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A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-45.0, Healthy Aged 18-45 years Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Had voluntarily given written informed consent to participate in this study Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs Had history of diarrhoea, vomiting or headache within past two weeks Had history of hypotension (systolic BP<100 mmHg) Had history of allergy or bronchial asthma Had history of muscle cramps or muscle weakness Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE) Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis Had history of erythema multiforme including Stevens Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-45.0, Healthy Be in the age range of 18.45 years Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Have voluntarily given written informed consent to participate in this study Be of normal health as determined by medical history and physical Examination of the subjects performed .within 28 days prior to the commencement of the study If female and Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) History of allergy to metformin and other related antidiabetic biguanide preparations Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection Female volunteers demonstrating a positive pregnancy screen Female volunteers who are currently breastfeeding Presence of values' which are clinically significantly different from normal reference ranges for hemoglobin, total white blood cells count, differential WBC count and platelet count Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive) | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-80.0, Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Ischemic Preconditioning Patient undergoing heart surgery on cardiopulmonary bypass Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection End-stage renal disease Inability to give informed consent | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 1.0-17.0, Purpura, Thrombocytopaenic, Idiopathic Subjects between 1 year and <18 years of age at Day 1 Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old) Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments Day 1 (or within 48 hours prior) platelet count <30 Gi/L Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1 Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease) Concurrent or past malignant disease, including myeloproliferative disorder Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1 History of platelet agglutination abnormality that prevents reliable measurement of platelet counts Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis) Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1 Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.082, Congenital Heart Disease Disorder of Fetus or Newborn Neonates Age </= 1 month Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures) Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery Prematurity: </= 36 weeks post gestational age at time of surgery Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization Suspected infection that would contraindicate steroid use (eg Herpes) Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding) Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization Inability to begin the pre-operative study drug at least 8 hours prior to surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-55.0, Healthy Study subject must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained Be > or equal to 18 years of age and < or equal to 55 years of age Be in general good health without history of any of the conditions listed in No use of any tobacco products for at least 6 months A woman must agree not to become pregnant from the time of study enrollment until at least 3 months after the completion of the monoclonal antibody infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel Sexually active male subjects must use a barrier method of contraception during the course of the study Screening laboratory values must meet the following WBC (>3,900 <11,000/mm^3) Platelets(>100,000/mm^3) Hemoglobin (>10.5 gm/dl) Creatinine (<1.1 x ULN) BUN (<1.25 x ULN) | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.019, Adrenal Insufficiency All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following would be enrolled Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min) Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age Major congenital malformations Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid) Postnatal corticosteroid treatment Refusal to give consent | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Premature Newborn Necrotizing Enterocolitis Premature infants with gestational age between <32 weeks regardless of birth weight Inborn errors of metabolism Need for exchange transfusion Multiple congenital anomalies Renal failure (defined as urine output <1ml/k/h >24h, creatinine >1.8, or diagnosis of "non-oliguric renal failure" as determined by Pediatric nephrology) | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-80.0, Minimal Change Disease from 18yrs to 80 yrs , man and women Minimal change disease is diagnosed by kidney biopsy On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0 On screening, the patient shows that the serum albumin is below 3.0g/dL the patient sign on the concent form the patient have experience to take tacrolimus or cyclosporin for 1 month If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day steroid dependent or steroid resistant or frequent relapse case uncontrolled hypertension pregnancy or anticipate pregnancy with 6 month hypersensitivity to tacrolimus or macrolide acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Spinal Cord Injury years or older Male signed informed Consent Neg. urine multistix Abnormalities diseases or surgical procedures performed in the lower urinary-tract | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Hepatorenal Syndrome Type 1 Written informed consent by subject or legally authorized representative At least 18 years of age Cirrhosis and ascites Rapidly progressive reduction in renal function characterized by SCr ≥ 2.5 mg/dL Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based for proportional increases likely to be representative of at least a doubling within 2 weeks No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin Note: Albumin doses recommended by the IAC are 1 g/kg on the first day (Maximum 100 g) and 20 g/day thereafter as clinically indicated.It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be ≥ 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value Serum creatinine > 7 mg/dL Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation Sepsis or systemic inflammatory response syndrome (SIRS) Note: SIRS: Presence of 2 or more of the following findings Temperature > 38°C or < 36°C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/µL or < 4,000/ µL Note: Sepsis: Documented infection and systemic inflammatory response syndrome < 2 days anti-infective therapy for documented or suspected infection Proteinuria > 500 mg/day Hematuria or microhematuria (> 50 red blood cells per high power field) Clinically significant casts on urinalysis, including granular casts | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-90.0, Proteinuria Kidney Injury Chronic Kidney Disease Male and females, 18 years to 90 years old Any subject with pre-existing clinical indication of a kidney biopsy including, but not limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state. Additionally, kidney transplant donors will be included for purpose of obtaining control tissue Willing and able to give consent Additionally, kidney transplant donors and patients requiring nephrectomy for removal of renal mass will be included for purpose of obtaining control tissue Subjects on longstanding immunosuppressive agents (empiric initiation of glucocorticoid therapy within 48 hours prior to kidney biopsy is acceptable) Kidney transplant recipient Inability to follow-up for future protocol laboratory evaluation | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-1.0, Peritoneal Lesion term neonates and infants undergoing heart surgery with cardiopulmonary bypass parents received written information preoperative documented kidney injury parents not informed, opposed | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-50.0, Polycystic Kidney, Autosomal Dominant Males and females, 18 to 50 years old at the time of consent Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed) Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI eGFR < 60 mL/min/1.73m2 Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg) Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-24.0, Ductus Arteriosus, Patent Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 μmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-18.0, Congenital Heart Disease Cardiopulmonary Bypass Myocardial Injury Acute Kidney Injury Acute Lung Injury Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.167-1.5, Postoperative Pain in Infants Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months Bleeding history in infant or family Coagulopathy Gastrointestinal bleeding history Renal or hepatic disease assessed by history and by pre-drug blood tests Premature birth (<36 weeks gestation) | 2 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 14.0-60.0, Nephrotic Syndrome Subjects of either sex, 14-60 years of age Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and secondary Nephrotic syndrome Refractory Nephrotic Syndrome Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid eGFR ≥ 60 ml/min/1.73 m2 Provision of written informed consent by subject or guardian Systemic disease eGFR < 60ml/min/1.73m2 Diagnosed DM Malignant tumors (except fully cured basal cell carcinoma) Familial nephritic syndrome History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C Known hypersensitivity or contraindication to tacrolimus, corticosteroids Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening Pregnancy, nursing or use of a non-reliable method of contraception | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-18.0, Kidney Failure, Acute Age < 18 years, including the newborn Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method Treatment by extra renal replacement therapy for terminal renal failure History of renal transplantation Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure Extra renal replacement therapy in the context of a drug intoxication without acute renal failure Treatment by technique in MARS (Molecular Adsorbent Recirculating System) Modified ultrafiltration during surgery | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 12.0-999.0, Malaria Patient age >12 years Presence of severe or moderately severe P. falciparum malaria, with and without blackwater fever, confirmed by positive blood smear with asexual forms of P. falciparum Temperature >38 degrees Celsius on admission or fever during the preceding 24hours Written informed consent from patient or attending relative able to and willing to give informed consent. Consent form and information sheets will be translated into Bangla and copies provided to the patient Patient or relatives unable or unwilling to give informed consent History of chronic liver disease History of alcohol use (>3drinks per day) Contraindication or allergy to paracetamol or artesunate therapy Contraindication to nasogastric tube insertion i.e. facial fracture, bleeding diathesis Pregnancy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-85.0, Hepatorenal Syndrome, Liver Regeneration Patient with neoplastic liver tumors undergoing elective hepatectomy Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.022, Prematurity infants born at less than 32 weeks postmenstrual age infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Proliferative Diabetic Retinopathy (PDR) Male or female healthy volunteers will be eligible if the following and none of the are met Ability to provide ethics committee approved written informed consent and comply with study-related procedures/ assessments for the full duration of the study, having age > 18 years Corrected visual acuity >20/25 in both eyes Intraocular Pressure (IOP) <21 mm Hg, with a difference between eyes of < 4 mm Hg Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff Tolerance of a commercially available non-preserved, artificial tear solution in one eye Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing Normal clinical laboratory profiles, defined as complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values Be neither overweight nor underweight for his/her height as per the Body Mass Index (BMI) scale (18.5-24.9) Female of childbearing potential | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 20.0-69.0, End Stage Renal Disease Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation Donor (1) Refusal of legal guardian Recipient Patient refusal Hypersensitivity to propofol, soybeans or peanuts History of vitamin C or E intake within 5 days before surgery History of acute myocardial infarct within 6 months before surgery Congestive heart failure (NYHA III-IV) Autoimmune disease patients BMI over 30 kg/m2 | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital Patients younger 18 Preexisting renal insufficiency | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-65.0, Urinary Calculi A、B group were enrolled standards: ① aged 18-65 years old; ② comply with percutaneous nephrolithotomy lithotripsy indications for surgery; ③ ECT tips ipsilateral normal or mildly impaired renal function Group C patients were enrolled standards: ① aged 18-65 years old; ② normal renal function, not associated with urinary calculi in patients; ③ cancer patients met radical nephrectomy indications for surgery; ④ emergency trauma patients suffering from kidney resection surgical indications aged <18 years or> 65 years; ② neurological disease or cognitive dysfunction; ③ can not be corrected or uncorrected coagulopathy; ④ associated with diabetes, hypertension and other metabolic diseases; ⑤ accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; ⑥ poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; ⑦ ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness <1.5cm), structural variation; ⑧ with severe systemic or urinary tract infection; ⑨ ECT tips ipsilateral renal function is severely impaired or solitary kidney | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-70.0, Acute Kidney Injury Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled Age < 18 or > 70 years Preexisting Chronic Renal Disease Patients with obstructive uropathy Cirrhosis with HCC (HepatoCellular Carcinoma) Advanced cardiopulmonary disease Pregnancy Patients with extrahepatic malignancy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-21.0, Acute Kidney Injury Congenital Heart Disease Subjects age ≤18 years Subjects scheduled for cardiac surgery with cardiopulmonary bypass Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved) Subjects with known metabolic disorder Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-10.0, Patients Undergoing Surgery for Congenital Heart Disease patients who underwent surgery for congenital heart disease between 2009 and 2013 in Samsung Medical Center incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury patients who expired within 24 hours after surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 20.0-999.0, Coronary Artery Bypass Surgery Acute Kidney Injury Creatinine Mortality patients who underwent coronary artery bypass surgery during between 2008 and 2013 in Samsung Medical Center lack of postoperative creatinine or urine output data patients who expired within 24hours after surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-10.0, Patients Who Underwent Surgery for Congenital Heart Disease pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Liver Cirrhosis and Acute Kidney Injury Age >18 years Cirrhosis of liver Hospitalization at University of Virginia Medical Center Diagnosis of acute kidney injury based on AKIN Known history of a right to left intracardiac shunt Known history of pulmonary hypertension, including portopulmonary hypertension Pregnancy or lactation History of allergies to Definity® History of Liver or Kidney Transplant Patient on hemodialysis | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Oliguria Polyuria Patient must ≥ 18 years of age Patient has a Foley catheter and urine collection system is in place per standard clinical decision Estimated length of placement of the Foley is 48 hours minimum Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA) Subject or subject's legally authorized representative is able to give informed consent before entering the study Currently pregnant or breastfeeding Clinical signs or symptoms of a urinary tract infection (UTI) Clinical signs or symptoms of a vaginal infection Currently has bladder or urethral trauma Use of investigational drug/device therapy within the past 4 weeks | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Microscopic Hematuria Post-menopausal women Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection Known urologic disease Presence of gross hematuria Presence of indwelling urologic foreign body (foley catheter, ureteral stent) Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy) History of pelvic irradiation or malignancy Not a candidate for vaginal estrogen Allergy to vaginal estrogen Current or prior diagnosis of breast or endometrial cancer History of deep vein thrombosis/pulmonary embolus Hypercoagulable state | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-79.0, Chronic Kidney Disease patients who had non-cardiac surgery in Seoul Paik Hospital have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level severe lung disease severe heart failure ( Ejection Fraction < 40% ) pregnancy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.25, Acute Kidney Injury Neonate < 3 months post natal age Diagnosed with acute kidney injury (AKI) Receiving aminophylline for AKI treatment as per local standard of care Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) Patient on renal replacement therapy Major genetic abnormalities (trisomy 13, 18 or 21) | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Progressive IgA Nephropathy Proteinuria Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months Quantified 24h creatinine clearance > 30 ml/min/1.73m2 Blood pressure < 130/80 mmHg at > 75% of the readings Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study Patient must be able to receive injections to be enrolled in the study Patient must have a kidney biopsy slide on file that can be sent to Mayo Clinic Clinical and histologic evidence of IgA predominant Lupus nephritis Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy Serum Cr > 3.0 mg/dL or creatinine clearance GFR < 30 ml/min at the time of screening | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 2.0-6.0, Neonatal Acute Kidney Injury Childhood Chronic Kidney Disease Premature birth UVA NICU admission prior to 7 days of life Birth weight less than 1500 grams Study group: Acute Kidney Injury as defined by KDIGO modified during NICU stay at UVA Control group: No AKI during NICU stay Parental or legal guardian consent obtained Patients with Congenital Anomalies of the Kidney and Urinary Tract SGA patients | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-45.0, Healthy Volunteers who met the following were included in the study Were in the age range of 18-45 years Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Had voluntarily given written informed consent to participate in this study Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Had a non-vegetarian diet habit History of known hypersensitivity to Felodipine, related drugs and or any other drug Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I History of chronic headache, dizziness and syncope History of peripheral edema History of grapefruit juice and / or grapefruit supplements intake in past 48 hours Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids) Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Delayed Graft Function Age ≥ 18 years Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis) Recipient of deceased donor kidney transplant Urine output less than 0.5 mL/kg/h before transplant Patient consents to the study Patient is not allergic to furosemide or sulfa English or Spanish speaking patient Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant Recipients of a living donor kidney transplant Patients who do not consent for the study Patients age <18 years Patients who are allergic to furosemide or sulfa containing medications Non-oliguric patients Patients who require immediate dialysis within 6 hours of the transplant (before enrollment) Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care Patients who return to the operating room due to complications within 24 hours Simultaneous multi-organ transplant recipients Hypotensive patients with BP <90/60 or MAP <60 mmHg | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Narrow Band Imaging in Flexible Cystoscopy Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC Patients not fullfilling the above | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 14.0-999.0, Acute Kidney Injury Critically ill, adult patients AND with acute oliguric renal failure AND within 6 hours of presentation i. Patients with pre-existing chronic renal failure ii. Patients on renal replacement therapy/ Dialysis iii. Patients with poor sonographic windows | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 65.0-90.0, Total Fluid Volume Increased Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-Ⅲ) Allergy and contraindication to HES Infections and malignancies Sepsis History of heart failure or New York Heart Association(NYHA)＞Ⅲ Renal failure or Cr>108μmol/L，BUN>8.3mmol/L Undergoing dialytic treatments Intracranial hemorrhages Taking non-steroidal antiinflammatory agent for a long time Inability to understand the Study Information Sheet and provide a written consent to take part in the study | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.192, Postoperative Feeding Following Pyloromyotomy Subjects to be included in the study infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.038, Acute Kidney Injury All infants born or admitted to a level 2 or 3 NICU will be screened Infants who received intravenous fluids for > 48 hours will be eligible Infants admitted to the NICU at 2 weeks of age or older Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life Infants diagnosed with a lethal anomaly upon admission Infants who die within 48 hours after birth | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Contrast Nephropathy All consecutive patients with chronic kidney disease (CKD) scheduled for coronary and/or peripheral angiography and/or angioplasty with an eGFR <45 ml/min/1.73 m2 and/or At high risk for CI-AKI according to Mehran's score ≥11 and/or Gurm's score >7 Age <18 years Women who are pregnant Acute pulmonary edema Acute myocardial infarction Recent contrast media exposure End-stage CKD on chronic dialysis Multiple myeloma Current enrolment in any other study when enrolment in the III would involve deviation from either protocol Cardiogenic shock Administration of theophilline, dopamine, mannitol and fenoldopam | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.083-1.0, Postoperative Pain Postoperative Vomiting ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia infection of the orbit increased intraocular pressure(IOP) history of allergy to local anesthetics history of previous eye surgery cardiovascular or clotting disorders full stomach,inner ear disorders or other conditions predisposing to vomiting airway abnormalities compromised sclera | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 3.0-5.0, Schistosomiasis lifelong residents of the area have provided at least 2 urine and 2 stool for parasitological examination have given a blood sample before and after each treatment episode be negative for schistosomes, hookworm, Trichuris and Ascaris have frequent contact with infective water clinical signs of tuberculosis or malaria presenting with fever have had a recent major operation, illness or vaccination have previously received antihelminthic treatment are infected with any helminths | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-80.0, Critically Ill Cancer Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal) Patients with informed consent signed by them or their responsible relative Patients who are likely to survive at least 48 hours after admission to the ICU Patients who have measured "baseline" creatinine before UCI admission, in the last three months Patients who have contraindications for enteral medications Patients who have acute kidney injury at the time of admission Patients on renal replacement therapy prior to ICU admission Patients with previous diagnosis of chronic kidney disease G3b stage Patients with plasma potassium greater than 5.1mEq/L Hypersensitivity to spironolactone Septic shock Obstructive uropathy Renal transplantation Postoperative period of nephrectomy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Bladder Cancer Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients should be included at the first surveillance cystoscopy after Transurethral Resection of the Bladder (TURB)) History of multiple or recurrent tumors Age 18 or older Written informed consent signed Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy) Patients who cannot undergo in-office cystoscopy Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure Porphyria Known allergy to hexaminolevulinate hydrochloride or a similar compound Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study and use adequate contraception during the study Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-7.0, Acute Kidney Injury Children aged less than 7 years old American Society of Anesthesiology (ASA) physical status 1-3 Preoperative creatinine > 1.5mg/dl History of dialysis Liver function abnormality Diabetes Mellitus History of allergic reaction Coagulation abnormality | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Histologically confirmed epidermoid carcinoma or adenocarcinoma of the esophagus eligible for potentially curative radiotherapy Disease in one of the following categories: Newly diagnosed Locoregional failure after prior resection with curative intent Positive microscopic margin after palliative resection of all gross disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial invasion on bronchoscopy, including tracheoesophageal fistula Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma PRIOR No prior chemotherapy or radiotherapy | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Esophageal Cancer Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0 Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix PRIOR No prior chemotherapy or radiotherapy | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Lung Cancer Histologically confirmed esophageal or non-small cell lung carcinoma Esophageal cancer: Biopsy proven esophageal carcinoma considered acceptable for curative esophageal resection Lung cancer: Stages IA-IIIB, T(any)N(any)M0 disease without pleural effusion, which constitutes locally advanced lung cancer Must be candidates for induction chemotherapy followed by surgical resection Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 65 mL/min Other: Not pregnant Adequate contraception required of all fertile female patients PRIOR Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgical mediastinal staging such as prior mediastinoscopy or Chamberlain procedures See Disease Characteristics | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction Potentially resectable disease No malignant celiac node involvement No cervical esophageal carcinoma Age and over Performance status ECOG 0-2 Life expectancy Not specified | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-60.0, Smoking Obesity for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking > 10 cigarettes per day, and agreement to participate in the study requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) > 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophagus Cancer Biopsy proven Carcinoma of the oesophagus Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment) Symptomatic patients with dysphagia scores of ≥ 1 i.e. able to eat only some solids (see Mellow Scale appendix 1) Performance status ECOG ≤ 2 Patients must begin treatment within 2 weeks of randomization Patient is at least 18 years old Adequate haematological function to undergo chemotherapy. Peripheral blood Neutrophils > 1.5 x 10^9/L Platelets > 100 x 10^9/L Adequate renal function, Creatinine Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest Synchronous active malignancies Pregnant or lactating patients Patients unfit for any treatment component Tracheo-oesophageal fistula Stents in situ Previous chemotherapy for Oesophageal Cancer CT scan of thorax and abdomen more than 8 weeks prior to randomization Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-90.0, Esophagitis Patients aged 18-90 presenting with dysphagia or food impaction Ability to undergo esophagogastroduodenoscopy and biopsies No significant cardiopulmonary disease, or other contraindication to EGD Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR Inability to provide informed consent Esophageal varices | 2 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Stroke Dysphagia FOR WITH DUE TO BRAIN Inclusive ages of 20 to 90 History of brain injury. No specific localization of brain injury or brain injuyr type will be required for inclusion Evidence of pharyngeal phase dysphagia following the brain injury that places the patient at risk for aspiration Risk for aspiration or frank aspiration will be based on the medical history and evidence from a videofluoroscopic swallowing study. Absence of aspiration is not cause for if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. If the patient does not demonstrate either aspiration or a risk for aspiration in previous assessment or during preliminary studies, they will be excluded from participation Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay hesitation of the material in the vallecula at times with spill over into the pyriform sinuses. Normally the pharyngeal phase of swallowing should be less than 1 second from onset until the passage of the bolus into the posterior pharynx. Delay will be defined as the time from the entry of the head of the bolus into the oropharynx at the posterior tongue and the lower posterior edge of the angle of the mandible, to the beginning of elevation of the hyoid bone and larynx. Reduced hyolaryngeal elevation will be identified when the larynx is not protected and remains open to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance will be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses Chronic dysphagia can occur as a result of stroke or other brain injury. Lesions in either hemisphere and/or the brain stem may cause dysphagia and aspiration Duration of 4 months or greater post-onset of brain injury and dysphagia Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant Prior history of tracheostomy or current tracheostomy is not a cause for exclusion. The otolaryngologist will determine if an individual with tracheostomy is an appropriate candidate for the study FOR WITH DUE TO BRAIN History of epileptic seizure If subject is participating in TMS, history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place History of progressive neurodegenerative disorders, such as progressive dementia, Parkinson's Disease, multiple sclerosis, and amyotrophic lateral sclerosis History of malignant brain tumor Severe oral phase swallowing deficits that prevent bolus retention in the oral cavity Esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach Pregnant women will be excluded from participation because the study involves radiation exposure and MRI scanning (for anatomical co-registration purposes) Current psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) and presence of certain tattoos with ferromagnetic metal or permanent makeup will subjects due to the exposure to high magnetic force through MRI/fMRI/TMS procedures due to the exposure to high magnetic force in both procedures. Subjects who were metal workers as a previous occupation will also be excluded only from MRI/TMS procedures due to the possibility of unknown/undetected metal in their body. Subjects who have MRI-compatible metal implants (e.g. titanium implants) may still be considered as candidates for MRI study, pending review and discussion of documentation regarding the device material and safety of the device in a 3T scanner by the Principal Investigator, LSS staff physician, and an MRI technologist | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-45.0, Healthy Volunteers Non-pregnant, non-breastfeeding females years old Body mass index between 20 and 32 kg/m2 No alarm indicators on clinical assessment (weight loss of more than 7kg, bleeding, recent recurrent vomiting, progressive dysphagia) No history suggestive of small bowel obstruction | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine) years or older Ability to understand the protocol and willing to provide written informed consent Membership in one of the following sub-cohorts Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/ chemotherapy Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/ chemotherapy Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of +/ Avastin or Erbitux.1 cycle defined as 2 doses of Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of +/ | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Lung Cancer Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy) HNSCC patients:Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment No evidence residual cancer Age > = 18 years Performance status of 0 (Zubrod) Patients must have no contraindications for undergoing bronchoscopy Patients must have no active pulmonary infections Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg % Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required) Participants with active pulmonary infections or recent history of pulmonary infection (within one month) Participants with acute intercurrent illness Participants requiring chronic ongoing treatment with NSAIDs except aspirin Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). "High dose" is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician History of biologic therapy | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Head and Neck Cancer years or older Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid All histological types of cancer All tumour stages according to American Joint Committee for Cancer (AJCC) Staging All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers Alert and mentally competent English speaking Unwilling to participate | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Pharyngitis The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Ovarian Cancer Primary Peritoneal Cavity Cancer Age ≥ 18 years Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS The following laboratory values obtained ≤7 days prior to registration ANC ≥ 1500/μL PLT ≥ 100,000/μL Total bilirubin ≤ upper normal limit AST ≤ 2 x ULN Creatinine ≤ 1.5 x ULN Hgb ≥ 9.0 g/dL Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred >6 mo from completion of primary (adjuvant) chemotherapy ECOG performance status (PS) 3 or 4 Active infection ≤5 days prior to registration History of tuberculosis or history of PPD positivity History of other malignancy ≤5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix Any of the following prior therapies Chemotherapy ≤ 3 weeks prior to study entry Immunotherapy ≤ 4 weeks prior to study entry Biologic therapy ≤ 4 weeks prior to study entry | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Oral Cavity Cancer 18 years of age or older Able to provide written informed consent to participate Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment Current treatment plan includes surgical intervention English speaking Previous treatment for malignancy in the head and neck region Significant preexisting facial disfigurement from a previous trauma or congenital defect Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Lung Cancer Histological or cytological diagnosis of non-small cell lung cancer Malignant pleural effusion proven by cytological examination Patient must have stage IIIB or IV disease with malignant pleural effusion We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group ECOG PS 0, 1 or 2 Measurable disease (in addition to malignant pleural effusion) No prior chemotherapy for metastatic or recurrent disease. Patient may have surgery or radiation or combined chemoradiation, or neoadjuvant chemotherapy at primary diagnosis. This kind of chemotherapy will not be counted as patient has had prior chemotherapy for metastatic or recurrent NSCLC WBC > 3500/uL and ANC > 2,000/uL, platelet > 100,000/uL AST/ALT < 3 X UNL, bilirubin < 1.5 mg/dL ( or < 35 uM), creatinine < 1.5 mg/dL (or < 125uM for men and 90uM for women) Age > 18 No history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, brachycardia < 40/min or atrial fibrillation or flutter with ventricular rate > 150/min) within 6 months of entry ECOG performance status 3 or worse Any prior chemotherapy regimen for metastatic or recurrent diseases No measurable disease, even after drainage of pleural effusion ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM) Plt < 100,000/uL or ALT/AST > 3 x UNL Creatinine > 1.5mg/dL (or > 125uM) Patient has history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation/flutter with ventricular rate > 150/min or bradycardia < 40/min) within 6 months before entry Prior history of breast cancer or ovarian cancer in female patients or any cancer except cured cervical carcinoma in-situ or skin cancer Fasting blood sugar > 200 mg/dL (> 14uM) except in patients on dexamethasone for brain metastases | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 21.0-79.0, Head and Neck Neoplasms The target population for this study is 125 patients with stages III or IV squamous cell lesions of the oral cavity, oropharynx, pharynx or larynx, or unknown primary No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow and no preexisting swallowing disorder | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 16.0-65.0, Pharyngitis Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate) First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already Counting of white blood cell in blood routine examination exceeds 10?109/L Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage) Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet Previous and/or existing tumour condition Pregnancy and/or breast-feeding Alcohol, and/or drug abuse | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Smoking Cessation Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day) Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months Fluent in English or Spanish History of mouth or throat cancer | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx No histologic diagnosis other than squamous cell carcinoma A primary site must be identified Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0) No stage IVC disease (stage IVB disease allowed) Deemed appropriate for definitive non-operative management with curative intent Resectable disease is not required No primary cancer of the nasopharynx, paranasal sinus, or salivary gland ECOG performance status 0-1 Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible Patients who might be a poor-compliance risk are ineligible Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Colorectal Cancer Esophageal Cancer Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy Not pregnant or nursing No blood disorder Not deprived of freedom or protected by law See Disease Characteristics | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Pharyngitis Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer Must have the ability to understand and provide informed consent Patients must be 18 years and older Ability to read, write, and speak English Resident of the United States Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested Previous cancer diagnosis excluding non-melanoma skin cancer Blood transfusion within the previous 6 months Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids) | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Willing and able to provide informed consent Willing to comply with follow-up requirements Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less) Indicated for chemotherapy and/or radiation therapy Ability to dilate stricture to 15mm diameter at extent of disease evaluation Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent Patients contraindicated for endoscopy Patients with prior esophageal stent placements Advance stage of disease, greater than T3 tumor or M1 disease | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Muscular Dystrophy, Oculopharyngeal Man or woman <18-75> years old Oculopharyngeal muscular dystrophy confirmed by genetic diagnosis (mutation of the GCG) on the chromosome 14) Oculopharyngeal muscular dystrophy with UES dysfunction salivary or alimentary stasis at fibroscopy of swallowing above the UES decreased opening of the UES at videofluoroscopy of swallowing A decreased of the pharyngeal propulsion may be associated Written consent of the patient History of myotomy of the UES in the context of the Oculopharyngeal muscular Dystrophy HIV, hepatitis B or C tuberculosis) Lupus, rheumatoid polyarthritis, sarcoïdosis, collagenosis) Other neuromuscular diseases History of malignant tumor History of neck radiotherapy Renal failure (creatinine clearance <60ml/min) Liver failure Pregnancy | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, First Line Chemotherapy Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel Advanced or Recurrent Esophageal Squamous Cell Carcinoma Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma Age > 18 years ECOG performance status 0 At least one measurable lesion(s) by Life expectancy ≥ 3 months Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen No previous palliative chemotherapy Prior radiotherapy must be completed 4 weeks before study entry Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl) Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min) Other tumor types such as adenocarcinoma, small cell carcinoma Evidence of CNS metastasis Contraindication to any drug contained in the chemotherapy regimen Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year Evidence of serious gastrointestinal bleeding History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) Serious metabolic disease such as severe non-compensated diabetes mellitus History of significant neurologic or psychiatric disorders | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-80.0, Esophageal Cancer Histologically confirmed primary cancer of esophagus Must be dysphagia caused by esophageal cancer Without esophageal fistulas Must be an inpatient Life expectancy is over 6 months Esophageal fistulas Tracheal compression with symptoms WBC <2000/mm3 and Platelet count <50,000/mm3 Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Resectable Esophageal Cancer Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained Weight loss < 10% in 0.5 yr WHO performance status 0-1 No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ Inadequate organ function as defined by Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) neutrophils < 1,5 109/L -platelets <100*109/L) Liver enzyme elevation (bili > 1,5*ULN ASAT > 2,5*ULN ALAT > 2,5*ULN) or Impaired renal function (creatinine clearance by cockcroft < 60 cc/min) Proteinuria >1,0gr/24hr Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus Locally advanced disease (any T, N0 or N1, M0 or M1a) No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a) Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed No radiographic evidence of enlarged (≥ 1.5 cm) celiac lymph nodes by CT scan or echography No small cell or undifferentiated carcinoma of the esophagus No multiple carcinomas of the esophagus (i.e., > 1 esophageal tumor) No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III) Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying > 1 cm-5 cm above gastroesophageal junction) allowed Inoperable disease OR surgery is contraindicated | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-65.0, Tobacco Dependence Alcohol Dependence Heavy Smokers/Heavy Drinkers Treatment seeking smokers Age 18 to 65 years Smoke ≥ 10 cigarettes per day Fagerstrom Test of Nicotine Dependence score > 3 Alcohol Use Disorders Identification Test (AUDIT) > 8 Drink > 25 drinks per week for males or > 20 drinks per week for females Able to provide written informed consent (Heavy Smokers/Social Drinkers) Treatment seeking smokers (Heavy Smokers/Heavy Drinkers) Any medical condition requiring immediate investigation or treatment Beck Depression Inventory score >16 Insulin-dependent diabetes Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females Pregnancy or lactation Current DSM-IV Axis 1 psychiatric disorder Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol (Heavy Smokers/Social Drinkers) Any medical condition requiring immediate investigation or treatment | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Suspected Eosinophilic Esophagitis Male and female volunteers ≥18 years old Patients with known or suspected Eosinophilic Esophagitis Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia Use of oral corticosteroids Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety Contraindication to esophageal dilation based on investigator's judgment Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 0.0-999.0, Lung Cancer Precancerous Condition Meets 1 of the following Smoker with no disease Smoker with airflow obstruction and abnormal sputum cytology Smoker with lung cancer Smoker with various grades of dysplasia Non-smoker Not specified Not specified | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer Diagnosis of adenocarcinoma of the esophagus Stage I-IV disease Received cisplatin-based treatment on clinical trial ECOG-1201 Not specified Not specified | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-54.0, Haemophilus Influenzae (NTHI) for Inoculated Volunteers Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension Availability for study visits over the next 1 month Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count Signed informed consent form In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable Negative urine pregnancy test for women of childbearing potential If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner) Negative human immunodeficiency virus (HIV) enzyme linked immunosorbent assay (ELISA) for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection Negative urine protein and glucose by dipstick for Inoculated Volunteers Acute illness within the week prior to inoculation Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation Allergic rhinitis requiring therapy in the past year Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years Abnormal gag reflex Active drug or alcohol abuse Smoking tobacco within the past year Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men Splenectomy or disease that results in functional asplenism such as sickle cell diseases | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-70.0, Tracheal Intubation ASA physical status I-II, aged between 20 and 70 years scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation recent respiratory tract infection or sore throat who were using analgesics or steroid preoperatively who have risk factors for oral cavity infection the surgical duration < 60 minutes or > 300 minutes | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, HIV Infections Tobacco Dependence HIV-infected patients adults regular smokers (at least 10 cigarettes a day during the last year) motivated to stop smoking followed in one of the participating clinical ward signed written inform consent current co-dependency to another psychoactive substance ongoing depressive episode history of suicidal attempt ongoing treatment by interferon treatment by efavirenz for less than three months or not tolerated previous use of varenicline ongoing treatment by bupropion-SR or nicotinic substitute ongoing pregnancy ongoing breastfeeding hypersensitivity to varenicline or to one of its excipients | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-50.0, Healthy Age 18-50 years, inclusive Expressed interest and ability to fulfill the study requirements Be in general good health as determined by a screening evaluation within 30 days of the first dose of LGG or placebo Able to ingest the study drug (LGG or placebo) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube) Willing to prevent pregnancy Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug Willing to comply with protocol and report on compliance and side effects during study period Informed consent obtained and signed prior to screening Consumption of supplements or food products containing LGG or probiotics 30 days prior to the start of the study or consumption of yogurt that has "live and active cultures" seal Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or any antibiotic that may be used to treat LGG bacteremia or infection (Ampicillin, Clindamycin, Moxifloxacin) Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on day of enrollment Drug or alcohol abuse within previous 12 months Major surgery or endoscopy within last 3 months Daily prescription or over-the-counter medicines except for vitamins, birth control products, and hormone replacement therapy Presence of any of the following Abnormal vital signs or clinically significant physical findings such as murmur (other than functional), hepatosplenomegaly, jaundice, lymphadenopathy, or focal neurological deficit Indwelling catheter or implanted hardware/prosthetic device or feeding tube Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug) | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Patients diagnosed with advanced NSCLC stage IIIB/IV who have not received previous chemotherapy Radiotherapy or both and who have tumor tissue embedded in paraffin blocks or formalin-fixed These patients must sign an informed consent letter Patients who refuse to participate in the study or those who decide to withdraw from it Patients without tumor tissue or with a poor quality sample | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-64.0, Sore Throat Pain Female patients undergoing outpatient laparoscopic gynecologic surgery ASA PS I and II Age between 18 and 64 years Fluent in English History of recent respiratory tract infection Pregnancy, breastfeeding Current treatment with analgesics Current use of corticosteroids Anticipated difficult intubation Risk factors for post-operative aspiration | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-80.0, Esophageal Cancer Endoscopically and histologically confirmed cancer of esophagus Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ[STOOLER stand] In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction Patients with clear consciousness，Cooperation，ECOG performance status of 0,1 and 3 Informed consent: authorization and signature Poor general status,ECOG performance status of 4 Dysphagia not caused by esophageal cancer Noncooperation or no authorization and signature The superior border of cancer higher than the seventh cervical vertebrae Ulcerative esophageal carcinoma Esophageal fistulas WBC less than 3000/mm3 Severe hepatic inadequacy or renal inadequacy | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 3.0-45.0, Pharyngitis patients with sore throat, classified 2-3 according to Cantor`s patients on antibiotic treatment suspected carriers of streptococcus | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Neoplasms, Lung Carcinoma, Non-Small Cell Lung Drug Therapy Genes, EGFR Male and female patients aged over 18 years Histologically proven lung adenocarcinoma clinical stage IIIB/IV ECOG performance status 0-2 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma At least one measurable lesion (according to Provision of written informed consent Life expectancy of at least 12 weeks History of malignant disease Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) Expected life expectancy less than 2 months As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 0.0-70.0, Thoracic Esophageal Squamous Cell Carcinoma Age≤70 years old Karnofsky Performance Status（KPS）≥80 Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic The preoperative evaluation of organ function is tolerant of surgery and chemotherapy The subject can understand and sign the informed consent form (ICF) The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer Advanced Esophageal Cancer Prior malignancy in 5 years recently History of previous chest radiotherapy History of cardio-cerebral vascular accident in 6 months lately The subject can not understand and sign the informed consent form(ICF) | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-35.0, Smoking Body Weight The selection for the clinical trial are designed to a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see ). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are *18 to 35 years old BMI > 22 kg / m2 Self report smoking > 10 cigarettes each day Have access to a telephone and the internet Demonstrate ability to access a specific web site Demonstrate ability to receive and respond to email Willing to accept random assignment *Intending to be available for a 24 month intervention *At risk for weight gain (e.g. plan to quit smoking) | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes Adenocarcinoma Squamous cell cancer Poorly differentiated epithelial malignancy Gastroesophageal junction with Siewert type I or II tumors Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course Measurable or evaluable disease by CT scan Patients with brain metastases must be stable and have received cranial irradiation prior to entry WHO performance status 0-2 Serum bilirubin ≤ 3 times the upper limit of normal (ULN) | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Chronic Cough Male and female subjects, age 18 years and over History of cough for more than 8 weeks Normal chest x ray Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers Smoking status Current smokers Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago Prohibited medications Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen Use of any anti-arrhythmic medication Use of cimetidine, beta blockers, or diuretics Cardiovascular conditions Sinoatrial disease, bradycardia or all types of heart blocks History of ischaemic heart disease or heart failure | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 21.0-90.0, Dysphagia Stroke identified by neurological and radiological examination Oropharyngeal dysphagia as confirmed by clinical and radiological examination No prior history of oropharyngeal dysphagia by patient and/or caregiver report No previous head/neck surgery or trauma that may impact swallowing ability No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not post-stroke deficits Physician and patient/family agreement to participate Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma Because of FDA Warnings, patients with cardiac demand pace makers will be excluded Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 70.0-85.0, Esophageal Cancer Histologically documented diagnosis of esophageal Cancer Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible age:70-85 years Written informed consent Performance status of 0 to 2 Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) Prior systemic chemotherapy or radiation therapy for esophageal cancer | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Neoplasms Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy) Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2) Age = 18 years Life expectancy = 3 months Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03) Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1 Additional in the expansion phase Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation in Solid Tumours (RECIST) (version 1.1, R09-0262) Serious concomitant non-oncological disease/illness Active/symptomatic brain metastases Second malignancy Pregnancy or breastfeeding Women or men who are sexually active and unwilling to use a medically acceptable method of contraception Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication | 0 |
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