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70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Histologically or cytologically confirmed adenocarcinoma of the pancreas Completely resected disease Underwent 1 of the following procedures 3-8 weeks ago Standard pancreaticoduodenectomy (for tumors of the pancreatic head) Distal pancreatectomy (for tumors of the pancreatic tail) No grossly positive surgical margins Positive microscopic margins allowed Nonmeasurable disease No known CNS disease ECOG performance status 0-1 | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 16.0-80.0, Head and Neck Cancer Histologically confirmed differentiated thyroid cancer T1-T3, Nx, N0, N1, M0 disease Has undergone one or two-stage total thyroidectomy with or without lymph node dissection All known tumor resected (R0) Requires radioiodine remnant ablation Does not require mandatory recombinant thyroid-stimulating hormone No Hurthle cell carcinoma or aggressive variants, including any of the following Tall cell, insular, poorly differentiated disease with diffuse sclerosing Anaplastic or medullary carcinoma | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, ERCP Pancreatitis All patients aged 18 years and above undergoing first ERCP procedure Active acute pancreatitis Lower end malignant bile duct block Patients undergoing repeat procedures,including those with previous sphincterotomy Ongoing therapy with nitrates, calcium channel blockers, somatostatin or octreotide Patients with bleeding diathesis Patients with chronic pancreatitis Patients with cardiac comorbidity | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Pancreatic Cancer Histological confirmation of pancreatic adenocarcinoma is required Only patients with unresectable, non-metastatic tumors are eligible Documentation of disease extent by endoscopic ultrasound and either laparotomy or laparoscopy must be performed within 42 days of registration All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan Confirmation of palliative surgical bypass at the time of laparotomy or whether a biliary stent was placed will be requested Disease must be locoregional and not amenable to surgery based on one or more of the following size of pancreatic tumor > 5 cm lymph nodes (bulky, > 2 cm, but within a radiation port) vascular involvement or impingement of major vessels (superior mesenteric artery, superior mesenteric vein, portal vein, hepatic artery) invasion into the adjacent structures Enrollment in this trial will be limited to patients for whom protocol therapy is safe and appropriate. Physicians should consider the risks and benefits of therapy together with all relevant medical and other considerations in deciding whether this protocol is appropriate for a particular patient. Specific considerations Psychiatric illness which would prevent the patient from giving informed consent Serious medical illness such as uncontrolled infection, severe cardiovascular disease including recent (< 6 months) myocardial infarction or uncontrolled congestive heart failure, or other serious illness which would limit anticipated survival to < 12 weeks Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for three months after the trial Inability to swallow medication. Patients should have adequate, unassisted oral intake | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Diverticulitis Informed consent Diverticular disease of sigmoid colon documented by colonoscopy AND 2 episodes of uncomplicated diverticulitis, one at least being documented with CT scan OR 1 episode of complicated diverticulitis, i.e. perforation, with or without pericolic abscess or pelvic abscess requiring percutaneous drain Age < 18 Associated colon cancer or any condition requiring extended colectomy BMI > 35 Emergency procedure Use of opiates and/or analgesics within 48 hours preceding the surgical procedure Patient unable to communicate in French, English or German Any cognitive impairment (psychiatric disorder, Alzheimer's disease, etc.) | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-120.0, Pancreatic Cancer Diagnosis of localized pancreatic cancer No metastatic disease Resectable or unresectable tumor based on spiral CT with both oral and intravenous contrast enhancement, defined by the following National Comprehensive Cancer Network (NCCN) for resectability* Resectable tumors meeting the following No distant metastases Clear fat plane around celiac and superior mesenteric arteries Patent superior mesenteric vein/portal vein Tumors considered borderline resectable according to NCCN including any of the following, are considered unresectable for the purpose of this study Severe unilateral superior mesenteric vein/portal impingement Tumor abutment on the superior mesenteric artery | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 21.0-999.0, the Efficacy and Safety of Off-pump CABG Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they: 1. require isolated CABG with median sternotomy 2. are able to give their informed written consent 3. are> 21 years of age and 4. have one or more of the following risk factors ≥ 70 years peripheral vascular disease (previous peripheral bypass or amputation or ABI <0.80) Cerebrovascular disease (history of stroke, TIA) Renal insufficiency (creatinine above upper limit of normal) >60 years of age and one of the following diabetes (oral hypoglycemic agent and/or insulin) urgent revascularization (waiting in hospital) LV ejection fraction <35% current or recent smoker Patients will be excluded if they have one of the following: 1. concomitant cardiac procedure associated with CABG, 2. contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels) 3. concomitant life-threatening disease likely to limit life expectancy to less than 2 years, 4. prior enrollment in this trial 5. emergency CABG surgery (immediate revascularization for hemodynamic instability) OR 6. redo CABG | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Abscess, Intra-Abdominal Cholecystitis Wound Infections Peritonitis Appendicitis Male or female patient of age 18 years or older Patient with intraabdominal/hepatobiliary infection.? Patients with known hypersensitivity to penicillins, cephalosporins, cefoperazone or to sulbactam | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Carcinoma, Hepatocellular Written informed consent Age between 18 and 70 years Documented by at least 2 out of three mentioned and evidence of non-resectability. 1. Radiological either CT Scan/US abdomen 2. Biopsy, 3. Serum alphafeto protein level Multi centric hepatoma or TNM Classification Stage IV Child's class B or C with a Child's score of maximum 11 No other active malignancy except localized basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Life expectancy of greater then 3 months Current laboratory values must be within the limits listed below: Haemoglobin > 8 g/dL WBC > 4,000/uL Absolute Neutrophil Count > 1,500/uL Platelets > 75,000/uL ECOG Performance status of < 2 Patients who have received adjuvant or neoadjuvant therapy are eligible. A minimum interval of 4 weeks since last chemotherapy will be required History of allergic reaction to compound chemically related to CAP Concomitant or previous malignancies within five years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix Active, uncontrolled infection. Concurrent medical problems which could limit the life expectancy or the ability of the patient to receive chemotherapy Mental condition that could limit the patient in comprehending the concept of clinical trial or complying with its requirements Brain or leptomeningeal involvement Pre-existing neurotoxicity of >=grade 2 Concomitant radiotherapy, unless localised for bone pain control or palliation Being of reproductive potential and not agreeing to practice an effective contraceptive method Pregnancy or lactation | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Crohn's Disease Ulcerative Colitis Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis 2. Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology Patients requiring stoma formation as part of the operative procedure 2. Patients undergoing loop ileostomy or colostomy closure thru the stomal site 3. Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values) 4. Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification >2 | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Pancreatitis Polyamines Patients who are diagnosed as acute pancreatitis Patients who are diagnosed as either of gallstone, duodenal ulcer or bleeding, gastric ulcer or bleeding, irritable bowel syndrome, hernia, diverticulitis, retrocecal appendicitis with non-pancreatic acute abdominal pain Patients who underwent operation Patients who underwent recurrent acute pancreatitis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Osteoarthritis, Knee Age 18-80 years Clinically diagnosed and radiologically verified knee osteoarthritis (OA) Pain and stiffness derived from OA lasting for more than one year Previous knee trauma (OA following previous meniscectomy is included) Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia Pronounced hip OA Severe somatic or mental illnesses Dementia Alcohol or drug abuse Pregnancy Anticoagulant treatment Corticosteroid treatment during the last 3 months Allergy to chlorhexidine or local anaesthetics | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Abdominal Abscess Hospitalized male or female patients greater than or equal to 18 years of age Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess Patients with a complicated intra-abdominal infection such as an intra-abdominal abscess an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving > 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess perforated diverticulitis complicated by abscess formation or fecal contamination complicated cholecystitis with evidence of perforation or empyema perforation of the large or small intestine with abscess, or fecal contamination purulent peritonitis or peritonitis associated with fecal contamination Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months Anticipated length of antibiotic therapy less than 5 days | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-99.0, Pneumonia, Ventilator-Associated Pneumonia, Bacterial Pneumonia Abdominal Abscess Bacterial Infections Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP) or complicated Intra-Abdominal Infection (cIAI) Patients with VAP must have been hospitalized (or been in a chronic care facility) for >= 5 days, have received mechanical ventilation for >= 48 hours, have a Clinical Pulmonary Infection Score (CPIS) of >= 5, have new or progressive radiographic infiltrates (not related to another disease process) Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of study entry Patients with a history of acute hepatic failure or acute decompensation of chronic hepatic failure, history of severe impairment of renal function, history of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months organ (including bone marrow) transplant recipients hematologic malignancy use of immunosuppressive therapy at screening, including use of high dose corticosteroids (e.g., > 40 mg prednisone or equivalent per day for > 2 weeks) history of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock) | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Type 2 Diabetes Mellitus Diagnosed with type 2 diabetes Treated with metformin and/or a thiazolidinedione HbA1c between 6.5% and 9.5%, inclusive Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2 Have previously received exenatide or glucagon-like peptide-1 analogs Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry Receiving beta blockers Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators Have been treated with drugs that promote weight loss (for example, Adipex® [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin]) Have donated blood within 60 days of screening | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent, locally advanced (that is not amenable to resection with curative intent), or metastatic disease Patients must consent to have a biopsy performed to obtain fresh tissue or be able to identify a FFPE tissue block in which tissue samples can be obtained to complete the testing for this study Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of metastatic breast cancer Females age > 18 years Written informed consent and HIPAA authorization for release of personal health information Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.) Patients must not have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days of starting protocol therapy Patients must not have had radiation within 2 weeks prior to study entry Previously radiated area(s) must not be the only site of disease for study entry Patients must not have a history of bleeding diathesis or have used anticoagulant therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed.) Patients with a history of deep vein thrombosis or pulmonary embolism are not eligible | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Gastric Cancer Histologically confirmed adenocarcinoma of stomach Age: 18-80 years Performance status: ECOG 0-1 Informed consent should be signed EGD finding of early gastric cancer EUS finding of mucosa and submucosa cancer The location of the tumor should be antrum, angle, lower body in greater curvature in UGIS No evidence of distant metastasis in abdomen CT, and chest PA Regional lymph node metastasis confined to perigastric node (N1) in CT and EUS Any comorbidity obviating major surgery Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy Previous upper abdominal operation Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration Complicated case needed to get emergency operation Any accompanying surgical condition needed to be performed in same time | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-75.0, Hypothyroidism Ages 20-75 Primary hypothyroidism on stable dose of L-T4 for > 3 months Documented elevated TSH off L-T4 Normal TSH level on usual dose of L-T4 No acute or chronic medical or psychiatric illnesses that affect thyroid function, mood or cognition No medication use that affects thyroid function, mood or cognition (oral contraceptives or estrogen therapy allowed) Normal score on screening Mini-Mental State Exam (MMSE) (to test for dementia) Normal vision by screening examination Normal hearing by screening examination Non smoker Failure to meet any of the above Inability to speak and comprehend English A history of coronary artery disease Screening hgb <10 Screening wbc > 10,000 Clinically significant abnormalities on screening metabolic set Screening LDL cholesterol > 160 Screening triglyceride > 300 Significant abnormalities on screening ECG Pregnancy or intent to become pregnant in next 6 months | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis Patients over the age of 18yr 2. The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission 3. Severe pancreatitis, as defined by: the Atlanta classification of severe disease (60), but with important modifications to sharpen the definition of severity, to one or more of the following: 1. The presence of organ failure (MOF) resistant to early aggressive IV fluid resuscitation as defined by a Marshall score of ≥2 in any one organ (for calculation, see Appendix (61)), excluding the liver component as the abnormality may be due to gall stones rather than the systemic inflammatory response (17) 2. Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8 3. score ≥ 8 (for calculation, see Appendix (63)) 4. Ranson's ≥3 (for calculation, see Appendix (64)) Inability to absorb enteral nutrients resulting in chronic intestinal failure and need for IV feeding, such as short bowel, malabsorption disorders such as celiac or intestinal proliferative disorders, chronic obstruction and pseudo-obstruction. 2. Time elapse since commencement of acute pancreatitis symptoms >10 days. In order to take advantage of the 'window of opportunity' to prevent the progression of 'transient' MOF to 'permanent' MOF, patients should be started on enteral feeding as soon as possible. However, in practice many patients present initially with mild disease which progresses to severe necrosis at the end of the first week, and these patients need nutritional support for long periods of time. Consequently, this is an important group to in this investigation. Post hoc analysis will be performed to see whether they behave differently to patients fed earlier in their disease 3. Any form of artificial feeding since commencement of acute pancreatitis symptoms 4. Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements, based on clinical history and specific investigations such as by ERCP, MRP, or CT scanning. 5. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult 6. Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy, supported by biopsy, and/or radiological imaging and endoscopy (portal hypertension, varices and gastropathy), as this will make assessment of severity difficult 7. Chronic immunodeficiency states such as AIDS defined by CD-4 count < 50, and immunoglobulin deficiencies as it may independently affect feeding tolerance and infection risk 8. Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy <6 months. 9. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk. 10. Contraindication to using the nose for enteral tube insertion 11. Severe traumatic brain injury with ICP>20mmHg despite treatment 12. Previous completion or withdrawal from this study | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-70.0, Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Patients between the ages of 18 and 70 years old referred to Indiana University Hospital for outpatient upper EUS for clinical purposes (e.g., pancreatic disease). 2. Increased hepatic enzymes (AST or ALT) above the upper limit of normal within the past 3 months. These values at University Hospital are ALT>45 U/L and AST> 41 U/L but may vary among laboratories at different institutions. 3. Evidence of fatty liver (as detected by an increase in echogenicity or brightness of the liver) by EUS exam. 4. Liver biopsy for suspected NAFLD is clinically indicated as determined by Dr Naga Chalasani, one of our staff hepatologists who is an expert in NAFLD Inpatient status. 2. Normal liver enzyme tests (AST, ALT). 3. Previous or current alcohol abuse (≥3 drinks/day for men; ≥2 drinks/day for women) 4. Planned liver biopsy within 30 days for known or suspected liver disease. 5. Suspected metastatic lesion in the liver by any previous imaging study or discovered during EUS exam. 6. EUS-FNA of the liver is required for another reason (i.e. suspected metastatic lesion) 7. Newly diagnosed, currently treated or suspected malignancy. (In this case, the diagnosis of NAFLD would not likely impact patient care or survival). Patients with a previously diagnosed malignancy that is in remission will be considered eligible. 8. Previously diagnosed NAFLD including steatosis or NASH (in this situation, another biopsy is not beneficial to the patient). 9. Chronic liver disease including Hepatitis B, Hepatitis C, Wilson's disease, alpha-1-antitrypsin disease, autoimmune hepatitis. 10. Known or suspected cirrhosis. 11. Esophageal or gastric varices by previous imaging or discovered during EUS. 12. Previous liver surgery including resection or transplant. 13. Thrombocytopenia (platelets <150,000) 14. Anemia (hemoglobin <10 gm/dL). 15. Coagulopathy (INR>1.2 or aPTT > 35 secs). 16. Use of coumadin or other anticoagulants. 17. Use of aspirin or nonsteroidal antinflammatory product within 7 days of EUS. 18. Total bilirubin >2.0 mg/dL and dilated bile duct on previous imaging study. 19. Inability to provide informed consent. 20. Pregnancy or suspected pregnancy | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 35.0-999.0, Pancreatic Cancer Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR Persons 35 years old or older with Peutz-Jeghers syndrome; OR Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks Persons with contraindication to iodinated contrast Allergy to iodinated contrast Renal insufficiency (serum creatinine > 1.5 mg/dl) Patients with contraindication to ionizing radiation Pregnancy Patients with previous pancreatic surgery Contraindication to secretin Allergy to secretin Acute pancreatitis | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Ductal Adenocarcinoma Chronic Pancreatitis Autoimmune Pancreatitis a. Suspected pancreatic adenocarcinoma, age 35 to 99 years. 2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP). 2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan. 2c. To answer pain questionnaire before first CT perfusion scan. 2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire. 3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or 3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation . Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion. 1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size. 2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification. 3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis . Any Cohort: 4. Pregnant. 5. Prior iodine contrast reactions. 6. Iodine allergy. 7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl. 8. Any contraindication to having a CT scan with iodine contrast | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Males or females at least 18 years old. 2. Patient has not been previously enrolled in the genebank registry. 3. Patient able to give informed consent. 4. Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year. 5. Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 6. Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only). 8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only). (Cleveland Clinic will follow 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8). 9. Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments. 10. Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D). 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias None except as noted in the | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Invasive Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v6 Stage IV Breast Cancer AJCC v6 and v7 Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting Stage IV disease or stage IIIB disease (using American Joint Committee on Cancer [AJCC] 6th edition) not amenable to local therapy Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse Tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells will be considered positive Postmenopausal women are eligible for this trial; before study registration, menopausal status must be defined according to the below Age >= 55 years and one year or more of amenorrhea Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml For women age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay < 20 pg/ml Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration) Ovarian suppression on a luteinizing hormone-releasing hormone (LH-RH) agonist | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer ECOG performance status of 0 or 1. 2. Patients must be >/= 18 years of age. There will be no upper age restriction. 3. Cytologic or histologic proof of adenocarcinoma of the pancreas. Patients can have tumor originating in any part of the pancreas. Islet cell tumors are not eligible. Only patients with non metastatic, unresectable disease are eligible. Patients who cannot undergo resection because of underlying medical problems are also eligible. Patients with regional nodal disease are eligible. 4. All patients must be staged with a physical exam, CXR, and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. If a tumor does not meet this definition and is found to be unresectable at surgical exploration, then that tumor is considered unresectable. 5. Patients may have received prior chemotherapy but not prior radiation therapy to the upper abdomen. 6. Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets >100,000/ul. 7. Hepatic function: Total bilirubin less than 5mg/dL. If the patient required an endobiliary stent, the bilirubin level must have declined on consecutive measurements indicating adequate biliary decompression; alanine aminotransferase (ALT) </= 5 times the upper limit of normal. 8. Renal function: BUN </= 30 mg%, creatinine </= 1.5 mg% and creatinine clearance >/= 30ml/min (estimated as calculated with Cockcroft-Gault equation). Note: In patients with moderate renal impairment (estimated creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose is recommended. 9. Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary Prior abdominal radiotherapy. 2. Imaging (CT or MRI) or endoscopic evidence of direct duodenal invasion by tumor. 3. Prior therapy with bevacizumab, cetuximab, or gefitinib. Prior therapy with erlotinib is permitted unless the patient was taken off erlotinib due to treatment failure. 4. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study. 5. Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a monoclonal antibody. 6. Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. 7. Proteinuria at baseline or clinically significant impairment of renal function as demonstrated by urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible). 8. Prior history of cancer within the last five years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with previous malignancies but without evidence of disease for 5 years will be allowed to enter the trial. 9. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable contraceptive method (oral contraceptive , other hormonal contraceptive, intrauterine device, diaphragm or condom). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. 10. Serious, uncontrolled, concurrent infection(s) requiring IV antibiotics or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy. 11. Uncontrolled hypertension [blood pressure of >/=140/90 mmHg on medication], New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease (e.g., aortic aneurysm, aortic dissection) or Class II or greater peripheral vascular disease, history of stroke or TIA within 6 months prior to study enrollment, history of hypertensive crisis or hypertensive encephalopathy. 12. History of active angina or myocardial infarction within 6 months. History of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality. 13. Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol. 14. History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke) 15. Prior history of pulmonary embolism or deep venous thrombosis. 16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study, other than that defined by protocol; fine needle aspirations or core biopsies within 7 days prior to Day 0. 17. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to swallow. 18. Known, existing uncontrolled coagulopathy, INR >/= 1.5. 19. Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed. Intravenous and low-molecular weight heparin are permitted. 20. Patients taking Sorivudine or Brivudine must be off of these drugs for 4 weeks prior to starting capecitabine. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it. 21. Current serious, nonhealing wound, ulcer, or bone fracture. 22. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0. 23. Patients who have had an organ allograft. 24. Inability to comply with study and/or follow-up procedures | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Brain Metastasis Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded 2. Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody. 3. Patients must be at least 18 years. 4. ECOG Performance Status 0, 1 or 2. 5. Life expectancy of at least 12 weeks. 6. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI. 7. Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. 8. Total bilirubin £ 1.5 x upper limit of normal (ULN) 9. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. 10. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).11. PT-INR/PTT < 1.2 x ULN. 12. Written informed consent.13. Able to comply with study and follow-up procedures Mixed small cell and non-small cell lung cancer histology. 2. Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy. 3. Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry. 4. Other concurrent anticancer therapy. 5. Patients with exposure to investigational drug therapy outside of this trial. 6. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. 7. Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication). 8. Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrhythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension. 9. Brain metastases or spinal cord compression, if treated before the start of study treatment, and have any symptoms. Symptoms signs of increased intracranial pressure ,headache,nausea and vomiting,cognitive or affective disturbances,seizures,and focal neurologic symptoms. 10. History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1]. 11. Pregnant or breast-feeding women. 12. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 13. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Chronic Pancreatitis Males and females older than 18 years of age Is clinically indicated for contrast-enhanced MDCT of the pancreas Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic pancreatitis Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative urine pregnancy test on the same day, but prior to, study drug administration Is able and willing to complete all study procedures specified in the protocol Has no clear written indication for contrast enhanced MDCT of the pancreas Has a history of hypersensitivity to iodine-containing compounds Has congestive cardiac failure (class III-IV in accordance with the classification of the New York Heart Association [NYHA]) Presence of a pancreatic stent Is unable to comply with the study requirements including follow-up History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease which, in the opinion of the investigator, precludes study participation History of sensitivity to any of the ingredients in the study drug Pregnancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Abscess, Intra-Abdominal Patients who attained full age (18 years) with intra-abdominal abscesses documented by: A) Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR B) Suspected intra-abdominal abscess and scheduled for operation with at least three of the following fever leucocytosis symptoms referable to the abdominal cavity (nausea, pain) tenderness with or without rebound / abdominal wall rigidity radiological evidence for abscess or gastrointestinal perforation Patients with the following indwelling peritoneal catheter presumed spontaneous bacterial peritonits peripancreatic sepsis or infection secondary to pancreatitis peptic or traumatic perforation of gastrointestinal tract of < 24 h duration traumatic perforation of the small or large bowel of < 12h duration transmural necrosis of the intestine due to acute embolic, thrombotic or obstructive occlusions acute cholecystitis appendicitis without perforation or abscess required open abdomen techniques for management | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Intra-Abdominal Infection Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity) Acute appendicitis: Ruptured or perforated with abscess Acute diverticulitis with perforation and/or abscess Acute cholecystitis (including gangrenous) with either rupture or perforation Acute gastric and duodenal ( > 24 hours) perforation Traumatic (> 12 hours) perforation of the intestines Secondary peritonitis due to perforated viscus Intra-abdominal abscess (including of liver and spleen) Traumatic bowel perforation requiring surgery within 12 hours Perforation of gastroduodenal ulcers requiring surgery within 24 hours other intra-abdominal processes in which the primary etiology was unlikely to be infectious Patients lactating or pregnant Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics Patients with rapidly progressive or terminal illness Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2) Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Carpal Tunnel Syndrome Patients with a clinical diagnosis of carpal tunnel syndrome English speaking patients only Patients less than 18 years old Patients who are pregnant by patient report or intending to become pregnant during the study Patients unwilling or unable to return for follow-up visits prescribed by the study protocol Patients who qualify for in the study, but refuse to participate Patients with evidence of thenar atrophy on exam Patients with a diagnosis of peripheral neuropathy or other neuropathy Patients with previous ipsilateral carpal tunnel injection or release | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 19.0-100.0, Pancreatic Cancer Patients must meet 1 of the following Histologically confirmed adenocarcinoma of the pancreas Resectable stage I-IIA disease or stage IIB or higher disease Must have undergone complete surgical resection of the tumor with curative intent Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan) No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria) Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer) Control participants must meet 1 of the following Chronic pancreatitis OR history of exocrine insufficiency meeting the following | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-85.0, Diverticulosis, Colonic Symptomatic diverticular disease with short lived recurrent abdominal pain on 3 or more days a month years of age Signed informed consent Presence of at least one diverticulum in the left colon Pregnant or lactating women Severe co-morbidity, alcoholism or drug dependence or inability to give informed consent Contraindications to use of Mesalazine as detailed in SmPC Inability to stop NSAIDs (non-steroidal anti-inflammatory agents) or long term antibiotics The use of specific concomitant medications as detailed in the section below Presence of other gastrointestinal inflammatory conditions such as ulcerative colitis, Crohn's disease and Coeliac disease | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Anemia Kidney Diseases Renal Failure, Chronic Kidney Failure, Chronic Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent Patients must already be receiving treatment at time of study entry Patients who are likely to receive for at least 1 year Known intolerance to EPO of any of its excipients Known of suspected Pure Red Cell Aplasia (PRCA) | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Colon Ischemia Aortic Aneurysm Aortic Aneurysm, intact or ruptured Repair by catheter based stent or by open surgery during monitoring Patent rectum Absence of rectal bleeding Lack of informed consent Rectal bleeding Obstructed rectum | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Irritable Bowel Syndrome Women of 18 years of age with IBS-D as defined by the Rome II criteria. The Rome II is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms. Note: Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings. Clinically significant findings may but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis. Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period: 1. ≥ 3 bowel movements/day 2. Bowel urgency 3. Loose or watery stool - Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms? Patients with hard or lumpy stools for more than one day during the baseline period Lactose intolerant patients relieved on a lactose free diet Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial Women of child-bearing potential who do not use an acceptable methods of contraception Pregnant or nursing (lactating) women | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Coronary Artery Disease Decision Making Age 18 and older Scheduled for an angiogram Able to read, write, and speak Norwegian Live within approximately 100 km of Oslo Have a telephone Cognitive impairment | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Recurrent Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IV Thyroid Gland Follicular Carcinoma Stage IV Thyroid Gland Papillary Carcinoma Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants Papillary Follicular Hürthle cell Must have surgically inoperable and/or recurrent or metastatic disease At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake > normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope [RAI] treatment) Presence of new or progressive lesions on CT scan or MRI New lesions on bone scan or PET scan | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible. 2. Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following on abdominal imaging No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence No evidence of visceral or peritoneal metastases NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging outlined above. 3. ≥ 18 years of age 4. ECOG/Zubrod performance status of 0 or 1 5. Baseline weight loss ≤ 15% of premorbid weight 6. Patient must have adequate hematologic, renal, and hepatic function as defined by WBC ≥ 2,000 cells/mm³ ANC ≥ 1,500 cells/mm³ Platelets ≥ 100,000 cells/mm³ Serum bilirubin ≤ 2.5 mg/dL Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min (24 hour urine collection) ALT < 2.5 times upper limit of normal (ULN) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-85.0, Peripheral Vascular Disease Cardiovascular Disease Subject must be 18-85 Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath Subject is an acceptable candidate for emergent vascular surgery Subject agrees to follow-up evaluations to assess for complications related to femoral access site If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7 Body Mass Index (BMI) ³ 35 kg/m2 Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%) Advanced Subject refusal of blood transfusions, should transfusion become necessary | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Mortality Acute Pancreatitis The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome Patients will not be enrolled to the study if any of the following will be present age < 18 and > 80 years recent surgical interventions psychoses pregnancy previously history of chronic pancreatitis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Multiple Myeloma Age ≥ 18 and ≤ 75 Histologic and serologic findings from MSKCC confirming the diagnosis of multiple myeloma. Standard diagnostic for multiple myeloma will be used, as per the revised International Myeloma Working Group diagnostic criteria Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma). If immediate therapy with radiation and high-dose steroids (eg, for cord compression) or with bortezomib-based therapy (eg, for renal failure) is required, the patient is not eligible for this trial Patients may have received 1 cycle of prior therapy with dexamethasone for multiple myeloma Adequate organ function is required, defined as follows ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due to multiple myeloma) Serum bilirubin ≤ 2.0 mg/dl AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of CrCl (see Appendix I): Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula Performance status (ECOG) ≤ 2 (Appendix E) Prior treatment for myeloma except for one cycle of dexamethasone History of thromboembolic disease within the past 6 months regardless of anticoagulation Myocardial infarction within 6 months prior to enrollment, or New York Hospital Association (NYHA) Class III or IV heart failure (see F), uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities Pregnant or breast-feeding women are excluded due to the potential teratogenicity of lenalidomide Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insitu of the cervix, or presence of myelodysplastic or myeloproliferative disease. Patients with prior malignancies with a disease-free interval of ≥ 5 years are eligible Patients who have had prior malignancies within the past 5 years but are considered to be "cured" with a low likelihood of recurrence may be eligible at the discretion of the Principal Investigator Active hepatitis B or C infection HIV 1 or 2 positivity Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Pancreatic Head Mass Age range 18-80 Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma Inability to obtain informed consent Pregnancy Intra-abdominal adhesions that preclude endoscopy Contraindication to upper endoscopy such as stricture, stenosis of the foregut Previous gastric surgery Diagnosis of pancreatic body or tail tumor History or current diagnosis of gastric ulcer Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging Antiplatelet medication not stopped at least 7 days prior to procedure | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Post-operative Pain Postoperative Nausea Postoperative Complications Patients undergoing elective laparoscopic colorectal resection at the Queen's Medical Centre, Nottingham Known allergies to the local anaesthetic Any condition which may cause tolerance to opiates (eg chronic opioid use) Inability to use a PCA Patients less than 45kgs for whom local anaesthetic toxicity may become an issue Adults unable to consent for themselves | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-79.0, Metastatic Pancreatic Cancer A participant will be eligible for in this study only if all of the following are met: 1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded. 2. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study. 3. Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media). 4. Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual. 5. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study. 6. Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained ≤14 days prior to randomization): Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100,000/mm^3 (100 × 10^9/L); Hemoglobin (Hgb) ≥ 9 g/dL. 7. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization): Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed Total bilirubin ≤ ULN Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m^2, lean body weight should be used instead. 8. Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%). 9. Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization). 10. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true. 11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1. 12. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities A patient will not be eligible for in this study if any of the following apply: 1. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart). 2. Patient has only locally advanced disease. 3. Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization. 4. Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization. 5. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years. 6. Patient uses Coumadin. 7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 8. Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C. 9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. 10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information. 11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa). 12. Patients with a history of interstitial lung disease. 13. History of chronic leukemias (e.g., chronic lymphocytic leukemia). 14. Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year. 15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease). 16. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity. 17. Patient is enrolled in any other clinical protocol or investigational trial. 18. Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Heart Failure Men and women of 18 years old or older history and clinical findings of heart failure for at least three months before screening Patients have to be in New York Heart Association (NYHA) class II, III, or IV and clinically stable Left ventricular ejection fraction <50% GFR ≤ 40 ml/min/1.73m² as calculated the abbreviated MDRD formula pregnancy as determined by urine test for reproductive-aged females current or past renal replacement therapy current treatment for hyperphosphatemia a history of renal transplantation or CABG Symptoms consistent with Canadian Cardiovascular Society > class 1 angina Inability to comprehend or unwillingness to sign informed consent chronic atrial fibrillation | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Complicated Intra-Abdominal Infections Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics Age under 18 years | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Acute Abdomen age > 18 abdominal pain > 2h and < 7 days pregnancy acute abdominal trauma allergy to iodinated contrast media severe renal insufficiency metformin medication combined with elevated plasma creatinin level lack of cooperation (if informed consent is not possible) abdominal pain combined with bleeding shock | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to treatment No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI with gadolinium and/or manganese), and all patients must be staged with a physical exam, chest CT, and abdominal CT with intravenous contrast Only potentially resectable patients are eligible. Potentially resectable is defined as: a)no extrapancreatic disease, b)no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, and c)no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence years of age or older ECOG Performance status of 0 or 1 Women of child bearing potential must practice adequate contraception and to refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment Lab values as specified in the protocol Patients cannot have hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, or ongoing infection as manifested by fever Pregnant or lactating women Life expectancy < 3 months Serious, uncontrolled, concurrent infection(s) Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor Treatment for other cancers within the last five years, except cured non-melanoma skin cancer and treated in situ cervical cancer Clinically significant cardiac disease or myocardial infarction within the last 12 months Other serious uncontrolled medical conditions that the investigator feels might compromise study participation Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-999.0, Liver Abscess Age greater or equal to 20 years Clinical diagnosis of liver abscess, supported by an abdominal CT scan, documenting the presence of liver abscess, in the absence of biliary tract stones (except for gallstones without biliary tract dilatation), biliary tract dilatation and biliary tract tumors. Clinical diagnosis of liver abscess includes symptoms of fever, chills, right upper quadrant abdominal pain or knocking tenderness Read, understood and signed informed consent form Presence of septic metastatic infections to the CNS or eye at presentation Cultures positive for an organism resistant to study drugs II score greater or equal to 20 Co-existent disease considered likely to affect the outcome of the study (e.g., biliary tract stones and malignancy) Patients with ruptured liver abscess Severe hepatic insufficiency (Child-Pugh C) or elevated serum transaminases (GPT) to greater than 5 times the upper limit of normal Patients who are pregnant or lactating Known hypersensitivity to b-lactams or fluoroquinolones Known prolongation of the QT interval Patients with uncorrected hypokalemia | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 35.0-999.0, Coronary Vasospasm Microvascular Angina Coronary Artery Disease Adults between 35 and 95 years old with angina pectoris and/or dyspnea suggestive of coronary artery disease with non-invasive proof of coronary ischemia or high pre-test probability for CAD who will be referred for coronary angiography Serum creatinine < 1,4 md/dl Left ventricular ejection fraction > 50% Patients under 35 years and above 95 years of age Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Colitis Crohn's Disease Inflammatory Bowel Disease Male or female; 18-75 years old 2. All female subjects must have negative pregnancy test results at screening and baseline. Women of childbearing potential (WoCBP) must be using simultaneously double-barrier or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc. Hormone replacement as either oral or implantable is acceptable as one form), from the time of screening and for the duration of the study, through study completion and for 4 months following study completion. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least two (2) years prior to initial dosing. Menopause will be confirmed by a serum FSH level of > 40 IU/L at screening. Pregnancy test will be required only at screening. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History/Current Medical Conditions section of the CRF. If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing. 3. Male subjects willing to use simultaneously two acceptable methods of contraception (e.g. spermicidal gel plus condom) for entire duration of the study, up to the study completion visit and at least for 6 months following the completion of the study. Periodic abstinence and withdrawal are not acceptable methods of contraception. 4. Diagnosis of Crohn's disease for at least 3 months prior to screening 5. Confirmation of Crohn's disease by endoscopic or imaging examination 6. Moderate to severe active Crohn's disease at baseline, defined as: --CDAI greater than or equal to 220 and less than or equal to 450 7. Patients with active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months Patients who are being treated with azathioprine, 6-MP or MTX are eligible but must have been on a stable dose for at least 10 weeks prior to baseline Patients treated with corticosteroids are eligible but must have been on stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline Patients who are being treated with immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not eligible. These subjects will be required to stop immunosuppressants prior to baseline. These patients are eligible after observing a wash out period as specified in criterion #7. 8. Absence of clinically relevant abnormalities for screening laboratory test results 9. Able to communicate well with the investigator, and to understand and comply with the requirements of the study. 10. Understand and sign the written informed consent Subjects meeting any of the following will be excluded from entry into or continuation in the study, unless sponsor approval is obtained: 1. Body Mass Index is greater than 34. 2. Positive Purified Protein Derivative (PPD) tuberculin skin test of greater than or equal to 5 mm at screening or 6 months prior to screening. A positive PPD test will be defined using the [MMWR 2000 guidance], summarized as for tuberculin positivity by risk group A PPD test should not be done in subjects who had a tuberculosis vaccination in the past. These subjects will be eligible to participate if, according to local guidelines, latent tuberculosis can be excluded For those study sites using QuantiFeron test a positive test at screening will the subject from the participation in the study If the result for either PPD or QuantiFeron test is indeterminate, the subject will be excluded. 3. Subjects with symptoms associated with active bowel stricturing disease and pre-stenotic dilation on radiographs. 4. Fistulizing disease if complicated by sepsis and/or untreated abscess. 5. Subjects with multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake. 6. a. Concomitant treatment with anti-TNF-alpha therapy (or other biological therapy) and systemic immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus, except azathioprine, its metabolite 6-MP and MTX. The following washout period will be required for subjects to be eligible to participate in the trial Three (3) months washout prior to baseline for certolizumab Two (2) months washout prior to baseline for adalimumab, etanercept and infliximab One (1) month washout prior to baseline for cyclosporine, mycophenolate, pimecrolimus, tacrolimus, and any other systemic immunosuppressants not listed under criterion # 7b 6b. Patients who are being treated with azathioprine, 6-MP or MTX are eligible but must have been on a stable dose for at least 10 weeks prior to baseline and throughout the whole study period. 7. Prior therapy with rituximab. 8. Receiving corticosteroid dose equivalent to a greater than 40mg dose of prednisone per day. 9. Subjects demonstrating clinical improvement due to other Crohn's therapy. 10. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the subject unsuitable for the trial. 11. Subjects with active or history of clinically significant cardiac abnormalities, for example Requiring drugs with QT-prolonging properties (e.g. antiarrhythmic drugs, such as amiodarone, sotalol, dofetilide, quinidine, procainamide, disopyramide) QTc greater than 450msec long QT-syndrome (own or with a family history) or with a family history of sudden unexplained death Left branch bundle block (LBBB), or subjects who have been hospitalized for heart failure of cardiac etiology, in the previous 6 months, and subjects who have significant and persistent left-ventricular dysfunction (LVEF less than 40%) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Skin Diseases, Bacterial Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia Must not have received treatment with another systemic antibiotic for the current ABSSI Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis Infections involving burns, human or animal bites, or chronic diabetic foot ulcers Suspected polymicrobial infection involving Pseudomonas aeruginosa Anticipated need for >14 days of antibiotic therapy Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis Known significant renal, hepatic, or hematologic impairment Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Coronary Artery Disease The subject is a man or woman and is 18 years of age or older. 2. For women of childbearing potential, the results of a urine or serum human chorionic gonadotropin (beta-HCG) pregnancy test, done at screening (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening. 3. The subject is conscious and able to comply with study procedures. 4. Written, informed consent is obtained. 5. The subject is suspected, as a results of their clinical signs and symptoms, of having CAD (most subjects will probably be included using these criteria). 6. The subject is referred to a quantitative CXA for known or suspected CAD or has undergone quantitative CXA within 4 weeks prior to MRI without any intervention or change of symptoms since the CXA examination. 7. The subject is referred for a SPECT for a functional evaluation of myocardial perfusion or has undergone SPECT within 4 weeks prior to MRI without any intervention, or change in symptoms, between the 2 examinations (the findings of SPECT will not be taken into account for purposes) The subject is lactating. 2. The subject is pregnant as defined by a urine or serum beta-HCG pregnancy test obtained within the 24 hours before dosing. 3. The subject was previously included in this study. 4. The subject received an investigational product in the 30 days before or will receive one during or in the 30 days after investigational product administration. 5. The subject has known allergies or a contra-indication to the investigational product. 6. The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month. 7. The subject received or is scheduled to receive an MRI contrast medium (other than the investigational product) within 24 hours prior to or in the 24 hours following the investigational product administration. 8. The subject received or is scheduled to receive an X-ray contrast medium within 12 hours prior to or 12 hours following the investigational product administration. 9. The subject received or is scheduled to receive a SPECT radiotracer within 24 hours prior to or 24 hours following the investigational product administration. 10. The subject received or is scheduled to receive a stress examination (other than the MR stress examination in this study) within 24 hours prior to or 24 hours following the investigational product administration. 11. The subject has experienced a myocardial infarction within the last 14 days. 12. The subject has experienced more than 1 previous myocardial infarction. 13. The subject has a bypass graft. 14. The subject has second or third degree atrioventricular block, sick sinus syndrome or a symptomatic bradycardia. 15. The subject suffers from asthma, bronchospasms or obstructive pulmonary disease. 16. The subject has severe hypotension (<90 mm Hg systolic). 17. The subject has unstable angina pectoris. 18. The subject has a decompensated congestive cardiac failure. 19. The subject's ECG shows a prolonged QT interval. 20. The subject has a contra-indication for MRI according to clinical guidelines, local regulations or manufacturer's recommendations. 21. The subject has cardiac arrhythmia considered by the investigator to be of a type or of a sufficient degree to make the subject unsuitable for the study. 22. The subject has consumed coffee, tea, coke, chocolate or other caffeinated beverages in the last 24 hours before the adenosine administration | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 14.0-999.0, Anemia, Sickle Cell Transfusion Hemosiderosis Male or female patients with sickle cell anemia (SS or SB thalassemia) with transfusional iron overload Currently not on chronic or frequent transfusion Age equal or greater then 14 years Patients with iron overload from repeated blood transfusion, as defined by one of the following: 1. For patients greater then 16 years old receiving simple transfusions: estimated lifetime history of receipt of at least 100 ml/kg or 15 adult units of packed red blood cells, OR 2. For patients equal to or less then 16 years old receiving simple transfusions: estimated lifetime history of receipt of at least 100 ml/kg of packed red blood cells, OR 3. For any patient: liver iron content equal/greater then 3 mg Fe/g dw as measured by biopsy or magnetic resonance imaging who have not been adequately chelated since that measurement, OR 4. a serum ferritin equal/greater then 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year. Samples must be obtained in the absence of concomitant infection Life expectancy equal/greater then 12 months Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) for treatment pilot study Meets all for screening LIC by MRI greater than or equal to 8 mg/g Blood transfusion within 12 weeks of the day 0 hemolysis labs Currently requires blood transfusion more than three times a year Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia Serum creatinine above the upper limit of normal Concomitant treatment with erythropoietin or its analogs AST or ALT greater then 250 U/L during screening (patients may be re-screened at a later date if the cause of the elevation is known to be due to a transient process) Patients receiving currently on chelation will be asked to stop for one week before starting or restarting Exjade. (a equal/greater then 1 week washout period prior to first dose of study drug is required) History of HIV positive test result (ELISA or Western blot) History of drug or alcohol abuse within the 12 months prior to enrollment Patients with uncontrolled systemic hypertension | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Tumors in Liver Tumors in Pancreas adult over 18 years tumors in liver and/or pancreas low coagulation factors mentally ill patients | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Appendicitis Suspected acute appendicitis on clinical and radiographic (CT) grounds Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis 2. Prior open laparotomy with incision through the umbilicus 3. Body Mass Index > 35 4. Age <18 years 5. Mental illness, dementia, or inability to provide informed consent 6. Chronic pain requiring daily medication (including opiate and NSAIDs) 7. Pregnancy 8. Alternative diagnosis found by diagnostic laparoscopy (post-randomization) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Metastatic Pancreatic Adenocarcinoma have advanced or metastatic pancreatic adenocarcinoma who have not previously received any chemotherapy or biotherapy. Patients who have received radiotherapy with or without radiotherapy enhancers (such as low dose 5-FU) will be eligible have evidence of measurable disease. However, lesions in a previous radiation field are considered non-evaluable for response. Therefore, patients must have a measurable lesion that is not in a previously irradiated field to be eligible have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy or surgical procedures, i.e., all such effects must have resolved to Common Terminology for Adverse Events (CTCAE, Version 3.0) Grade ≤1. Surgery (except biopsies) must have occurred at least 28 days prior to study enrolment have received NO radiotherapy within 28 days prior to receiving study drug have an ECOG Performance Score ≤ 2 have a life expectancy of at least 3 months absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI units 10^9/L]; Platelets ≥ 100 x10^9 [SI units 10^9/L] (without platelet transfusion); Serum creatinine ≤ 1.5 x ULN; Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if patients have liver metastasis) negative pregnancy test for females of childbearing potential no concurrent therapy with any other investigational anticancer agent while on study have a history of or current evidence of brain metastasis(es) be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C be a pregnant or breast-feeding woman have clinically significant cardiac disease have dementia or altered mental status that would prohibit informed consent have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Colonic Diverticulitis adults with CT sign of acute colonic uncomplicated diverticulitis elevated CRP and LPK Temp.38c or more patients with peritonitis, sepsis or CT sign of complicated diverticulitis with abscesses or free abdominal air pregnancy immunological incompetence and immunosuppressive therapy | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Recurrent Uterine Corpus Carcinoma Histologically confirmed* endometrial epithelial carcinoma, including any of the following cell types Endometrioid adenocarcinoma Serous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma not otherwise specified Mucinous adenocarcinoma Squamous cell carcinoma Transitional cell carcinoma | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Diverticulitis Informed consent A first episode of uncomplicated diverticulitis (see definitions), which was documented with CT scan, required hospital admission, and was successfully managed with intravenous antibiotics Or A first episode of complicated diverticulitis (Hinchey I or II see definition), requiring CT scan-guided percutaneous drainage, and successfully managed without surgery in a patient either unfit for, or refusing to undergo elective sigmoid resection Age < 18 or > 90 Associated condition of the colon or rectum (cancer, IBD, polyps) Patient unable to communicate in French, English or German | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Age 18 years or older Informed written consent Patient scheduled for previously planned EGD with upper EUS Patients with known adenocarcinoma of the pancreas included in the cancer group Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample) Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor) Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome) Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer) Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm) Active visible inflammation/ulcer in the stomach or the duodenum Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Diverticulitis age over 18 clinical suspicion of perforated diverticulitis with indication for urgent surgery CT scan with free air and findings suggesting diverticulitis patient tolerates general anaesthesia patients written consent pregnancy bowel obstruction | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 19.0-100.0, Cardiovascular Risk Factors Age ≥ 65 years 2. Hypertension (HTN) 3. Diabetes 4. Obesity (body mass index [BMI] >35) 5. Renal insufficiency 6. Tobacco usage 7. Hypercholesterolemia 8. Sleep apnea/heavy snoring at night 9. Clinical diagnosis of CHF as defined by: 1. Dyspnea on exertion 2. Paroxysmal nocturnal dyspnea 3. Orthopnea 4. Elevated jugular venous pressure 5. Pulmonary rales 6. Third heart sound 7. Cardiomegaly or pulmonary edema on chest x-ray 8. Peripheral edema 9. Hepatomegaly 10. Pleural effusion 10. Palpitations/irregular heart beats 11. Chest pain at rest and or exercise 12. Murmur on examination 13. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) 14. Known valvular disease 15. Known stroke or transient ischemic attacks (TIA) Patients expected to say in the hospital for less than 24 hours. 2. Inability of undergo TEE and TTE 3. Clinical evidence or suspicion of elevated intracranial pressure. 4. Preoperative shock or systemic sepsis 5. Emergency Operation 6. ASA Class V 7. Inability of give informed consent 8. Participation in another clinical trial 9. Prisoner | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 19.0-75.0, Renal Interstitial Fibrosis Recipient of a primary or secondary deceased or living (related or not) donor kidney transplant and who requires basiliximab induction therapy Cold ischemia time < 30 hours Women of child-bearing age, even those with a history of infertility, must have had a negative pregnancy test during the 7 days before screening or at the time of screening, and must use a recognized and reliable method of contraception throughout the study and for 2 months after discontinuing the study treatment Patients who want and are able to take part in the entire study, and have given their written consent Patients who are registered with a French national health insurance scheme or are covered by such a scheme Recipient of multi-organ transplantation, including dual kidneys, or who have previously received non renal transplant organ Patients receiving a graft from a non-heart-beating donor Anti-HLA antibody levels ≥ 20% in the last 3 months before the inclusion ABO incompatible graft or with positive cross match T Severe hyperlipidemia: total cholesterol ≥ 9.1 mmol/L (≥ 350 mg/dL) and/or triglycerides ≥ 8.5 mmol/L (≥ 750 mg/dL) despite appropriate lipid-lowering therapy Known hypersensitivity or contraindications to mycophenolic acid, cyclosporine or lactose Known hypersensitivity or contraindications to macrolides or drugs of the mTOR inhibitor class HIV seropositive, or active chronic hepatitis B (HBs Ab) or C. Results obtained during the 6 months before the are accepted. Recipients from donors with hepatitis B or C will be excluded Patients with thrombocytopenia (≤ 75000/mm3), absolute neutrophil count (≤ 1500/mm3), leukocytopenia (≤ 2500/mm3) and/or hemoglobin < 8g/dL at the visit ASAT, ALAT or total bilirubin ≥ 3 UNL | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-65.0, Pancreatic Cancer At least two first or two second degree relatives with pancreatic adenocarcinoma (the study subject will be either 10 years younger than the youngest age at which a relative was diagnosed with pancreatic cancer, or the study subject will be at least 25 years of age) Fulfills or has undergone genetic testing which confirms BRCA1 (BReast CAncer gene 1), BRCA2 (BReast CAncer gene 2), Familial Atypical Multiple Mole Melanoma, PeutzJeghers, Hereditary nonpolyposis colorectal cancer (HNPCC), Hereditary Pancreatitis, or ataxiatelangiectasia Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker,berry aneurysm clips, neural stimulator or cochlear implants) Known pancreatic malignancy or dysplasia Pregnancy History of sensitivity to secretin Creatinine greater than 2 Unwillingness or inability to provide informed consent | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Knee Osteoarthritis Disuse Atrophy Individuals who are scheduled for elective Total Knee Replacement surgery Individuals who are at least 18 years of age Individuals with a body mass index (BMI) <40 Individuals who are walking independently with or without assistive devices Must be able and willing to complete all study assessments and to be followed for the full course of the study Must be able to read, write and follow instructions in English Must be able and willing to provide informed consent Must be willing and able to attend for pre-op assessment Individuals who have failed the pre-operative assessment Individuals with a history of foot and/or ankle pathology Individuals with a history of tibial or femoral fractures Individuals with a history of underlying neurological conditions Individuals with physical conditions which would make them unable to perform study procedures Individuals with a total hip replacement Individuals undergoing revision TKA of the same operated leg Pregnant women or inadequate precautions to prevent pregnancy Diagnosis of a medical condition that would contraindicate treatment with the product,e.g skin lesions at electrode site Individuals with an active implanted medical device (i.e. pacemaker, pump) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Diverticulitis Only left-sided uncomplicated (mild) acute diverticulitis Clinical suspicion of acute diverticulitis. For acute diagnostic work-up: ultrasound or CT proven diverticulitis. In the case of diverticulitis-negative ultrasound in clinically suspected patients an intravenous contrast-enhanced CT scan is mandatory for confirmation of diverticulitis or of other pathology. CT for Hinchey/Ambrosetti classification (which is a CT-based classification system) is needed for all patients, but can be delayed 1 day in those with ultrasound diagnosis. Staging diverticulitis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and "mild" diverticulitis (1a Confined pericolic inflammation, 1b Confined small (smaller than 5cm) pericolic abscess) are included All patients with informed consent Previous radiological (ultrasound and/or CT) proven episode of diverticulitis Colonic cancer Inflammatory bowel disease (ulcerative colitis, Crohn's disease) Hinchey stages 2, 3 and 4 or "severe" diverticulitis according to the Ambrosetti which require surgical or percutaneous treatment Disease with expected survival of less than 6 months Contraindication for the use of the study medication (e.g. patients with advanced renal failure or allergy to antibiotics used in this study) Pregnancy, breastfeeding ASA (American Society of Anaesthesiologists) classification > III Immunocompromised patients Clinical suspicion of bacteraemia (i.e. sepsis) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Diverticular Disease age ≥ 18 years both males and females patients positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare patients who have given their free and informed consent complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding) ascertained hypersensitivity to the salicylates any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial clinically significant renal or hepatic impairment esophageal, gastric or duodenal ulcer within 30 days prior to randomisation patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) treatment with any investigational drug within the previous 30 days treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets recent history or suspicion of alcohol abuse or drug addiction patients who become unable to conform to protocol | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Bladder Cancer Histologically confirmed invasive bladder carcinoma, including the following cellular types Adenocarcinoma Transitional cell carcinoma Squamous cell carcinoma Clinical stage G1-3, pT2a-4 disease Localized disease No bone or visceral metastases No lymph node metastases Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy WHO performance status 0-1 | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-85.0, Pancreatic Cancer Tissue confirmed diagnosis of pancreatic adenocarcinoma Underwent surgical resection for adenocarcinoma at the Columbia University Medical Center between 2001-2009 Did not undergo surgery | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Cytological or histological confirmation of pancreatic adenocarcinoma is required. 2. Only patients with localized and apparently resectable, non-metastatic tumors are eligible. All patients must be staged with a chest X-ray or chest CT and abdominal and pelvic CT scan or MRI. One of the following radiological must be met and recorded in chart by dedicated surgeon prior to enrollment. A)Localized, potentially resectable : 1) no evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery; 2) no evidence of tumor encasement or occlusion of superior mesenteric vein (SMV) or the SMV/portal vein(PV) confluence; 3) no evidence of visceral or peritoneal metastasis B)Borderline resectable: 1) no extra pancreatic disease, (2) the following possible tumor-vessel relationships: an SMV-PV confluence that can be reconstructed even if short segment venous occlusion is present; tumor abutment of the SMA of ≤180°; or short segment encasement of the hepatic artery amenable to resection and reconstruction. Patients with the following radiological are NOT eligible: A) Locally advanced disease: (1) no extra pancreatic disease, (2) tumor encasement of the SMA or celiac axis defined as tumor involvement of >180° of the arterial circumference. B) Radiographic evidence of distant organ or peritoneal metastases. 3. Age > 18 years. 4. ECOG performance status 0 and 1. 5. Patient must have adequate hematological, renal and hepatic function defined as: WBC > 2,000 cells/mm3 ANC>1500 cells/mm3 Hemoglobin > 9.0 g/dL Platelets > 100,000 cells/mm3 Serum creatinine < 1.5 x upper limit of normal (UNL) or a calculated creatinine clearance of > 50 mL/min calculated by Cockcroft-Gault method Total bilirubin < 2.5 mg/dl AST < 3x upper limits of normal ALT < 3x upper limits of normal 6. Serum calcium and magnesium levels within limits of normal 7. Patients may not have any prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 2. Psychiatric illness which would prevent the patient from giving informed consent. 3. Serious medical illness which would limit anticipated survival to < 12 weeks. 4. Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for six months after the trial. Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential. All patients (men and women) of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy. 5. Inability to swallow medication. Patients should have adequate, unassisted oral intake. 6. Inability to hold still and cooperate during radiotherapy. 7. Prior history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis 18 years or older 2. Able to provide consent 3. More than one documented episode of pancreatitis (>3 fold elevation of amylase and or lipase with abdominal pain or with body imaging consistent with pancreatitis: need two of the three) 4. Subjects with abdominal pain and enzyme elevation which is <3 fold above normal or absence of imaging findings: these subjects who are undergoing endoscopic interventions but do not fit the "classic criteria" for pancreatitis will be included but the analysis of data of these subjects would be done separately. Note: subjects with a diagnosis of pancreas divisum and or Sphincter of Oddi dysfunction diagnosed prior to or after entry into the study will be included in the study but their data will be analyzed separately because of the controversy regarding the association of these entities with pancreatitis Unable to give informed consent. 2. Definite evidence of biliary or alcoholic pancreatitis. 3. Clear evidence of hypertriglyceridemia-induced pancreatitis (triglycerides >1,000 mg/dl). 4. Post-ERCP pancreatitis, drug-induced pancreatitis, or any identifiable cause for pancreatitis. 5. History of pancreatic surgery | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-40.0, Carcinomas Amyloidosis Anal Cancer Anemia Cholangiocarcinoma of the Extrahepatic Bile Duct Transitional Cell Carcinoma of Bladder Bone Marrow Transplant Failure Bone Cancer Cancer of Brain and Nervous System Breast Cancer Carcinoma of the Large Intestine Endocrine Cancer Esophageal Cancer Eye Cancer Gall Bladder Cancer Gastric (Stomach) Cancer Gastrooesophageal Cancer Gastrointestinal Stromal Tumor (GIST) Gynecologic Cancers Head and Neck Cancers Hepatobiliary Neoplasm Kidney (Renal Cell) Cancer Leukemia Lung Cancer Hodgkin Disease Lymphoma, Non-Hodgkin Mesothelioma Multiple Myeloma Myelodysplastic Syndromes (MDS) Neuroendocrine Tumors Myeloproliferative Disorders Pancreatic Cancer Prostate Cancer Skin Cancer Soft Tissue Sarcoma Testicular Cancer Thymus Cancer Thyroid Cancer Criteria:1.) Past exposure to anthracycline chemotherapy for cancer 2.) Echocardiogram at least six months after exposure to anthracyclines (in patients over the age of 40, the echocardiogram must be obtained within 6 months of anthracycline exposure) 3.) Ability to understand and the willingness to sign a written informed consent document. We have no age, gender, or ethnic background limitations. Due to the increased frequency of cardiovascular disease from other causes in adults over 40 years, we will limit enrollment to those patients with an echocardiogram 6 months after the completion of anthracycline exposure. Children will be included and will be eligible if they have an echocardiogram at least 6 months after completion of anthracycline treatment ) Congenital heart disease (other than patent foramen ovale) 2.) Pre-existing cardiomyopathy before anthracycline administration 3.) Patients with Down syndrome 4.) Patients receiving B-blocker therapy at the time of anthracycline exposure 5.) Pregnant patients (if their echocardiogram was obtained either during pregnancy or within three months of pregnancy) All participants will be cancer survivors. To minimize bias from post-partum cardiomyopathy, pregnant patients will be excluded if their echocardiogram was obtained during pregnancy or within three months of pregnancy. HIV-positive persons will not be excluded from the study. Of note, some patients receive a MUGA (multigated acquisition) study to evaluate left ventricular ejection fraction. Patients who receive only a MUGA scan will NOT be included in the study an echocardiogram is necessary | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-95.0, Nephrotoxicity of CT Contrast Agents CT Scans in Those With Renal Compromise Sensitivity to CT Contrast Agents US With CEUS as Replacement for Unenhanced CT Scan unenhanced CT scan of abdomen known renal compromise known hypersensitivity to CT contrast agents CT scan performed with contrast agent | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Chronic Pancreatitis Diagnosis of Chronic Pancreatitis Exocrine Pancreatic Insufficiency Chronic abdominal pain Acute pancreatitis Active alcohol consumption Uncontrolled diabetes | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Diverticulosis Diverticulitis Adult patients affected by symptomatic diverticulosis Informed consent obtained and signed Expected compliance Patients supplemented with other probiotics Patients treated with antibiotics Patients affected by hearth failure, renal failure, neoplasia | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 1.0-30.0, Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome Hypodiploid B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 B-ALL patients must have an initial white blood cell count < 50,000/uL Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932 Patients receiving prior steroid therapy may be eligible for AALL0932 Patients with central nervous system 3 (CNS3) leukemia CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy B-ALL patients with testicular leukemia are not eligible for AALL0932 For B-LLy patients the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Appendicitis History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant Fever ≥ 38°C and/or WCC > 10 X 103 cells per mL Right lower quadrant guarding, and tenderness on physical examination All patients included were 18-75 years old Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable to urinary or gynaecological problems) History of symptoms > 5 days and/or a palpable mass in the right lower quadrant, suggesting an appendiceal abscess treated with antibiotics and possible percutaneous drainage Patients with the following conditions are also excluded: history of cirrhosis and coagulation disorders, generalized peritonitis, shock on admission, previous abdominal surgery, ascites, suspected or proven malignancy, contraindication to general anesthesia (severe cardiac and/or pulmonary disease), inability to give informed consent due to mental disability, and pregnancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Inflammatory Bowel Diseases Major Patient IBD (RCH or MC) diagnosed according to the clinical, endoscopic and histological Accepting the sampling of blood Patient member or legal successor of a national insurance scheme Taken care medical in the service of gastroenterology of CHU de Saint Etienne Patient having signed the form of consent Minor Patient or uncapable Patient suffering from indefinite colitis Refusal of the sampling of blood Pregnant Woman Incapacity or refusal to sign the consent writes Subjects deprived of freedom by a court or administrative order Use of an anti-TNF. According to the indications ensuing from the Sonic trial or from the strategy " Top Down " | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma Not amenable to potentially curative surgical resection At least 1 prior regimen of chemotherapy, preferably gemcitabine-based, for metastatic disease Evidence of disease progression Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan Available archived tumor tissue (baseline core biopsies or surgical tumor blocks) No diagnosis by fine-needle aspiration only No known brain metastases Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (Karnofsky 70-100%) White blood cell count (WBC) ≥ 3,000/mm³ | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Mass on Imaging Patients 19 years of age and older 2. Patients undergoing EUS FNA for solid lesions in the pancreas Pancreatic cystic lesions without significant mass effect 2. Pancreatic masses that cannot be accessed by transduodenal FNA in surgically resectable cases 3. Known chronic pancreatitis with pancreaticolithiasis 4. History of acute pancreatitis in the preceding 4 weeks 5. History of gastric surgery or symptoms of gastric outlet obstruction 6. Pregnancy | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Bacterial Infection Postoperative Infection Abdominal Infection Suspected infection in the GI tract or after abdominal surgery Age < 18 years | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Wound Infection Abscess Systemic Inflammation Cellulitis Subjects may be included in the study if they meet all of the following 1. Males or females ≥18 years old 2. Diagnosis of suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 7 days of IV therapy 3. An includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess 4. must present with at least 2 signs and symptoms 5. Able to give informed consent and willing to comply with all required study procedures Subjects will be excluded from the study if any of the following apply prior to randomization: 1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days The causative Gram-positive pathogen(s)isolated from the site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or Documented failure to previous antibiotic therapy is available. Documentation of treatment failure must be recorded Patient received a single dose of a short acting antibacterial therapy three or more days before randomization 2. Infections associated with, or in close proximity to, a prosthetic device 3. Severe sepsis or refractory shock 4. Known or suspected bacteremia at time of screening 5. due to or associated with any of the following Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens Diabetic foot infections Concomitant infection at another site not including a secondary lesion Infected burns | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Wound Infection Abscess Systemic Inflammation Cellulitis Subjects may be included in the study if they meet all of the following 1. Males or females ≥18 years old 2. Diagnosis of suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy 3. An includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess 4. must present with at least 2 signs and symptoms 5. Able to give informed consent and willing to comply with all required study procedures Subjects will be excluded from the study if any of the following apply prior to randomization: 1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days The causative Gram-positive pathogen(s) isolated from the site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or Documented failure to previous antibiotic therapy is available. Documentation of treatment failure must be recorded Patient received a single dose of a short acting antibacterial therapy three or more days before randomization 2. Infections associated with, or in close proximity to, a prosthetic device 3. Severe sepsis or refractory shock 4. Known or suspected bacteremia at time of screening 5. due to or associated with any of the following Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens Diabetic foot infections Concomitant infection at another site not including a secondary lesion Infected burns A primary infection secondary to a pre-existing skin disease with associated inflammatory changes | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 12.0-999.0, Melanoma of Unknown Primary Recurrent Melanoma Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must a total body positron emission tomography (PET)-computed tomography (CT) scan (with or without brain) and brain magnetic resonance imaging (MRI) or CT (if MRI is contraindicated); if PET-CT cannot be done, CT of neck, chest, abdomen, and pelvis should be done If for some reason a CT cannot be done, an MRI may be done instead; any other imaging studies if performed (eg, bone scan) must show no evidence of disease Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System) Stage IIIB T1-4b N1a M0 T1-4b N2a M0 T1-4b N1b M0 T1-4b N2b M0 T1-4b N2c M0 Stage IIIC | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Diverticulitis All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain leukocytosis (>11x109) fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) The CT for the diagnosis included at least one of a localized thickening (≥4 mm) of the colonic wall signs of inflammation of the pericolic fat abscess extraluminal air extraluminal contrast The ultrasound included at least two of bowel wall thickening (>4 mm) inflammatory bowel disease irritable bowel syndrome colorectal cancer diseases precluding adequate follow up | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Appendicitis Abdominal Abscess Periappendicular abscess at least 2 cm in size Missing written informed consent Antimicrobial therapy lasted over 24 hours before randomization Attempt of drainage before randomization Age over 80 years or under 18 years old Pregnancy Allergy to either Cefuroxime or Metronidazole Severe chronic disease, that substantially increases the risk for operative mortality Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions Carrier of a resistant bacterial strain Being institutionalized or hospitalized for at least 2 weeks before randomization | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Adenocarcinoma Pancreas Chronic Pancreatitis Patients with suspicion of solid pancreatic tumor masses by previous cross-sectional imaging techniques (US, CT, MR) Age 18 to 90 years old, men or women Signed informed consent for EUS with contrast-enhancement, elastography and EUS-FNA Prior surgical treatment with curative intent or chemo-radiotherapy Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis, Chronic abdominal pain compatible with pancreatic ethiology since at least 3 months chronic pancreatitis on Computed Tomography (CT), Endoscopic Retrograde Cholangiopancreatography (ERCP) or EUS EUS feasible inform consent pregnant women allergy to local anesthetic acute pancreatitis in the last 2 weeks suspicious lesion on pancreatic EUS examination celiac bloc in the last 3 months | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Coronary Artery Disease Coronary Disease The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has a documented coronaropathy The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state The patient is participating in another study The patient is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations Unstable, acute coronary syndromes unstable needing emergency coronary angiography Patient with contraindication for conducting a stress test | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Cystinosis Nephropathic Cystinosis Renal Fanconi Syndrome Diagnosis of cystinosis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 16.0-40.0, Infertility infertile women who seeking for HSG testing suspect of pregnancy acute low reproductive duct infection a known hypersensitivity to iodine genital bleeding genital malignancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-80.0, Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II papillary or follicular thyroid cancer stage 1 or 2 according to TNM system version 6 surgery and radioiodine treatment levothyroxine suppression treatment cardiopulmonary failure liver failure renal failure pregnancy drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin) | 0 |
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