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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Muscles Exercise Arnica age 18 or older two fully functional legs allergy or sensitivity to the ester family open wound or inflammatory condition on legs chronic or acute leg pain neuropathy involving one or both legs
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Gout Patients of either gender and of any race ≥18 years of age. 2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12 consecutive months. 3. Patients must present with a confirmed diagnosis of gout. 4. Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months prior to randomization. 5. Patients on urate lowering therapy must be on a stable dose and schedule with no changes in therapy for 4 weeks prior to randomization and expected to remain on a stable regimen during study participation. 6. Patients must be willing to adhere to the study schedule and the protocol requirements. 7. Patients must be willing and able to give written informed consent. A HIPAA and/or state privacy consent must also be signed Patients with acute polyarticular gout (>4 joints). 2. Patients who have experienced >2 acute gouty arthritic attacks per month, or >12 attacks overall, in the 6 months prior to randomization. 3. Patients with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion. 4. Patients with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening. 5. Patients with active myeloid leukemia, obstructive gastrointestinal cancer, or metastatic cancer. 6. Patients with chronic renal dysfunction (creatinine clearance <60 mL/min as estimated with the Cockcroft Gault formula). 7. Patients with chronic hepatic dysfunction. 8. Patients with a history of alcohol or substance abuse within the 12 months prior to randomization. 9. Patients who have any concomitant illness or other finding that, in the opinion of the Investigator, would confound the study data or place the patient at unacceptable risk if the patient were to participate in the study, or that would require frequent adjustments in concomitant medications during the course of the study. 10. Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept, infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants (warfarin, heparin, low molecular weight heparin [LMWH], antithrombin agents, thrombin inhibitors, or selective Factor Xa inhibitors [note, use of aspirin ≤325 mg/day is allowed]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs), acetaminophen, tramadol, and other analgesics such as opiates at screening 11. Use of any investigational drug within 30 days prior to randomization. 12. Patients currently participating in another research study or anticipated to enroll in such during participation in this study. 13. Patients for whom informed consent cannot be obtained. 14. Patients who have previously been randomized into this study and begun ingestion of study drug
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Recurrent Acute Pancreatitis Patients who survived their first acute alcoholic pancreatitis. The diagnostic for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded High alcohol consumption was detected
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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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. 1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate). 2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already. 3. Counting of white blood cell in blood routine examination exceeds 10?109/L. 4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage). 6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet. 7. Previous and/or existing tumour condition. 8. Pregnancy and/or breast-feeding. 9. Alcohol, and/or drug abuse. 10. Simultaneous participation in another clinical trial
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital Other etiologies of pancreatitis besides alcohol Uncertain diagnosis Recurrent disease Refusal
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Diabetes Mellitus Type 2 Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened Patients taking any medicines that affect body fluid level such as a diuretic or water pill Patients taking niacin or other certain medications Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Impaired Glucose Tolerance Greater than or equal to 18 years old Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7% Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women) Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study Type 2 diabetes Current use of glycemic control medications within one month of randomization Fasting glucose >126 mg/dL Current use of weight loss medication Previous weight loss surgery History of severe gastrointestinal disease Standard clinical contraindications to exenatide or metformin therapy Unstable angina Heart failure Stroke or coronary artery bypass graft within 3 months of screening
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Irritable Bowel Syndrome Female from 18 to 65 years of age, inclusive Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Negative serum and urine pregnancy tests Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization Serious underlying diseases, including psychiatric disorders Current history of conditions affecting bowel transit Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome Presence of a medical condition which could interfere with the interpretation of study data Significant use of nicotine or caffeine
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-999.0, Gallbladder Disease Pancreatitis All patients referred to the principal investigator for unexplained pancreatitis will be enrolled There are no gender nor racial exclusion
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-30.0, Alcoholism Male and female between the ages of 21 and 30 years; 2. medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day. For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID)) 2. Subjects who meet for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months. 3. history of counseling or psychotherapy; except family therapy centered around another family member 4. extended unwillingness to remain alcohol-free for 48 hours prior to test days; 5. for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study 6. alcohol naïve 7. Adoptee and no contact with family members
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. 2. Subjects who completed the screening process within 21 days prior to Period I dosing. 3. Subjects who were healthy adult men and women at least 18 years of age at the time of dosing. 4. Subjects who weighed at least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women. All subjects must have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19. 5. Subjects who were healthy as documented by the medical history, physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range which was considered clinically relevant by the study physician and investigator was evaluated for individual cases, documented in study files, and agreed upon by the investigator and clinic personnel prior to enrolling a volunteer in this study and for continued enrollment. 6. Subjects who had a negative urine drug screen. 7. Female subjects who had a negative pregnancy screen. 8. Female subjects were physically incapable of pregnancy surgically sterile (bilateral oophorectomy with an absence of bleeding for six months, with or without a hysterectomy, or total hysterectomy and an absence of bleeding for at least three months) or post-menopausal with an absence of menses for at least 12 months. 9. During the course of the study, from study screen until study exit including the washout period, all men used a spermicide containing barrier method of contraception Institutionalized subjects were not used. 2. Social Habits: a. Use of any tobacco-containing products within one (1) year prior to dosing. b. Ingestion of any alcoholic, caffeine or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. c. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. d. Any recent, significant change in dietary or exercise habits. e. A positive test for any drug included in the urine drug screen. f. History of drug and/or alcohol abuse. 3. Medications: a. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication. b. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing. c. Use of any medication within 28 days prior to initial dose of study medication unless the Pharmacokinetics/Drug Metabolism Department at Mylan was consulted and a decision was made to allow the subjects to enroll based on the medications pharmacology and pharmacokinetics. d. Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dosing of study medication. 4. Diseases: a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. b. Acute illness at the time of either the pre-study medical evaluation or dosing. c. A positive HIV, hepatitis B, or hepatitis C test. 5. Abnormal and clinically significant laboratory test results: a. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities. b. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who received an investigational drug within 30 days prior to the initial dose of study medication. 8. Allergy or hypersensitivity to paroxetine or other related products. 9. History of difficulties swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within seven (7) days of drug administration. 11. History of depression, mania, seizure, akathisia, narrow angle glaucoma, and/or suicidal ideation or behavior (suicidality)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, To Determine the Bioavailability of Tranylcypromine Subjects will be normal, healthy adult men and women who volunteer to participate Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has/s/he provided written informed consent? A no answer to any of the above questions indicates taht the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to tranylcypromine? Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken? Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-79.0, COPD Inflammation Medically optimized COPD patients Age 40-79 years serum CRP levels >3mg/l Current smoker COPD exacerbation in the last 2 months Active hepatic or severe renal dysfunction connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets) Recent h/o myocardial infarction, angina in the last 6 months Pregnancy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Age > 18 years Acute pancreatitis Written formal consent Pregnancy Missing formal consent Individual contraindications for CT-scan MRI or endoscopic ultrasound
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-100.0, Early Pancreatic Neoplasia Familial Pancreatic Neoplasia High Risk Group 1 (familial Peutz-Jeghers syndrome): 1. At least 30 years old and <100 years old, and 2. at least 2 of 3 diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome) 3. known STK-11 gene mutation carrier 2. High Risk Group 2 (familial pancreatic cancer relatives): 1. > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old 2. come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and 3. have a first-degree relationship with at least one of the relatives with pancreatic cancer. If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened 3. High Risk Group 3 (germline mutation carriers): 1. > 40 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old 2. patient is carrier of a known BRCA1, BRCA2, PALB2, or FAMMM (p16/CDKN2A) mutation, and there is > 1 pancreatic cancer in the family, one of whom is a first or second-degree relative of the subject to be screened. 3. Hereditary pancreatitis syndrome 4. High Risk Group 4 (young-onset pancreatic cancer relative): 1. > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old 2. have a first-degree relationship with at least one relative with young-onset pancreatic cancer ( age of onset < 50 years) 5. High risk group 5 (both parents affected) 1. > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old 2. two parents affected by pancreatic cancer 6. Control 1 (Negative Controls): 1. are undergoing EUS and/or ERCP for non-pancreatic indications as part of their standard medical care, and 2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer) 7. Control 2 (Chronic Pancreatitis) 1. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and, 2. have no clinical or radiologic suspicion of pancreatic cancer 8. Control 3 (Pancreatic Cancer) a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence) 9. Control 4 (Intraductal Papillary Mucinous Neoplasm or IPMN) a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system) Additional requirements for eligible high risk patients: i) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry iii) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate. All control patients must be > 18 and < 80 years old and no personal or family history of pancreatic cancer or a germline mutation linked to pancreatic cancer Patients will be excluded if they have any of the following: 1. medical comorbidities or coagulopathy that contraindicate endoscopy, 2. Karnosfky performance status of < 60, 3. had partial or complete resection of their pancreas 4. had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis 5. a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope 6. life expectancy less than 5 years due to coexisting advanced cancer or AIDS. 7. inability to provide informed consent 8. pregnant patient 9. history of pancreatic cancer, 10. suspicion of pancreatic neoplasia based on clinical history (weight loss, unexplained abdominal pain), physical examination (obstructive jaundice, cachexia), laboratory tests (cholestastic liver function tests, markedly elevated CA19-9), and/or imaging studies (pancreatic mass or cyst, dilated pancreatic and/or bile duct); 11. there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by screening. 12. history of chronic kidney disease, serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, ongoing acute renal failure, cirrhosis of the liver, chronic hepatitis (The estimated glomerulfiltration rate (eGFR) will be calculated based on age, race, and serum creatinine, using the on-line calculator at nephron.com). 13. history of dementia
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 60.0-999.0, Oxidative Stress Healthy subjects (>60 yr, n=5) subjects with metabolic syndrome (>60 yr, n=5) Subjects who has high fasting plasma glucose (>5.6 mmol/L) central obesity (waist-hip ratio, >0.9 for men, >0.85 for women) either high blood pressure (>130/85 mmHg) or high triacylglycerol (>1.7 mmol/L) will be selected to have metabolic syndrome normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function no history of smoking or alcoholism consume >7 alcoholic drinks/wk taking cholesterol medication or hormone replacement
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, HIV-1 Patients aged between 18 and 55 years, extremes included Non-smokers for at least 3 months prior to selection Normal weight as defined by a Body Mass Index (BMI: weight in kg divided by height in meters squared) of 18.0 to 30.0 kg/m2, extremes included Informed Consent Form signed voluntarily Able to comply with protocol requirements Normal 12-lead electrocardiogram (ECG) (in triplicate) at screening including: a) normal sinus rhythm (heart rate [HR] between 40 and 100 bpm), b) QTc interval <= 450 ms, c) QRS interval lower than 120 ms, d) PR interval <= 220 ms Healthy on the basis of a pre-study physical examination, medical history, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening Patient agrees not to participate in any other clinical trial until 6 weeks after being informed that his/her TMC278 exposure is below 20 ng/ml (all panels) Females participating in the clinical study must be of non-childbearing potential (e.g. surgically sterilized or postmenopausal with no menstrual bleeding for at least 2 years prior the clinical study If the patient is a sexually active man and not surgically sterilized, he must be willing to abstain from sexual intercourse, or use a condom plus another form of contraception (e.g., spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant. This will avoid pregnancy caused by possibly damaged sperm. Males must use a condom during sexual intercourse with pregnant or lactating females. Male patients must not father a child from administration of the first dose and up to one month after the last dose of the IMP Past history of heart arrhythmias (extrasystolic, tachycardia at rest) or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT Syndrome) History or suspicion of alcohol, barbiturate, amphetamine, recreational or narcotic drug use that could impact compliance to protocol requirements and/or safety Hepatitis A infection (confirmed by hepatitis A antibody), or hepatitis B infection (confirmed by hepatitis B surface antigen), or hepatitis C infection (confirmed by hepatitis C virus antibody) or HIV-1 or HIV-2 infection at screening A positive urine drug test at study screening. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates Currently active or underlying gastro-intestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease History of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous clinical studies with experimental drugs Use of concomitant medication, including over-the-counter products, herbal medication (including St. John's Wort) and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen in a period of 14 days before the first IMP administration Participation in an investigational drug trial within 30 days prior to the first injection with IMP, Donation of blood or plasma in the 60 days preceding the injection with the IMP, Having previously participated in a clinical study with oral TMC278 (previously known as R278474) or TMC278LA, Vulnerable subjects (e.g., persons kept in detention)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-75.0, Female Reproductive Cancer Preoperative diagnosis for probable gynecologic pathology No benign pathology or final histopathology diagnosis confirmed as non-gynecologic disease Admitted to the European Institute of Oncology Elected to undergo laparotomic surgery No total or anterior pelvic exenteration No emergency laparotomy No metabolic pathology (e.g., diabetes mellitus type I) No preoperative ASA score ≥ 4 No preoperative infection No severe malnutrition (weight loss > 10% within the past 3 months)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Depressive Disorder Key Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG. Key Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Chronic Pancreatitis Male or female patients between the ages of 18 and 75 years with a diagnosis of chronic pancreatitis diagnosed using the Mayo Clinic Diagnostic ((Layer P, Gastroenterology 1994;107:1481-1487]). Both diabetic and non-diabetic patients will be allowed to enter the study. 2. The patients must suffer from chronic abdominal pain typical for pancreatitis, meet the for chronic pain (pain ≥ 3 days per week in at least 3 months) and must consider their pain as severe enough for medical treatment. 3. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 4. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator 2. Presence or history of major depression 3. Patients with previously diagnosed moderate to severe renal impairment. Patients with creatinine values > 2x ULN and/or with a significant change to their normal values should be excluded. 4. Patients with a screening 12-lead ECG demonstrating any of the following: heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury. 5. Patients with any clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. 6. Patients treated with pregabalin (Lyrica®) during the previous 4 months. 7. Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator. 8. Female patients who are pregnant or lactating, or intend to become pregnant. Male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at visit 1 and 3 to ensure that female patients are not pregnant during the study period. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 35 hours after termination of the study period. The following methods are considered as safe contraception methods The pill IUD Gestagen Injection Subdermal Implantation (Implanon) Hormone vaginal ring Transdermal Plaster 9. Patients unwilling or unable to comply with the lifestyle guidelines. 10. Patients must not suffer from generalized painful conditions other than chronic pancreatitis; however patients with localized painful disorders will be allowed to enter the study 11. Clinical significant illness within two weeks of participating in this study. 12. Involved in planning or conducting the study. 13. Hypersensitivity to pregabalin or any of its components
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-64.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-45.0, Cesarean Delivery Elective cesarean delivery under spinal anesthesia patients >28 weeks gestation ASA 1 and 2 classification of health Mothers presenting to the assessment unit with ruptured membranes or in early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery Able to read and understand English Only patients expected to deliver before midday will be approached for participation in the trial to facilitate post-operative data collection Mothers in active labour ASA classification 3 or above Emergency cesarean delivery for fetal heart rate abnormalities Cesarean delivery under general anesthesia Maternal age <19 BMI >40 Cesarean deliveries where a CSE is planned Mothers with a history of drug allergy to morphine or to local anesthetics Mothers who are likely to deviate from standard postpartum analgesia protocol because of history of morphine tolerance or sensitivity
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 50.0-80.0, Total Knee Replacement Due to Osteoarthritis, Osteonecrosis, Rheumatoid Arthritis and/or Post-traumatic Degenerative Problems Patient is indicated for total knee replacement with a posterior stabilized device. 2. Patient is between the ages of 50 and 80 years old 3. Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 4. Patient is skeletally mature. 5. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires. 6. Patient is willing and able to review and sign a study Informed Consent Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 2. Patient is skeletally mature 3. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires. 4. Patient is willing and able to review and sign a study Informed Consent
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-79.0, Metabolic Syndrome Patient has a diagnosis of metabolic syndrome according to the modified 2005 AHA/NHLBI Scientific Statement with at least Abdominal obesity defined as: *Males: waist circumference >102cm Females: waist circumference >88cm and two of the following 4 other Triglycerides>150 mg/dL HDL Cholesterol Males: HDL-C<40 mg/dL Females:HDL-C<50 mg/dL Blood pressure Systolic Blood Pressure ≥130 mmHg or Diastolic Blood Pressure ≥85 mmHg Patient has a BMI > 35. 2. Patient has hypersensitivity or intolerance to ezetimibe or simvastatin or any component of these medications, or to latex. 3. Patient routinely consumes more than 14 alcoholic drinks per week. 4. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent. 5. Patient has a smoking history > 10 pack-years (1 pack-year = at least 20 cigarettes per day for a year) OR patient who has smoked within 3 months prior to Visit 1 (Week -2). 6. Patient has exclusionary laboratory values at Visit 1 (Week -2) as listed in the table below: liver transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) > 1.5 X ULN with no active liver disease Serum glucose > 7.0 mmol/L Creatine kinase(CK)> 2 X ULN Albumin:creatinine ratio > 34 TSH <0.3 mcIU/mL or > 5.0 mcIU/mL 7. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 8. It is not possible to obtain a FMD measurement of sufficient quality at screening (Visit 1) 9. Patient has congestive heart failure, atherosclerotic vascular disease or acute or chronic coronary heart disease. 13. Patient has had a partial ileal bypass, gastric bypass, gastric banding, celiac disease or other significant intestinal malabsorption. 15. Patient has untreated and uncontrolled hypertension with systolic blood pressure >160 mm Hg or diastolic >100 mm Hg at Visit 1 (Week -2). (Patients with untreated hypertension and with office BP at Visit 1 and Visit 2 averaging 160/100 or less can be enrolled). Patients using blood pressure-lowering medication are excluded. 16. Patient has estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 based on the 4-variable MDRD 17. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins at Visit 1 (Week -2). 18. Patient has diabetes mellitus defined as a history of diabetes or fasting serum glucose > 126 mg/dL. For the full please check the protocol
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 1.0-18.0, Abdominal Pain Children aged 1 to18 years of age who present with acute abdominal pain and signs of peritoneal irritation of less than 5 days duration Pain scores from moderate to severe Need for intravenous access and require surgical consultation Pregnancy Chronic pain (defined as pain of more than two weeks' duration). 3. Constipation (Bowel movement less than 3imes/week, hard, small, or difficult to eliminate) Prior abdominal surgery or traumatic abdominal pain History of gastritis, peptic ulcer disease, gastro esophageal reflux disease Chronic illnesses associated with pain such as Ulcerative colitis, Crohn's disease, sickle cell disease or altered perception to pain (autism, spina bifida, altered mental status) Previous use of morphine sulfate or other narcotic/medication known to alter pain Perception or mental status six hours prior to presentation in the ED Prior allergy or anaphylaxis to morphine Acute respiratory distress, hypotension (less than 5thpercentile for age) Renal, pancreatic or biliary disease
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1
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis acute pancreatitis diagnosed by at least 2 adult patients at least 18 years of age history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease concurrent metabolic or physiologic derangement requiring specific fluid management pregnancy patients transferred from acute care hospital
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Gallstone Pancreatitis All adults are included between the age of 18 and 100 with mild to moderate gallstone pancreatitis A subject is classified as having gallstone pancreatitis if they had the following: 1. upper abdominal pain, nausea, vomiting and epigastric tenderness; 2. absence of ethanol abuse; 3. elevated amylase level to at least twice the upper limit of normal and elevated lipase level to at lease three times the upper limit of normal; and 4. imaging confirmation of gallstones The classification of mild to moderate pancreatitis is defined by the presence of the following: 1. three or fewer Ranson's on admission: age > 55 years, glucose > 200 mg/dL , LDH> 350 mg/dL, AST > 250 units/L, and WBC>16 K/mm3; 2. clinical stability with admission to a non-monitored ward bed; 3. absence of acute cholangitis: defined as a temperature >38.6°C, right upper quadrant pain and tenderness, and significant hyperbilirubinemia; and 4. low suspicion for a retained common bile duct (CBD) stone (total bilirubin <4 mg/dl on admission) Severe pancreatitis (as defined by the presence of more than three Ranson's on admission) Suspected concomitant acute cholangitis High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg/dl on admission or ultrasound demonstration of CBD stone) Patient refusal to participate Severe preexisting medical comorbidities contraindicating cholecystectomy (as determined by the primary physicians) Pregnancy Prior gastric bypass surgery (making ERC difficult ) Admission to a monitored unit. The need for admission to a monitored bed is determined by the admitting surgeon and is guided primarily by a need for aggressive fluid administration as demonstrated by severe volume depletion (e.g., admission tachycardia >110 beats/minute, blood urea nitrogen > 15 mg/dl) or evidence of cholangitis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI between 19 and 30, inclusive? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does he have serious psychological illness? Does he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is he unable to refrain from the use of all concomitant medications during the study?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 28.0-75.0, Laparoscopic Cholecystectomy Body Mass Index less than 30 Attacks of cholelithiasis Body Mass Index more than 30 Signs of acute cholecystitis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, Healthy Written informed consent (IC) obtained Good general health ascertained by detailed medical history, and laboratory and physical examinations Finnish speaking males and females, 18-55 (inclusive) years of age Normal body weight defined as body mass index > 19 and < 30 kg/m2 (BMI = weight/height2) Weight at least 50 kg Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems) Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study Intake of any medication that could affect the outcome of the study. As an exception, contraceptives intra uterine device (IUD) containing levonorgestrel and hormonal implant are allowed Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator Known hypersensitivity to the active substance(s) or to any of the excipients of the drug History of vasovagal collapses History of anaphylactic/anaphylactoid reactions History of seizures including febrile seizures Pregnant or lactating females Females of childbearing potential if they are not using proper contraception (IUD, hormonal implant or surgical sterilization, spermicidal foam in conjunction with condom on male partner) (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Abdominal Pain Abdominal Cramps Flatulence Subject is 18-75 years of age Subject self-reports at least one of the following symptoms after eating a meal or snack Abdominal pain/cramps Distended feeling/bloating Flatulence/gas Subject is in otherwise general good health as determined by physical exam and medical history Subject is willing and able to comply with the protocol Female subjects not defined as post-menopausal (excluding hysterectomized and post bilateral tubal ligations) must use a reliable method of birth control as defined within this protocol Subject is able to understand and sign the informed consent (English or Spanish) to participate in the study Subject has any of the following medical conditions active heart disease renal or hepatic impairment/disease Type I or II diabetes psychiatric disorders (hospitalized within the past one year) bipolar disorder Parkinson's disease unstable thyroid disease immune disorder (such as HIV/AIDS) any medical condition deemed exclusionary by the Principal Investigator (PI)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 2.0-90.0, Hypersensitivity, Immediate Autoinflammatory Syndromes Physical Urticaria Familial Cold Autoinflammatory Syndromes Affected subjects/guardian must: 1. Be at least 2 years of age and no older than 90 years of age. 2. Have a history of a physical urticaria, which has been evaluated by the patient's healthcare practitioner. 3. Provide copies of pertinent medical history and laboratory studies. 4. Have a health care provider outside of NIH. 5. Be willing to give informed consent. 6. Be willing to donate blood for sample storage to be used for future research. Non-affected relatives/guardian must: 1. Be at least 2 years of age and no older than 90 years of age. 2. Have a relative who is enrolled on this protocol and is known to have documented history of a physical urticaria. 3. Not have a history of physical urticaria. 4. Be willing to give informed consent. 5. Be willing to donate blood for sample storage to be used for future research. Normal volunteers must: 1. Be 18-65 years of age. 2. Be non-atopic (not have a history of allergic rhinitis, asthma, atopic dermatitis) per subject s medical history. 3. Have the ability to give informed consent. 4. Be willing to donate blood for sample storage to be used for future research. 5. Not have a history of physical urticaria The following apply to all subjects: 1. Presence of conditions which, in the judgment of the investigator or the referring physician, may put the subject at undue risk, such as acute infection, severe thrombocytopenia (minimum platelet count of 30,000), or significant cardiovascular disease 2. Any condition that in the view of the principal investigator (PI) would make the subject unsuitable for enrollment in this study 3. History of HIV or other known immunodeficiency 4. History or evidence of chronic Hepatitis B and/or C infection 5. Pregnancy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Metabolic Syndrome Hypertension Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation Blood pressure greater than or equal to 130/85 mmHg AND hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria) abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women fasting blood glucose greater than or equal to 110mg/dL Insulin depended diabetes or type-1 diabetes Severe or resistant hypertension Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome Any acute or chronic inflammatory disease Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception) Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Diagnosis of pancreatitis Typical pain Increase in serum lipase or amylase 2. Onset of abdominal pain within <=48h before admission 3. II >= 8 4. Evidence of >= 1 predictor of severe pancreatitis Haematocrit >44% (male) or >40% (female), respectively Blood glucose > 125 mg/dl CRP >= 10 mg/dl Age > 55 years Leukocytes >= 16 G/L GOT > 250 U/L LDH > 350 U/L Pregnancy 2. NYHA >II 3. Pre-existing disease with life expectancy < 3 months
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Pain Healthy subjects of either gender Age between 18 and 45 years Body mass index between 19 and 27kg/m2 Normal medical history Normal or no clinically significant physical examination findings Normal or no clinically significant findings in analytical tests Negative hepatitis B, hepatitis C or HIV serology Negative drugs of abuse in urine Negative pregnancy test in females The subject understands and accepts the study procedures and grants in writing his/her informed consent Did not fulfill the Organic disorders or underwent major surgery, within 90 days before study screening Psychiatric history Alcohol drink intake greater than 30gr/day Cigarette smoking greater than 10 cigarettes/day Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day) Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study Participation in other clinical study or donate blood within 90 days before starting this study Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug) Hepatitis B, hepatitis C or HIV positive serology
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-64.0, Depressive Disorder Healthy Japanese adult males between 20 and 64 years of age inclusive BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher Non-smokers AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range QTc(B) interval <450 msec Able to attend all visits and complete the study Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests Medical history that is not considered as eligible for in this study by the investigator Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) History of psychiatric disorder or suicide attempts or behaviours History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs History of sensitivity to any of the paroxetine formulations, or components thereof Positive for urine drug screening Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Asphyxiating Thoracic Dystrophy Short ribs with narrow thorax Trident acetabular roof Short hands All ages Informed consent signed Other disease Ellis van creveld syndrome No social security
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 25.0-70.0, Healthy Subjects healthy subjects alcoholic first degree relatives
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pain Recent cerebrovascular stroke Severe dementia, aphasia or psychosis Patients who cannot cooperate at time of Patients who do not understand Danish
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Postoperative Nausea and Vomiting Male or female >=18 years of age. 2. American Society of Anesthesiologists (ASA) physical status 1 to 3. 3. Presence of at least 2 of the following PONV risk factors female gender history of PONV and/or currently prone to motion sickness (if the subjects cannot remember their last experience of motion sickness or if they suffered from it as a child, then they will not be classified as "prone") non-smoking status (never smoked or quit >=12 months ago) 4. Outpatient undergoing elective laparoscopic gynecological or abdominal surgery 5. Surgery for which anesthesia is expected to last at least 30 minutes 6. General endotracheal anesthesia conducted as outlined in the anesthetic procedures section of the protocol 7. If a subject has a known hepatic, renal or cardiovascular impairment, he/she may be enrolled in this study at the discretion of the Investigator 8. If a subject has or may develop prolongation of cardiac conduction intervals, particularly QTc, he/she may be enrolled at the discretion of the Investigator. 9. If a subject is female of childbearing potential, she must be using reliable contraceptive measures and have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours prior to surgery on Day 1. Reliable contraceptive measures implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence. Non-childbearing potential is defined as post-menopausal for at least 2 years or documented surgical sterilization or hysterectomy at least 3 months before study start Inability to understand or cooperate with the study procedures as determined by the Investigator. 2. Women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 72 hours prior to surgery on Day 1. 3. A cancer patient who has had chemotherapy within 4 weeks prior to study entry (Screening visit). 4. Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit). 5. Has received any investigational drugs within 30 days before study entry. 6. Having taken any drug with potential antiemetic efficacy within 24 hours prior to anesthetic procedures. 7. Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia . 8. Body mass index (BMI) > 40. 9. Known or suspected current history of alcohol abuse or drug abuse. 10. Known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients. 11. Epileptic patients. 12. Any condition, which in the opinion of the Investigator would make the subject ineligible for participation in the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Family Characteristics Health Status Family Research Male and Female Patients who receive primary care at one of the study selected Primary Care Practices are between 18-75 years old are English or Spanish speakers, and have appointments scheduled in the upcoming 1 months for an annual or comprehensive visit We will not individuals over the age of 75 because the role of family risk assessment and prevention is less established Also will not non-English or non-Spanish speakers Patients will also be excluded if they are hearing impaired
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0
|
The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Acute Necrotizing Pancreatitis Clinical diagnosis of severe acute pancreatitis Consent informed Diabetes mellitus Allergy for any ingredient of PN or EN regimen Pregnancy
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-999.0, Infective Complications Post-transrectal Prostate Biopsy All subjects scheduled at Vancouver General & UBC Hospitals for a transrectal ultrasound guided prostate biopsy are eligible for this study. The indication for biopsy is made according to standard clinical reasoning and judgment, and is not affected by this study All subjects must be willing and able to sign an informed consent and to take the ciprofloxacin prophylaxis before biopsy
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0
|
The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-64.0, Depressive Disorder Healthy Japanese adult males between 20 and 64 years of age inclusive BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher Non-smokers AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range QTc(B) interval <450 msec Able to attend all visits and complete the study Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests Medical history that is not considered as eligible for in this study by the investigator Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) History of psychiatric disorder or suicide attempts or behaviours History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs History of sensitivity to any of the paroxetine formulations, or components thereof Positive for urine drug screening Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms
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0
|
The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-45.0, Pregnant Women Undergoing Cesarean Delivery women aged 18-45 years (ASA physical status II-III)with uncomplicated, singleton pregnancies of at least 36 weeks' gestation scheduled for elective cesarean delivery under general anesthesia women with a history of cardiac, liver, or kidney diseases women with allergy to amide local anesthetics women with epilepsy those taking cardiovascular medications those with pregnancy-induced hypertension women with evidence of intrauterine growth restriction or fetal compromise
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-20.0, Obesity Diabetes Mellitus, Type 2 Abnormal Glucose Metabolism Type 2 Diabetes Any patient with type 2 diabetes mellitus as documented by his or her primary physician 1. Age 12-20 years at enrollment 2. Most recent HbA1c greater than or equal to 7% Significant comorbidity that, in the opinion of the investigators, may limit adequate study participation 2. Significant psychiatric or cognitive disorder, or communication difficulty that will, in the opinion of the investigators, limit the subject's ability to interact with the patient assistant or may present a danger to the patient assistant; patients with current suicidal or homicidal ideation, history of arrest for violent behavior, or history of school suspension/expulsion for violent behavior will be excluded. 3. Pregnancy or intention to become pregnant within 6 months
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-70.0, Hypertension Age: 40 to 70 years old Untreated patients or those on monotherapy of antihypertensive drugs but with uncontrolled blood pressure in the ranges of 140-160/90-100 mmHg Patients on antihypertensive medication should discontinue their antihypertensive treatment for at least 4 weeks. During the 4 weeks run-in period, all patients should have 2 clinic visits. At each visit, blood pressure will be measured 3 times consecutively. The average of these 6 readings from 2 clinic visits should be in the range of 140-180 systolic or 90-110 diastolic mm Hg. 24-h mean blood pressure should be equal to or higher than 130 mm Hg systolic and 80 mm Hg diastolic The patients should sign the consent form prior to the participation in the trial, adhere to the study design, and can visit the outpatient clinic on his/her own With life-threatening disease With myocardial infarction or stroke in the last 2 years With contraindications to a dihydropyridine calcium channel blocker Current participation in another trial or trials
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-76.0, Eosinophilic Esophagitis Established diagnosis of eosinophilic esophagitis, determined by eosinophils >15/high power field in the distal esophagus and/or microabscesses Patients should be on therapy either by food avoidance or swallowed steroids, with no change in the food avoidance and steroid dose during therapy One active symptom of disease (epigastric pain, vomiting, nausea, dysphagia or heartburn) at least 2 days of the week Failed response to proton pump inhibitors or a negative ph probe test or Negative impedance study Males and females between ages 12-76 years Patients with gastrointestinal reflux disease Eosinophilic disease in the stomach or duodenum Peripheral eosinophil counts >1500 (hyper eosinophilic syndrome) Women of childbearing potential not using two forms of contraception method(s) including but not limited to condoms, diaphragm, oral contraceptive pills, other hormonal methods, intrauterine device or tubal ligation and vasectomy, as well as women who are breastfeeding Known sensitivity to study drug(s) or class of study drug(s) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) Use of any other investigational agent in the last 30 days Use of systemic or inhaled steroids within the past 1 month History of malignancy Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Type 2 Diabetic Patients Erectile Dysfunction type 2 diabetes mellitus type 1 diabetes mellitus < 18 years old anatomic abnormalities of the penis patients taking erectile dysfunction therapy at the moment of the enrollment
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 30.0-70.0, Vascular Function Exercise Training patients with diabetes mellitus and hypertension age 30-70 years，systolic blood pressure 140-160 mmHg and HbA1c ≤ 8% no history of ACEI or ARB use within 6 months active cardiovascular diseases severe hepatic renal dysfunction (CRE ≥ 3 mg/dl，T-Bil ≥ 3 mg/dl)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-90.0, Healthy Obesity Subject giving his written informed consent Male from 20 to 35 years old and more than 60 Affiliated to the French National Health Insurance Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm Complete blood count (CBC)-platelet, normal liver function and normal coagulation Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative normal Thyroid Stimulating Hormone(TSH) Previous medical and/or surgery judged by the investigator as incompatible with this study Glaucoma C-reactive protein > 10 mg/l people over 120 kg People with triglyceridemia > 3 g/L or with familial hypercholesterolemia Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test Dietary habits judged by the dietitian as incompatible with the study aim Vegetarians Nutritional allergies or xylocaïn allergy People with eating disorders
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Parkinson's Disease Written informed consent (IC) obtained Good general health ascertained by detailed medical history, and laboratory and physical examinations Finnish speaking males or females, 18-70 years of age inclusive Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2) Weight at least 50.0 kg Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems) Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed Intake of any medication that could affect the outcome of the study Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing decrease of ≥ 20 mmHg for systolic BP decrease of ≥ 10 mmHg for diastolic BP Strong tendency to motion sickness Known hypersensitivity to the active substance(s) or to any of the excipients of the drug Pregnant or lactating females
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Clinical diagnosis with CLL Clinical decision made to initiate first-line therapy, second-line therapy or subsequent line of therapy prior to enrollment into the ConnectTM CLL registry, but within 2 months of enrollment Age≥18 years Willing and able to provide signed informed consent Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel Participation in a clinical study in which study treatment is blinded Patient condition is considered terminal (i.e.<6 months to live)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 50.0-80.0, Type 2 Diabetes Hypogonadism male patients with type 2 diabetes mellitus T2DM as judged by WHO onset of diabetes mellitus after the age of 30 years blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes no history of diabetic ketoacidosis Symptomatic Hypogonadism as defined by Total testosterone below 10 nmol/l Aging males' symptom score (AMS) above 36 Hypogonadic men with erectile dysfunction Age range Patients with uncontrolled hypertension (BP>145/95 on treatment) or significant hypotension. (BP<100 systolic) Current smokers Recent myocardial infarction (<6 months), unstable angina or ongoing chest pain, recent (within 6 months) cardiac intervention (e.g. angioplasty, stenting or CABG) or stroke Patients with clinical nephropathy (24 hr protein >0.5 g or urine protein +) or moderate renal failure (serum creatinine >150 micromol/l) History of prostate cancer or suspicion of prostate cancer on clinical examination Androgen dependent carcinoma of the male mammary gland Liver tumours Hypersensitivity to or Polycythaemia General systemic illness, including cardiac, renal or hepatic insufficiency
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Asthma Patients who have given their informed consent and expressed interest in participating in the study Asthmatic Patients Patients with communication difficulties Persons who obtain symbicort but not for their own use Patients with other major diseases: Heart problems, COPD, lung cancer, AIDS Patients with a respiratory infection Patients with seasonal asthma Pregnant women Patients who have previously participated in a health education study in asthma
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Low Back Pain Understand and voluntarily sign the informed consent and HIPAA forms Age >18 years at the time of signing the informed consent Scheduled for epiduroscopy assisted epidural neurolysis A diagnosis of low back pain with or without radiculopathy Not scheduled for epiduroscopy assisted epidural neurolysis In the opinion of the investigator, the patient's overall condition is not suitable for
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pain Patient ≥ 18 years-old, male or female, whatever his/her ethnic group Patient with untreatable cancer Patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week Pain unresponsive to conventional treatments Effectiveness of the injection test Signed informed consent Patients > 18 years-old Patients with pain other than cancer pain Patient's refusal Coagulation disorders Local infection Known hypersensitivity to local analgesics Inefficacy of the injection test Contraindication for analgesics
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 65.0-999.0, Abdominal Pain Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS) included known allergy or contraindication to morphine, or any opioid analgesic Hemodynamic instability (systolic blood pressure less than 100 mm-Hg) Use of any analgesic within 6 hours before ED presentation Patients refused to participate to the study Incooperated to the VAS Isolated flank pain or previous study enrollment Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded
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1
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, ST Elevation (STEMI) Myocardial Infarction of Other Sites *Selection Any patient hospitalised in the CCU of the participating centers with a diagnosis of a first MI with ST segment elevation and/or Q wave at admission with troponin elevation seen within the first 24 hours after symptom onset aged between 18 and 80 years is selected consent emergency clause: His/her informed consent is obtained and he/she signs the consent form or However, if a member of the patients' family is present, his/her consent must be obtained or no consent *Inclusion The first transthoracic echocardiography is performed at day 4±2 in all patients selected In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included *Non-selection Informed consent not obtained Patients with diagnosis of previous MI, hypertrophic or dilated cardiomyopathy, significant valvular heart disease, chronic atrial fibrillation, or pace maker or any permanently implanted device susceptible to interfere with LV remodelling Patients with preexisting heart failure Patients having undergone previous cardiac surgery Patients having received chemotherapy susceptible to induce LV remodeling (anthracyclines) Patients with an associated short-time life-threatening disease Patients with poor echogenicity Patients without health insurance
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis 18 years or older 2. Able to provide consent 3. More than one documented episode of pancreatitis (>3 fold elevation of amylase and or lipase with abdominal pain or with body imaging consistent with pancreatitis: need two of the three) 4. Subjects with abdominal pain and enzyme elevation which is <3 fold above normal or absence of imaging findings: these subjects who are undergoing endoscopic interventions but do not fit the "classic criteria" for pancreatitis will be included but the analysis of data of these subjects would be done separately. Note: subjects with a diagnosis of pancreas divisum and or Sphincter of Oddi dysfunction diagnosed prior to or after entry into the study will be included in the study but their data will be analyzed separately because of the controversy regarding the association of these entities with pancreatitis Unable to give informed consent. 2. Definite evidence of biliary or alcoholic pancreatitis. 3. Clear evidence of hypertriglyceridemia-induced pancreatitis (triglycerides >1,000 mg/dl). 4. Post-ERCP pancreatitis, drug-induced pancreatitis, or any identifiable cause for pancreatitis. 5. History of pancreatic surgery
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.083-0.583, Hydronephrosis Urinary Tract Infection Infants with AHN (one to seven months of age) confirmed postnatally with renal-bladder ultrasound and/or a dilated ureter ≥ 7mm 2. SFU grade III and IV AHN (high grade hydronephrosis) 3. Patients without grades II to V VUR determined by voiding cystogram (includes UPJO-like and primary megaureter (hydroureteronephrosis) only); 4. Parent or legal guardian able to give free and informed consent Infants with grades II to V VUR 2. Infants with posterior urethral valves or Prune-Belly syndrome 3. Duplication anomalies (ureteroceles, ectopic ureters) 4. Other conditions that may require chronic use of antibiotics 5. Previous renal failure 6. Allergy to trimethoprim 7. Co-enrollment in another intervention trial
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 55.0-75.0, Type 2 Diabetes Mellitus Men and women with type 2 diabetes From 55-75 years of age (Women post-menopausal for at least 5 years) Sedentary: < 3 bouts of planed physical activity of >30 min per week Smoking (defined as more than one cigarette per day) Inability to speak and read English Diseases known to affect body fat distribution (e.g., polycystic ovary syndrome, Cushing's syndrome, HIV-AIDS or lipodystrophies) Taking medications that may affect body fat distribution (e.g., Thiazolidinedione, Insulin, Growth Hormone) Limitations to regular exercise training (e.g., musculoskeletal limitations, heart disease, chronic obstructive pulmonary disease) Answering "yes" to any of the questions on the physical activity readiness questionnaire (PAR-Q) Having undergone major changes in physical activity, diet or medication in the previous 6 months (or be planning such changes in the next 4 months). Changes in physical activity will be considered as an increase or decrease of more than 1 hour per week. A change in body weight greater 3 kg will also lead to exclusion Body weight > 300 lbs (maximum weight for Dual Energy X-Ray Absorptiometry (DXA) table) HbA1c > 0.09% blood pressure above 140/90 mmHg
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Liver Transplantation normal fasting plasma glucose normal hemoglobin informed consent type 1 diabetes mellitus or type 2 diabetes mellitus body mass index > 30 inflammatory bowel disease intestinal surgery serum creatinine > 250 µM and/or albuminuria ALAT > 2 x normal value Severe cardiac insufficiency in treatment with medicine which cannot be paused for 12 hours
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-90.0, Vagotomy, Truncal normal fasting plasma glucose normal hemoglobin informed consent type 1 diabetes mellitus or type 2 diabetes mellitus body mass index > 30 inflammatory bowel disease intestinal surgery serum creatinine > 250 µM and/or albuminuria ALAT > 2 x normal value Severe cardiac insufficiency in treatment with medicine which cannot be paused for 12 hours
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Metabolic Syndrome Age >18 Informed consent Fasting blood glucose >95mg/dL Metabolic syndrome defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel-III (ATP-III) (3 out of 5) Abdominal obesity (waist circumference >102 in men or >88 in women) Elevated blood pressure (>135/>85) or drug treatment for elevated blood pressure Fasting blood glucose >100mg/dL or previously known type 2 diabetes mellitus High Density Lipoprotein (HDL) cholesterol <40 mg/dL (men) or <50 mg/dL (women) or drug treatment for low HDL cholesterol Triglycerides >150 mg/dL or drug treatment for elevated for high triglycerides HbA1C ≤7.0% Drug treatment for diabetes mellitus Liver cirrhosis (biopsy proven) or elevated transaminases (>2x Upper Limit of Normla (ULN)) Inflammatory bowel disease (Crohns disease, ulcerative colitis) Celiac disease Alcohol abuse (more than 40g alcohol per day in the history) Clinical evidence of active infection Antibiotic treatment within 7 days prior to enrolment Use of immunomodulating agents within previous month (steroids etc.) Concomitant use of supplements (pre-, pro-, or synbiotics) likely to influence the study Any severe illness unrelated to metabolic syndrome
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 50.0-75.0, Lung Cancer Persons 50-75 Asymptomatic for lung cancer Current or former (stopped smoking less than 10 years ago) cigarette smokers History of cigarette smoking of at least 20 pack years History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years) Mentally competent individuals to sign an informed consent Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy A fully informed signed consent form must have been obtained
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL > 18 OLD THAT TAKE MORE THAN 1 WEEK LIVER
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Heart Failure Patients of both sexes, aged 18 years or above, with a diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%), hospitalized for decompensation of HF Who agree to participate in the study by signing the Informed Consent Patients with communication disabilities and people with degenerative neurological diseases Are also excluded patients who presented acute coronary syndrome (ACS) in the last 6 months before randomization Patients with renal, hepatic, pulmonary or systemic disease that may confuse the interpretation of the findings or result in limited life expectancy Surgical plan or therapeutic that might influence the follow-up Pregnancy, diagnosis of acute heart failure secondary to sepsis myocarditis myocardial infarction acute peripartum and other cause Have no interest in receiving home visits
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer Histologically or cytologically proven adenocarcinoma of the pancreas Patients must have locally advanced unresectable disease not amenable to curative resection or extrapancreatic metastases; patients must have radiographically measurable disease (defined as at least one lesion that can be accurately measured in at least one dimension [longest diameter to be recorded] as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography [CT] scan) AND/OR a serum CA19-9 measurement > 2 x ULN One prior line of systemic therapy for advanced disease (locally advanced or metastatic) The following represent acceptable examples meeting the definition of one prior line of therapy Gemcitabine as a single agent or in combination with other agents; patients receiving (a) gemcitabine initially alone, with the eventual addition of a second agent; or (b) gemcitabine as part of a combination regimen, followed by gemcitabine alone; are eligible A non-gemcitabine-based regimen, including (but not limited to) leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) or any combination of components therein Treatment as part of a clinical trial involving cytotoxic agents, small molecule inhibitors, monoclonal antibodies, and/or immunomodulatory agents For patients with locally advanced disease, prior radiation to the primary tumor is allowable as long as there is clear evidence of disease progression (either radiographic locoregional disease progression and/or a rising CA19-9 level); patients may have received chemotherapy both concurrently and/or sequentially with (either before or after) the radiation and still be eligible for the study, as this would be considered all part of the same course of treatment Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or sequentially) does not count as prior therapy as long as progressive disease occurs > 6 months following completion of treatment Life expectancy of greater than 8 weeks Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 (or its excipient Captisol) or erlotinib Previous mitogen-activated protein kinase kinase (MEK) or epidermal growth factor receptor (EGFR) inhibitor use Patients with corrected QT (QTc) interval > 480 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that (i) meets New York Heart Association (NYHA) class III and IV definitions or (ii) is demonstrated by an left ventricular (LV) ejection fraction < 55% on baseline echocardiogram, are excluded Required use of a concomitant medication that can prolong the QT interval There are potential interactions between erlotinib and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and CYP3A4 promoters; although caution and careful monitoring are recommended when use of these compounds is necessary, use of these compounds does not patients from participating in this trial Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-55.0, Abdominal Fat Body Weight Healthy subject, as determined by clinical examination, and medical history Non-menopausal woman BMI between 27 and 34 kg/m² Waist circumference > 80 cm No diet within the last 3 months with weight loss or gain not more than 3kg Non-smoking subject, or smoking less than 15 cigarettes/day since three months Normal blood pressure (BP) and heart rate (HR) after 10 minutes in supine position. Individuals values out of the normal range can be accepted if judged clinically non relevant by the investigator Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator Subject with a habitual low (< 16 g/day) intake of whole grain foods (from cereal food intake questionnaire) willing to eat breakfast cereals Subject having a history of metabolic disease (i.e, diabetes) Subject suffering from chronic renal insufficiency Subject receiving a local or general treatment (i.e, prescription medications, over-the-counter medications, dietary supplements or herbal supplements) susceptible to interfere with the evaluation of the studied parameters and in particular weight (eg, appetite suppressants, slimming or treatment which could interfere with the metabolism and dietary behaviour) Subject with ongoing medication not stabilized since more than 3 months Subject having had a general anaesthesia in the month preceding or gastro-intestinal surgery at any time in his/her life, with the possible exception of appendectomy Pregnant or breast-feeding subject (positive urinary pregnancy test) Subject in an period of a previous study or having participated in another clinical study in the last month Use of laxatives, except in few occasions, if, in the opinion of the investigator, does not interfere with the optimal participation Subject having received more than 4500 Euros in indemnity for participation in clinical studies in the last 12 months, including participation in the present study Subject in a situation that, in the opinion of the investigator, could interfere with his optimal participation in the study or constitute a particular risk for the subject
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Chronic Abdominal Pain age 18-65 years abdominal pain at least 6 months previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection ASA class I-II psychiatric disorder significant other somatic diseases (ASA class III-V) refusal to participate
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Patients With Acute Pancreatitis Age>=18 years Diagnosis of acute pancreatitis confirmed by at least 2 of the following: 1. Typical epigastric abdominal pain 2. Elevation amylase/lipase >3 times upper limit normal and/or 3. Confirmatory findings on cross-sectional imaging Enrollment within 8 hours of presentation Class II or greater NYHA heart failure Oxygen dependent COPD Chronic kidney disease>stage 2 Cirrhosis Existing necrosis on abdominal CT Organ dysfunction prior to enrollment Sepsis Acute respiratory distress syndrome Malignancy not in remission for at least 5 years Active drug use
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-34.0, Type 2 Diabetes Mellitus You are one of a sibling pair with the same mother and father, and your mother had diabetes (gestational or type 2) while she was pregnant with the younger sibling but not the older sibling Your sibling is willing to participate in the study You are between the ages of 20 and 34 years (inclusive) Your body mass index is between 20 and 29 Kg/m2 inclusive (this is a number calculated for your height and weight and indicates that you are either normal weight or overweight, but not obese) You are healthy as assessed by medical history and standard physical examination You are weight stable (your body weight has not changed .6.5 lbs over the last 3 months) You do not smoke You provide written informed consent to participate in the study You are willing to stay overnight one time at the Pennington Center You have low physical activity (< 100 min of exercise per week) You were born prematurely (<37 weeks of pregnancy) You are currently taking medication that may influence your body weight or metabolism You have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Diverticulitis All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain leukocytosis (>11x109) fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) The CT for the diagnosis included at least one of a localized thickening (≥4 mm) of the colonic wall signs of inflammation of the pericolic fat abscess extraluminal air extraluminal contrast The ultrasound included at least two of bowel wall thickening (>4 mm) inflammatory bowel disease irritable bowel syndrome colorectal cancer diseases precluding adequate follow up
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Pancreatitis diagnosis of acute pancreatitis written informed consent inpatient treatment time interval between onset of abdominal symptoms and study >96h patients unable to consent
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 16.0-50.0, Constipation Abdominal Pain Nausea Vomiting All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS Unable to give informed consent A basic level of literacy sufficient to complete postoperative form History of constipation Regular opiate use Previous bowel surgery or bowel adhesions Lactose intolerant Diabetic Any patient unable to have spinal Anaesthesia Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose Patients receiving injury to bowel intraoperatively
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Healthy Obesity Type 2 Diabetes Mellitus General Male sex Generally healthy with specifically no known cardiovascular disease or gastric ulcers, which can affect the study parameters Stable dietary habits (no weight loss/gain > 3 kg in the last 6 months) Group 1, type 2 diabetes participants Ages 40-70 years BMI > 30 kg/m2 Non-insulin dependent type 2 diabetes Must be on sulphonylurea (SU)-derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months Well-controlled diabetes: HbA1c < 8% No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy Group 2, obese healthy control participants Regular smokers Participation in other studies Female sex Insulin dependent diabetic individuals Participants with diabetes related diseases (diabetic foot, diabetic polyneuropathy, diabetic retinopathy etc.) Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone) Use of anti-coagulants (not thrombocyte-aggregation inhibitors) Aberrant ECG (with signs of ischemia or cardiac failure or arrythmias) Weight gain/loss > 3 kg in the last 6 months HbA1c < 7.8 in type 2 diabetic individuals
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-999.0, Serious Gram-positive Infections Patients started daptomycin therapy since January 2009 Patients completed daptomycin therapy by the end of December 2010 Patients had Gram positive infections Patients received daptomycin therapy for at least 3 days Daptomycin therapy will be chosen by the treating physician based on clinical indication and it is expected that risks of therapy will have already been considered subjects are only to be excluded if he/she was enrolled in any antibiotics clinical trial during daptomycin treatment
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Heart Failure Previously fitted with an ICD or a CRT-D device for primary or secondary prevention (for at least 34 days) with a Medtronic Optivol capable Device Previous hospital admission for decompensated heart failure Left ventricular systolic dysfunction (EF <50%) Currently compensated heart failure with a functional class of III or better All patients will be on optimal medical treatment including a beta blocker, an ACEI (or ARB) and spironolactone unless contraindicated or not tolerated Decompensated patients who have NYHA class IV or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their NYHA class improves) Patients with a high Optivol fluid index at time of evaluation (these patients may be included later when the Optivol fluid index comes down) Patients with advanced renal failure ± dialysis (Chronic Kidney Disease class 4 or 5 with an estimated GFR of <30 ml/min)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 50.0-999.0, Heart Failure Left Bundle Branch Block Heart Disease years of age or older Patients willing and capable of providing informed consent, participating in all testing associated with this clinical investigation Patients undergoing a CRT implant procedure (pacemaker or defibrillator) for one of the following reasons Indicated for a new device Device upgrade Device replacement Lead revision Note: recognized indications for CRT-P and CRT-D as of October 2009 are valid for in this study. Should new indications become approved during the study conduct; those will also be applied within the criteria Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent Patients in AF that cannot be cardioverted for the study RBBB pattern Sustained, uncontrolled ventricular tachycardia Sinus rhythm < 30 bpm or >100 bpm Complete AV node block Second degree AV block Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion) History of (hemorrhagic) cerebro-vascular accident or TIA
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Type 2 Diabetes Male or Female over 18 years of age Type 2 diabetes for at least 6 months Taking 1 or more oral hypoglycemic agents Patient attending your community pharmacy where you decided that addition of insulin glargine may be of benefit to the patient Baseline HbA1c 7.5 Signed informed consent Have used, or currently using, Insulin History of ketoacidosis Pregnant Works night shift Renal impairment(Serum Creatinine: females ≥ 124 mmol/l, males ≥ 133 mmol/l) Clinically unstable Unwilling/unable to attend follow up visits Unlikely to adhere to study procedures (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-29.0, Smoking Born on 1979 Living in Vaasa, Pietarsaari, Kokkola or Seinäjoki at school age Other year of birth
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Severe Acute Pancreatitis Diagnosis of acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase >= 3 times the upper limit of normal range, characteristic CT-scan of severity of acute pancreatitis diagnosed at <= 72 hours following admission: severity Index of Balthazar's CT-scan (with contrast) >= grade D, >= 8, C-reactive protein >= 150 mg/L Inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth >= 5 days <= 3 mmol/L of triglycerides in the blood Men and women aged >= 18 years old Acceptance of informed consent Known hipersensitivity to the fish, egg or soy proteins Lipid etiology > 3 mmol/L of triglycerides in the blood Severe hepatic impairment Severe renal insufficiency without dialysis or haemofiltration Serious disturbances of blood clotting Acute shock Infusion therapy general contraindications Clinical conditions of instability that must not be taken with parenteral nutrition Have other acute or chronic inflammatory diseases
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Hyperlipidemia Male or female ≥ 18 to ≤ 80 years of age On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks Fasting LDL-C ≥ 85 mg/dL Fasting triglycerides ≤ 400 mg/dL Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%) Uncontrolled hypertension New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30% Uncontrolled cardiac arrhythmia
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Crohn's Disease provide written informed consent ability to orally ingest study medication male or female between 18 to 75 inclusive diagnosed with Crohn's disease for at least 3 months CDAI score of 220-300 at screening sexually active participants of childbearing potential must agree to birth control no clinically significant conditions which the doctor would feel exclusionary stable medication (including probiotics) history of any bowel condition that may interfere with the evaluation of the study drug positive stool cultures currently pregnant or lactating receiving total parenteral nutrition history of alcohol or drug abuse within one year history of malignancy within 5 years current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics treatment with Anti-TNF agents 12 weeks before screening treatment with corticosteroids four weeks prior to screening treatment with cyclosporine or tacrolimus eight weeks prior to screening
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Abdominal Sepsis Patient > 18 years old 2. 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group. 3. Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures Patient's Manheim Peritonitis Score < 29 2. Patient's pre-operative SOFA score < 6 3. The use of other temporary abdominal closure system 4. Decease before the first VAC dressing change 5. Patient is participating in another clinical trial which may affect this study's outcomes 6. Patients with immune deficiency 7. Documented seropositivity for human immunodeficiency virus (AIDS) 8. Patient receiving steroids treatment for other medical condition 9. Patient receiving chronic anti-inflammatory treatment 10. Patient receiving anti TNF treatment 11. Pre-existing parechymal liver disease ( Cirrhosis Child-Pugh C) 12. Pregnancy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Type 2 Diabetes Mellitus Caucasians 18 years or older with Type 2 diabetes (WHO criteria) HbA1c >9 % Liver disease (ALAT/ASAT >2 x upper normal limit) Diabetic nephropathy (s-creatinine >130 µM or albuminuria) Proliferative diabetic retinopathy (anamnestic) Severe arteriosclerosis or heart failure (NYHA group III og IV) Anemia treatment with medication not applicable to pause for 12 hours Fasting plasma glucose >15 mM on screening day
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0
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