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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 1 Diabetes Type 2 Diabetes Potential subjects for the study will have type 1 or type 2 diabetes. Patients presenting for their periodic examinations at his practice will be given the opportunity to participate. Enrollment will conclude when the target of 250 subjects have been examined Wounds or injuries on the volar forearm in the field of view of SCOUT including blisters, cuts, scabs, cracked skin, tattoos and bleeding or oozing skin Rash on forearm in field of SCOUT scan including eczema, psoriasis, shingles, rosacea, swimmer's itch, Christmas tree rash, lichen planus, contact dermatitus, ringworm, heat rash or drug rash Receiving other investigational treatments Receiving medications that may alter skin fluorescence/photosensitivity, including Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline and/or Quinidine Known to be pregnant Prisoner, mentally incompetent or unable to follow study procedures
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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 Pulmonary Disease, Chronic Obstructive Inflammation Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction < 40%) Outpatients New York Heart Association (NYHA) class I-IV years and older Informed consent Patients who do not meet the Patients who are not able to cooperate or undergo pulmonary function tests Other diseases that can lead to obstructive lung function: asthma, cystic fibrosis Malignancy with bad prognosis (survival < 6 months) Hospitalisation to the pulmonary department in the past 6 weeks, in this case patients will have the pulmonary function tests ≥ 6 weeks after discharge Patients who are already participating in another study within the cardiology department Additional for the first primary objective Disorders/diseases that can lead to pulmonary function impairment Pulmonary: lung surgery (lobectomy/pneumectomy), parenchymal neoplasms, interstitial lung disease, sarcoidosis, pneumoconioses, lung abscess, lobar pneumonia, post infectious scarring, atelectasis, radiation fibrosis
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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): 35.0-75.0, Chronic Periodontitis Atherosclerotic Cardiovascular Disease Patients should have ≥ 20 teeth present; (ii) absence of oral soft tissue lesions; (iii) have ≤ 3 carious lesions in all teeth. In addition, to be included in the Test group the subject had to present chronic periodontitis (involvement of at least 5 teeth with at least one site presenting probing depth (PD) ≥ 5 mm and clinical attachment loss (CAL) ≥ 3 mm) while to be included in the Control group the patient had to exhibit periodontal healthy (bleeding on probing (BOP) < 30% of the sites and absence of any PD > 4mm associated with BOP) (i) periodontal disease treatment in the previous six months; (ii) aged less than 35 years; (iii) systemic conditions such as history of CVD or any other chronic or immunologic diseases and the use of related drugs in the previous six months; (iv) smokers or former smokers; (v) pregnant or lactating women; (vi) hypertension (>140 systolic and > 90 diastolic mmHg); (vii) obesity (Body Mass Index (BMI) ≥ 30 kg/m²); (viii) levels of HDL-cholesterol > 35.0 mg/dL (ix) levels of LDL-cholesterol < 160.0 mg/dL (x)levels of triglycerides < 400.0 mg/dL and (xi) levels of glucose levels < 100 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): 18.0-999.0, Acute Pancreatitis All patients in whom accidental pancreatic duct cannulation had occurred during guide wire directed ERCP Patients who had undergone previous endoscopic papillectomy or sphincterotomy and those with an indwelled nasobiliary or nasopancreatic tube
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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 Diabetes Mellitus, Type 2 Healthy Healthy subjects aged 18-45 years inclusive Healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results Women who are not of childbearing potential Signed and dated written informed consent obtained Body mass index (BMI) within the range 19-30 kg/m^2, inclusive WITH Subjects aged 40-70 years inclusive Subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months Women who are not of childbearing potential Signed and dated written informed consent obtained Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmHg systolic, 40-90 mmHg diastolic: heart rate 40-100 beats/min History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women) Alcohol intake within 48 hours prior to visit Evidence of drug abuse on urine testing at study entry The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies History of significant drug allergy or drug hypersensitivity
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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, Arthroplasty, Replacement, Hip The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for a 4 month follow-up The patient weight between 50 and 100 kg Patient scheduled for unilateral hip arthroplasty Patient has creatinine clearance > 50 ml/min (Cockroft) Patient with ASA-PS score of 1, 2 or 3 (American Society Anesthesiology Physical Status) The patient is participating in another study The patient is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding Patient with ASA score of 4 Patient has a known deficit in cytochrome P450 Uncontrolled epilepsy Chronic 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): 0.0-65.0, Urea Cycle Disorders All study groups: • Written informed consent given by subjects or his/her parents/legal guardians who are able to understand and follow instructions related to the study Group 1 Healthy Volunteers Age: 18 years Healthy subjects No clinical or laboratory parameter outside normal ranges at screening and judged as clinically relevant by the investigator Group 2 Symptomatic UCD patients with genetically confirmed CPSD, OTCD, ASSD, or ASLD: Age: 0 years Symptomatic subjects with genetically confirmed Carbamylphosphate synthetase I Deficiency [CPSD], Ornithine Transcarbamylase Deficiency [OTCD], Argininosuccinate Synthetase Deficiency [Citrullinaemia type I], Argininosuccinate Lyase Deficiency [ASLD] at least 1 metabolic decompensation with clinical signs of hyperammonemia in medical history or genetically confirmed and prospectively treated siblings of symptomatic patients, even without clinical symptoms Confirmed diagnosis and medical history available (in particular number and severity of metabolic crises) Group 3 Asymptomatic carriers of UCD mutations Age: 0 Acute illness, including vomiting, fever or other sign of infection Participation in other invasive clinical trials within 30 days prior to Liver or renal disease Acute seizures Coma Bleeding disorder Blood ammonia > 100 µmol/l for patients with a urea cycle disorder and blood ammonia > normal for healthy probands and asymptomatic carriers Metabolic acidosis Pregnancy or lactation Body weight < 8kg
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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 Transitional Cell Carcinoma of the Urothelium Age ≥ 18 years Karnofsky Performance Status (KPS) ≥60% Urothelial carcinoma of the bladder, urethra, ureter or renal pelvis, with histologic confirmation at MSKCC. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present Patients must have progressive metastatic disease. Progressive disease will be defined as new or progressive lesions on cross-sectional imaging (RECIST Version 1.1) Patients must have been previously treated, as defined by the following Patients must have received treatment with at least one prior cytotoxic chemotherapy agent but not more than four prior cytotoxic chemotherapy agents for urothelial carcinoma. Up to four prior chemotherapy agents are allowed, since conventional chemotherapy ranges from just one drug (e.g., gemcitabine) to regimens that contain four agents (e.g., M-VAC is a four-drug regimen containing methotrexate, vinblastine, doxorubicin, and cisplatin). The prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine. o The prior cytotoxic agents may have been administered in the perioperative or metastatic setting and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or as part of a single regimen Patients must have at least one site of measurable disease per 1.1 that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation Patients enrolling in the Phase II study must have pre-treatment tumor tissue available for PI3K/Akt pathway marker analysis: One paraffin block, frozen curls or 10 freshly-prepared unstained slides from the most representative single paraffinembedded tumor tissue block should be submitted. Slides from the primary tumor are preferred. If both the primary and metastatic tumor blocks are available, 10 slides from each of the sites should be submitted. If tissue from the primary tumor is not available, a paraffin block or unstained slides from a metastatic site are acceptable. Fine needle aspirates (FNAs) have insufficient tumor tissue and are not permitted Patients enrolling in the Expansion Cohort must have prior mutational testing demonstrating alterations within the PI3K/Akt/mTOR pathway predicted to result in pathway activation Life expectancy of ≥ 12 weeks Patients who have received prior treatment with a P13K inhibitor Patients receiving any other investigational therapies Patients with a known hypersensitivity to Buparlisib 120 or to its excipients Patients with untreated brain metastases are excluded. However, patients may participate in this trial if > 4 weeks from completion of therapy (radiation and/or surgery) for CNS metastases, are clinically stable at the time of registration and are not receiving corticosteroid therapy Patients with acute or chronic hepatic or renal disease or pancreatitis Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient's mood assessment questionnaire: o Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) ≥ CTCAE grade 3 anxiety o Meet the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or select a positive response of "1", "2", or "3" to question number 9 regarding the potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) Patients with diarrhea ≥ CTCAE grade 2 or other impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Buparlisib120 (e.g., ulcerative diseases, uncontrolled, nausea, vomiting, malabsorption syndrome, or small bowel resection) Patient has active cardiac disease including any of the following: Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated acquisition (MUGA) scan or echocardiogram (ECHO) QTc > 480 msec on screening ECG (using the QTcF formula)
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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 Mellitus (T2D) Registry Patient ≥ 18 years old Patient with T2D Ambispective Cohort Patient ≥ 18 years old Patient with T2D Patient initiated with Saxagliptin in the last 6 months before the or day of visit (whatever his/her ongoing hypoglycaemic treatment) Patient agreeing to participate, and not yet enrolled by another physician Patient participating in a 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): 18.0-99.0, Sickle Cell Disease FOR WITH CELL IN PAIN 1. Age 18 years or older. 2. Diagnosis of sickle cell anemia: 1. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required). 2. Acute onset pain crisis in a distribution typical for that subject, onset within the last 7 days and for which hospitalization and parenteral narcotic pain treatment are required. 3. Ability to provide informed written consent FOR WITH CELL IN PAIN 1. Pregnancy. 2. History of non-trivial injury, burns, surgery or skin ulcers on the arms. 3. Carrier of drug resistant bacteria that normally requires isolation while visiting a hospital. 4. Administration of any of the following drugs within the last 14 days Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil) Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan) Nitric oxide donors (nitroglycerin, nitroprusside, nitrates) 5. Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment. 6. Diagnosis with any of the following chronic diseases or conditions Uncontrolled high blood pressure (systolic blood pressure must not be greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg) Uncontrolled high cholesterol (total cholesterol must not be greater than 240 mg/dL) Uncontrolled diabetes (must not have both a documented history of diabetes and random blood glucose of greater than 200 mg/dL) Chronic kidney disease (serum creatinine must not be greater than 2 mg/dL) Coronary artery disease Peripheral vascular disease 7. Received a blood transfusion within 7 days of the study procedure. CELL IN STATE FOR WITH CELL IN STATE: 1. Age 18 years or older. 2. Diagnosis of sickle cell anemia: a.Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required). 3. Ability to provide informed written 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): 20.0-79.0, Chronic Kidney Disease Type 2 Diabetes CKD patients with type 2 diabetes mellitus Patients whose eGFR levels are eligible for this study Patients being treated with stable dose of ACE inhibitors and/or ARB etc Patients with Type 1 diabetes Patients with known non-diabetic renal disease Patients with a history of renal transplantation Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg Patients with HbA1C > 10% Patients with cardiovascular disease specified in the study protocol 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, Acute Pancreatitis clinical diagnosis of severe acute pancreatitis written informed consent Time from onset of abdominal pain to admission ≤ 72 hours SIRS score ≥ 2 confirmed infection pregnancy patients needing emergency operation for abdominal compartment syndrome chronic renal diseases needing blood purification previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy acute flare-up of chronic pancreatitis malignancy
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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): 10.0-12.0, Child Healthy and physically active (as determined by medical and activity questionnaire) 12 years of age Within approximately 2 years of estimated age of peak height velocity (PHV) Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol Having obtained his/her informed assent Having obtained his/her legal representative's informed consent Post-pubertal Taking any medication Smoker Undergoing medical treatment or investigations Body mass index > 24 Suffer from chronic diseases (with regular intake of drugs, medical history) Vegetarians Vaccination in the last 4 months Any know food allergies or intolerance 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): 50.0-999.0, Diabetic Polyneuropathy Diabetic Gastroparesis Diabetes Mellitus age > 50 years written informed consent Diabetes mellitus (only Diabetes mellitus group) Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group) actually measured HbA1c (only Diabetes mellitus group) Subject who is pregnant or breast feeding Subject unwilling or unable to comply with study requirements Any investigational agent or participation in another clinical trial within 28 days prior to randomization Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results Known allergy to the investigational product, to any of its excipients Active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease Implanted cardiac cardioverter-defibrillator or cardiac pacemaker Stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy Long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) < 3 days before randomisation and before magnetic marker monitoring
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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 All adult patients >18y.o Diagnosis of acute pancreatitis (defined as an amylase >3 times the upper limit of normal and typical symptoms) Inability to provide informed consent Declines participation Uretheral catheterisation not required on clinical grounds
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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, Effect of NOAC on POCT The indication for the use of NOAC is provided by the attending physician. The for and for the use of the new oral anticoagulants must meet appropriate and the clinical guidelines that are described in the SOPs. Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included. Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included
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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): 45.0-75.0, Diabetes Type 2 The diagnosis of type 2 diabetes will be based on the WHO guidelines. These are 2 fasting plasma glucose readings of greater than 7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meeting the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed Diabetes managed by diet alone or diet and metformin. If metformin is used the dose should have been stable for a minimum of 3 months prior to the start of the study Hba1c up to and including 9.9% Age 45-75 If female, should be post-menopausal BMI 25-39kgm-2 Patients will have attended a structured group patient education programme (and be on stable medication for hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. Subjects will be encouraged to incorporate the chocolate into their diet as advised during the education programme Having obtained his/her or his/her legal representative's informed consent Patients with concurrent illness or any changes in medication in the last 3 months Patients whose diabetes is managed with TZDs, DPP-IV inhibitors, GLP-1 analogues, insulin or sulphonylureas or prandial regulators Patients not wishing to allow disclosure to their GPs Pregnancy Hba1c at recruiting stage of >10.0% Patient who cannot be expected to comply with treatment Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study Patients who consuming more than 20g/d of chocolate or having a very high polyphenol content of their diet, who are not willing to change their diet Patients taking high dose antioxidant supplements including single and multivitamin preparations including A,C,E Women on HRT 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): 3.0-18.0, Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Male or female subject ages 3 to 1711/12 years. 2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.) 3. Subject and/or parent/legal guardian is capable of giving assent or consent. 4. Subject is able to complete the urea breath test by investigator's assessment Subject is hypersensitive to mannitol, citric acid and/or aspartame. 2. Previous diagnosis of phenylketonuria (PKU. 3. Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions. 4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples. 5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.) 6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing. 7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing. 8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing. 9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing. 10. Treatment for eradication of H pylori within 28 days before testing or retesting. 11. Participation in a drug or device study within 30 days of testing
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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 Hypercholesterolemia Hypertriglyceridemia Hyperglycemia waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following blood pressure ≥ 130/85 or taking antihypertensive medication fasting plasma glucose (FPG) > 100 mg/dL serum triglycerides (TG) > 150 mg/dL high-density lipoprotein (HDL) < 40 mg/dL in men,and < 50 mg/dL in women- using insulin or glucose sensitizing medication preexisting cardiovascular disease psychiatric problems non-compliance of patients not presenting at times determined for treatment and evaluation
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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 Subject ages 18-75 years, inclusive 2. Subject has known CD and signs and symptoms of active disease including one of the following Chronic diarrhea Chronic abdominal pain Rectal bleeding 3. Subject has at least one of the following within three months of enrollment Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) Anemia (hemoglobin level below normal reference range) Hypoalbuminemia (albumin below normal reference range) Weight loss 4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment. 5. Subject agrees to sign consent form Indeterminate Colitis 2. Ulcerative Colitis 3. Antibiotic Associated Colitis 4. Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months of enrollment 5. Other known infectious cause of increased symptoms 6. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment. 7. Definite long stricture seen on radiological exam. 8. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment 9. Suspected GI stricture, followed by Pillcam Patency study or other imaging study that could not prove patency of the GI tract. 10. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. 11. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 12. Subjects with known or suspected delayed gastric emptying 13. Subjects with known or suspected delayed Small bowel motility 14. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions. 15. Subject has Type I or Type II Diabetes. 16. Subject has any allergy or other known contraindication to the medications used in the study. 17. Subject has any condition, which precludes compliance with study and/or device instructions. 18. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. 19. Concurrent participation in another clinical trial using any investigational drug or device. 20. Subject suffers from a life threatening condition. 21. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters
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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, Eosinophilic Esophagitis Food Allergies Male and female subjects 18 years and older 2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus 3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy Male and female subjects less than 18 years of age 2. Pregnant female subjects 3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment 4. Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment 5. Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study 6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing 7. Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit -
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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): 20.0-74.0, Diabetes, Type 2 Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24） Patients who are capable of giving informed consent prior to participating in this clinical study Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) Patients who withdrew from Study 262-09-001 Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001 Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study Patients who met the of Study 262-09-001 during the study period of Study 262-09-001 Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study Patients otherwise judged by the investigator or subinvestigator to be inappropriate for in the study
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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, Healthy Subject is a healthy, male, between 19 and 45 years inclusive Subject's body weight is between 50.0 and 100.0 kg inclusive and body mass index (BMI) is between 18.0 and 31.6 kg/m2 inclusive Subject is certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) by the study doctor Subject has normal vital signs after 10 minutes resting in supine position mmHg ≤ systolic blood pressure ≤ 140 mmHg mmHg ≤ diastolic blood pressure ≤ 90 mmHg beats per minute ≤ heart rate ≤100 beats per minute Subject has a normal standard 12-lead ECG after 10 minutes resting in supine position; 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 450 ms. Subject must be fasting Laboratory parameters for the subject are within the normal range (or defined screening threshold for the Investigative site), unless the Investigator considers an abnormality to be not clinically significant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (AST/ ALT, amylase, lipase, and fractional bilirubin (direct and indirect) should not exceed the upper laboratory norm) Male subjects must continue to use their approved contraceptive method and to refrain from donating semen for 30 days after participating in the study The subject has any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness The subject has frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month) The subject has significant blood loss or blood donation, within 56 days prior to IP administration The subject exhibits symptomatic hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within 3 minutes when changing from the supine to the standing position The subject has the presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician The subject has a history or presence of drug or alcohol abuse (alcohol consumption > 2 drinks per day) The subject smokes more than 5 cigarettes or equivalent per day, unable to stop smoking during the days the subject is confined or returning for study related testing Excessive consumption of beverages with xanthine bases (> 4 8 ounce glasses per day) including energy drinks, weight loss drinks, protein mixes (i.e. for body building), etc Any medication, herbal supplement or other natural products (including St John's Wort) within 14 days before the Day 1 visit or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever is longest; any vaccination within the last 28 days. This includes taking analgesics 2 days before Day 1 visit which will interfere with pain assessment Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development
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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, Gastroparesis Nausea Vomiting Abdominal Pain Participants will be at least 18 years old and able to provide informed consent Participants will have symptoms of idiopathic gastroparesis for at least 6 months duration prior to enrollment with documented abnormal solid phase gastric emptying scintigraphy Gastroparesis due to: diabetes, medication (e.g. post-chemotherapy), iatrogenic post-surgical gastroparesis, and severe neurologic conditions such as Parkinson's disease known to be associated with gastroparesis An active eating disorder Participants currently lactating, or preparing to conceive will also be excluded A history of inflammatory bowel disease Known bowel obstruction, or strictures
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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, Prolonged Postoperative Ileus Age > 18 years Current inpatient following elective laparoscopic or open surgery Classified as having prolonged postoperative ileus Able to understand risks/benefits of the study Able to give informed consent Pregnancy ASA of 4 or greater Previous allergic reaction to gastrografin or iodinated contrast agents Manifest hyperthyroidism
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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, Metabolic Processes Body weight between 60 and 100 kg, and BMI ≤30 kg/m2 Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic Abnormal pulse rate measurement (<40 or >90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows Systolic blood pressure <95 or >160 mmHg Diastolic blood pressure <40 or >95 mmHg Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm Regular use of any prescribed or OTC (over the counter) drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit
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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): 15.0-90.0, Early Gastric Cancer gastric cancer patients in St.mary's hospital gastric lymphoma, gastric GIST patients in St.mary's hospital
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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, Umbilical Hernia Epigastric Hernia Umbilical or epigastric hernia repair
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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, Non-specific Abdominal Pain age greater than 18 admission with abdominal pain for up to one week prior to admission deemed to be non-specific pain by senior surgical team member patient willing to give full informed consent for participation patients less than 18 years of age pain of greater than 7 days duration admission with abdominal pain in previous 6 months history of inflammatory bowel disease previous history of appendicectomy previous surgery rendering laparoscopy unsafe eg. multiple laparotomies history of intra-abdominal transplant including retroperitoneal renal allografting clinical picture necessitating immediate surgical procedure cases involving trauma patients who are unable or unwilling to give full 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): 18.0-999.0, Non-Alcoholic Fatty Liver Disease Both men and women Age > 18 years Liver fat diagnosed on normal clinical grounds including in most cases liver assessed by Kleiner scoring system to classify severity, with no known aetiological factors for underlying liver disease (e.g. of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis). Last liver biopsy will be within 3 years of recruitment to the study Liver fat diagnosed by ultrasound, CT or magnetic resonance imaging (MRI) in patients who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis) Alcohol consumption ≤ 14 units / week for women ≤ 21 units / week for men Alcohol consumption > 15 units /week for women and > 22 units /week for men Decompensated acute or chronic liver disease A history of viral hepatitis, diarrhoea, diverticulosis, irritable bowel syndrome, inflammatory bowel diseases, coeliac disease (seropositivity for anti-endomysial immunoglobulin A antibodies; immunoglobulin A (IgA) EMA) Previous bariatric or other abdominal surgery Continuous use of antibiotics that may change gut microflora, probiotics, or antisecretory drugs capable of causing achlorhydria within the 2 months preceding enrolment, or evidence of immunoglobulin A or immunoglobulin deficiency (both of which produce confounding effects during assessments of intestinal permeability and small intestinal bacterial overgrowth)
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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, Tobacco Dependence Age 18+ Smoke an average of at least five cigarettes per day for at least 1 year Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2) Intention to quit smoking in the next 30 days Currently seeking treatment for smoking cessation Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable) A quit attempt in the past 30 days resulting in greater than 3 days of abstinence Using other tobacco products more than 9 days in the past 30 days Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site) Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) Schizophrenia and schizoaffective disorder Psychiatric medication changes in the past 3 months Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP 1. Marijuana will be tested for but will not be an exclusionary criterion. 2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. 3. Participants failing the toxicology screen will be allowed to re-screen once
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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): 16.0-999.0, Community-acquired Pneumonia Patients with community-acquired pneumococcal pneumonia, which was confirmed by 1. detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND 2. positive urinary pneumococcal antigen AND 3. presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND 4. radiologic signs of pneumonia Pneumonia of other cause (e.g. non-pneumococcal pneumonia) Hospital-acquired or ventilator-associated pneumonia Patients referred from or transferred to another hospital
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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): 18.0-60.0, Patients With Gastroparesis Who Have Failed Standard Therapy Male or Female 2. Age 18 3. Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, and abdominal pain. 4. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy (EGD), and the patient's subjective symptoms. 5. Subject has signed informed consent for the administration of domperidone that informs the patient of potential adverse events 6. Female subjects must be: 1. surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation) 2. if sexual active, practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel may be used as a method of birth control History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, atrial fibrilation and Torsade des Pointes, subjects with minor forms of ectopy (PACs) are not necessarily excluded 2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTC>450 milliseconds for males, QTc>470 milliseconds for females) 3. Clinically significant electrolyte disorders 4. Gastrointestinal hemmorrhage or obstruction 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor) 6. Pregnant or breast feeding female 7. Known allergy to domperidone The following medications are prohibited during the study: antidepressants: doxepin, clomipramine, amopxapine, trazodone, venlafaxine, nefazodone, fluvoxamine, paroxetine, fluoxetine, sertraline, amitriptyline, maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline; anti-psychotics: haloperidol, chlorpromazine, chlorpromazine pimozide, sertindole, quetiapine, mesoridazine, perphenazine, lfluphenazine, promazine, trifluoperazine; anti-emetics: prochlorperazine, thioridazine, promethazine, mesoridazine, theiethylperazine, perphazine, dolasetron, dronabinol, droperidol; anti-infective agents: erythromycin, clarithromycin, troleandomycin, norfloxcin, quinine sulfate, quinupristin and dalfopristin, pentamidine, sparfloxacin, grepafloxacin, azithromycin, ofloxacin, levofloxacin; anti-fungal agents: fluconazole, itraconazole, ketoconazole, miconazole, terconazole, ticonazole, butaconazole; antivirals: foscarnet; protease inhibitors: indinavir, amprenavir, ritonavir, nelfinavir, squinavir; antihypertensives: nicardipine, isradipine, moexipril/HCTZ; calcium channel blockers: verapamil, diltiazem, deltiazem/enalapril, verapamil/trandolapril, tocainide, bepridil; anti-arrhythmics: disopyramide, quinidine, procainamide, flecainide, sotalol, bretylium, amiodarone, ibutilide, moricizine; diueretics: bumetanide, furosemide, torsemide, etharcrynic acid, chlorothiazide, indapamide; antilipemics: probucol, bepridil, mibefradil; hematological agents: cilostazol; respiratory agents: zafirlukast, salmetrol; gastrointestinal agents: cimetidine, cisapride; antidiarrheal: octreotide; antihistamines: azelastine, clemastine; migraine treatment: naratriptan, sumatriptan, zolmitriptan; antimalarial: halofantrine; muscle relaxants: tizanidine; narcotic dependence: levomethadyl; miscellaneous: tamoxifen, warfarin, phenytoin, ziprasidone, risperidone, formoterol fumarate, sildenafil; drugs that prolong the QT Interval: albuterol, alfuzosin, amantadine, amisulpride, amphetamine, arsenic trioxide, astemizole, atazanavir, atomoxetine, chloral hydrate, chloroquine, ciprofloxacin, citalopram, clozapine, cocaine, dexmethylphenidate, diphenhydramine, dobutamine, dofetilide, dopamine, dronedarone, ephedrine, epinephrine, eribulin, escitalopram, famotidine, felbamate, fenfluramine, fingolimod, fosphenytoin, galantamine, gatifloxacin, gemifloxacin, granisetron, iloperidone, isoproterenol, lapatinib, levalbuterol, lisdexamfetamine, lithium, metaproterenol, methadone, methylphenidate, midodrine, moxifloxacin, nilotinib, norepinephrine, ondansetron, oxytocin, paliperidone, perflutren lipid microspheres, phentermine, phenylephrine, phenylpropanolamine, protriptyline, pseudoephedrine, ranolazine, ritodrine, toxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus, telithromycin, terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib, vardenafil, voriconazole
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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, Post ERCP Pancreatitis Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years Patients were excluded from study participation if they had a contraindication for diclofenac including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks renal failure (Cr > 1.4) those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable) those who developed acute pancreatitis during the 2 weeks before ERCP those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection
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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, Type 1 Diabetes Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2. Regularly measuring blood sugars four times daily. 3. HbA1c of less than 8.5%. 4. Well versed with carbohydrate counting. 5. Age 18-75 years. 6. BMI 20-40 kg/m2 Type 1 diabetes for less than 6 months; 2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3. Hepatic disease (transaminase > 3 times normal) or cirrhosis; 4. Renal impairment (serum eGFR < 30ml/min/1.73m2); 5. HIV or Hepatitis B or C positive status; 6. Participation in any other concurrent clinical trial; 7. Any other life-threatening, non-cardiac disease; 8. Use of an investigational agent or therapeutic regimen within 30 days of study. 9. history of pancreatitis 10. pregnancy 11. inability to give informed consent 12. history of gastroparesis 13. history of medullary thyroid carcinoma or MEN 2 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): 55.0-999.0, Alzheimers Disease Low Probability for AD Participants (Group 1) Participant is of any race/gender/ethnicity who has reached his or her 55th birthday at the time of informed consent Participant provides written informed consent Participant is capable of complying with study procedures Participant is capable of communicating with study personnel Participant understands and speaks English Participant has at least an 8th Grade education In the Investigator"s opinion, participant has a low probability of being currently positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined in VI of XXX protocol Participant has no significant hepatic or renal disease as defined by previous medical history and lab results are within the following ranges: Total bilirubin within 2x institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x institutional upper limits of normal BUN within 2x institutional upper limits of normal High Probability for AD Participants (Group 2) Participant is of any race/gender/ethnicity who has reached his or her 55th birthday at the time of informed consent Participant or participant"s legally acceptable representative provides written informed consent Participant is capable of complying with study procedures
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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): 20.0-40.0, Healthy BMI : 19 9 kg.m-2 Normal fasting glycemia Having obtained his informed consent Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis Have had a gastrointestinal surgery (with the exception of appendices resection) Malabsorption disorders Lactose intolerance Significant weight loss during the past three months (more than 5% of initial weight) Have a regular consumption of medication Regular supplements (vitamins and minerals) intake during the previous month Have an alcohol intake: > 2 units a day Smoker (more than 2 cigarettes a day) Illicit substances intake, as stated on the medical screening questionnaire
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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, Acute Pancreatitis diagnosis of acute pancreatitis age > 18 years written informed consent ongoing need for opiates >96 hours after onset of symptoms chronic pancreatitis post-ERCP pancreatitis intraoperative diagnosis pregnancy malignancy received nutrition before randomisation
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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): 15.0-999.0, Chemotherapy-Induced Nausea and Vomiting Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve Written informed consent and HIPAA authorization for release of personal health information Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this is met No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy No concurrent participation in a clinical trial which involves another investigational agent No use of agents expected to induce the metabolism of fosaprepitant which rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates No concurrent use of agents which may inhibit metabolism of fosaprepitant which cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir No concurrent use of warfarin while on study No known history of anticipatory nausea or vomiting No clinically significant infections as judged by the treating 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): 15.0-999.0, Advanced Malignant Solid Neoplasm C-KIT Tyrosine Kinase Protein Overexpression Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Gastrointestinal Stromal Tumor Metastatic Malignant Solid Neoplasm Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Unresectable Melanoma Unresectable Solid Neoplasm For dose escalation study, patients must have histological confirmation of solid tumors that is metastatic or unresectable. For expansion cohorts, patients must have metastatic or unresectable gastrointestinal stromal tumor (GIST), melanoma, or uncategorized tumors with tumor biopsies that are positive for c-KIT mutations by polymerase chain reaction (PCR) or immunohistochemistry (IHC). For patients enrolled in the melanoma expansion cohort, only select KIT mutations will be eligible. Patients with mutations in exon 13 V654X, 14 T6701, 17 D816X and all exon 18 mutations will not be eligible for enrollment Patients who have completed previous therapies 4-weeks prior to (or within 5 drug half lives) enrollment on study. Radiation therapy wash out period will be 2 weeks. This includes an exception of patients with metastatic GIST tumors who are taking maintenance imatinib mesylate therapy. These patients are allowed to remain on imatinib mesylate therapy up to enrollment in this study Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%) Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL Total bilirubin < or = 2.0 mg/dL. (Does NOT apply to patients with Gilbert's syndrome) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal (patients with liver involvement will be allowed < or = 5.0 X institutional upper normal limit) Serum creatinine < 2.0 mg/dL Patients MUST have recovered from all treatment related toxicities to grade 1 National Center Institute (NCI) Common Terminology for Adverse Events (CTCAE) (version [v] 4.0) in severity Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus or autoimmune vasculitis [e.g., Wegener's granulomatosis] are excluded from this study History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab) Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses) Patients who do not agree to practice appropriate birth control methods while on therapy Pregnant women are excluded from this study. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician
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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): 22.0-999.0, Coronary Artery Disease Subjects clinically indicated for nuclear stress test and who satisfy all the and are eligible for participation. Age 22 years or older Willing and able to give informed consent Clinical indication for nuclear stress test evaluation Chest pain syndrome Two or more coronary artery disease risk factors as defined by: 1. Dyslipidemia: low-density lipoprotein (LDL) >130 mm/dL or high-density lipoprotein (HDL) <35 mm/dL or on treatment for dyslipidemia 2. Hypertension: blood pressure >140 millimeter of mercury (mmHg) systolic, >90 mmHg diastolic or on blood pressure altering treatment 3. Obesity: body mass index (BMI)>28 4. Current cigarette smoking 5. Diabetes: Type 1 or 2 6. Family history: coronary disease in a first or second degree relative Body Mass Index (BMI)<18.5 or BMI >40 Known coronary disease as defined as: Prior bypass surgery or coronary stenting Q-wave infarction on a past electrocardiogram (EKG) (>0.01 sec Q-wave duration in two adjacent leads) Presence of pacemaker/defibrillator Presence of artificial valve Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta Presence murmurs including valve lesions, ventricular septal defects, and arteriovenous (AV) fistulae. Presence of moderate or severe valve disease as defined by >1/6 heart murmur on physical diagnosis Left Ventricular Assist Device (LVAD) Presence of scars on the site thorax areas Participation in trial within 30 days prior to collecting CADence data except participation in registry studies Asthma with wheezing Inability to lie flat in the supine position Acute coronary syndrome with elevated cardiac biomarkers (troponin (TP)>3x upper limit of normal (ULN) or creatine kinase MB (CKMB) >3x ULN) Heart Transplant Current cocaine use (within the past 24 hours, as reported by subject) Chronic Obstructive Pulmonary Disease (COPD) Contraindication to computed tomography (CT) angiography Renal failure with glomerular filtration rate (GFR)<50 (angio risk) Iodinated contrast allergy Elevated heart rate which cannot be controlled sufficiently to achieve a good computed tomography angiogram Body weight >350lbs Sinus rhythm rate greater than 100 beats per minute at screening Atrial fibrillation with average heart rate of greater than 70 beats per minute on resting screening electrocardiogram (ECG)
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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, Pancreatitis mild to moderate pancreatitis SIRS (2/4) a) HR >90 b) RR>20 or paCO2 <32 on room air c) T>100.4 F <96.8 F d) WBC >12, <4 or >10% severe pancreatitis renal insufficiency, Cr >2 mg/dl cardiac insufficiency respiratory insufficiency, O2 saturation <90% room air liver dysfunction, aklbumin <3mg/dL pregnancy hyponatremia, Na < 135meq/L clinical findings of volume overload peripheral edema ascites pancreatitis following endoscopic, radiographic, or surgical procedure
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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): 40.0-65.0, Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls <40 years of age >65 years of age smoking cardiovascular disease diabetes related manifest vascular complications Type 1 Diabetes Mellitus use of Glibenclamide use of HIV drugs use of calcineurin inhibitors use of drugs that interfere with CYP3A4 and CYP2C19
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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): 40.0-65.0, Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls <40 years of age >65 years of age smoking cardiovascular disease diabetes related manifest vascular complications Type 1 Diabetes Mellitus use of Glibenclamide use of HIV drugs use of calcineurin inhibitors use of drugs that interfere with CYP3A4 and CYP2C19
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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): 2.0-5.0, Diarrhea Acute Respiratory Infection Children who Belong to institute FAN in Medellín Attend full time to institute FAN (eight hours) Have 2 to 5 years Children who Children at the began of the study are with acute diarrheal disease and acute respiratory infection Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease Failure to attend the educational institution for more than 10 days No consumption of zinc supplementation for more than 10 days, because of insistence to the school
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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): 18.0-999.0, Respiratory Tract Infections patients with lower respiratory tract infections/acute cough (including acute bronchitis, pneumonia, and infectious exacerbations of chronic obstructive pulmonary disease or asthma) age 18 years or older an illness of less than 28 days duration first consultation for the illness episode being seen in a physician's office written consent to participate an inability to fill out study documentation being previously included in the study immunocompromised status (HIV patients, immunosuppressive treatment) ongoing treatment with oral corticosteroids
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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 AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis Presentation within 48 hours of symptom onset Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis The presence of organ failure by the Atlanta on the first day of presentation The presence of clinical signs and/or symptoms of sepsis Alcoholic acute pancreatitis A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications Coagulopathy (international normalized ratio >1, and/or platelet count <50,000/mm3 Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)
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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, Tobacco Use Disorder Must report currently smoke at least 10 cigarettes per day and been smoking for at least 1 year Must not be planning to quit smoking in the next 30 days, nor tried to quit in the last 30 days Must be able to read and speak English Should not concurrently using other tobacco products or nicotine medications Willing to try new tobacco products and substitute other brands of cigarettes Not current participating in any other ongoing research study Must be in good general health Medically eligible to receive nicotine replacement products (based upon the New York State [NYS] Smokers Quit line criteria) No history of heart attack or stoke in last 2 weeks No current use of Zyban, bupropion, Wellbutrin, or Chantix/varenicline, or other smoking cessation medication
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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): 18.0-999.0, Periumbilical Subcutaneous Adipose Tissue Reduction >18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
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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): 18.0-999.0, Advanced Malignant Solid Neoplasm HIV Infection Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm Unresectable Solid Neoplasm Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 12 weeks Leukocytes >= 3,000/mcL (within 1 week of study entry) Absolute neutrophil count >= 1,500/mcL (within 1 week of study entry) Platelets >= 100,000/mcL (within 1 week of study entry) Total bilirubin=< 1.5 x upper limit of normal (ULN) (within 1 week of study entry) (if, however, the participant has Gilbert's disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal (within 1 week of study entry) Creatinine =< 1.5 x ULN (within 1 week of study entry) Prior treatment with cabozantinib (XL184) The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment The participant has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 4 weeks or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; note: participants with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents The participant has received any other type of investigational agent within 28 days before the first dose of study treatment The participant has not recovered to baseline or Common Terminology for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) The participant has a primary brain tumor The participant has active brain metastases or epidural disease; participants with brain metastases previously treated with whole brain radiation or radiosurgery or participants with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; participants with treated brain metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2 weeks of registration, though non-enzyme inducing anticonvulsive drugs such as levetiracetam are allowed; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for participants with known brain metastases is required to confirm The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted The participant requires chronic concomitant treatment with the following strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers OTHER than antiretroviral agents: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, primidone, modafinil, and other enzyme inducing anti-convulsant drugs (EIACD), and St. John's wort; use of efavirenz or etravirine is permitted for participants considered for the CYP3A4-inducer based antiretroviral therapy (ART) regimen arm (Stratum B) of the trial; because the lists of CYP3A4 inducers are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
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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): 4.0-12.0, Functional Constipation Age 4-12 years Receiving enema in ED for presumed constipation Critically ill patient Any history of renal insufficiency, renal disease, or elevated creatinine Any history of intestinal anatomic abnormality (i.e. anal stenosis, anal surgery, bowel obstruction, hirschprung's disease) An inability to self-report pain Presence of gastrostomy or jejunostomy tube Any history of gastrointestinal dysmotility Inability to read or speak English or Spanish
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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, Diarrhea A participant is considered eligible for participation in the trial if the following are satisfied on admission (Day 1, before randomization) to the hospital: 1. Participant is a male between 18 and 65 years of age inclusive 2. Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission) 3. Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline) 4. Dipstick test/Dark-field examination positive for Vibrio cholera 5. Written informed consent is provided 6. Participant is willing and able to comply with all trial requirements A participant who meets any of the following on admission (before randomization) to the hospital will not qualify for the study 1. Evidence or history of any clinically significant illness as per the Investigator's discretion. 2. Known case of HIV or Hepatitis B 3. History of cancer 4. Known renal disease 5. Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years 6. History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission 7. Concomitant infection requiring antimicrobial therapy 8. Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation 9. Clinically significant abnormal laboratory test results as determined by the investigator 10. Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device 11. History of seizure (including febrile seizure) or loss of consciousness; 12. History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis 13. For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee 14. Prior enrolment in this 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): 18.0-90.0, Acute Diverticulitis Acute Diverticulitis Other Abdominal Pathologies
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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): 21.0-60.0, Alcohol Abuse Alcohol Dependence Heavy Drinking Days Treatment seeking for alcohol abuse or dependence Non cigarette smokers are preferred, but will accept those who smoke less than 10 cigarettes per day Marijuana use of less than once per week. Other drug use less than 20 lifetime uses Absence of current Axis I disorders except alcohol abuse or dependence. Past diagnosis (greater than 1 year) is acceptable BMI within 18-30 Physically healthy (normal physical exam, ECG, blood and urine chemistries) Female participants must use medically approved method of contraception. If barrier method is used, must agree to using two methods simultaneously (e.g., diaphragm and condom) Taking any prescription medication (except oral contraceptives, certain short term anti -fungal agents and some topical creams for dermal conditions) On psychotropic medications Drug use (other than nicotine, alcohol or marijuana) greater than 20 lifetime uses Meets for current drug abuse or dependence (other than alcohol and nicotine). Past abuse/dependence (greater than 3 years) is acceptable History of major head trauma History of cardiac problems Pregnancy, lactating, or planning to become pregnant during the study period
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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 for Patients: 1. Patient must be greater than or equal to 18 years of age. 2. Patient must be able to comprehend English. 3. Patient must be able to provide written informed consent. 4. Patient must have had chronic widespread pain for at least one year prior to participation with an average daily intensity at least 4 out of 10. for Healthy Controls: 1. Healthy control must be greater than or equal to 18 years of age 2. Healthy control must be able to comprehend English. 3. Healthy control must be able to provide written informed consent for patients: 1. Patient is unable to comply with study procedures or follow-up visits 2. Patient smokes more than 10 cigarettes of nicotine per week. 3. Patient uses recreational drugs. 4. Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks per week. Further, patient consumes more than 5 drinks at one time. 5. Patient is pregnant or breastfeeding. 6. Patient has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition. 7. Patient has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts. 8. Patient has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have. 9. Patient is uncomfortable in small closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine. 10. Patient cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI scanner. 11. Patient has allergies to topical treatment. 12. Patient has a chronic pain condition other than FM. 13. Patient has taken within the last two weeks opioids. Other medications used to treat fibromyalgia at the standard doses in the community can be taken. We will not ask participants to stop any medication to participate in the study. 14. Patient has previously taken opioids for more than one month on a continual basis, within the last 6 months. 15. Patient had seen study information on clinicaltrials.gov prior to September 23, 2013. 16. Patients who decline to be audio and/or videotaped will be excluded from the qualitative interview component of the study for healthy controls: 1. Healthy control is unable to comply with study procedures or follow-up visits 2. Healthy control smokes more than 10 cigarettes of nicotine per week. 3. Healthy control uses recreational drugs. 4. Female healthy control consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male healthy control consumes 14 such drinks per week. Further, healthy control consumes more than 5 drinks at one time. 5. Healthy control is pregnant or breastfeeding. 6. Healthy control has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition. 7. Healthy control has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts. 8. Healthy control has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments
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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, Pancreatic Cancer Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer unresectable pancreatic cancer can be due 1) distant metastasis, 2) involvement of superior mesenteric artery or celiac artery, or 3) if the patient was unfit for surgery due to severe concomitant illness Significant biliary obstruction presenting for ERCP Significant obstructive-type abdominal pain despite use of opioid analgesics. Obstructive-pain is defined as abdominal pain that is intensified after food intake in the setting of dilated upstream pancreatic duct (>4mm in diameter) Ability to give informed consent Unable to give informed consent Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) Estimated life expectancy of 4 weeks or less Malignant infiltration of the papilla as determined endoscopically or radiographically Serum bilirubin level ≥ 2 mg/dl (to avoid a confounding variable with respect to the impact of PD stenting on the pain severity and the quality of life; concomitant biliary obstruction should be managed successfully before enrollment) Acute gastrointestinal bleeding Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000 Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy Cirrhosis with portal hypertension, varices, and/or ascites
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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): 20.0-75.0, Type 2 Diabetes Caucasian men with type 2 diabetes diagnosed according to ICD10 Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily Age 20-75 years HbA1c ≤80 mmol/mol BMI: 20-40 kg/m2 Liver disease or ALAT three times above upper reference range Diabetic nephropathy (GFR < 50 mL/min/1.73 m2 or albuminuria) Proliferative diabetic retinopathy Treatment with any glucose-lowering medication except metformin Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months Previous surgery on the gastrointestinal tract Larger surgical intervention during the last 12 weeks Treatment with oral steroids or thiazide diuretics Treatment with digoxin Smokers
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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, Acute Pancreatitis acute onset of abdominal pain pancreatitis at first onset three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and abdominal MR examination inability to cooperate when MR imaging was performed a history of chronic pancreatitis AP due to pancreatic carcinoma hypoproteinemia with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases with iron deposition disorder (e.g. diabetes or blood system diseases)
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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): 18.0-80.0, Type 2 Diabetes Males or females between the ages of 18 and 80 years discharged after hospital admission from general surgery and medicine services (non-surgical and non-ICU setting). 2. Admission HbA1c between 7% and 10% 3. Patients with T2D treated with diet alone or with oral antidiabetic agents as monotherapy or in combination therapy (excluding GLP1 receptor agonists) or on low-dose insulin therapy (TDD ≤0.4 unit/kg/day) prior to admission. 4. Subjects with a hospital admission BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones). 5. BMI > 25 Kg/m2 and < 45 Kg/m2 Age < 18 or > 80 years. 2. Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia) 3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria). 4. Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission. 5. Recurrent severe hypoglycemia or hypoglycemic unawareness. 6. Subjects with gastrointestinal obstruction, gastroparesis or those expected to require gastrointestinal suction. 7. History of medullary thyroid cancer or multiple endocrine neoplasia 8. Patients with acute or chronic pancreatitis, pancreatic cancer or gallbladder disease. 9. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 30 ml/min). 10. Treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment. 11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Female subjects who are pregnant or breast feeding at time of enrollment into the study. 13. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
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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, Tobacco Dependence Age 18-65 Less than 16 years of education Able to understand, and sign consent Smoke >4 cigarettes/day for at least a year No quit attempt in prior 1 month and not planning to quit smoking within next 6 months Plan to live in local area for next 8 months Able to read and write in English Women not pregnant and taking steps to avoid pregnancy College graduate Use of psychotropic drugs Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months Currently pregnant or nursing Uncontrolled serious psychotic illness or substance abuse History of difficulties providing blood samples-fainting, poor veins, anxiety
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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, Tobacco Dependence Smoke >4 cigarettes/day for at least a year No quit attempt in prior month Not planning to quit smoking within next 6 months Plan to live in local area for next 8 months Meet diagnostic for a current or lifetime Anxiety Disorder or Mood Disorder as determined by the Mini-international Neuropsychiatric Interview Read and write in English Women not pregnant or nursing and taking steps to avoid pregnancy Able to understand and consent to study procedures Unstable or significant medical condition such as Chronic Obstructive Pulmonary Disease or kidney failure Use of non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior month Currently reducing or planning to reduce cigarette consumption in next month Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the past 6 months Current suicide risk on clinical assessment Aged <18 or >65 History of difficulty providing blood samples (fainting, poor venous access) Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the 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, Diabetes Diabetes Mellitus, Type 2 People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 2 years and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected 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, Hepatocellular Carcinoma The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents The patients must be willing and able to complete the biweekly visits for the first 3 months The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment The patient's life expectancy is ≥3 months The patients must provide written informed consents The patients participated in other clinical trials The patients received sorafenib therapy prior to enrollment The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy The patient's sorafenib dosage exceeds 400mg, twice daily
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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): 45.0-75.0, Chronic Heart Failure The basic primary heart disease is coronary heart disease ( with diagnosis for coronary heart disease : confirmed by coronary angiography; confirmed by coronary CT; history of acute myocardial infarction; limb-salvage Q wave for ECG; ecg ECG test and radionuclide examination support, etc.); no history of hypertension or taking antihypertensive drugs, with blood pressure under 160/100 mmHg With a history of coronary heart disease, symptoms and signs; with difficult breathing, fatigue and fluid retention (edema); with left ventricular enlargement, end systolic volume of left ventricular increase and left ventricular ejection fraction (LVEF) ≤ 40; with New York Heart Association (NYHA) functional classificationⅡ or Ⅲ Male or female subjects between 40 and 75 years old Serious valvular heart disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction ( within 4 weeks), cardiac shock, acute myocarditis or serious arrhythmia with the variation of hemodynamics Pulmonary artery hypertension caused by pulmonary heart disease, acute or chronic pulmonary embolism, or stroke within a half year Serious hepatic insufficiency ( the index of liver function being 2 times of normal one), renal insufficiency (Ccr>20%, Scr>3mg/dl or 265 μmol/L), diseases of blood system, malignant tumor, diabetes mellitus with serious complications, hyperthyroid or hypothyroid Infection: fever; the numeration of leukocyte being more than 10×109/L, the percentage of neutrophile granulocyte being more than 85%; patchy shadows in X ray of Chest, meeting one of the above three Pregnancy or lactation; mental disease and infectious disease patients Take part in other trials within two 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): 40.0-75.0, Coronary Artery Disease Age between 40-75 years old 2. Male sex 3. History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) Unstable angina or myocardial infarction by history, ECG, and/or enzymatic within 1 month of enrollment. 2. Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. 3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit. 4. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment. 5. Known history of cognitive impairment or inability to follow study procedures 6. Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations. 7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks. 8. Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to 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): 18.0-999.0, Acute Pancreatitis onset of symptoms consistent with AP within 72 hours before admission to the hospital an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal II score 6 or more a signed informed consent patients < 18 years of age pregnant and breastfeeding women
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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, Diabetes Chronic Kidney Disease Established Atherosclerotic Vascular Disease Framingham Risk Score More Than 20 Percent Adults (≥18 years of age) at high risk for cardiovascular events, including Patients with diabetes Patients with chronic kidney disease [eGFR <60 ml/min/1.73m2 and/or (ACR >= 30 mg/mmol or two consecutive ACR tests which are >= 3 mg/mmol)] Patients with established atherosclerotic vascular disease including cerebrovascular disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral arterial disease (symptomatic and/or ankle brachial index <0.9) Primary prevention patients with multiple risk factors and Framingham risk score >20% In order to qualify for all patients must have at least one uncontrolled risk factor (i.e., blood pressure, LDL-cholesterol, HbA1c, or current smoking) Unwilling to participate/sign consent form Unwilling or unable to participate in regular follow-up visits 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, Postoperative Pain Nausea Vomiting Anxiety Depression English or Spanish speaking Admitted to Mt Zion Hospital for a minimum anticipated length of stay for at least 4 days Aged 18 or older In a ward included in the roll out of the Osher Center's acupuncture program at Mt Zion Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction, severe depression, patients in the intensive care unit) Acupuncture contraindication (e.g., sepsis, endocarditis) Inability to consent or complete surveys (e.g., cognitive or communication impairment)
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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, Psoriasis Type 2 Diabetes Mellitus People who satisfy all of the following may be included in the study: 1. Have a diagnosis of generalized chronic plaque and/or guttate psoriasis; 2. Are male or female aged between 18 and 75 years inclusive; 3. Have a psoriasis area and severity index (PASI) greater than 7; 4. Have a diagnosis of type 2 diabetes; 5. Have a glycated haemoglobin (HbA1c) level between 48mmol/mol and 69mmol/mol; 6. Are able and willing to stop sulphonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitor and glucagon-like peptide-1 (GLP-1) analogue therapy for the duration of the study; 7. Have a negative pregnancy test at screening (women of child bearing potential only); and 8. Are willing to voluntarily sign a statement of informed consent to participate in the study People with any of the following conditions will be excluded from the study: 1. Allergy or hypersensitivity to sitagliptin (Januvia®) or gliclazide (Diamicron®); 2. Current or recent (within 8 weeks) receipt of phototherapy; 3. Type 1 diabetes; 4. Severe kidney disease as defined by a previous diagnosis of chronic kidney disease in the presence of an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 m2; 5. Severe heart disease as defined by a previous diagnosis of heart disease and a left ventricular ejection fraction which is known to be less than 35% (as measured by echocardiogram or cardiac catheterisation study); 6. Severe lung disease as defined by a previous diagnosis of chronic lung disease and a forced expiratory volume in 1 second (FEV1) or a forced vital capacity (FVC) that is known to be less than 50% that which would be estimated for a person of that age and gender; 7. Severe liver disease as defined by a previous diagnosis of chronic liver disease in the presence of an alanine transferase concentration greater than 150 international units (IU)/L (greater than three times the upper limit of the normal reference range); 8. Any other contraindications, as stated in the SPCs for sitagliptin (Januvia®) or gliclazide (Diamicron®); 9. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception during participation in the study abstinence will be permitted only if it is in keeping with a person's lifestyle; 10. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial; 11. Any current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness; 12. Previous randomisation into this study; 13. Concurrent participation in another clinical trial; and 14. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit)
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Pancreatitis,Acute Necrotizing severe Acute Pancreatitis according to Atlanta revisited in 2012 concurrent sepsis or (peri)pancreatic infection caused by a second disease patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease) recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis pregnancy, malignancy or immunodeficiency a history of allergy to meropenem, cefoperazone and metronidazole a history of antibiotic administration within 48 h prior to enrollment possible death within 48 h after 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): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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 Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 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): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/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): 18.0-999.0, Prostate Cancer Histologically proven prostate adenocarcinoma 2. Biopsy within 12 months of date of registration 3. Clinical Stage I-IV, MX-M0 (AJCC 6th Edition) M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients. 4. Prostate volume: ≤ 100 cc (recommended not required) Determined using: volume = π/6 x length x height x width Measurement from CT or ultrasound ≤90 days prior to registration. 5. ECOG performance status 0-1 6. No prior prostatectomy or cryotherapy of the prostate 7. No prior radiotherapy to the prostate or lower pelvis 8. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. 9. Completion of patient questionnaires 10. Consent signed
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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 Male or female subject Age 18 years or higher First in a lifetime episode of acute pancreatitis Diagnosis of acute pancreatitis based on 2 of the following 3 (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must a stone obstruction at the time of study screening) BISAP score of 3 or higher Study treatment initiation is possible within 48 h of symptom onset Ability to provide informed consent Drug-induced, viral, hereditary or post-ERCP pancreatitis Recurrent episode of pancreatitis CT evidence of pancreatic necrosis at study entry Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis) High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week Class II or greater New York Heart Association heart failure Oxygen-dependent chronic obstructive pulmonary disease (COPD) Cirrhosis of the liver Severe anemia (hemoglobin less than 8 g/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): 18.0-75.0, Diabetic Gastroparesis Male subjects between the ages of 18 and 75 years Willingness and ability to give written informed consent The ability to read, understand and speak English Prior diagnosis of Type 1 or Type 2 diabetes Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product A history of, or physical findings suggestive of, tardive dyskinesia A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening Hemoglobin A1c >11.5% at 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): 18.0-60.0, Mechanical Low Back Pain Chronic Low Back Pain chronic low back pain for a minimum of 12 months currently experiencing low back pain symptoms but not in a recurrence or an acute flare-up Modified Oswestry Disability Index score of ≥ 20% or more functional activities limited due to low back pain able to stand and walk without assistance able to understand and sign a consent form BMI >30 any structural spinal deformity including scoliosis, kyphosis, or stenosis spinal fracture or dislocation low back pain due to trauma osteoporosis ankylosing spondylitis rheumatoid arthritis fibromyalgia symptomatic disc herniation spondylolisthesis
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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): 15.0-65.0, Pancreatitis, Chronic Diagnosis of chronic pancreatitis confirmed by at least 2 of the following: 1. Typical Chronic epigastric abdominal pain 2. Elevation of serum Amylase>3 times upper limit normal or 3. Fecal elastase less than 200ug/g stool. 4. Confirmatory findings on cross-sectional imaging: 1. Changes in size, shape and contour of pancreas 2. Dilatation of main pancreatic duct 3. Calcification 4. Pseudocyst 5. Pancreatic duct stricture 5. Patients who fulfill the for surgical intervention Not agreeing for surgical management On going acute pancreatitis Postop alcohol intake Pregnancy Chronic pancreatitis with Malignancy
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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, Renal Cancer Kidney Cancer Case Cohort Must be ≥ 18 years of age AND Must be an English-speaker AND Must have a diagnosis or suspicion of kidney cancer Family Member Cohort Must be ≥ 18 years of age AND Must be an English-speaker AND Must be a blood relative of the proband. Family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. These individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting DNA from relatives is required. Control Cohort Must be ≥ 18 years of age AND Must be an English-speaker AND Must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, AND Patients who, in the opinion of the primary MSKCC clinician or the investigator, have a condition that precludes their ability to provide an 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): 18.0-999.0, Chronic Heart Failure Heart failure diagnosed on a first hospitalization for acute exacerbation during the last twelve months, without high age limit Men or women More than 18 years old Minimal knowledge of the French language (patient or his relatives) The patient need to fill an informed written consent Patient resides or is treated in Ile de France Patient is insured under the social security system Myocardial infarction or revascularization or Heart Valve Surgery < 3 months Inability to execute the feasibility test Major cognitive disorders do not allow access to the platform Patient does not have the necessary autonomy to use the equipment Sensitive subject, under Article L32 of the Code of Public Health Patient enrolled in another clinical trial Renal failure with creatininemia clearance (cockcroft) <15 ml/min /day oxygen
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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): 3.0-999.0, Amblyopia Strabismus a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye strabismic amblyopia patients of any age were included structural damage to the eye (organic amblyopia) ametropic amblyopia
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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): 18.0-85.0, Anorectal Surgery Haemodynamic Changes Adult patient ASA (American Society of Anaesthesiologists) I-IV Surgery in prone position or in lithotomy position Anorectal surgery inability to give consent to in trial age less than 18 years the regional anaesthesia is contraindicated the overweight more then 30% taking psychotropic and painkillers to treat chronic diseases the movement of the patients body, including the shivering the patients height is the <120 or> 230 cm the patients body weight is <30 or> 155 kg 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): 18.0-75.0, Sciatica for pain subjects: 1. Subject is 18-75 years old. 2. Subject is able to give written informed consent. 3. Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies. 4. Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities. 5. Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment. for healthy subjects: 1. Subject is 18-75 years old. 2. Subject is able to give written informed consent. 3. Subject has no history of chronic back/spine pain for all groups: 1. Subject recently received a lumbar ESI (within 8 weeks). 2. Subject starts new NSAID medication for pain during the study. 3. Subject has predominantly axial low back pain. 4. Subject has known pain condition secondary to hip joint arthritis. 5. Subject is pregnant or breastfeeding. 6. Subject has allergy to lidocaine. 7. Subject is treated with chronic corticosteroid therapy. 8. Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox). 9. Subject has a known bleeding disorder (i.e. hemophilia). 10. Subject has uncontrolled high blood pressure [>170/100]. 11. Subject has a known heart condition. 12. Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing spondylitis; etc.). 13. Subject has known liver dysfunction or renal insufficiency or impaired elimination (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3x ULN). 14. Subject has been hospitalized recently (within one month) for a major psychiatric disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychosis). 15. Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, or claustrophobia). 16. Subject had research-related radiation exposure in the last 12 months. 17. Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs
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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, Organophosphate Poisoning Male (females usually wear national dresses considered to provide adequate protection (43) Age min. 18 years (implies being a legal worker) Grows crops in knee and abdomen height in given data collection period Willing to spend 1.5-3 hours working with organophosphates under normal working conditions Involved in farming minimum two years (implies being active) Usually sprays at least once in two weeks with organophosphates on average (implies being active) Uses a hand pressured backpack sprayer placed at home (necessary to complete non-intervention) Works with crops in 5-10 katha land (sufficient to apply organophosphates for given time) Has a mobile/landline number (necessary for easy contact) Has a helper during work with organophosphates (organophosphate exposure reduced)
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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, Nicotine Dependence Tobacco Smoking Age 18+ 2. Daily smokers who smoke an average of at least five cigarettes per day for at least 1 year 3. Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip level must indicate regular smoking) Planned quit date in the next 30 days 2. Currently seeking treatment for smoking cessation 3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable) 4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence 5. Using other tobacco products or e-cigarettes more than 9 days in the past 30 days 6. Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site) 7. Unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) 8. Schizophrenia and schizoaffective disorder 9. Psychiatric medication changes (e.g., new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms. 10. Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP 1. Marijuana will be tested for but will not be an exclusionary criterion. 2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. 3. Participants failing the toxicology screen will be allowed to re-screen once. 11. Blood alcohol level > 0.01 a. Participants failing the blood alcohol screen will be allowed to re-screen once. 12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks per day (female/male)) 13. Pregnant, trying to become pregnant or breastfeeding 14. Predominant use of 'roll your own cigarettes' 15. CO reading >80 ppm 16. Systolic BP greater than or equal to 160 a. Participants failing for blood pressure will be allowed to re-screen once. 17. Diastolic BP greater than or equal to 100 a. Participants failing for blood pressure will be allowed to re-screen once. 18. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) a. Participants failing for blood pressure will be allowed to re-screen once. 19. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) a. Participants failing for blood pressure will be allowed to re-screen once. 20. Heart rate greater than or equal to 105 bpm a. Participants failing for heart rate will be allowed to re-screen once. 21. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) a. Participants failing for heart rate will be allowed to re-screen once. 22. Indicating any suicidal ideation in the past month, suicide attempts in the past 5 years (if within past 5 to 10 years, requires physician approval), or score of >4 on the MINI suicide subscale 23. Household member enrolled in the study concurrently. 24. Inability to independently read and comprehend the consent form and other written study materials and measures because participants are required to complete parts of the protocol at home independently. 25. Participated in prior study that involved reduced nicotine content cigarettes. 26. Having participated in a research study during the past three months in a study that would impact baseline smoking or response to study products. 27. Currently taking the following anticonvulsant medications: 1. Phenytoin [Brand Name: Dilantin] 2. Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol] 3. Oxcarbazepine [Brand Name: Trileptal] 4. Primidone [Brand Name: Mysoline] 5. Phenobarbital 28. Currently taking the following medication: 1. Bendamustine (Treanda) 2. Clopidogrel (Plavix) 3. Clozapine (Clozaril, FazaClo) 4. Erlotinib (Tarceva) 5. Flecainide (Tambocor) 6. Fluvoxamine (Luvox) 7. Irinotecan (Camptosar) 8. Olanzapine (Zyprexa) 9. Ropinirole (Requip) 10. Tacrine (Cognex) 11. Theophylline (Theo Dur, 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): 15.0-60.0, Postoperative Ileus Patients of either gender with age ranging from 15 to 60 years. 2. Patients whose ileostomies were made for typhoid or tuberculous perforation 3. Patients with no distal obstruction on loopogram Patients with age less than 15 years and greater than 60. 2. Patients having co-morbid factors such as diabetes and ischemic heart disease. 3. Patients whose ileostomy was made for any condition other than typhoid or tuberculosis
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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): 0.25-10.0, Acute Gastroenteritis Children aged 3 months to 10 years with recent significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway The following definitions are used to determine according to the pathway: Recent, significant vomiting Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway These Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked
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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, Abdominal Infection Be consistent with severe sepsis and septic shock diagnosis standards Age above 18 years old, is expected in more than 5 days in ICU score>15 By the patients themselves or their authorized person agreed to participate in the clinical trial and signed the informed consent Allergic to penicillin, or of tigecycline allergic patients Patients with abnormal liver function is severe Be pregnant or lactating women Be not signed the informed consent of patients Any can be expected to increase patient risk or other factors can interfere with the results of a 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): 21.0-50.0, Healthy Participants should be healthy males and females Age range from 21 to 50 years Broca Index: within 20% of their normal weight All female volunteers must use a safe contraception (i.e. oral contraception, spiral, sterilized) All female volunteers must have a negative pregnancy test Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice (GCP) and local legislation) in writing each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG within 14 days before the administration of the test substance. Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of a drug with a long half-life (>= 24 hours) within ten half-lives of the respective drug before enrolment in the study or during the study Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial Participation in another study with an investigational drug within two months prior to administration or during the trial Smoker (> 10 cigarettes or 3 cigars or 3 pipes/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): 18.0-45.0, Healthy Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. 2. Healthy as defined by the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. pre-dosing is at the discretion of the Qualified Investigator the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease the absence of history or known pyloric stenosis the absence of known gastric or duodenal ulcer the absence of urinary tract obstruction. 3. Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study sterile male partner (vasectomized since at least 6 months). 4. Capable of consent Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening. 2. Positive urine drug screen at screening. 3. History of allergic reactions to mesalamine, salicylates, aminosalicylates, hyaluronic acid, or other related drugs. 4. Positive pregnancy test at screening. 5. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study. 6. Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening. 7. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]). 8. History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening. 9. Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration. 10. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives prescription medication within 14 days prior to the first dosing over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily) a depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing. 11. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. 12. Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening. 13. Breast-feeding 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): 18.0-60.0, Type 2 Diabetes Body mass index (BMI) 27-37 kg/m2 Male Age 18-60 years old Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone Not taking anti-diabetes medication other than metformin Understand verbal and/or written explanation of the study requirements Malignancy (excluding localised basal and squamous cell skin cancer) Metabolic diseases (stable treated hypothyroidism allowed) Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months) Primary muscle disorders Cerebrovascular disease Neurological disease e.g. epilepsy, Parkinsons disease Active respiratory disease Active gastrointestinal or liver disease Renal impairment (eGFR <60 ml/min) Clotting dysfunction
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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 clinical diagnosis of acute pancreatitis，both mild type and severe type pregnant or suckling cancer in late time patient near death
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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): 0.0-999.0, Diabetes Endothelial Dysfunction Men and women with type 2 diabetes who are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks have diabetes diagnosed >6 months have maintained stable weight for 2 months (within 3%) have a valid Ontario Health Insurance Plan (OHIP) card and a family physician if prescribed lipid medication, have taken a stable dose for at least 2 weeks if prescribed blood pressure medication, have taken a stable dose for at least 1 week can keep written food records carotid intima-media thickness (cIMT) < 1.2 mm and ankle brachial index (ABI) of >0.9 Individuals who take insulin take steroids have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS) have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months take warfarin (Coumadin) have had major surgery in the past 6 months have a major debilitating disorder have clinically significant liver disease ( liver transaminase levels > 130 U/L), excluding Nonalcoholic fatty liver (NAFL) disease or NASH have hepatitis B or C
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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): 35.0-80.0, Healthy Subjects Pharmacokinetics of ASP8232 Pharmacodynamics of ASP8232 Chronic Kidney Disease (CKD) Type 2 Diabetes Mellitus (T2DM) Main Part 1 Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable) Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 28 days (or 5 half-lives of the study drug whichever is longer) after final study drug administration Male subject must not donate sperm starting at screening and throughout the study period and for at least 90 days after final study drug administration Female subject must be either post-menopausal (defined as at least one year without any menses) prior to screening, or premenarchal prior to screening, or documented surgically sterile or status post hysterectomy (at least 1 month before screening), or if of childbearing potential, must have a negative urine pregnancy test at screening and must be using highly effective contraception. All females of childbearing potential will be required to use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and throughout the study period and for 28 days (or 5 half-lives of the study drug whichever is longer) after final study drug administration Female subject must not be lactating, and must not be breast feeding at screening or during the study period and for 28 days [or 5 half-lives of the study drug whichever is longer] after final study drug administration
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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, Diverticulitis Diverticulosis Diverticular Disease Groups A and B. Patients with acute diverticulitis patients presenting to A&E at King's College Hospital with new onset abdominal pain, with or without a known diagnosis of diverticulitis Groups C and D. Patients with asymptomatic diverticulosis and normal controls Patients being assessed through the 2ww Colorectal Cancer pathway with a chief complaint of fresh PR bleeding and no other 'red flag' symptoms, who are not overly anxious over their diagnosis as assessed by a physician outside the study team Groups A and B. Patients with acute diverticulitis Patients in extremis e.g. systolic blood pressure less than 80 on arrival or pulse greater than 115 Patients who have received antibiotics in the three months prior to presentation Vulnerable patient populations Groups C and D. Patients with asymptomatic diverticulosis and normal controls Patients with high levels of pre-test anxiety, as determined by their assessing physician, outside the study team Patients who received antibiotics for any reason in the 3 months prior to Vulnerable patient populations
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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 Acute pancreatitis Hospitalisation Adult patients Recurrent pancreatitis Chronic pancreatitis Outpatient follow up Loss of follow up within 3 months of discharge
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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): 10.0-30.0, Crohn's Disease All the subjects considered eligible for the study will be screened and reviewed by the Gastroenterology (GI) physicians prior to enrollment (Dedrick Moulton, MD or his designee at Vanderbilt Children's Hospital) 2. Age ≥ 10 and < 30 years 3. Disease status: 1. Confirmed diagnosis of Crohn's Disease: Diagnosis of Crohn's disease that has been established based on typical endoscopic/histologic and/or radiological appearances. 2. Active disease, defined as: Pediatric Crohn's Disease Activity Index (PCDAI) >30 (see Appendix I) or Crohn's Disease Activity Index (CDAI) of >250 (see Appendix II) at any time within 3 months prior to enrollment and any one of the following i. Endoscopic evidence of active disease confirmed on histology within 3 months prior to enrollment, or ii. Clear evidence of active small bowel Crohn's disease on small bowel imaging within 3 months prior to enrollment. 3. Refractory disease Moderate to severe disease that has been unresponsive to current or prior therapy with mercaptopurine and/or azathioprine (thiopurines), methotrexate and anti-TNF therapy. Patients should have relapsing disease (i.e. ≥ 1 exacerbation/year) or corticosteroid dependence despite current or prior thiopurines, methotrexate and anti-TNF maintenance therapy or clear demonstration of intolerance or toxicity to these drugs. Patients who fail induction therapy with corticosteroids and anti-TNF therapy, and are therefore not eligible to receive maintenance therapy with thiopurines or methotrexate will also be candidates for enrollment. 4. Negative stool culture, C. difficile, and negative CMV pcr (in stool or colonic biopsy). Patients with CMV colitis will receive a trial of anti-viral treatment and only responders will be considered eligible for inclusion. 5. Patients with a prior ileostomy or colostomy may enter the study. For this group of patients', physician's global assessment will be used to assess clinical activity of CD, as Pediatric CDAI and CDAI scoring method may not be representative of disease activity. 6. Patients with abscesses are eligible to enroll once the abscesses or any other significant infection has resolved Pregnancy or unwillingness to use adequate contraception during the study if a woman is of childbearing age. 2. HIV infection. 3. Organ function 1. Renal: creatinine clearance < 50 ml/min/1.73m2 (measured or estimated). 2. Cardiac: left ventricular ejection fraction <30% by multigated radionuclide angiography (MUGA) or a shortening fraction of < 25% by cardiac echocardiogram. 3. Pulmonary Function tests: DLCO < 30% or patient on oxygen. 4. Hepatic: serum bilirubin > 3 mg%; AST and ALT > 3x ULN for the institutional lab. 4. Uncontrolled Hypertension (using age based criteria) despite at least 2 anti- hypertensive agents. 5. Active Infection or risk thereof- 1. Current abscess or significant active infection 2. Perianal infection is not an criterion, provided there is drainage with or without placement of drain. 3. Abnormal chest x ray (CXR) consistent with active infection or neoplasm. 6. Severe diarrhea due to short small bowel; patients believed to have < 700 mm of small bowel and diarrhea attributable to this will be excluded. 7. Patients with toxic megacolon, active bowel obstruction or intestinal perforation. 8. Unable to collect minimum of 3 x106/kg CD34+ cell dose. These patients will be excluded from receiving the preparative regimen
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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, Advanced Malignant Solid Neoplasm ALK Positive Metastatic Pancreatic Adenocarcinoma Stage III Pancreatic Cancer Stage IV Pancreatic Cancer Arm 1: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine-based treatment is considered a clinically appropriate option Arm 2: histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic Arm 3: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine plus cisplatin treatment is considered a clinically appropriate option Arms 1E, 2E and 3E: solid tumor that demonstrate anaplastic lymphoma kinase (ALK) positivity; ALK positivity can be assessed using the assays below, and documentation of ALK positivity using one of the tests below is required Fluorescence in situ hybridization (FISH) test for ALK positivity using the Food and Drug Administration (FDA)-approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); OR Harboring a confirmed ALK positivity, as determined by positivity to the Ventana immunohistochemistry (IHC) assay Arms 1E: previously treated with and progressed on gemcitabine-containing therapy Arms 1, 2, 3: patients should have clinically measurable or evaluable malignant disease Arms 1E, 2E, 3E: patients with at least one measurable site of disease as defined by Response Evaluation in Solid Tumors (RECIST) version 1.1 that have not been previously irradiated Eastern Cooperative Oncology Group (ECOG) performance status =< 1 Arms 2, 2E, 3, 3E: patients who previously received > 2 lines of systemic chemotherapy for advanced or metastatic disease Previous pelvic radiation affecting >= 25% of the bone marrow; patients who received whole pelvic radiation are excluded Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy and radiation) =< 4 weeks prior to starting study drug Patients who have received the last administration of nitrosourea or mitomycin-C =< 6 weeks prior to starting study drug Patients who have had radiotherapy =< 4 weeks prior to starting study drug, or =< 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture) Patients who have received targeted therapy (e.g., sunitinib, sorafenib, pazopanib), except ALK inhibitors, =< 2 weeks prior to starting study drug Patients who have residual toxicity(-ities) from previous anti-cancer treatment(s) that is/are clinically significant or > grade 1 are excluded; those whose toxicity(-ities) improved to grade 1 or better will be eligible The patient is less than 5 half-lives from prior ALK inhibitor or targeted therapy (for adequate wash-out) without recovery from treatment toxicities to < grade 1 or to their pre-treatment levels Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury =< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device =< 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
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