnancy or breast-feeding are not eligible. 7. Patients with severe cardiopulmonary diseases are not eligible. 8. Patients with clinically significant psychiatric disorder are not eligible. 9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. 10. Patients who had prior lamividine and/or adefovir dipivoxil therapy are not eligible. 11. Anti-HCV positive patients are not eligible
|
0
|
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
|
eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study American Society of Anesthesiologists (ASA) classification of physical status > III An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods A myocardial infarction or coronary artery stent placement within 6 months of the treatment Neurogenic lower urinary dysfunction A post-void residual (PVR) volume ≥ 400 mL Pre-existing urinary incontinence Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function Pre-existing damage of external urinary sphincter Presence of cystolithiasis, urethral stricture, or bladder neck contracture Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
|
2
|
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
|
eligible ages (years): 18.0-999.0, Urinary Tract Infections Men or non-pregnant women, 18 years of age or older with a suspected complicated urinary tract infection with an onset of symptoms 72 hours or less prior to study entry Patients must present with a least one sign or symptom of a lower UTI (dysuria, urgency, frequency, suprapubic pain) or for spinal cord injury patients if such symptoms are not present, at least one of the following: fever (T > 38º C or 100.4º F orally), onset of urinary incontinence, increased spasticity, autonomic hyperreflexia, increased sweating, or cloudy and odorous urine Patients must have at least one of the underlying conditions Indwelling urinary catheter or intermittent catheterization mL of residual urine after voiding Neurogenic bladder Obstruction due to nephrolithiasis, tumor or fibrosis Urinary retention due to benign prostatic hypertrophy, bladder cancer or other urological anatomic abnormalities Patients must have pyuria prior to enrollment (within 48 hours) defined as > 10 leukocytes/mm3 in unspun urine by hemocytometer or > 5 leukocytes/hpf in resuspended sediment of centrifuged urine Patients must have one clean-catch, midstream urine culture or culture from catheter (obtained using sterile technique, not from a Foley bag) that was obtained within 48 hours of enrollment and had a positive results: 1. Defined as >= 100000 CFU/mL (>= 10000 CFU/mL for S. saprophyticus) for a causative pathogen 2. If more than 1 pathogen is identified, each should be present at a colony count >= 100000 CFU/mL (>= 10000 CFU/mL for S. saprophyticus) to be included in the analysis 3. For catheterized patients two or more pathogens (>= 100000 CFU/mL) (>= 10000 CFU/mL for S. saprophyticus) isolated from a baseline urine culture will be considered contaminants unless simultaneous blood culture yields the same pathogen(s) 4. The causative pathogen must be susceptible to ciprofloxacin on in vitro susceptibility testing 5. Enrollment and start of treatment is permitted prior to the availability of the culture report Have a history of allergy to quinolones Are unable to take or inability to tolerate oral medications History of prostatitis or epididymitis Have signs and symptoms of pyelonephritis [all of the following: fever (T>38° C/100.4° F orally), chills, and flank pain or costovertebral angle tenderness] Have an intractable infection requiring > 14 days of therapy Have an uncomplicated UTI Have a renal transplant Have ileal loops or vesico-ureteral reflux Have a ciprofloxacin-resistant pathogen upon urine or blood culture Have received systemic antimicrobial therapy within 48 hours prior to enrollment
|
0
|
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
|
eligible ages (years): 18.0-999.0, Prostatic Neoplasms Prostate Cancer Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation in Solid Tumors (RESIST) Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dL) Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (<=) 2 (Karnofsky Performance Status >= 50 percent) Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection Uncontrolled hypertension (high blood pressure) Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
|
0
|
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
|
eligible ages (years): 18.0-999.0, Hormone-Resistant Prostate Cancer Recurrent Prostate Carcinoma Histologically or cytologically confirmed prostate cancer Must have received prior hormonal therapy, including either medical (luteinizing hormone-releasing hormone [LHRH] agonist) or surgical (orchiectomy) castration Castrate level of testosterone (< 50 ng/dL) Patients treated with LHRH agonists must continue or restart this therapy Must have radiological documentation of either measurable or non-measurable disease Must show documented progression of prostate cancer while on hormonal therapy as indicated by PSA increase Rising PSA is defined as ≤ 2 consecutive rises in PSA taken ≥ 1 week and ≤ 2 months apart PSA >= 5 ng/mL No known brain metastases Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
|
0
|
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
|
eligible ages (years): 50.0-80.0, Prostatic Hyperplasia Adrenergic Alpha-Antagonists Age between 50 and 80 years old Clinically diagnosed to have BPH Suffered from lower urinary tract symptoms with IPSS>=8 Detectable prostatic enlargement determined by DRE Urinary flow between 5 and 15ml/second in a total void volume >=150mL Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA >25% or>=4 with cancer excluded by biopsy Acute retention of urine Congestive heart failure, unstable angina, arrhythmia, myocardial infraction Prostatic surgery Prostatic malignancy Gastrointestinal disease Renal impairment with serum creatinine >140 umol/l Hepatic disorder
|
1
|
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
|
eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Bladder Outlet Obstruction Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20 Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion for Baseline also) Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry History of urinary retention in preceding 12 months Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
|
2
|
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
|
eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Prostatic Hyperplasia male patients with LUTS associated with BPH diagnosed > 3 months IPSS score > 13 voiding and storage symptoms maximum flow rate of > 4 mL/s and < 15 mL/s post void residual volume > 200 mL symptomatic urinary tract infection
|
2
|
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
|
eligible ages (years): 18.0-999.0, Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following No prior chemotherapy and relatively minimal cancer spread Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following (despite androgen deprivation and anti-androgen withdrawal when applicable) Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans) Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug Measurable disease is not required but is allowed Must be surgically or medically castrated If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530 Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation Prior surgical procedures affecting absorption Active peptic ulcer disease Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier Use of specifically prohibited CYP3A4-active agents or substances Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
|
0
|
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
|
eligible ages (years): 41.0-999.0, Benign Prostatic Hyperplasia Male over the age of 40 Diagnosed with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention as determined by their urologist Experienced lower urinary tract symptoms (LUTS) secondary to BPH > 3 months in duration IPSS value of > 12 Peak urinary flow < 15mL/sec on voided volume (minimum of 150 ml) Prostate size, as measured by transrectal ultrasonography (TRUS), less than 100cc in volume American Society of Anesthesiology (ASA) classification of physical status, class 1-3 Able to read, understand, and sign the Informed Consent Willing and able to comply with all follow-up requirements including multiple follow-up visits Transvesically measured post-void residual volume >400 mL Currently in urinary retention Chronic urinary retention Medications impairing bladder contractibility Uncorrectable bleeding disorders or long term anticoagulation that cannot be stopped Recent myocardial infarction or coronary artery stent placement Any of the following diseases which appear to involve the bladder: myasthenia gravis, diabetes neuropathy, multiple sclerosis, spinal cord injury or Parkinson disease Any patient with idiopathic atonic bladder Major pelvic fractures that involved damage to the external urinary sphincter
|
2
|
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
|
eligible ages (years): 55.0-75.0, BPH Each patient must comply with all of the following to be allowed to be randomised into the study: 1. Man, 55 to 75 years of age. 2. Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening. 3. A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study. 4. Has a baseline testosterone level above 3 ng/mL at screening Any patient meeting one or more of the following will not be included into the study: 1. Previous surgery of the prostate. 2. Previous treatment with GnRH agonists or GnRH antagonists. 3. Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study. 4. Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I). 5. Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I)
|
2
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Men aged greater than or equal to 50 years with a history of lower urinary tract symptoms (LUTS) related to BPH for greater than or equal to 6 months, an International Prostate Symptom Score (I-PSS) (0 to 35 points scale) of at least 13 points, a maximum urinary flow rate (Qmax) between 5 and 12 mL/sec (with a voided volume of greater than or equal to 150 mL), a residual urine volume of less than or equal to 350 mL, and a bothersomeness score (0 to 6 points scale) of at least 3 points. All patients will undergo prostate size assessment by transrectal ultrasonography (TRUS) if not done within past 12 months but are not limited to: concomitant lower urinary tract disease; previous prostatic surgery; history of postural hypotension or syncope; concomitant use of medications that may alter the voiding pattern; and clinically relevant biochemical abnormalities. Patients with a serum prostate-specific antigen (PSA) >10 ng/mL will be excluded, and those with an elevated serum PSA between 4 and 10 ng/mL must have prostate cancer excluded to the satisfaction of the investigator. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
|
1
|
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
|
eligible ages (years): 25.0-80.0, Prostate Cancer for trial group Age between 45 and 80 years old Presumably Stage 2 and higher prostate carcinoma as determined by the PI At least 6 weeks after the last biopsy session Prior to any PC treatment. for control group Age between 25 and 35 years old No family history of PC No lower urinary tract symptoms for both groups History of hemorrhoids History of prostetitis
|
0
|
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
|
eligible ages (years): 45.0-999.0, Prostatic Hyperplasia Prostate month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study Meet required prostate symptom score and urine flow rate Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months Prostate removal and various other pelvic surgeries Neurological disease or condition known to affect the bladder Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis Have taken medications such as nitrates, finasteride, or dutasteride within the year
|
2
|
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
|
eligible ages (years): 18.0-999.0, Prostatic Diseases Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH Patients requiring BPH surgery immediately or within the 12 following months Acute renal obstruction Chronic renal obstruction Chronic renal failure from BPH Bladder stone Recurrent urinary tract infection Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size) Hematuria from BPH Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase) Patients previously not improved by an alpha1-blocker treatment
|
2
|
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
|
eligible ages (years): 18.0-999.0, Urinary Tract Infections Bladder, Neurogenic Patients suspected or at risk for complicated urinary tract infections Gross contamination of urine samples at the time of collection
|
0
|
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
|
eligible ages (years): 45.0-999.0, Urological To be eligible for the study, potential participants must meet all of the following 1. Male at least 45 years of age. 2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml. 3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits. 4. Voluntarily signed informed consent agreement prior to the performance of any study procedures Potential participants that meet any of the following will be excluded from the full-scale trial: 1. Any prior invasive intervention for BPH. 2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months. 3. Alpha blocker within one month. 4. Reported allergic reaction to Serenoa repens. 5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma. 6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months. 7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl). 8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement. 9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement. 10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome. 11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit. 12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score >14 at screening. 13. Unstable medical condition within the past 3 months. 14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction. 15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery. 16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function. 17. Documented bacterial prostatitis within the past year. 18. Two documented independent urinary tract infections of any type in the past year. 19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin. 20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not. 21. Unable to follow protocol directions due to organic brain or psychiatric disease. 22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol. 23. Any serious medical condition likely to impede successful completion of the study
|
2
|
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
|
eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Overactive Bladder Syndrome Male patients with lower urinary tract symptoms Female patients with overactive bladder syndrome None
|
2
|
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
|
eligible ages (years): 40.0-999.0, Benign Prostatic Hyperplasia Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present Necessity of surgical intervention immediately or within 12 months because of BPH The patient has earlier /within 6 months/ obtained treatment because of BPH The patient did not improve on earlier alpha-1 blocker treatment Known hypersensitivity to alfuzosin Orthostatic hypotension in the history Concomitant application with another alpha-1 blocker Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/ Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/ Intestinal obstruction /because of the castor oil content of the drug/ Tumorous disease
|
1
|
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
|
eligible ages (years): 50.0-80.0, Prostate Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study but not limited to Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function
|
1
|
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
|
eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia (BPH) Signed written informed consent, obtained before screening evaluations Men diagnosed with LUTS suggestive of BPH: Baseline IPSS score of = 12 (moderate to severe); Prostate volume of = 40 mL and < 100 mL (based on TRUS); Peak urinary flow rate = 15 mL/s with a voided volume of =125 mL Age at least 50 but not older than 80 years at screening PSA < 10 ng/mL and of prostate cancer to the satisfaction of the investigator (e.g. by biopsy) A post void residual volume >250 mL Use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug) Acute urinary retention within the past 12 months History of surgery for BPH, including other minimally invasive procedures Presence of urinary tract infection Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation Cardiac or cerebrovascular event within the past six months Presence or history of any neurological disease associated with primary bladder dysfunction Presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal Clinically relevant abnormal laboratory result as judged by the (sub)investigator
|
2
|
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
|
eligible ages (years): 18.0-999.0, Urologic Diseases Patients with lower urinary tract dysfunction Controls with normal lower urinary tract function Age < 18 years old Pregnancy
|
0
|
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
|
eligible ages (years): 18.0-999.0, Voiding Dysfunction Female aged ≥ 18 Have voiding symptoms as chief complaints over 3 months IPSS symptom score ≥ 15 A peak flow rate <12 mL/sec with a minimum voided volume of 100 mL and/or a postvoid residual urine volume >150 mL Underwent pressure-flow study Patients who meet any of the following are to be excluded from the study Neurogenic voiding dysfunction Anatomic causes of bladder outlet obstruction Perform physical examination in patients diagnosed as BOO in pressure-flow study by urethral evaluation with 16 Fr urethral sound: if there is resistance to 16Fr sound, it will be diagnosed as anatomical BOO and the patients can not participate in the study Previous surgical procedures related to incontinence or cystocele Pregnant or nursing women Intake of medications and drugs affecting bladder function: alpha blocker, anticholinergic Anticholinergic drugs: Tolterodine, Oxybutynin, Propiverin, Trospium, Solifenacin, SSRI including TCA Cholinergic drug: Bethanechol Any other blocker other than alfuzosin
|
1
|
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
|
eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia Who had the treatment of BPH with alpha-1 blockers for more than 3 months Who have the IPSS(International Prostatic Symptom Score) >= 15 Who have the maximum flow rate(Qmax) < 15 with voided volume > 150mL Who have the PPBC(patient's perception of bladder condition) >= 3 (The PPBC was assessed by the use of a six point ordered categorical scale(1-6 point). The higher score means the higher bother) Who had the PSA level < 4 ng/mL within 6 months (But, the patient who are revealed not to have prostate cancer by prostate biopsy can be included even if he had PSA level of 4-10 ng/mL) Who underwent the transrectal ultrasound of prostate within 6 months Who can understand this study and can give the informed consent Who had regular intake of 5-alpha reductase inhibitor or NSAID within 6 months before screening Who have peptic ulcer and/or asthma Who have urologic malignancies such as prostate cancer and bladder cancer Who have urethral strictures, large bladder diverticuli, and bladder neck contractures Who had surgical treatment for BPH Who have histories of bladder and/or urethra Who have serum PSA level more than 10 ng/ml Who have histories of orthostatic hypotension Who have serum creatinine level more than 2.0 mg/dl Who have serum ALT and/or AST level more than 1.5 times of normal upper limit
|
1
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Male ≥50 yrs 2. Diagnosed BPH by medical history and physical examination, including a digital rectal examination 3. International Prostate Symptom Score ≥12 points at Screening 4. Prostate volume ≥30cc (by transrectal ultrasonography; TRUS) 5. Total serum Prostate Specific Antigen ≥1.5 ng/mL at Screening 6. Maximum flow rate ≥5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids) 7. Able to give written informed consent and comply with study procedures 8. Literate in English language with the ability to read, comprehend, and record information on the IPSS, BII, and PPSM questionnaires 9. Able to swallow and retain oral medication 10. Able to participate for study duration Total serum PSA >10.0 ng/mL at Screening. Patients with total serum PSA >10.0 ng/mL may be acceptable for if the PSA elevation is thought to be due to BPH and not prostate cancer (by TRUS and biopsies showing no evidence of prostate cancer). 2. History or evidence of prostate cancer 3. Previous prostatic surgery or other invasive procedures to treat BPH 4. History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Screening. Catheterization (<10F) is acceptable with no time restriction. 5. History of AUR within 3 months prior to Screening 6. Post-void residual volume >250mL (suprapubic ultrasound) at Screening 7. Any causes other than BPH, which may in the judgment of the investigator, result in urinary symptoms or changes in flow rate 8. History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy 9. Use of 5 alpha-reductase inhibitor, any drugs with antiandrogenic properties, or drugs noted for gynecomastia effects, within past 6 months and throughout the study. Previous use of within 12 months of the baseline or historical TRUS. Chronic use of Metronidazole is prohibited. 10. Concurrent use of anabolic steroids 11. Use of phytotherapy for BPH within 2 weeks of Screening 12. Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening 13. Use of any alpha-adrenoreceptor agonists, anticholinergics or cholinergics within 48 hours prior to all uroflowmetry assessments. 14. Hypersensitivity to any alpha-/beta adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs. 15. Concurrent use of drugs known or thought to interaction with Tamsulosin. 16. History of hepatic impairment, abnormal liver function at Screening, History of renal insufficiency, serum creatinine >1.5 times the upper limit 18. history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 2 years. 19. History of any illness the investigator might confound the results of the study or poses additional risk to the patient. 20. Any unstable, serious co-existing medical condition(s) 21. History of postural hypotension, dizziness, vertigo, or any other signs and symptoms of orthostasis. 22. History of 'first dose' hypotensive episode on initiation of alpha-l-adrenoreceptor antagonist therapy. 23. History of unsuccessful treatment with finasteride or Dutasteride 24. History or current drug or alcohol abuse within the previous 12 months. 25. Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding Screening and/or during the course of this study
|
2
|
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
|
eligible ages (years): 18.0-999.0, Severe Sepsis Septic Shock Patients with severe sepsis or septic shock, if each one of the following is satisfied Proved or suspected infection in at least one site lung abdomen genito-urinary tract other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter-related infection, other) Two or more of the following a core temperature ≥ 38° C o ≤ 36° C a heart rate ≥ 90 beats/min a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process Age below 18 years Terminal state Known adverse reaction to albumin administration Severe sepsis or septic shock in patients after proved or suspected head injury, clinically active Congestive heart failure (NYHA score III and IV) Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephritic syndrome, burns) More than 24 hours since were met Religious objection to the administration of human blood products in other experimental study
|
0
|
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
|
eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Males, 50 years or older, who are on an alpha blocker and/or a 5-alpha reductase inhibitor or a combination, and are candidates for interventional therapy. Patients to continue on an alpha blocker and/or 5-alpha reductase inhibitor for at least one-month after the Litx™ treatment, then tapered off medication at physician's discretion Patients who understand and have the ability to sign written informed consent prior to any study procedures and discontinuation of exclusionary medications Patients with moderate to severe BPH bother score >3 requiring non-medication intervention Patients with an IPSS1 Score of >15 points Maximum urinary flow rate (Qmax) ≤15 mL/sec Post void residual volume (PVR) ≤300 mL Prostatic volume >50g by TRUS Patients with any previous minimally invasive or surgical intervention for BPH Patients who have enrolled, or are currently enrolled in, another clinical trial for any disease within the past 30 days Patients with an active urinary tract infection Patients with a urethral stricture Patients with a predominant middle lobe obstruction Patients who have evidence or history of prostate or bladder cancer Patients with a PSA of >10 ng/ml. If the PSA is 4-10 ng/ml, preliminary biopsy should be done within one-year prior to entry into the study to rule out prostate cancer Patients who had a biopsy of the prostate within the past 6 weeks Patients with bleeding diathesis Patients with clinically significant renal or hepatic impairment
|
1
|
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
|
eligible ages (years): 18.0-120.0, Prostate Cancer Histologically confirmed adenocarcinoma of the prostate, meeting one of the following Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/mL) Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA < 20 ng/mL OR T1-T2a, Gleason score 7, and PSA < 10 ng/mL) No known nodal (N0 or NX) or distant (M0 or MX) metastases No pubic arch interference, as defined by either of the following Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension < 4.3 cm No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound American Urological Association voiding symptom index ≤ 12 Peak uroflow rate (Q_max) ≥ 12 cc/second
|
0
|
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
|
eligible ages (years): 18.0-999.0, Warfarin current patient of the Anticoagulation Management Service anticipated need for long term anticoagulation have a regular primary care physician previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation have a planned procedure (surgery) mandating discontinuation of warfarin are taking warfarin for a mechanical valve indication
|
0
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) (All must be answered yes): 1. Has the patient given written informed consent? 2. Is the patient at least 50 years old? 3. Is the patient diagnosed with BPH and has he had clinical signs and symptoms of BPH for ≥ 6 months? 4. Does the patient have an IPSS ≥ 13? 5. Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec (utilizing the 2-second rule) established on a voided volume of at least 125 mL? 6. Does the patient have an IPSS QoL score of ≥ 3? 7. Does the patient have a PSA > 0.8 ng/mL? 8. For patients with a PSA between 4 and 10 ng/mL or suspicion of prostate cancer, has the patient had a diagnostic evaluation (e.g., biopsy, PSA, velocity, etc.) that reasonably excludes the diagnosis of prostate cancer? 9. Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including but not limited to alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? 10. Is the patient willing to restrict use of PDE 5 inhibitors exclusively to the use of Viagra, one dose per week only and with no dosing in the 5 days immediately preceding scheduled study visit? 11. Is the patient willing and able to abide by the protocol? 12. Does the patient have an IPSS ≥ 13? 13. Does the patient have an IPSS QoL score of ≥ 3? 14. Does the patient have a post-void residual ≤ 350cc? (all must be answered No): 1. Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL? 2. Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? 3. Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL? 4. Does the patient have a post void residual urine volume ≥ 350 mL by ultrasound? 5. Has the patient taken or is the patient currently taking any of the following: 1. Estrogens, phytoestrogens, androgens, antiandrogens or LHRH agonists within the past 4 months (e.g. testosterone gel [Androgel ®1%, Testim ® 1%], testosterone buccal [Striant®], oxymetholone [Anadrol®-50], oxandrolone [Oxandrin®], esterified estrogen and methyltestosterone [Estratest®]), bicalutamide [Casodex®], nilutamide [Nilandron®], flutamide [Eulexin®], leuprolide acetate [Lupron®, Eligard®, Viadur®], goserelin acetate [Zoladex®] or, 2. 5 α-reductase inhibitors within the past 4 months (e.g. finasteride[Proscar®, Propecia®], dutasteride [Avodart®]) or, 3. Alpha blockers or anti-cholinergic preparations within the past 6 weeks (e.g. doxazosin [Cardura®], terazosin [Hytrin®], tamsulosin [Flomax®], alfuzosin [Uroxatrol®], oxybutinin [Ditropan®], tolteredine [Detrol-LA®], amytriptyline [Elavil®, Limbitrol®]) or, 4. Class 1A (e.g. quinidine, procainamide, disopyramide) or Class III Anti-arrhythmic (e.g.sotalol [Betapace®], amiodarone [Cordarone®]) 6. Does the patient have or has the patient ever had a diagnosis of acute or chronic prostatitis or chronic pelvic pain syndrome? 7. Has the patient had a urinary tract infection or instrumentation (e.g catheterization, cystoscopy, prostate biopsy) within the past 4 weeks? 8. Does the patient have a history of urethral stricture, bladder stones, obstructing median lobe or neurogenic bladder dysfunction? 9. Does the patient have microscopic hematuria greater than trace by dipstick urine at Visit 1? 10. Did the patient have a positive drug screening result? 11. Does the patient have a history of urinary retention? 12. Does the patient have any serious medical condition (e.g., CHF, poorly controlled diabetes (HgbA1c > 9), psychiatric disorder, drug or alcohol abuse) that might interfere with his ability to comply with or complete the protocol? 13. Is the patient's QTc interval on the screening ECG > 450ms, or does he have a family history of long QT syndrome? 14. Does the patient anticipate or plan to have an elective surgery or surgical procedure requiring general, spinal or epidural anesthesia during the course of the double-blind treatment portion of the study(within the next 12 months)? 15. Has the patient ever received ozarelix, cetrorelix, tevarelix or degarelix? 16. Has the patient participated in any other study of an investigational drug or treatment for the signs and symptoms LUTS or BPH in the past 12 months? 17. Has the patient participated in any other clinical research study or study of an investigational drug in the past 90 days?
|
2
|
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
|
eligible ages (years): 50.0-79.0, Benign Prostatic Hyperplasia Age≥50 and <80 years old 2. Presence of LUTS for at least 3 months 3. IPSS≥15 4. Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20) 5. Prostate volume measured by TRUS ≥ 30ml and < 100ml 6. Able to comply with the prescribed treatment protocol and evaluations Patients with neurogenic voiding disorders 2. Patients with prostate or bladder cancer 3. Patients underwent urethral, prostate or bladder neck surgery 4. Patients with urethral stricture or bladder neck contracture 5. Serum PSA≥4ng/ml (if the patient confirmed as no malignancy by prostate biopsy can be included). 6. Patients who medicated with 5ARI within 6 months 7. Patients who do not agree with the informed consent
|
2
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms males ≥50 years with LUTS secondary to BPH Moderate to severe LUTS : IPSS ≥ 8 An enlarged prostate : TRUS ≥25 mL Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL) Having signed the informed consent to participate in the study Post voided residual urine ≥ 200mL Patients performing catheterization Urinary tract infection patients Patients taking 5 alpha reductase inhibitor Known hypersensitivity to alfuzosin History of postural hypotension or syncope Hypertension patients treated with other alpha1-blockers Patients newly taking anticholinergic medication within 1 month Hepatic insufficiency (AST/ALT ≥ 2 times of normal range) Renal insufficiency (s-Cr ≥ 2mg/dL)
|
2
|
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
|
eligible ages (years): 0.0-999.0, Overactive Bladder Syndrome Voiding Dysfunction OAB symptoms (based on relevant domains of questionnaire and Urgency Perception Scale) which have not improved with 2 anticholinergic treatments. 2. Maximum flow rate of less than 15 ml/s on a volume voided of 200mls or more, with a normal or high detrusor pressure at maximum flow on pressure flow studies 3. Patients must be able to give informed consent for the study Presence of concurrent urodynamic stress incontinence 2. Patient unfit or unwilling to undergo a general anaesthetic 3. Patients with bladder pathology or haematuria of unknown origin 4. Patients with neurological disorders (as these may affect voiding)
|
0
|
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
|
eligible ages (years): 40.0-80.0, Benign Prostatic Hyperplasia Males aged 40 to 80 years Lower urinary tract symptoms (LUTS), such as frequency, nocturia, urgency, weak urine stream, hesitancy, intermittency or post-void dribbling attributable to BPH for at least 6 months prior to dosing Untreated, intolerant or refractory to α-blockers; should not have received the medication for at least 2 weeks prior to screening and 4 weeks prior to dosing Subjects with PSA values 4 ng/mL should be assessed or medical records checked (e.g. biopsy report) to rule out the presence of prostate cancer Untreated, intolerant or intolerant to 5-α reductase inhibitors AND must be off medication for at least 6 months prior to dosing IPSS of 15 or higher Prostate volume at screening estimated at 30 to 100 mL as determined by TRUS Provided written Informed Consent for participation in the study Maximum urine flow rate (Qmax) of greater than 12 mL/sec Inability to void at least 150 mL of urine Post voiding residual urine volume (PVR) of greater than 200 mL Subjects unable to stand to void Subjects with acute or chronic bacterial prostatitis Using drugs (e.g. estrogen, androgen) that can produce androgen depression or anabolic steroids Penile prosthesis or artificial urinary sphincter Presence of prostatic cyst larger than 1 cm in diameter Unwilling to use condoms for 3 weeks post-treatment to prevent pregnancy and to avoid semen contact with partner(s) Urethral stricture disease
|
2
|
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
|
eligible ages (years): 45.0-65.0, Precancerous Condition Prostate Cancer Meets 1 of the following Patient at high risk for developing prostate cancer, due to 1 of the following risk factors Histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation Abnormality observed during digital rectal exam or transrectal ultrasonography Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at least 1 of the following Screening PSA > 4.0 ng/mL Free PSA < 18% PSA velocity > 0.75 ng/mL within the past year Healthy volunteer meeting the following Age-matched
|
0
|
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
|
eligible ages (years): 50.0-999.0, Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Symptomatic BPH International Score Prostate Symptom (IPSS) of 13 or greater prostate volume of 30 to 100 ML Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL Able to give fully informed consent Subjects with histological diagnosis of prostate cancer Subjects with history of chronic urinary retention Subjects with urethral stricture Subjects with bladder neck contracture Subjects with urinary tract infection Subjects with prostate volume on TRUS of >100 mL Subjects with suspected neurogenic bladder dysfunction Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason
|
2
|
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
|
eligible ages (years): 45.0-999.0, Prostate Cancer Age ≥ 45years 2. Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy. 3. PSA value < 20 ng/ml within 6 weeks before enrolment. 4. Gleason score ≤ 3+4 at diagnostic biopsy 5. Adequate renal function: Creatinine < 1.5 times upper limit of normal. 6. Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal. 7. Negative dipstick for bacturia. 8. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit Previous or ongoing hormone therapy for prostate cancer. 2. Ongoing or previous therapy (within3 month) of finasteride or dutasteride. 3. Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT). 4. Symptoms or signs of acute prostatitis. 5. Symptoms or signs of ulceric proctitis 6. Severe micturation symptoms (I-PSS >17) 7. Concomitant systemic treatment with corticosteroids, or immunomodulating agents. 8. Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes). 9. Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment
|
0
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months at screening: 1. Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools 2. Subject has provided written informed consent and HIPAA authorization 3. Ambulatory male subjects ≥ 50 years of age 4. Able to use the toilet without difficulty 5. History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs 6. Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS) 7. International prostate symptoms score (IPSS) ≥12 8. Post Void Residual Volume < 150 mL at baseline 9. Uroflowmetry-Qmax > 5 mL/sec and ≤ 15 mL/sec 10. Prostate specific antigen (PSA) ≥ 1.5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer 11. Have an average of ≥ 8 micturitions per 24 hrs 12. Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more) Concurrent use of 5-ARI therapy within the past 3 months 2. Concurrent use of alpha blockers within the past 2 weeks 3. Concurrent use of antimuscarinics within the past 4 weeks 4. Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis 5. Evidence of chronic inflammation such as interstitial cystitis and bladder stones. 6. Evidence of untreated urethral stricture disease 7. Uncontrolled narrow angle glaucoma 8. Increased post-void residual volume (PVR) defined as PVR > 150 mL 9. Uroflowmetry-Qmax ≤ 5 mL/sec 10. Acute urinary tract infection (UTI). These subjects may be treated and re-screened 11. Acute urinary retention (AUR) requiring catheter within the last 3 months 12. Previous or planned transurethral resection of the prostate (TURP) 13. Minimally invasive surgery (MIS) such as transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other minimally invasive procedures within 12 months. Those patients who in the opinion of the investigator did not respond adequately to MIS and fulfill the are eligible to participate 14. A known diagnosis of prostate cancer. 15. A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator 16. Renal or hepatic impairment defined as 2.5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient. 17. PSA > 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer) 18. Known or suspected hypersensitivity to dutasteride or tolterodine ER . 19. Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment. 20. History of diagnosed gastrointestinal obstruction disease. 21. Myocardial infarction within the past 8 weeks. 22. Known or suspected drug and/or alcohol abuse. 23. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study
|
2
|
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
|
eligible ages (years): 50.0-999.0, Lower Urinary Tract Symptoms (LUTS) Signed informed consent obtained before any trial-related activity is performed Men, aged 50 or older Clinical signs and symptoms of BPH for ≥6 months Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) ≥13 An IPSS QoL score of ≥3 at screening Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is >4 ng/mL, except in the USA where patients with a PSA >4 and ≤10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial) Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening Post void residual volume (PVR) >250 mL Stone in the bladder or urethra causing symptoms Acute or chronic prostatitis Interstitial cystitis / painful bladder syndrome Acute or recurrent urinary tract infections History of acute urinary retention (AUR) Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2 Clinical evidence of any of the following urinary tract conditions: 1. Mullerian duct cysts 2. Atonic, decompensated, or hypocontractile bladder 3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation) History of any of the following pelvic conditions: 1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery 2. Pelvic radiotherapy 3. Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies 4. Lower tract malignancy or trauma Clinically significant microscopic haematuria at screening
|
2
|
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
|
eligible ages (years): 0.0-80.0, Prostate Cancer Age ≤ 80 years Karnofsky index ≥ 80 First prostate biopsy Presence of at least one of the following Total PSA 10 ng/mL Total PSA 2.5-10 ng/mL with free-PSA <20% and/or PSA velocity 0.75 ng/mL/year Suspicious hypoechoic lesion at TRUS and/or suspicious finding at digital rec¬tal examination Informed signed consent Impaired capacity to consent Coexistence of clinically-proven prostate cancer Neoadjuvant hormonal treatment (including 5-α reductase inhibitors) Contraindications to surgery Contraindications to MR Imaging (see below) Age ≤ 90 years Karnofsky index ≥ 80 Previous treatment for prostate cancer No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy) Biochemically proven relapse of prostate cancer (PSA > 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy)
|
0
|
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
|
eligible ages (years): 18.0-100.0, Prostate Specific Antigens Prostate Neoplasms Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate HLA-A*201 positive Patients must have Completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitive-intent local therapy Stage D0 disease with documented biochemical progression documented by a rising PSA No evidence of metastatic disease by physical examination, CT scan or bone scan For patients following definitive radiation therapy or cryotherapy: a rise in PSA of >2ng/mL above the nadir For patients following radical prostatectomy: 2 absolute PSA values > 0.3 ng/mL Non-castrate level of testosterone: greater than or equal to 50 ng/dL (prior ADT allowed; must be greater than or equal to 6 months since last dose of ADT) A Pre-Enrollment/Baseline PSADT > 3 months and less than or equal to 15 months HLA-A*201 negative Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin, or superficial bladder carcinoma Patients with active infection Patients with brain, visceral or bony metastatic disease Patients in who live attenuated intranasal influenza vaccine (FluMist ) is contraindicated including individuals with asthma or reactive airways disease, cardiovascular or pulmonary disease, chronic metabolic diseases (including diabetes mellitus), renal dysfunction or hemoglobinopathies
|
0
|
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
|
eligible ages (years): 18.0-999.0, Chronic Kidney Disease Men and women 18 years of age or greater and able to comply with the study protocol eGFR within appropriate target ranges (15-40 ml/min/m² for late stage CKD stage 3 stage 4, and eGFR > 60 ml/min/m² for normal subjects) Stable kidney function defined as an eGFR which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. This will be determined from historical laboratory data Willing to follow study protocol Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel Overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods Able to read the consent form and provide informed consent Serum calcium and phosphorus within the normal range off of vitamin D analogues, calcium supplements, and phosphate binders for 1 month Age less than 18 years Are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female Patient declines participation GI malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis Subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates
|
0
|
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
|
eligible ages (years): 17.0-65.0, Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin. Relative At the principal investigator's (PI) discretion, an individual may be treated with IV Ribavirin, with caution, if one of these is present
|
0
|
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
|
eligible ages (years): 18.0-999.0, Hemophilia A Von Willebrand Disease Males or females >= 18 years of age A diagnosis of hemophilia A, moderate (FVIII:C 0.01-0.04 U/ml) or mild (FVIII:C >= 0.05 U/ml); or a diagnosis of VWD, defined by a low VWF:RCo and past bleeding history For those with VWD, an inability to use DDAVP due to i) unresponsiveness defined as VWF:RCo or FVIII:C level lower than 50 IU/dl or less than a 3-fold increase after 0.3 microgram/kg DDAVP; ii) allergic reactions or seizures; or iii) a contraindication to DDAVP Willingness to have blood drawn Willingness to sign informed consent Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia Use of immunomodulatory or experimental drugs, or diuretics Pregnant or lactating women Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis Past allergic reaction to Neumega Surgery within the past 8 weeks Inability to comply with study protocol requirements Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study Baseline safety and/or hematology lab values outside the normal limits and/or an EKG indicating an arrhythmia
|
0
|
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
|
eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months A total International Prostate Symptom Score (IPSS) of ≥13 A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization) Any significant Post Void Residual volume (>150 mL) A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound Evidence of a symptomatic urinary tract infection
|
2
|
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
|
eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
|
0
|
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
|
eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.