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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, Diabetes Mellitus Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Male or female aged 18-65 years (both inclusive) T2DM diagnosis Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics Use of GLP-1 mimetics or DPP-IV inhibitors Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%
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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, Tobacco Use Disorder Male or Female Ages 18-70 Past-year major depressive disorder, dysthymic disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobia, or panic disorder with or without agoraphobia, based on MINI structured interview, OR lifetime diagnosis of one of the above based on MINI with a self-report of currently receiving treatment (prescribed psychoactive medication, behavioral therapy, etc.) Report smoking 5 or more cigarettes per day for the past year Provide an intake breath CO sample > 8 ppm Be without current substance abuse/dependence other than nicotine Be sufficiently literate to complete the research-related tasks Be in good physical health without serious illness or change in health in the past 3 months as determined by the licensed medical professional at each site Not pregnant or nursing and report using oral, implant, patch, ring, IUD, injection or barrier contraceptives or report being surgically sterile or post-menopausal Report no significant use of other tobacco or nicotine products within the past month (> 9 days in the past 30) Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content) Exclusive use of roll-your-own cigarettes Planning to quit smoking in the next 30 days A quit attempt in the past 30 days resulting in > 3 days of abstinence Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once) Breath alcohol level > 0.01 (participants with a positive screen will be allowed to re-screen once) Self-report of binge drinking alcohol (> 9 days in the past 30, 4/5 drinks in 2 hours for women/men Systolic blood pressure below 90 mmHg or greater than or equal to 160 mmHg (participants outside the range will be allowed to re-screen once) Diastolic blood pressure below 50 mmHg or greater than or equal to 100 mmHg (participants outside the range will be allowed to re-screen once) Breath CO > 80 ppm
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 30.0-75.0, Alcohol Use Disorder (AUD) -All Participants 1. Between 30 and 75 years of age. 2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those giving the informed consent. 3. Females: Negative urine pregnancy test and not currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy); or not sexually active with a male partner and able to get pregnant; or documented agreement to use an effective form of birth control. Acceptable forms of contraception hormonal contraceptives (birth-control pills, injectable hormones, vaginal-ring hormones); IUD; diaphragm with spermicide; condom with spermicide. -Specific For AD Participants 4. DSM-IV diagnosis of alcohol dependence or alcohol abuse or DSM-5 diagnosis of moderate or severe alcohol use disorder (established through history and clinical exam). We subjects that drink high doses of alcohol since alcohol's detrimental effects are greater with larger doses and particularly with binge drinking. 5. Participants seeking treatment for their AD as well as those not seeking treatment for their AD will be included. 6. Minimum 5 year history of heavy drinking (self-report). 7. Must consume at least 20 alcoholic drinks per week (male) or 15 per week (female) (self-report). 8. Must have had the last drinking episode (females 3 or more drinks; and males 4 or more drinks) within 1 week of baseline PET scan (self-report). 9. Alcohol specified as the preferred drug (self-report) All Participants 1. Unwilling or unable to refrain from use within 24 hours of scheduled study procedures: psychoactive medications or medication that may affect study results (e.g., analgesics [non narcotic], antibiotics (must finish course at least 24 hours prior to a scheduled procedure), antidiarrheal preparations, anti-inflammatory drugs (systemic corticosteroids are exclusionary), antinauseants, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted as long as they have been taken for at least 1 month before procedure visits and dose has been stabilized. The use of benzodiazepines such as alprazolam (( )Xanax), diazepam (( )Valium) and lorazepam (( )Ativan), will not participants from this study. 2. Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder (other than alcohol in AD participants and nicotine/caffeine use disorders) that required hospitalization (any length), or chronic medication management (more than 4 weeks) and that could impact brain function at the time of the study as determined by history and clinical exam. The following chronically used medications are exclusionary from the study: analgesics containing narcotics; anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives; anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antipsychotics; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); anxiolytics; cough/cold preparations (dextromethorphan preparations, pseudoephedrine); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics. Note that nicotine and/or caffeine use will not participants. 3. Major medical problems that can permanently impact brain function (e.g., CNS, cardiovascular, metabolic, autoimmune, endocrine) as determined by history and clinical exam. 4. Any clinically significant laboratory finding as determined during the screening procedures that could impact brain function or study procedures (evidenced from clinical laboratory results). 5. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that with the exposure from this study, would exceed NIH annual research limits (self-report, medical history) 6. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history); 7. Positive test for alcohol on the day of the PET, the MRI or the NP tests (clinical laboratory results). 8. Urine positive for psychoactive drugs (clinical laboratory results) on study days involving imaging (PET and MRI) and neuropsychological testing. 9. Pregnant or breast feeding (self-report) 10. History of coagulation disorder (clinical laboratory results, medical history) 11. Have a history of allergic reaction to lidocaine (self-report, medical history) 12. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist). 13. Cannot lie comfortably flat on your back for up to 2 hours in the PET and MRI scanners (self-report). 14. Body weight > 250 kg. The MR scanner bed is tested to a weight limit of 250 kg (~550 lbs). 15. Have a positive HIV test (clinical laboratory results, medical history). 16. Homozygosity for the rs6971 polymorphism on TSPO that results in LB (Owen et al 2011) (genotyping results). 17. NIH employees who meet as AD subjects. Although we will NIH employees as healthy volunteers, study investigators and their superiors, subordinates and immediate family members (adults children, spouses, parents, siblings) will be excluded FOR Consumption of moderate to high levels of alcohol. That includes if female, currently (within past 6 months) consuming more than 2 drinks on a given episode and if male, consuming more than 3 drinks on a given episode; and/or consuming if female, more than a total of 7 drinks a week or if male, more than 10 drinks a week (self-report)
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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 Pain Written Informed Consent given by the patient 2. Male and female patients aging from 18 to 70 3. Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months 4. The pain intensity score upon screening is at least 4 cm in VAS score Patients with the following concomitant disease were not eligible for enrolment Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms Pain related with malignancy Patients with other severe pain states of organic origin Mechanical stenosis of the gastrointestinal tract, megacolon Urinary retention associated with mechanical stenosis of urinary tract Narrow-angled glaucoma Tachyarrhythmia Myasthenia gravis Meulengracht-Gilbert syndrome
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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): 45.0-999.0, Healthy Volunteers For new or healthy volunteers currently participating in an NIH trial: no CT scan in the last year OR For patients enrolled in a treatment or interventional trial at the NIH: no CT scan in the last 6 months Lab parameters For CT and MRI contrast enhanced scans: ---eGFR greater than or equal to 60 mL/min/1.73m(2) within 7 days prior to scanning For female participants ages 45-60 within 3 days prior to scan (unless post-menopausal or no longer able to bear children, note exemption on initial visit) Pregnancy test result(blood or urine): Negative Willing to travel to the NIH for follow-up visits Greater than or equal to 45 years old Able to understand and sign informed consent Stable clinical status Volunteer indicates no history of participation in NIH protocols using research radiation in the last 12 months (e.g. PET research scans, NCI Molecular Imaging Center PET scans, etc) Prior CT scan in the last 12 months for new volunteers or healthy volunteers enrolled in NIH trials OR Prior CT scan in the last 6 months for patients enrolled in a treatment or interventional trial Pregnant women Over 500 lbs and/or a body circumference that prevents the study subject from lying flat in the scanner Claustrophobia requiring sedation or anesthesia Known or suspected genetic predisposition to cancer Any contraindications that the research team identifies from the subject, radiology department CT and/or MRI questionnaires, and/or History and Assessment. for participation for iodinated contrast for CT (Inclusive of the above Allergy to iodinated contrast for scans (study subject will be eligible for non-contrast scans) Acute renal failure, renal transplant, dialysis and renal failure (clinically diagnosed).<TAB> Lactating women Patient preference to not undergo intravenous line placement and/or receive iodinated contrast. Contrast administration is optional and participants may still undergo a non-contrast 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): 21.0-65.0, Type 2 Diabetes Mellitus Part 1 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Not diabetic and has a fasting plasma glucose (FPG) between 70 mg/dL and 105 mg/dL, inclusive. 4. Good health with no significant concomitant pathology based on medical history, physical examination, electrocardiogram (ECG), routine laboratory tests (chemistry, hematology, lipid profile, international normalized ratio, and urinalysis), and vital signs. Part 2 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Has T2DM according to American Diabetes Association criteria. 4. Currently on stable metformin therapy (unchanged dose for greater than or equal to 12 weeks prior to screening). At the discretion of the investigator, subjects who are drug naïve or whose metformin dose has not been stable for at least 12 weeks at screening, may be started on metformin or have their metformin dose stabilized. Following 12 weeks of stable metformin, they may undergo re screening including assessment of HbA1c and FPG (inclusion 5 and 6). 5. Has an HbA1c level between 6.5% and 10.5% at screening. One retest is permitted. 6. Venous FPG is 125 mg/dL and 260 mg/dL at screening and either the Day -1 venous FPG or the Day 1 capillary blood glucose (CBG) is 115 mg/dL and 260 mg/dL. One retest is permitted. 7. Has a body mass index between 20 and 45 kg/m2, inclusive Part 1 1. Has a recent history of drug and/or alcohol abuse. 2. Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions as specified in the protocol. 3. Unwilling to comply with restrictions on strenuous exercise as specified in the protocol. 4. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 5. Has liver transaminase levels (aspartate transaminase [AST] or alanine transaminase [ALT]) >10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels >2 × ULN at screening or admission to clinic (Day -1). 6. Has a plasma triglyceride level >400 mg/dL. If triglyceride level is between 400 mg/dL and 500 mg/dL. 7. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. 8. Is taking prescription or non-prescription drugs, vitamins, herbal, and dietary supplements, within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or is unwilling to refrain from taking any such medication until after the last protocol-specified blood sample. The use of acetaminophen, not to exceed a total daily dose of 1 g, is permitted up to 24 hours prior to admission to the investigational site and then prohibited until after the last protocol-specified blood sample. The use of stable hormone replacement medication by women, topical steroids, and stable thyroid medication is permitted. Part 2 1. Has a history of hypoglycemic unawareness or recurrent hypoglycemia requiring assistance. 2. Has liver transaminase levels (AST or ALT) >10% × ULN, or has CK levels >1.5 × ULN at screening or admission to clinic (Day -1). 3. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 4. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. One retest of blood pressure within 24 hours is permissible at the discretion of the Investigator. Therapy for hypertension (beta blockers excluded) that has been stable for at least one month prior to screening is permitted. At the Investigator's discretion, one anti-hypertensive medication (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, hydrochlorothiazide, or dihydropyridine calcium-channel blocker) may be initiated, or the dosage of a current antihypertensive medication up titrated, in a subject with blood pressure slightly above the criterion at screening. After at least 4 weeks of stable blood pressure treatment, if the subject's blood pressure has decreased to within the 140/90 mmHg limit, the subject will be fully reassessed for eligibility. 5. Has received insulin for more than 6 consecutive days within 6 months prior to screening or has received insulin within 3 months prior to screening. 6. Has been treated with peroxisome proliferator-activated receptor gamma agonist, incretin therapy, amylin mimetics, or sodium-glucose linked transporter-2 inhibitor therapy within 12 weeks prior to screening; treatment with other diabetic medications (excluding metformin) within 3 weeks prior to screening. 7. Is taking concomitant medications. At least 3 months of stable therapy for thyroid replacement and hypercholesterolemia (gemfibrozil, Welchol, and cholestyramine are not permitted) and at least 4 weeks of stable hypertension medications (as described above) and low dose aspirin are permitted
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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, Radiodermatitis Being an adult, over the age of 18 years old; Owning diagnosis of breast or head and neck cancer; Being first referred to the radiotherapy protocol; Presenting radiodermatitis grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae or Compositae family or Urea; Demonstrate understanding to continue the intervention in their home environment when necessary Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis
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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, Post-ERCP Acute Pancreatitis Pancreatic Duct Stricture Pancreatic Duct Stones Pancreatic Duct Leakage Subjects age 18 or older. 2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques. 3. Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study. 4. Subjects satisfying at least one of the following clinical presentations: 1. high risk of acute pancreatitis post ERCP 2. impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery 3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak 4. need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy Subjects for whom endoscopic techniques are contraindicated. 2. Subjects with known sensitivity to any components of the stents or delivery systems. 3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice 4. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 5. Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome
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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, Myelodysplastic Syndromes Completion of the treatment period in the base study A536-03 (ClinicalTrials.gov Identifier: NCT01749514) Adequate birth control measures Patient is able to adhere to the study visit schedule, understand and comply with all protocol requirements Patient understands and is able to provide written informed consent. In addition, patients with treatment interruption (defined as patients who complete their end-of-study visit in A536-03 and cannot directly roll over to A536-05) must also meet the following Documented diagnosis of idiopathic/de novo MDS or non-proliferative chronic myelomonocytic leukemia (CMML) according to the World Health Organization (WHO) 2 (white blood count (WBC) < 13,000/μL) that meets International Prognostic Scoring System (IPSS) classification (Appendix 2) of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC) obtained during screening Anemia defined as Mean hemoglobin concentration < 10.0 g/dL of 2 measurements (one performed within one day prior to Cycle 1 Day 1 and the other performed 7-28 days prior to Cycle 1 Day 1), for non-transfusion dependent (NTD) patients (defined as having received ˂ 4 units of red blood cells (RBCs) within 8 weeks prior to Cycle 1 Day 1), OR Transfusion Dependent (TD), defined as having received ≥ 4 units of RBCs within 8 weeks prior to Cycle 1 Day 1 Platelet count ≥ 30 x 109/L Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia) Discontinuation/withdrawal from the base study A536-03 (due to patient request, patient unwillingness or inability to comply with the protocol, pregnancy, use of prohibited medication [e.g. azacitidine], medical reason or adverse event (AE), hypersensitivity reaction to the study drug, at the discretion of the sponsor, or loss to follow-up) prior to completion of the treatment period Prior treatment with azacitidine or decitabine Treatment within 28 days prior to Cycle 1 Day 1 with an erythropoiesis-stimulating agent (ESA) Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF) Lenalidomide Iron chelation therapy if initiated within 56 days prior to Cycle 1 Day 1 Treatment with another investigational drug (including sotatercept [ACE-011]) or device, or approved therapy for investigational use ≤ 28 days prior to Cycle 1 Day 1, or if the half-life of the previous investigational product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer Major surgery within 28 days prior to Cycle 1 Day 1. Patients must have completely recovered from any previous surgery prior to Cycle 1 Day 1 Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B (HBV) or active infectious hepatitis C (HCV)
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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, Alcohol Withdrawal Alcohol Dependence for the inpatient phase (alcohol withdrawal treatment) of the study 1. Meeting for DSM-IV (Diagnostic and Statistical Manual-IV-TR) alcohol dependence. *2. At least one prior episode of DSM-IV alcohol withdrawal as assessed by SCID Alcohol Dependence Module or scoring > 6 on the CIWA scale since admission to the inpatient unit, or having any of the following elevated vital signs since admission: pulse > 110; diastolic blood pressure > 100; systolic blood pressure > 160. 3. At least 12 heavy drinking days in the 28 days prior to enrollment in the study. A heavy drinking day is defined as >5 standard drinks for men or >4 standard drinks for women. 4. Women who are able to conceive children must be on an effective form of birth control such as oral contraceptives, intrauterine devices or the use of condoms with spermicide. 5. Competency to give valid informed consent as indicated by a) a breathalyzer reading at the time the consent form is signed showing an estimated blood alcohol level (BAL) <.08 gm/dL (the consent process is repeated when the BAL level has dropped to 0.00 gm/dL) and b) ability to understand the written informed consent form demonstrated by correctly answering questions about the contents of the form after reading the consent form without help (this will also determine whether prospective subjects can read and understand the study questionnaires). 6. Ability to get to appointments either through personal or public transportation for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same as those listed above for the inpatient phase of the study apply except for the marked with an asterisk for the outpatient phase of the study for prospective subjects recruited from the community and screened during an initial outpatient clinic visit The same as those listed above for the inpatient alcohol withdrawal treatment phase of the study apply except for having a previous history of alcohol withdrawal (inclusion criterion #2) for the inpatient alcohol withdrawal treatment phase of the study History of alcohol withdrawal-related seizures, delirium tremens or hallucinations. 2. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder). Clinically significant psychiatric illnesses including any psychotic disorder, bipolar disorder, eating disorder, severe depression, or suicidal ideation. 3. Other substance dependence disorder with the exceptions of nicotine or caffeine. Substance abuse disorders are not exclusionary Chronic or subchronic ( >3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants Receipt of >6 mg of lorazepam or any dose of a long half-life benzodiazepine between admission for medical detoxification and beginning participation in the study (i.e., receiving the first intranasal dose of test treatment). 6. AST or ALT (liver function tests) > 5 times ULN (upper level of normal), bilirubin (liver function test) > 1.5 X ULN, sodium < 132 or > 150 mMol/L, potassium < 3.2 or > 5.3 mMol/L. 7. Women who are pregnant or breastfeeding. 8. Intent to participate in an additional alcohol treatment program other than Alcoholics Anonymous 9. Court-mandated participation in alcohol treatment or pending incarceration for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same as those listed above for the inpatient phase of the study apply except for the marked with an asterisk
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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, Prebiotics Effect Stable weight (+/ kg) for the last 3 months Body Mass Index (BMI) between 18.5 and 27 kg/m² Consuming between 13 and 18 g of dietary fiber a day Student on campus at the Institut Polytechnique LaSalle Beauvais Informed consent form signed Able to follow the requirement of the study Have a social security Has a serious pathology Has a gastrointestinal, vesicular or pancreatic disease Took an antibiotic or a laxative treatment in the last 6 months Surgery of the gastrointestinal tract in the last 12 months Orange juice intolerance Chronic or recurring diarrhea, constipation or abdominal pain Taking drugs known to have an effect on the gastrointestinal, pancreatic and vesicular function Recent gastroenteritis or foodborne illness Diabetes Consuming regularly of probiotics
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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): 45.0-999.0, Ovarian Neoplasms Sign an approved informed consent form (ICF). 2. Be ≥ 45 years of age. 3. Have at least one symptom outlined in below for a period of ≥2 weeks but ≤ 1 year Feeling full after eating only a few bites, loss of appetite Diarrhea, constipation, bowel or rectum feels full, change in bowel habits, constant urge to have a bowel movement, painful or burning bowel movements, rectal pain, painful defecation Bloating, distension of abdomen, clothes around the waist feel too tight, feel an abdominal mass Weight loss not because of dieting Nausea, vomiting, heartburn, gas, burping, indigestion Increased urinary frequency, need to urinate urgently, pressure on the bladder, leaking urine, burning sensation when urinating, need to urinate but unable to do so, unable to empty bladder completely, feeling full after urinating Vaginal discharge, bleeding, spotting, deep pain on intercourse Discomfort or pain in abdomen, or pelvic region, or lower back 4. Subjects must be willing to comply with study protocol Previous bilateral salpingo-oophorectomy (BSO) 2. Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum 3. Current bleeding per rectum, not due to haemorrhoids 4. Current frank haematuria 5. Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Cigarette Smoking Age 18+ 2. Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days. 3. Breath CO levels > or = 10 ppm (if < 10 ppm, then NicAlert Strip = 6) 4. Fulfills need for participants in the required strata (menthol status) Intention to quit smoking in the next 30 days 2. Currently seeking treatment for smoking cessation 3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable) 4. Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional. 5. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence 6. Using other tobacco products more than 9 days in the past 30 days 7. 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) 8. Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional) 9. Schizophrenia and schizoaffective disorder 10. Positive toxicology screen for any of the following drugs: marijuana, cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP Participants with valid prescriptions for any toxicology results will not be excluded. 11. Breath alcohol level > 0.01 12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male)) 13. Pregnant, trying to become pregnant or breastfeeding 14. Smoking 'roll your own cigarettes' exclusively 15. Currently taking any one of the following medications Phenytoin [Brand Name: Dilantin] Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol] Oxcarbazepine [Brand Name: Trileptal] Primidone [Brand Name: Mysoline] Phenobarbital Bendamustine [Brand Name: Treanda] Clopidogrel [Brand Name: Plavix] Clozapine [Brand Name: Clozaril, FazaClo]
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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, Leukocytosis Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System none
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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, Pancreatitis Pancreatic Neoplasms Metabolic Diseases Hypertension, Portal Respiratory Failure Quality of Life Clinical diagnosis of acute pancreatitis from our hospital Must be signed the informed consent Failed to complete the questionnaire survey and the follow-up examination
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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): 21.0-65.0, Alcohol Dependence Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
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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, Pancreatic Cyst A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated. 2. Pancreatic cystic tumour between 0.5 and 3cm in size. Cysts greater than 3cm or with mural nodules can be included only if patients are unsuitable for surgical resection. 3. ECOG performance status 0, 1 or 2. 4. Estimated life expectancy of at least 12 weeks. 5. Age >18 years. 6. Capable of giving written informed consent. 7. Women of child-bearing potential must have a negative pregnancy test (qualitative serum hCG) in the week before treatment, AND be using an adequate contraception method, which must be continued for at least 1 week after RF A diagnosis of a pancreatic cystic tumour where surgical resection is indicated. 2. Pancreatic cysts greater than 3cm or less than 0.5cm in size. 3. Benign pancreatic cysts (e.g. pseudocyst). 4. Serous cystadenomas. 5. Pancreatic cysts with malignant transformation. 6. Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures. 7. Cysts arising from the main pancreatic duct. 8. History of active or prior malignancy that will interfere with the response evaluation (exceptions in-situ carcinoma of the cervix treated by cone-biopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously). 9. Acute pancreatitis within the previous 4 weeks. 10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial. 11. Any psychiatric disorder making reliable informed consent impossible. 12. Pregnancy or breast-feeding. 13. ECOG performance status 3 or 4
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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, Psoriatic Arthritis Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) Men must agree to use a reliable method of birth control or remain abstinent during the study Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs) Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance Current use of biologic agents for treatment of Ps or PsA Inadequate response to greater than 2 biologic DMARDs Current use of more than one cDMARDs Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy Serious disorder or illness other than psoriatic arthritis Serious infection within the last 3 months Breastfeeding or nursing (lactating) 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): 8.0-21.0, Drug Distribution Children 8-21 years of age 2. LDL cholesterol >130mg/dl (>95% percentile) 3. Successfully genotyped for SLCO1B1 4. Willing to sign the assent/permission/consent form Underlying structural heart disease including congenital heart disease or acquired heart disease. 2. History or laboratory evidence of an underlying intestinal, metabolic, autoimmune, or renal disease that could alter the disposition of simvastatin or pravastatin. 3. Underlying pathology of the gastrointestinal tract or recent surgery which would be expected to alter the rate and/or extent of drug absorption 4. Evidence of previous hypersensitivity to statin medications 5. Unwillingness or inability to have screening labs drawn 6. Refusal to participate in the study 7. Unwillingness or inability to participate in an overnight fast 8. Subjects taking drugs with interactions with statins (CYP3A4 inducers/inhibitors, OATP1B1 inducers/inhibitors) 9. Inability to swallow a tablet drug 10. For females, a positive urine beta-human chorionic gonadotropin pregnancy test result 11. Evidence of hepatic abnormality as determined by values > 3 times the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin, serum albumin, Alkaline Phosphatase, and GGT. 12. Abnormal red blood cell morphology and/or a hemoglobin less than 9 gm/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): 18.0-60.0, Healthy All subjects must comply with all the following Having respected dietary restrictions 2 days before the visit Having obtained his/her or his/her legal representative's informed consent Subjects representing one or more of the following are excluded from participation in the study Pregnancy as per precaution principal to avoid risks linked to X-ray exposure Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study Any therapy (contraception apart) within the 2 days before the visit day Subject who cannot be expected to comply with measures Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Hepatic Encephalopathy Patients aged between 18 and 65 years of either gender Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West Haven Criteria) HE Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or 4 (West Haven Criteria) HE Patients treated with agents other than lactulose retention enema for grade 3 or 4 (West Haven Criteria) HE Patients who had significant concomitant diseases that could impair or contribute to the impairment of consciousness Patients who had a major neuropsychiatric illness Patients who had a contraindication to lactulose, including Hypersensitivity to the active substance or to any of the ingredients; Galactosaemia; Gastrointestinal obstruction, digestive perforation or risk of digestive perforation
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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, Fasting Diet Biosensing Techniques Awake and alert Not on a regular diet No mild to moderate acute pancreatitis No obstructed bowel not amenable to feeding tube placement beyond the obstruction No massive GI hemorrhage No impending or established toxic megacolon No colonic perforation No severe dysmotility making enteral feeding not possible No high output intestinal fistula Able to access the gut for enteral feeding Not awake and alert On regular diet Mild to moderate acute pancreatitis Obstructed bowel not amenable to feeding tube placement beyond the obstruction Massive GI hemorrhage Impending or established toxic megacolon Bowel perforation Severe dysmotility making enteral feeding impossible High output intestinal fistula Unable to access the gut for enteral feeding
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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 Abdominal Pain Presentation at ED with acute abdominal pain, aged at least 18 years No informed consent, pregnancy, homeless, no social assurance
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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): 18.0-70.0, Crohn Disease Colitis, Ulcerative Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy N/A
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Volunteers We are targeting healthy men and women greater than or equal to 18 years old, inclusive of all races and ethnicity within a BMI of 20 30 kg/m(2). Specifically, we have defined healthy to mean: normal fasting glucose and hemoglobin A1c less than or equal to 6%, normal Hb, no glucosuria, normal renal function (based on normal serum creatinine + Cystatin C), urine albumin:creatinine ratio, protein:creatinine ratio, and GFR > 80 as calculated by the CKD-Epi equation and normal lab urinalysis If you have any of the following health issues, you cannot participate in the study Presence of heart disease, untreated high blood pressure (>140/90 mm Hg), orthostatic hypotension or symptomatic hypotension, cancer, diabetes, recurrent symptomatic hypoglycemia and /or history of recurrent genital or urinary tract infection, thyroid disease, or any other condition that affects bone health Past history of eating disorder or psychiatric disorders, including severe depression, anxiety, or psychosis or presently on treatment with medications for any of these conditions Taking certain medications, especially those that affect bone metabolism (e.g., high dose vitamin D [>1000 units daily] or calcium supplements [>800mg daily], high dose vitamin A [>20,000 units daily], phosphate binding antacids, calcitonin, calcitriol, growth hormone, or any anti-seizure medications for any reason including valproic acid, lamotrigine), certain medications for high blood pressure (diuretics), steroids including inhalers, diet/weight loss medications, or any other medications at the discretion of the principal investigator and/or study team Have started, increased or decreased calcium [>400mg daily] or vitamin D [>1000 units daily] supplements within 2 weeks of the study Dependence or regular use of alcohol (>2 drinks per day), tobacco (smoking or chewing), amphetamines, cocaine, heroin or marijuana over the past 6 months Volunteers will be excluded if they have abnormal blood concentrations of inorganic phosphate level (less than or equal to 2.5 mg/dl or greater than or equal to 4.8 mg/dl) parathyroid hormone (PTH) (less than or equal to 60 pg/ml) creatinine (less than or equal to 1.5 mg/dl) or eGFR (< 80 ml/min/1.73sq.m)
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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 diagnosis of acute pancreatitis; must meet at least 2 out of the 3 following critiera: 1. abdominal pain consistent with acute pancreatitis 2. serum amylase/lipase >3 times upper limit of normal 3. characteristic findings from abdominal imaging able to provide informed consent unable to provide consent transfer patients cognitive inability to follow directions to maintain sensors in place unable to place abdominal sensors on patients abdominal cellulitis pregnant women
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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): 18.0-65.0, Morbid Obesity Group A: non obese individuals (Body Mass Index; BMI < 30 Kg/m2) Group B: Fulfilling the National Health Institute (NHI) for bariatric surgery (BMI higher than 40 Kg/m2 or 35 Kg/m2 when related comorbidities) Group C: Previous morbidly obese individuals who had had a sleeve gastrectomy at least 6 months ago Group A: previous gastric surgery or gallbladder removal. Group B: previous gastric surgery or gallbladder removal. Group C: previous gallbladder removal
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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): 21.0-65.0, Tobacco Smoking Behavior Age 21-65 Smoke 10 cigarettes/day or more for at least one year Read and write in English Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes Able to understand and provide consent to study procedures Plan to live in the local area for the next month Women not pregnant or nursing and taking steps to avoid pregnancy No quit attempt in the last one months and not planning to quit in the next month Currently pregnant or nursing Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana) Currently reducing or planning to reduce cigarette consumption in the next month Use of smoking cessation medicine in the past 3 months History of difficulties providing blood samples: fainting, poor veins, anxiety, etc Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate) Significant medical condition, i.e. stroke, MI, cancer, in the last month Currently using illegal 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, Gastroparesis Patients must have gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying Patients may have been or currently on therapy for their gastroparesis including metoclopramide, domperidone, macrolide antibiotics, sapropterin dihydrochloride, or pyloric botox injections can be included Patients who have undergone placement of electrical gastric stimulator >6 months after enrollment can be included Patients with suspected mechanical obstruction resulting in delayed gastric emptying, patients chronically using narcotics (>3 times per week) Patients who have undergone placement of gastric electrical stimulation device within 6 months of enrollment Patients with any history of small bowel obstruction and major abdominal surgeries (excluding appendectomy, cholecystectomy, Nissen fundoplication, or pelvic surgeries)
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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, Obesity Diabetes Type 2 Age > 18 years of age Subjects without diabetes with BMI 23-37 Patients with Type 2 diabetes and diabetes duration between 0.5-12 years and BMI 25-37 BMI below 23 Waist circumference 80 cm or less for women and 94 cm or less than for men Total fat percent of body weight less than 23% Treatment with insulin and sulfonylurea drugs Chronic kidneys disease (CKD) stage 4 and 5 (eGFR <30 ml/min) Pregnancy and breast-feed Active athletes History of eating disorder Participation in another ongoing study If participant is not eligible to complete the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Alcoholic Hepatitis Alcoholic hepatitis Jaundice < 3 months Bilirubin > 5 mg/dl PTI (INR) Increased: >1.4 Leucocytosis >> 11,000/micro L. AST< 300 IU/l ; AST/ALT >2 2. Hepatic Encephalopathy 3. Men and women age > 18 years and above 4. DF>32 5. MELD≥21 6. Actively consuming alcohol within 6 weeks of entry into the study 7. Patient with controlled upper GI bleed, resolved sepsis and acute kidney injury can be enrolled 8. Voluntary informed consent Failure to obtain informed consent 2. Jaundice more than 3 months 3. AST>500 IU/L, ALT>300 IU/L 4. Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease 5. HIV positive 6. Cow milk allergy or severe lactose intolerance 7. Active Gastrointestinal bleeding 8. Acute kidney injury at time of randomization with Creatinine> 1.5 mg/dL 9. Evidence of acute pancreatitis or biliary obstruction 10. Subjects who are pregnant or lactating 11. Significant systemic cardio-pulmonary illness (what if on ventilator for HE or respiratory failure) These are terminally ill patients, hence be excluded 12. Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization 13. Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week. 14. Any patient who has received any investigational drug or device within 30 days entering into the study. 15. Patient who withdraw 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): 0.0-999.0, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft
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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, End Stage Renal Failure on Dialysis Participants will be selected from the Vancouver Community Dialysis Unit. The for participant selection will be: 1. Dialysing for greater than six months to ensure access patency, viability, and stability; 2. Undergoing thrice weekly, four-hour dialysis sessions for uniform dialysis duration; 3. Dialysing with an arteriovenous fistula, either brachio-cephalic or radio-cephalic, to control variances in blood flow rates related to vascular access; 4. Dialysing with 15g needles as organization policy restricts greater flow rates with smaller needle gauge; 5. Dialysing with a dialysate flow (Qd) of 500 mL/min to reduce the possibility of clearance being attributable to differences in Qd; 6. Maintaining transonic vascular access flows of >600 mL/min for the past 6 months, per Kidney Dialysis Outcomes Quality Initiative (KDOQI) (NKF, 2006) minimum flow guidelines, to ensure access patency Patients who speak a language other than English, Cantonese, Mandarin, or Punjabi will be excluded due to funding constraints for providing translated informed consent documents. Informed consent documents will only be available in the languages listed above, which are the most common languages spoken/read at the dialysis unit. Patients who dialyse with a central venous catheter, arteriovenous graft, or femoral arteriovenous fistula will not be invited to participate due to potential confounding from known differences in access flows and vessel quality that may impact clearance values. Patients who are involved in any other research study that would interfere with their dialysis treatment would be excluded from the study. Patients who are hemodynamically unstable (e.g.: frequent 'crashing' due to severe hypotension) will be excluded due to the instability this would pose on achieving their prescribed dialysis time (e.g.: if they crash, they may be taken off dialysis early) and resulting data
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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, Postpartum Haemorrhage Parturients aged more than 18 years old 2. American Society of Anesthesiologists (ASA) physical status class 1 to 3 3. Parturients planned for caesarean sections (both emergency and elective) under regional anaesthesia 4. Parturients who have increased risks of bleeding during caesarean deliveries as follows: Moderate Risk for Bleeding Induction of labour Prolonged labour >12 hours Large baby > 4kg Pyrexia in labour Age > 40 years (not multiparous) Obesity (BMI >35) Anaemia (Hb < 9g/dl) Multigravida Previous history of PPH Parturients who have an urgent/emergency indication for caesarean sections where timing of the operation may be critical in determining the maternal and/or foetal outcomes 2. Patients who are planned for caesarean sections under general anaesthesia 3. Patients who are already clinically bleeding prior to surgery 4. Parturients who received blood transfusion within 48 hours prior to the caesarean section 5. Patients with known allergy to tranexamic acid 6. Patients with clear contraindications for tranexamic acid (e.g. thromboembolic event, history of convulsions) 7. Patients with severe renal failure with creatinine clearance <10
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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, Diabetes Mellitus, Type 2 Between 18 and 65 years of age Healthy Have venous access sufficient to allow for intravenous (IV) infusion and blood sampling as per protocol Subject's body mass index (BMI) is >=18 kilogram (kg)/meter(m)^2 and <=30 kg/m^2 Male or Female: if she is not pregnant (as confirmed by a test at screening and at other timepoints), not lactating, and at least one of the following conditions applies: a) cannot bear children OR b) agrees to follow contraception requirements defined in the protocol Capable of giving signed informed consent Alanine aminotransferase (ALT) >1.5x Upper limit of normal (ULN) Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Current or chronic history of liver disease, or known hepatic or biliary abnormalities QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 milliseconds (msec) Systolic blood pressure is >=140 millimetre (mm) mercury (Hg) at Screening Diastolic blood pressure is >=90 mm Hg at Screening Heart rate is >100 beats/min at Screening Fasting triglyceride level >300 milligram/decilitre at Screening History of cholecystitis or other gallbladder disease History of gallstones, biliary motility dysfunction, or any condition rendering the subject unsuitable for ultrasonography assessments
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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, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey
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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, Cystic Fibrosis Parents of adolescents (aged 11 to 16) with Cystic Fibrosis Self reported difficulties with their child's treatment adherence Families already receiving psychological support from specialist Cystic Fibrosis clinical psychologists Parents requiring reading assistance who do not have anyone to help them Families where the parent/ child is currently being treated for a mental health difficulty
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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): 35.0-60.0, Type 2 Diabetes Overweight Obesity Masked Hypertension Male or female, age between 35-60 years old 2. Type 2 diabetes 3. 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female 4. Grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmHg, night time blood pressure load 50%≥125/75 mmHg or 24h blood pressure load 50%≥130/80 mmHg） Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications. 2. Type 1 diabetes. 3. Diagnosed moderate to severe sleep apnea syndrome(SAS). 4. Grade 2 or Grade 3 hypertension. 5. Triglyceride≥5.65mmol/L 6. History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. 7. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. 8. Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. 9. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia. 10. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. 11. Fertile woman without contraceptives. 12. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs. 13. Allergic to or have contraindication to the intervention 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, Low Back Pain additional for asymptomatic healthy adults no existing LBP and no LBP in the past year additional for patient participants existing LBP near the L5-S1 level with an average pain intensity score ≥ 2/10 (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain) previous low back surgery systemic joint disease (e.g. rheumatoid arthritis) cancer of the lower quadrant neurological disorders allergic reaction to ultrasound gel, or inability to obtain testing positions (prone lying)
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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, Athletes Healthy The subject must have given his/her informed and signed consent The subject must be insured or beneficiary of a health insurance plan The subject is participating in the 2015 Mont-Blanc Ultra Trail and has no contra-indication for ultra-trail activities The subject is participating in another study The subject is in an period determined by a previous study The subject is under judicial protection, under tutorship or curatorship The subject refuses to sign the consent It is impossible to correctly inform the subject The subject is pregnant or breastfeeding The subject will be excluded from the study in case of early drop out (before 15 km of trail)
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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, Cirrhosis Patients who develop new onset feed intolerance to enteral nutrition Any patient with current or past surgical abdomen including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery. 2. Patients receiving enteral nutrition through gastrostomy or jejunostomy. 3. Patients in whom, prokinetics are contraindicated or are allergic to the same. 4. Patients who received prokinetic more than one day prior to the start of enteral feeding. 5. Patients with uncontrolled sepsis with DIC. 6. Requirement of two or more vasopressors. 7. Organ failure requiring high inotropic support. 8. Advanced cardiopulmonary disease, with prior history of arrhythmias, structural heart disease. 9. History of traumatic brain injury, raised intracranial pressure, history of myasthenia gravis. 10. Endocronolgic illnesses: Hypothyroidism, hypoparathyroidism 11. Connective tissue diseases (systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosis, amyloidosis). 12. Known case of diabetes with diabetic gastroparesis 13. Pregnancy 14. Patients or concerned family member who fail to give consent for study enrollment 15. Age less than 18 years and more than 70 years
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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): 18.0-100.0, Acute Upper Gastrointestinal Bleeding patients with overt signs of upper gastrointestinal bleeding (hematemesis, melena and/or circulatory instability) documented bleeding (Forrest I) from a non-variceal upper gastrointestinal source (gastro-duodenal ulcers, Mallory Weiss tear, cancers, Dieulafoy's and other vascular lesions) at endoscopy without a full informed consent from the patient or his next of kin Age <18 years Pregnant Lactating 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): 18.0-75.0, Abdominal Pain Diarrhea Hematochezia Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or Patients who volunteer to the colonoscopy screening Dysphagia or swallowing disorder Congestive heart failure Renal insufficiency Prior major abdominal surgery of the gastrointestinal tract Known or suspected bowel obstruction Presence of a cardiac pacemaker or other implanted electromedical devices Allergy or contraindication to the medications used in the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Cigarette Smoking generally healthy (i.e. ambulatory, not currently sick) interest in quitting smoking smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6) inability to attend all required experimental sessions desire to quit smoking prior to the study quit date a quit attempt resulting in greater than 3 days of abstinence in the past 30 days report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems) unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician) schizophrenia and schizoaffective disorder 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 use of other tobacco products or e-cigarettes more than 9 days in the past 30 days current alcohol or drug abuse use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen
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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): 40.0-69.0, Prostate Cancer Prostate Biopsy Genetic Counselling Genetic Markers Men with either: 1. A positive family history of PrCa defined as Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at <70 years Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at <70 years Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age 2. Of African or Caribbean ancestry defined as: Both parents and all 4 grandparents from that origin Age 40 years WHO performance status 02 (see Appendix A) Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule Previous cancer with a life expectancy of less than five years Previous PrCa Negative biopsy within one year before recruitment Comorbidities making prostate biopsy risk unacceptable (Warfarin or Clopidogrel) Contraindications to having an MRI (pacemakers, aneurysm clips, claustrophobia)
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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, Cardiovascular Risk Factors Coronary Disease Cardiac Arrest Subjects must be present with their family member at the hospital The family member must be at high risk for cardiac arrest (CA), including previous myocardial infarction (MI) previous CA history of diabetes history of high cholesterol history of high blood pressure This includes subjects with family members being discharged from the Cardiac Intermediate Care Unit (CICU), Telemetry units, ICU, Cardiac Care Unit (CCU), cardiology clinics, or physicians office within the participating hospitals/health systems Volunteers and subjects must be 18 years of age or older Individual must be fit and able to perform moderate physical activity Volunteers must be English speaking and/or Spanish speaking
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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 stable CHF Cardiac Resynchronisation Therapy (CRT) device for >3 months able to walk on treadmill unable to walk on treadmill unstable angina pectoris uncontrolled heart rate prescribed calcium channel blocker significant aortic stenosis significant airways disease
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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, Phantom Limb Pain Amputation or peripheral nerve damage of an upper limb Injury should be in the chronic, stable phase, such that any traumatic injuries or surgical wounds have healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiment Other treatments for PLP tried with poor results Patient accepts the study protocol as explained by the physician The subject experienced intractable PLP (i.e. pain in the denervated or missing extremity) of more than 6 on numerical rating scale (NRS) or visual analog scale (VAS) (0-10 scale). The frequency of PLP episodes presents more than once a week Amputee subjects without PLP are eligible for part of the study that targets the sensory feedback induction within advanced bidirectional prosthesis control Cognitive impairment Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I Pregnancy History of or active substance abuse disorder Acquired brain injury with residual impairment Intellectual Disability (IQ < 70) Prior neurological or musculoskeletal disease Current or prior dermatological conditions Excessive sensitivity to electrical stimulation with surface electrodes. People afraid of electrical stimulation or pain People with other diseases which may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
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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 Adult patients age 18 years of age and older 2. Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas Pediatric patients younger than age 18 2. Pregnant patients 3. Patients undergoing distal pancreatectomies performed en bloc for non pancreatic pathologies (gastric cancer, renal cell cancer, 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): 21.0-99.0, Healthy Participants Healthy, male or female, aged 21 years or older at Screening 2. Regular time spent in bed between 7.0 and 8.5 hours per night 3. Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 hours and 09:00 hours 4. Body mass index (BMI) ≥18 and <31 kg/m2 at Screening 5. Subjective sleep onset latency (sSOL) <30 minutes and subjective wake after sleep onset (sWASO) <60 minutes on the Sleep Diary 6. At least 3 years of experience driving at least 3000 km per year 7. Holds a valid license to drive a vehicle in the European Union (EU) as confirmed at the Screening visit 8. Has driving ability during the practice driving test that is judged to be adequate by the driving instructor 9. Able to communicate adequately (written and verbal) in either Dutch or English as determined by the investigator A current complaint or diagnosis of insomnia disorder (per either The Diagnostic and Statistical Manual of Mental Disorders Version IV [DSM-IV] or Version 5 [DSM-5] criteria), sleep-related breathing disorder, periodic limb movement disorder, restless legs or narcolepsy, or an exclusionary score on a subscale of the SLEEP50 2. Habitually naps more than 3 times per week 3. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 4. Females of childbearing potential who Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]). 5. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation. 6. Clinically significant illness that requires medical treatment between Screening and Baseline 7. Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment 8. Has a QT interval corrected using Fridericia's formula interval (QTcF interval) >450 ms demonstrated on repeated ECGs (repeated only if initial ECG showed corrected QT interval (QTc) >450 ms) at Screening or Baseline 9. Has a history of or a family history of congenital QT prolongation or with a history of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome), or uses concomitant medications that prolong the QT/QT interval corrected for heart rate (QTc interval) 10. Has systolic blood pressure (BP) >140 mmHg (age 21-59) or >150 mmHg (age ≥60) or diastolic BP >90 mmHg (all ages) at Screening or Baseline 11. Has a resting heart rate <50 or ≥100 beats/min at Screening or Baseline 12. Has a history of drug or alcohol dependency or abuse (as defined by DSM-5 criteria) within approximately 2 years before Screening 13. Any suicidal ideation with intent with or without a plan within 6 months of the Screening Period (ie, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) 14. Habitually consumes more than 14 drinks per week (females) or more than 21 drinks per week (males) 15. Has a positive alcohol breathalyzer test at Screening or Baseline check-in 16. Smokes more than 6 cigarettes per day habitually and is unwilling to abstain from smoking cigarettes on evenings spent in the clinic until discharge after the driving test 17. Habitually consumes more than 3 cups of caffeinated beverages per day 18. Used any prohibited prescription or over-the-counter (OTC) concomitant medications within 1 week prior to starting the Sleep Diary during the Screening Period 19. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline or plans for transmeridian travel across more than 3 time zones during the study 20. A positive urine drug test at Screening or unwilling to refrain from use of illegal recreational drugs or marijuana during the study 21. Hypersensitivity to the study drug or any of the excipients or to zopiclone 22. Participated (received investigational product) in another clinical trial less than 1 month (or 5 elimination half-lives of the investigational product) before dosing or is currently enrolled in another clinical study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Type 1 Diabetes >18 years No residual beta-cell function (stimulated C-peptide < 60 pmol) Pancreatitis gastroparesis history of alcohol and/or drug abuse pregnancy and lactation other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment contraindications to gastroscopy cancer (unless in complete remission > five years)
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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, Gallstone Pancreatitis Patients aged 18-70 years admitted with first gallstone acute pancreatitis (GAP) is evaluated for eligibility. Diagnosis and severity of GAP is based upon Atlanta Consensus modified at 2012. Acute pancreatitis is diagnosed when at least two out of three are met; acute upper abdominal pain, elevated serum amylase/lipase level (more than thrice upper limit of normal range) and evidence of pancreatitis at any imaging modality (abdominal ultrasonography, computed tomography or magnetic resonance image). Biliary etiology is verified by abdominal ultrasonography showing stones or sludge at gallbladder. All other etiologies should be excluded. Exclusions (1) acute cholecystitis at abdominal ultrasonography, (2) suspected or confirmed acute cholangitis according to 2013 Tokyo Guidelines (fever or laboratory data with inflammatory response, cholestasis and imaging study with biliary dilatation/evident etiology), (3) history of Roux en Y gastric by pass or open supraumbilical surgery, (4) acute alcohol consumption, (5) chronic hepatic/pancreatic disease, (6) comorbidities contraindicating emergency surgery, (7) mental condition that preclude informed consent, (8) pregnancy, (9) patient refusal, (10) no endoscopist availability. There is no exclusions based on choledocolithiasis risk. All patients must complete clinical, anthropometric, and general laboratory/liver function tests at admission and daily until third day of stay or surgery
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Patients who was diagnosed acute pancreatitis Male or female Years and older written informed consent Symptoms of acute pancreatitis present for more than 72 hours Age under 18 years Pregnancy patients unable to consent
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Patients with acute pancreatitis 2. Patients who agree to participate in the study Patients who do not agree to participate in the study 2. Patients who experience any absolute contraindication to epidural block 3. Patients with platelet counts below 80,000 mcl 4. Patients with data gastrointestinal or urinary bleeding
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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, Malnutrition Adult patients (≥18 years) who are able to communicate their views regarding acceptability Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day Patients expected to require oral nutritional supplementation for at least 2 further weeks Informed consent obtained Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study Patients requiring a milk free Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list) Patients with significant renal or hepatic impairment Patients with dysphagia requiring stage 1,2 or 3 thickened fluids Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Substance Withdrawal Syndrome Any patients who present to the emergency department where the providers are concerned for opioid withdrawal contributing to their symptoms on presentation is eligible for inclusion Age less than 18 Allergy to either medication (olanzapine, clonidine) Inability to give informed consent Known 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): 18.0-65.0, Obesity Overweight and obese adults (≥30 kg/m^2 or ≥27 kg/m^2 with an obesity-related co-morbidity) Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrolment and before each radiation exposure Subjects must have the ability to provide informed consent before any trial-related activities Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes) Abdominal surgery other than appendectomy, Caesarian section or tubal ligation Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia-type 2 Patients with a personal history of pancreatitis (acute or chronic) Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory, a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety Depression (HAD) score >8 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers,Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia [which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation Hypersensitivity to the study medication, liraglutide
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-999.0, Diabetes Mellitus, Type II A healthy male whose age is over 19 years old when visiting for initial screening test 2. Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg • Body mass index (BMI) = weight (kg) / height (m)^2 3. A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area 4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc. 5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs. 6. The participants must have an ability and willingness to participate throughout the entire trials A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease. 2. Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy) 3. Who had following results after examination a. ALT or AST > twice higher than normal value 4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g) 5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial 6. Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic pressure) 7. Who had a medical history of alcohol and drug abuses. 8. Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug 9. Who smokes more than 20 cigarettes per day 10. Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug 11. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs. 12. Who has a potent to increase a danger by participating in the clinical trials or who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination. 13. Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine drugs 14. Who has a serious heart failure or a congestive heart failure that must be drug-treated 15. A patient with hepatopathy 16. A patient with severe nephropathy 17. Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history of acute metabolic acidosis or ketoacidosis 18. A patient with serious infectious disease or severe injuries before and after a surgery 19. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders 20. A patient who has kidney disease or renal insufficient that are caused by cardiovascular collapse (shock) and acute myocardial infarction (a male with higher serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min) 21. A patient who is being tested to inject radiological iodine contrast agent into blood vessels (ex: intravenous urography, intravenous cholangiography, angiography, using contrast medium computer tomography, etc.) 22. Who has severe systematic infection or severe trauma 23. Who has nutritional status, starvation, debilitating condition, pituitary dysfunction, or adrenal insufficiency patients 24. Who has respiratory dysfunction, gastrointestinal disease 25. Who is unable to take high fat foods 26. Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from the first dosing of clinical testing drug to collect pharmacokinetic blood samples 27. Test subjects who is not willing or unable to comply with guidelines described in this protocol 28. A person who is not determined unsuitable to participate in this test by the researchers
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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, Diabetes Mellitus, Type 2 Between 18 and 65 years of age Healthy Subject is a nonsmoker Subject's body mass index (BMI) is >=18 kilogram/meter square (kg/m^2) and <=30 kg/m^2 Male or Female Alanine aminotransferase (ALT) >1.5 x upper limit of normal range (ULN) Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]) Current or chronic history of liver disease, or known hepatic or biliary abnormalities QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec) Systolic blood pressure is >=140 millimeter of mercury (mmHg) at Screening Diastolic blood pressure is >=90 mmHg at Screening Heart rate is >100 beats/min at Screening estimated glomerular filtration rate (eGFR) <=80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) at Screening Fasting triglyceride level >300 milligram per deciliter (mg/dL) at Screening History of significant cardiovascular or pulmonary dysfunction prior to Screening
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-60.0, Healthy Subject is between ages of 18 to 60 years at enrollment with a body mass index (BMI) between 18 and 35 kg/m2 Female subjects must not be lactating, and must either a) be postmenopausal or b) agree to use an acceptable form of birth control from screening until 14 days after completion of the study Subject is in good health based on medical history, physical exam, laboratory profile, and electrocardiogram (ECG) as judged by the Investigator If subject smokes, subject agrees to limit smoking while in the study to not more than 10 cigarettes per day History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication over the past 12 months History or presence of allergic or adverse response to lofexidine, paroxetine, or related drugs Received any drugs capable of inhibiting CYP enzymes CYP1A2, CYP2C19, or CYP2D6 within 14 days or 5 half-lives (whichever is more) before Day 1 Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year Has a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-999.0, Diabetes Mellitus, Type II A healthy male whose age is over 19 years old when visiting for initial screening test 2. Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg Body mass index (BMI) = weight (kg) / height (m)^2 3. A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area 4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc. 5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs. 6. The participants must have an ability and willingness to participate throughout the entire trials A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease. 2. Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy) 3. Who had following results after examination a. ALT or AST > twice higher than normal value 4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g) 5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial 6. Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic pressure) 7. Who had a medical history of alcohol and drug abuses. 8. Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug 9. Who smokes more than 20 cigarettes per day 10. Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug 11. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs. 12. Who has a potent to increase a danger by participating in the clinical trials or who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination. 13. Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine drugs 14. Who has a serious heart failure or a congestive heart failure that must be drug-treated 15. A patient with hepatopathy 16. A patient with severe nephropathy 17. Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history of acute metabolic acidosis or ketoacidosis 18. A patient with serious infectious disease or severe injuries before and after a surgery 19. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders 20. A patient who has kidney disease or renal insufficient that are caused by cardiovascular collapse (shock) and acute myocardial infarction (a male with higher serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min) 21. A patient who is being tested to inject radiological iodine contrast agent into blood vessels (ex: intravenous urography, intravenous cholangiography, angiography, using contrast medium computer tomography, etc.) 22. Who has severe systematic infection or severe trauma 23. Who has nutritional status, starvation, debilitating condition, pituitary dysfunction, or adrenal insufficiency patients 24. Who has respiratory dysfunction, gastrointestinal disease 25. Who is unable to take high fat foods 26. Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from the first dosing of clinical testing drug to collect pharmacokinetic blood samples 27. Test subjects who is not willing or unable to comply with guidelines described in this protocol 28. A person who is not determined unsuitable to participate in this test by the researchers
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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, Foot Dermatoses Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline Subjects with matrix involvement on the great toenails Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure) Known immunodeficiency, radiation therapy, immune suppressive 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, Walled-off Necrosis WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer) 2. All WON centered within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, ≥ 6cm, located within 2cm of the enteric wall, not extending into the flanks or pelvis 3. WON with single loculation, with no extension into the flanks, pelvis or into the root of the small bowel mesentery. Collections should have an estimated solid component of = or >25% based on cross sectional imaging and/or endosonographic evaluation of the collection at the time of study procedure. 4. Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum WBC ≥ 15x199/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material) and/or 5. Symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) at a time interval of ≥ 4 weeks from attack of acute pancreatitis complicated by pancreatic necrosis 6. Documented history of acute or chronic pancreatitis a) Acute pancreatitis is diagnosed if 2 of the following 3 are met: i) Abdominal pain characteristic of acute pancreatitis ii) Serum lipase/amylase ≥ x3 upper limit of normal iii) Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat (1) b) Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with MRCP (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) (11) or EUS (≥5/9 of Rosement criteria) (12) 7. Able to undergo general anesthesia Age < 18 years 2. Unable to obtain consent for the procedure 3. Pregnancy 4. Irreversible coagulopathy: INR > 1.5, platelets < 50 x 109/L 5. Use of anticoagulants that cannot be discontinued for the procedure 6. Unable to tolerate general anesthesia 7. WON with ≥ 3 loculations 8. WON that is not accessible for EUS-guided drainage 9. Percutaneous drainage of WON is required or performed prior to EUS-guided drainage 10. Prior endoscopic, percutaneous or surgical drainage procedure(s) for pancreatic/peri-pancreatic fluid collections. 11. Contraindication to endoscopic drainage: Gastrectomy with Billroth II, gastric bariatric surgery, prior pancreatic surgery, prior esophagectomy, cirrhosis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 30.0-80.0, Esophageal Cancer Males and females, ≥30 years old Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer The lung cancer will be histologically confirmed or results of histology will be available Females planning to bear a child recently or with childbearing potential Known severe allergy or hypersensitivity to IV radiographic contrast Inability to lie still for the entire imaging time because of cough, pain, etc Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance
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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 Abdominal Wall Pain Abdominal Cutaneous Nerve Entrapment Syndrome Clinical diagnosis of chronic abdominal wall pain Prior ultrasound or cross-sectional imaging of the abdomen to other causes Baseline Brief Pain Inventory score ≥ 5 Multiple trigger points Abdominal wall hernia on exam Weight loss Rectal bleeding Recent change in bowel habits Decompensated cirrhosis or recurrent ascites Allergy or contraindication to study medications Known thrombocytopenia with platelet count < 50,000 Other diagnosis of chronic pain syndromes including fibromyalgia Unable to provide 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): 18.0-80.0, Irritable Bowel Syndrome With Diarrhea Male and female patients age≥18 years (with a minimum of 35% males in the study) 2. Patient meets FDA guidance and Rome III for IBS-D: a. Recurrent abdominal pain or discomfort over ≥6 months, with frequency ≥3 days/month in the last 3 months associated with ≥2 of the following: i. Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in the form of stool b. Loose or watery stools (Bristol stool form scale 6 or 7) ≥2 days per week 3. Average worst daily pain intensity ≥3.0 for each of the two baseline weeks 4. Major laboratory parameters within the following limits (no worse than grade 1 abnormalities per NCI-CTCAE v4): a. Adequate hematologic function, as demonstrated by i. Hemoglobin ≥10 g/dL ii. Absolute neutrophil count (ANC) 1.5-10 x 10^9/L iii. Platelets ≥100 x 10^9/L b. Adequate liver and renal function as demonstrated by i. Aspartate transaminase (AST) and Alanine transaminase (ALT) each ≤ 3.0 x upper limit of normal (ULN) ii. Total bilirubin ≤1.5 x ULN iii. Creatinine ≤1.5 X ULN c. Euthyroid based on thyroid-stimulating hormone (TSH) and free T4 levels 5. Patients on thyroid hormone replacement must be on a stable dose for at least one month prior to study entry. 6. C-reactive protein ≤2 x ULN for lab 7. Patients of childbearing potential and male patients with partners of childbearing potential must utilize effective contraceptive measures Women of childbearing potential are women who have menstruated in the past 12 months, with the exception of women who have undergone surgical sterilization 8. All patients must sign informed consent Evidence of other cause for bowel disease: 1. Relevant abnormalities seen on colonoscopy if previously performed or if required per this protocol. These but are not limited to Crohn's disease, ulcerative colitis, diverticulitis, ischemic colitis, microscopic colitis. 2. History of and/or positive serologic test for celiac disease 3. Known or suspected lactose intolerance. 2. History of abdominal surgery other than appendectomy or cholecystectomy at any time 3. Any elective major surgery (of any organ) planned for the period of the study, including follow-up 4. History of organic abnormalities of the GI tract including but not limited to intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aortoiliac disease) 5. Current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas). With approval of the medical monitor patients with curatively treated neoplasm in complete remission <5 years may be entered in the study. 6. Patients with a history of positive tests for ova or parasites or Clostridium difficile must be retested during the screening period and tests for the relevant agents must be negative 7. Use of any 5-HT3 antagonist (5hydroxytryptamine receptor antagonists) within 4 weeks of the start of baseline data collection. 8. Use of rifaximin within 4 months of the start of baseline data collection. 9. Use of any other agent specific for IBS (such as alosetron or eluxadoline) or for symptomatic treatment of IBS (such as antispasmotics and antidiarrheals other than loperamide) within 2 weeks of the start of baseline data collection. 10. Uses of any investigational agent for any indication within 4 weeks of the start of baseline data collection. 11. Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT syndrome 12. Patients who have Corrected QT interval (QTc) prolongation>450 msec noted on screening ECG, or who are taking medication known to cause QT prolongation Note: For current list of medications known to cause QT prolongation see: https://www.crediblemeds.org/healthcare-providers/drug-list/ There are several risk categories. Use the list showing those drugs known to cause torsade de pointes (TdP) 13. Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists 14. Patient has taken apomorphine within 24 hours of screening 15. Pregnant or lactating 16. Patients with other major illnesses, either physical or psychiatric, or social situations which may interfere with participation in the study or interpretation of results 17. Patients with severe hepatic impairment, defined as Child-Pugh score ≥10 at baseline
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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): 6.0-999.0, Atopic Asthma atopic patients Subjects who are diagnosed with atopic condition Subjects or legal guardians who are able to give informed consent Other protocol-defined may apply atopic patients Subjects who have received anti-IgE antibody treatment Subjects who have elevated IgE levels for reasons other than allergic conditions Other protocol-defined may apply healthy subjects Subjects who are able to give informed consent for participation in the study according to local requirements / law healthy subjects Subjects who have received anti-IgE antibody treatment Subjects with a suspected or confirmed clinical diagnosis of an atopic condition Other protocol-defined
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Low Back Pain, Mechanical Spinal Stenosis Nerve Root Disorder Radiculopathy, Cervical Benign Hypermobility Syndrome Clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating to the extremity, with suspected diagnosis of a specific pain generator amenable to a pain procedure, including disorders of the nerves, joints, and muscles as listed immediately below Clinical decision to schedule patient for a pain procedure, including procedures targeting the following disorders Facet arthropathy: intra-articular facet joint injection, medial branch block, medial branch radiofrequency ablation Sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block, lateral branch radiofrequency ablation Myofascial pain syndrome: trigger point injection Radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid injection, selective nerve root block Piriformis syndrome: piriformis injection Greater trochanteric bursitis: greater trochanteric bursa injection Able to provide HIPAA authorization to share prior medical records/imaging Previous diagnosis of cancer Currently pregnant Previously enrolled for the same procedure or the same pain generator site. (For example, this would a patient who had an intra-articular facet joint injection at the right L5/S1 if: 1) he had the same injection 3 months ago and was enrolled at that time, or 2) the patient was already enrolled for a medial branch block at the right L5 and sacral ala, as this targets the same facet joint.) Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state)
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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, Leukemia, Lymphocytic, Chronic, B-Cell Age≥3 at the time of consent Survival time>12 weeks B cell hematological malignancies by pathological examination Chemotherapy failure or recurrent B cell malignancy Creatinine< 2.5mg/dl Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level Karnofsky Performance Status>50% at the time of screening Bilirubin<2.0mg/dl Adequate pulmonary, renal, hepatic, and cardiac function Fail in autologous or allogenic haemopoietic stem cell transplantation Pregnant or nursing women Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening Previous treatment with any gene therapy product Abnormal vital signs Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 General infection or local severe infection, or other infection that is not controlled Dysfunction in lung, heart, kidney and brain Severe autoimmune diseases other symptoms that are not applicable for CAR-T
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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, Smoking Cessation smoke at least 5 cigarettes daily for the past year expired-air carbon monoxide (CO) > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2) current motivation to quit smoking able to speak and read English sufficiently for completion of consent form and questionnaires years of age or older pregnant or breastfeeding significant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician or principal investigator (PI) positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or PCP (NOTES: THC will be tested but will not be an exclusionary criterion; participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; participants failing the toxicology screen will be allowed to re-screen once) breath alcohol level > 0.01 (one re-screen allowed) binge alcohol drinking (4/5 [female/male] drinks per day more than 9 days in the past month) systolic/diastolic blood pressure (BP) greater than or equal to 160/100, or below 90/50 (one re-screen allowed) heart rate greater than or equal to 105 beats per minute (bpm), or below 45 bpm (one re-screen allowed) ever used reduced nicotine cigarettes smoke 'roll your own' cigarettes exclusively used smoking cessation medications within the past three 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, Autoimmune Pancreatitis IgG4-related Sclerosing Cholangitis Obstructive Jaundice adults greater than 18 years-old autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis obstructive jaundice malignancies; active infections pregnancy or breast feeding standard contraindications to ERCP unwillingness or inability to consent for the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 30.0-75.0, Diabetes Mellitus, Type 2 Male and postmenopausal female participants aged between 30-75 years of age inclusive 2. Type 2 diabetes on diet and lifestyle control or stable dose of metformin only for at least 3 months 3. Stable weight (less than 5% change in body weight in last 3 months) determined by self-reporting or documentation in clinical records 4. HbA1c 48-86mmol/mol (6.0 ) 5. eGFR≥60ml/min/1.73m2 6. BMI ≥ 25kg/m2 7. Able and willing to give informed consent 8. Able to understand English Females who are not postmenopausal (as menstrual cycle can affect appetite hormone concentrations) which is defined as "2 years post last menstrual period <50 years of age or 1 year post last menstrual period >50 years of age." 2. Type 2 diabetes on any other glucose lowering treatment except metformin 3. Patients with Type 1 diabetes 4. Patients on loop diuretics 5. Age <30 years and >75 years 6. BMI <25kg/m2 7. Not able to give informed consent 8. Not able to understand English 9. Moderate to severe renal impairment (eGFR<60ml/min/1.73m2) 10. Unstable diabetes i.e. HbA1c >86mmol/mol (10%), recent hospital admission with diabetic emergency in last 3 months 11. Patients with familial renal glycosuria 12. Patients with recurrent balanitis, vaginal or urinary tract infections 13. Shift workers 14. Patients who have participated in another study of an investigational medicinal product in the last 3 months 15. Active malignancy 16. Serious illness with a life-expectancy of less than 1 year 17. Hypersensitivity to Empagliflozin (Jardiance™) or to any of the excipients 18. Patients with latent autoimmune diabetes in adults (LADA) 19. Patients with a history of chronic pancreatitis 20. Evidence of conditions that lead to restricted food intake or severe dehydration 21. Patients with a history of excessive alcohol consumption 22. Patients on a severely calorie restricted diet (i.e., ≤800 calories per day)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging • Severe acute pancreatitis defined as the presence of any of the following Organ failure (oxygen saturation<90% on room air, mean arterial pressure<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine>2.0, Glasgow coma score<15) Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization Abdominal surgery within 60 days prior to hospitalization History of gastrointestinal motility disorder Inflammatory bowel disease Chronic comorbid illness including but not limited to >New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission Documented allegy to any of the following medications: dilaudid, Tylenol Patients transferred from an outside hospital for ongoing care
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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, Abdominal Surgery Hospital patient in general surgery and digestive department Adult Digestive sus mesocolic surgery with direct abdominal approach justifying a semi-invasive hemodynamic monitoring by arterial catheterization (liver, pancreatic, gastric and duodenal surgery) Surgical approach by laparotomy Patient under general anesthesia with mechanical ventilation Agreeing to participate in the study after receiving information note Known left systolic ventricular and/or diastolic failure Arrhythmias Surgery performed with thoracic approach Surgery by laparoscopy Emergency surgery Hypersensitivity or allergic to any of the product used for usual anesthesia, hypersensitivity to soya or egg lecithin Personal or familial history of malignant hyperthermia Severe kidney impairment (creatinin clearance <30ml/min) Patients who participated in the previous month to another study protocol Pregnant women or nursing
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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, Pancreatitis patients at age between 18-65 years old undergoing first time ERCP Ongoing acute pancreatitis Chronic pancreaittis Prior sphincterotomy Ongoing hypotension including those with sepsis Cardiac insufficiency (CI, >NYHA Class II heart failure) Renal insufficiency (RI, creatinine clearance <40mL/min) Severe liver dysfunction (albumin < 3mg/dL) Respiratory insufficiency (defined as oxygen saturation < 90%) Pregnancy Hyponatremia (Na+ levels < 130mEq/L))
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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): 21.0-65.0, Alcohol Drinking Alcohol Drinking Related Problems age between 21 and 65 years inclusive Drinking at high levels for at least 10 different weeks during the last 90 days. High-level drinking for a given week can be either of the following:: --For women, more than 3 drinks on any single day that week, or more than 7 drinks that week For men, more than 4 drinks on any single day that week, or more than 14 drinks that week a score greater than or equal to 8 and less than or equal to 15 on the self-report version of the Alcohol Use Disorders Identification Test (AUDIT), with endorsement of at least one item other than 1-3, because 1-3 assess only consumption, not concern or consequences self-report of liking or having neutral feelings about the sight and smell of alcoholic beverages for women, practicing an effective method of birth control before entry and throughout the study (or postmenopausal for at least one year, or surgically sterile); negative urine pregnancy test at each visit. Effective methods of birth control are those approved by the Food and Drug Administration (FDA) used as described in the FDA Birth Control Guide These methods are: (1) intrauterine device (IUD) copper; (2) IUD with progestin; (3) implantable rod; (4) contraceptive shot/injection; (5) oral contraceptives (combined pill, progestin-only pill, or extended/continuous-use combined pill); (6) contraceptive patch; (7) vaginal contraceptive ring; (8) diaphragm with spermicide; (9) sponge with spermicide; (10) cervical cap with spermicide; (11) male condom; (12) female condom; (13) male partner with a vasectomy. Abstinence from sexual intercourse is also an effective method of birth control -risk of alcohol withdrawal, as determined by any of the following: a score greater than or equal to 8 on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar) following a negative breath test for alcohol (i.e., BAC of 0.0), lifetime history of delirium tremens or seizures (related to alcohol or not), endorsement of a drinking to avoid withdrawal symptom on the SCID or M.I.N.I. (M.I.N.I. Section I, Alcohol Use Disorder, items k1 and/or k2 answered affirmatively with counselor s evaluation to verify that symptoms indicated in item k1 are related to the individual s cutting down on drinking and/or the response to item k2 refers to withdrawal symptoms and not hangover);or physician s judgment currently trying to quit drinking, or planning to quit or reduce alcohol drinking via formal treatment or support-group attendance in the next six months for women: pregnancy, breastfeeding, or planning to become pregnant during the experiment current liver disease or dysfunction, assessed by physical examination and medical history; and hepatitis C, chronic hepatitis B, or other current liver disease or dysfunction as assessed by physical examination and medical history or as reflected in blood levels more than 5 times the upper limit of normal in any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyltransferase (GGT) any other medical illness or condition that in the judgment of the investigators is incompatible with alcohol consumption current use of prescription or over-the-counter medications or herbal products for which drinking alcohol is strictly prohibited. When the metabolic half-life of the medication/product is known, we will require at least 7 half-lives to have elapsed before any session involving alcohol consumption. If the half-life is not known (as might be the case for some herbal preparations), we will require at least 7 days to have elapsed since the last use before any session involving alcohol consumption substance-use disorder for any drug(s) other than alcohol or nicotine in the previous 12 months past or present diagnosis of bipolar disorder or any psychotic disorder; any history of suicide attempt or current suicidal ideation; present diagnosis of uncontrolled or untreated mood or anxiety disorder cognitive impairment severe enough to preclude informed consent or valid self-report
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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, Dermatological Emergency Male or female aged ≥ 18 years Written informed consent prior to study participation Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel Dermatological emergency patient Male or female aged < 18 years Missing informed consent prior to study participation Patient has been committed to an institution by legal or regulatory order Persons in dependence from the sponsor or working with the sponsor Participation in another clinical trial within the previous 2 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, Chronic Pain Adhesions Patients aged 18 years and above with chronic abdominal pain that was likely to be caused by adhesions due to previous abdominal surgery were recruited. Before attributing abdominal pain to the existence of adhesions all patients had an extensional diagnostic work-up to other pathology Current treatment by psychologist or psychiatrist Use of laxatives, sedatives, morphine, antipsychotics, antidepressants, or drugs that stimulate the central nervous system Abnormal outcome of standardized non-invasive diagnostics Biochemical investigation Lactose tolerance tests or H2 respiration test Feces analysis of worms and worm eggs Ultrasound or CT scan of the abdomen Radiographic studies of small and large bowel (or colonoscopy)
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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, Urinary Tract Infection Diabetes Mellitus Atrial Fibrillation OSA COPD Pneumonia Acute Otitis Media Leukocytosis Iron Deficient Anemia Hypertension Healthy Volunteers Age 18 to 65 years of age English speaking Established diagnosis of one of the thirteen required conditions with evidence in Medical Record Lack of patient consent Has pacemaker or internal medical device Pregnancy Concurrent enrollment into a clinical trial that may affect subject treatment Age less than 18 or over 65 Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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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, Obesity Diabetes All patrons who purchase a beverage at our study site (retail cafe) during the intervention are eligible for inclusion. The cafe is open to the public, though it primarily serves staff, patients and guests of the research labs in the building There are no
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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 Coronary Syndrome Chest pain in ED STEMI Prisoners Pregnant women Unable to 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): 18.0-60.0, Suicidal Behavior right-handed arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide Cons-indications to the use of MRI Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture
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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, Nausea Abdominal Pain Chief Complaint of nausea or abdominal pain with nausea Inability to tolerate oral nausea medication Patients with a negative pregnancy test Patients younger than 18 years of age Patient's chief complaint includes headache, chest pain, or dizziness Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease) Blood sugar greater than 300 Non-English speaking subjects
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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 Males and females, age > 18 years. 2. Normal amylase level before undergoing ERCP. 3. Signed inform consent form and agreed to follow-up on time Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent. 2. Patients involved in other study within 60 days. 3. Billroth II or Roux-en-Y anatomy 4. Acute pancreatitis. 5. a history of previous ERCP 6. Pregnancy or history of allergy to pentoxifylline 7. Patient treated for arterial hypertension 8. Patient with severe coagulopathy 9. Patient with hyper sensibility of pentoxifylline 10. Nursing mothers
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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): 45.0-70.0, Drug Action Increased All cases were immature cataract at different stages No complicated cataract included in this study either due to local or systemic diseases
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-85.0, Blood High Pressure Aortic Dissection Type B Newly diagnosed patients with Stanford type B acute aortic dissection and systolic blood pressure>160mmHg Age <18 years In pregnancy Diagnosis of aortic dissection was made 48 hours or more prior Dissection due to aortic intramural hematoma or penetrating atherosclerotic ulcer With history of previous surgical or interventional endovascular treatment for aortic diseases With traumatic aortic injury With history of cerebrovascular accident, brain surgery, chronic renal insufficiency, and mesenteric vascular thrombosis or dissection AD patient concomitant with new cerebral infarction, or ischemic mesenteric artery or lower limb arteries which requiring urgent surgical interventions With obvious contraindications for antihypertensive therapy, such as severe carotid stenosis, cerebral infarction in acute phase Pathogenesis of the dissection was due to congenital aortic hypoplasia, such as Marfan syndrome, connective tissue diseases
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Bradycardia Heart Failure HF Group Recommended to undergo CRT-P or CRT-D implantation LBBB, RBBB or IVCD with a QRS duration > 120 ms LVEF ≤ 35% AV Block Group Recommended to undergo dual chamber pacemaker implantation Second or third degree AV block Age < 18 years Pregnant
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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, Gastrointestinal Motility Disorder Intestinal Disease Consecutive patients with evidence of small bowel motility disorders, referred to (or) are patients of the Gastroenterology and Motility Center at Northwell Health System. 2. Aged between 18 and 70 years. 3. Subjects should be capable of understanding the study and be able to give informed consent. 4. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to > 6 hours. 5. To participate in the study, patients will have to stop taking Octreotide (because it has the same mechanism of action as the study medication) if they are currently taking it; it should be stopped for at least 4 weeks before taking the first dose of this study medication. General Age <18 or age >70 2. Pregnancy as assessed by urine pregnancy test for performing wireless motility capsule testing 1. History of gastric bezoar 2. History of Disorders of swallowing 3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse) 4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y) 5. History of Severe dysphagia to food or pills 6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump 7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.) 8. Any person unable or unwilling to undergo abdominal surgery. 9. BMI > 40 due to Lanreotide 1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility. 2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose > 250, glycosylated hemoglobin (HbA1c) > 8.5%) 3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers. 4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain). Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate. ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG Bradycardia <60 beats/min Tachycardia >100 beats/min Atrial Fibrillation Rapid irregular atrial signal with no real P-waves and irregular ventricular rate Ventricular Fibrillation Irregular ventricular waveforms Sinus Arrhythmia
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 35.0-999.0, Pulmonary Disease, Chronic Obstructive Adult >= 35 years old At least one of the following risk factors for COPD: • being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview); Current or past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure >=100 hours/year Capable of giving signed informed consent Physical or mental disability to complete the study procedures Heart above 120 beats per minute Participants under treatment for tuberculosis Participant in current clinical trial Pregnancy Patients with one of the following contraindications to spirometry: chest surgery in the last month; abdominal surgery within the past three months; neuromuscular disease, acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem in the prior 3 months
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Gastric Cancer Gastrointestinal Disease Patient should be diagnosed as gastric cancer by pathology and have received radical gastrectomy. They should finish the following radiotherapy and chemotherapy and the treatment for surgical complications (such as leak, stricture, and marginal ulcer) Patient should be constitution of spleen qi deficiency, that is, meet two primary symptoms of spleen deficiency + two primary symptoms of qi deficiency, or meet two primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + one auxiliary symptoms, or meet one primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + two secondary symptoms + one auxiliary symptoms as follow: 1. Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon 2. Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity 3. Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, polysialia; b) abdominal pain, as a result either patients like warm or press, or remit after meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema 4. Auxiliary symptoms: pale or swollen or teeth-printed tongue with thin and white fur Age ranges from 18 to 70 years; both male and female Patient should be in fair performance status, indicated by a score of Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 Sign the informed consent Stage IV gastric cancer according to the Japanese classification [16] Impaired liver function (total bilirubin > 2 × upper limit of normal (ULN), alanine transaminase > 2 × ULN, or aspartate aminotransferase > 2 × ULN), kidney function (serum creatinine > 2 × ULN), or hematopoiesis (neutrophil counts < 0.5×109/L or, thrombocyte counts < 20×109/L or, absolute reticulocyte counts < 15×109/L) Obviously abnormal electrocardiogram Severe mental disorders Other severe diseases (e.g. multiple organ failure, HIV infection) Pregnant or breast-feeding women Allergic to the test sample Unwilling to provider personal information and sign the 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): 0.0-999.0, Acute Pancreatitis The patients were classified into the group of patients with acute pancreatitis (AP) due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with tenderness on palpation on physical examination), personal interview and clinical method used in the diagnosis of pancreatitis laboratory tests (elevation in serum lipase or amylase to three times or greater than the upper limit of normal) and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography). In patients with characteristic abdominal pain and elevation in serum lipase or amylase to three times or greater than the upper limit of normal, no imaging was required to establish the diagnosis of acute pancreatitis. In patients with abdominal pain that was not characteristic for acute pancreatitis or serum amylase or lipase levels that were less than three times the upper limit of normal, or in whom the diagnosis was uncertain, the investigators performed abdominal imaging with a contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis and to other causes of acute abdominal pain. In patients with severe contrast allergy or renal failure, the investigators performed an abdominal MRI without gadolinium The volunteers classified as healthy based on the research conducted by clinicians of primary medical care (control group) other accompanied diseases than acute pancreatitis (the patients groups) Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers
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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, KRAS NP_004976.2:p.G12R Stage III Pancreatic Cancer AJCC v6 and v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Patients must have histologically confirmed locally advanced or metastatic pancreas cancer Patients must have received at least 6 months fluorouracil (5-FU) or gemcitabine-based treatments for pancreas cancer (fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin [FOLFIRINOX], fluorouracil, leucovorin calcium and oxaliplatin [FOLFOX], 5-FU+ nal-IRI [MM-398; nanoliposomal irinotecan], or 5-FU [including capecitabine], gemcitabine-based gemcitabine plus abraxane, gemcitabine monotherapy among others) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic Kirsten rat sarcoma (KRAS) G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70% Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 75,000/mcL Patients who have received prior treatment with tyrosine kinase inhibitors (e.g. erlotinib), or anti-Epidermal growth factor receptor (EGFR) agents (e.g. cetuximab, panitumumab) Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous Patients with active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial; no additional workup is needed to brain metastases if the patient is asymptomatic or has no history of brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib (AZD6244) or other agents used in study Previous Mitogen-activated protein kinase kinase (MEK), RAS, or Rapidly Accelerated Fibrosarcoma (RAF) inhibitor use Patients with the following cardiac conditions are excluded
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Healthy male subjects. 2. At least 18 years of age . 3. Weight at least 50kg and body mass index between 19 and 26 kg/m2. 4. Informed consent and voluntary to sign a written informed consent. 5. Can communicate with researchers and complete the study in accordance with the provisions of the research Abnormal diagnostic findings, and clinical significances determined by researchers (physical examination,vital sign, ECG,X-ray,blood routine examination, urine routine examination,blood biochemical examination and coagulation test). 2. Having functional gastrointestinal disease or inadequate secretion of gastric acid or is treated for a acid suppression. Which including gastro upset, dyspepsia, gastritis, gastric ulcer, duodenal ulcer, gastric secrete melanoma, etc. 3. Taking drugs that alter the environment of the gastrointestinal，especially alter the gastrointestinal pH，within 30 days before the first dose. Such as， Proton pump inhibitors：thiophene, omeprazole, lansoprazole, esomeprazole, etc .and H2 antagonist ranitidine：cimetidine, famotidine, etc .and antacids hydrogen carbonate Sodium, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc .and gastric mucosal protective agent：sucralfate，and so on. 4. Not comply with a unified diet( such as standard meal) or has swallowing difficulties. 5. Allergic to any ingredient or excipients of the study drug. 6. History of gastrointestinal disorders and severe liver and kidney diseases ，which affect the absorption or metabolism of drugs so far. 7. History of ocular surface damaging diseases (such as corneal perforation, ulcers, etc.). 8. History of serious blood diseases. 9. With skin, cardiovascular, liver, kidney, digestive, neurological, psychiatric, metabolic disorders, or any other disease that can interfere with the results of the trial. 10. History of long-term excessive drinking (more than 8 cups a day, 1 cup = 250 mL) of tea, coffee or caffeinated beverages，or 48 hours before the first dose intake of any food or drink containing caffeine (such as coffee, tea, chocolate, etc.). 11. Ingested any drinks or foods that are rich in xanthine and grapefruit or affect the drug absorption, distribution, metabolism and excretion. 12. A positive result in breath alcohol test or previous alcohol abuse (ie, men drink more than 28 standard units a week [1 standard unit defined as containing 14 grams of alcohol, such as would be found in a standard shot of hard liquor, a 12-ounce bottle of beer, or a 5-ounce glass of wine] Or regular drinking(more than 14 standard units of alcohol per week) within 6 months before the trial. 13. Daily intake of more than 3 cigarettes from 3 months before the study to 48 hours before the first dose or intake of tobacco or any type of tobacco product within 48 hours before the first dose. 14. Taking drugs that interact with gefitinib （such as CYP3A4 inhibitors： itraconazole, ketoconazole, clotrimazole, Ritonovir, etc .and CYP3A4/5 inducers：rifampicin, carbamazepine, phenobarbital, phenytoin, dexamethasone, etc .and CYP2D6 inhibitors：Fluoxetine, paroxetine , etc .） within 30 days before the first dose. And use of any prescription drugs, non-prescription drugs, Chinese herbal medicine, health products within 14 days before the first dose. 15. Volunteer in any other clinical drug study or taking any clinical trial drug within 3 months prior to this study. 16. Blood donation or lost more than 450mL blood within 3 months prior to the study，or has a plan to donate blood or blood components within the study period or within 3 months after the end of study. 17. Suffering from a serious illness or having undergone major surgical procedures within 1 years before the firs dose. 18. Abnormal blood coagulation, or having a known tendency of severe bleeding.. 19. A positive result in drug test or existing drug abuse (eg, morphine, marijuana, methamphetamine, dimethylene bisoxamine amphetamines, ketamine, etc.) within 1 year prior to the trial. 20. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test. 21. Having fertility planning or reluctant to take appropriate contraceptive during the study or within 6 months after the study. 22. Other unfavorable factors diagnosed by investigators
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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 Men and women ages 18 and older ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease) Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block Patients staying for at least 24 hrs post operatively Patients who provide informed consent Patients presenting for surgery >1 hour in length and <6 hours History of recent common colds, upper respiratory infections or immune deficiencies Patients allergic to clonidine Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol) Patients who are already on chronic clonidine therapy for management of blood pressure Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following Abdominal pain consistent with the disease Serum amylase and/or lipase greater than three times the upper limit of normal, and or Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis) Known or newly diagnosed chronic pancreatitis based on cross sectional imaging findings Pre-existing exocrine pancreatic insufficiency (meaning EPI present before the onset of AP; development of EPI during early refeeding is not an criterion) History of gastric or pancreatic resection History of small bowel disease (celiac disease, or Crohn's disease) History of pancreatic malignancy History of gastroparesis History of cystic fibrosis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 1.0-999.0, Pancreatitis Organ Failure, Multiple for Subjects (all three) Males and females of 16 years of age and older. Body weight at least 40kg Diagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND Elevated amylase levels by at-least three times the upper limit of normal and/or elevated lipase levels by at-least three times the upper limit of normal (25, 26). Acute pancreatitis must be defined by 2 of the 3 following Serum amylase or lipase elevated greater than 3X upper limit of normal epigastric acute pancreatitis pain abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis Willingness to participate in the study and sign the informed consent. (Children and subjects who are cognitively impaired for temporary reasons as mentioned in the section 4.7 of this protocol will require a representative to sign the informed consent). for Controls (all three) Males and females of 18 years of age and older. a. Unrelated family member or a friend of the subject or a patient having blood drawn in general medicine outpatient clinic, without a history of pancreatitis, OR Willingness to participate in the study and sign the informed consent. Additional for subjects with a previous attack of acute pancreatitis: age as defined above Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48 hours or evidence of pancreatic necrosis on computerized tomography. Willingness to participate and sign informed consent for Subjects: Persons unwilling to sign the informed consent Disorientation secondary to irreversible organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger. Blood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic cancer History of cancer requiring chemotherapy or radiation within the past 1 year History of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical complications for Controls: Persons unwilling to sign the informed consent
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis The diagnosis of AP based upon presence of two out of the three following 1. Abdominal pain typical to AP 2. Serum amylase or lipase levels more than three times the upper limit of normal 3. Imaging findings suggestive of AP 2. Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak) Age under 18 years 2. Unwilling to provide consent by patient or his/her proxy 3. Presence of pancreatic cancer 4. Presence of chronic pancreatitis 5. Occurrence of AP following a multiple trauma episode 6. Having history of organ transplant 7. Presence of any cancer which required chemotherapy or radiation therapy in the past year
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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, Pancreatitis The diagnosis of AP based upon presence of two out of the three following 1. Abdominal pain typical to AP 2. Serum amylase or lipase levels more than three times the upper limit of normal 3. Imaging findings suggestive of AP 2. Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak) Age under 18 years 2. Unwilling to provide consent by patient or his/her proxy 3. Presence of pancreatic cancer 4. Presence of chronic pancreatitis 5. Occurrence of AP following a multiple trauma episode 6. Having history of organ transplant 7. Presence of any cancer which required chemotherapy or radiation therapy in the past year
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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): 18.0-70.0, Crohn Disease Ulcerative Colitis Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy
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0
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