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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): 18.0-75.0, Heart Failure Systolic Heart Failure Acute Decompensated Heart Failure Adults (18 years of age and <75 years of age); AND 2. Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered; i. BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during hospital admission or clinic visit. OR c. Seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of HF and with signs of worsening HF condition or decompensation, where worsening HF condition is defined as one or more of the following; i. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity ii. Symptoms requiring change in dosage of one or more of the following medications: 1. diuretic 2. beta blocker 3. ACE inhibitor iii. Physical evaluation consistent with worsening HF signs (i.e. elevated JVP, ankle edema, dyspnea, abdominal distension, >4 lb or >1.8 kg weight increase in past week) iv. HF admission in last 30 days with a documented BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during or since admission AND d. Presence of left ventricular systolic dysfunction (ejection fraction <40%); e. Successfully trained and deemed proficient on how to perform a fingerstick and to use the Test System. Each subject will undergo two proficiency assessments. i. The first assessment will be performed at the time in which the subject is found to meet the and deemed willing, able and reliable to complete the study tasks, and following initial training on the use of the test system. Successful completion of this first proficiency assessment will result in the enrolment of the subject into the study. The second assessment will be performed following one week (7 days ± 2 days) of home testing to demonstrate retention of the training. Successful completion of this second proficiency assessment will result in randomization of the subject into one of the three study arms of the study. Failure to demonstrate proficiency at this second assessment will result in the withdrawal of the subject from the study Unwilling or unable to provide written informed consent; 2. Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis that is concomitant with the primary diagnosis of decompensated HF and for which treatment will be provided. Note: A history of ACS is not cause for if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion. 3. Previous cardiac transplantation or cardiac transplantation anticipated within 3 months; 4. Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months; 5. Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer); 6. End stage renal disease (dialysis dependency); 7. Receiving any investigational medication; 8. Hematocrit outside the 25 to 50% range of the HeartCheck system; 9. Prisoner or other institutionalized or vulnerable individual; 10. Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver); 11. Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions; 12. Residence in regions where either transmission of test system data or home visits are not possible | 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, Solid Tumors Patient with advanced solid tumors for which there is no approved or curative therapy has any advanced solid tumor with diagnosed alteration in 1 or more genes of the PI3K, and mitogen-activated protein kinase (MAPK) pathways and/or has a histologically or cytologically confirmed diagnosis of 1 of the following solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma and melanoma The patient has previously been treated with a PI3K inhibitor or a Mitogen-activated protein extracellular signal-regulated kinase (MEK) inhibitor The patient has received Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy within 28 days or 5 half lives for noncytotoxics (whichever is shorter) of Day 1 of trial drug treatment (6 weeks for nitrosureas or mitomycin C) Any investigational agent within 28 days of Day 1 of trial drug treatment The patient is currently receiving anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin ≤1 mg/day, heparin, and low-molecular weight heparins are permitted) History of central nervous system metastases The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study. The patient has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion, or has medically relevant abnormalities identified on screening ophthalmologic examination. The above information is not intended to contain all considerations relevant to a patient's potential participation in a 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): 18.0-70.0, Atrial Fibrillation Patients ≥ 18 years of age EHRA class ≤ 2 Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery Patients will have elective coronary surgery planned Able of providing informed consent Patients ≥70 years of age Pregnancy Patients with contraindications for oral anticoagulant agents Patients undergoing emergency operation Patients undergoing concomitant valve replacement Severely enlarged LA (>50 mm) on echocardiography Prior AF ablation or AF surgery | 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, Congestive Heart Failure Ambulatory. 2. Chronic systolic heart failure ≥ 12 months. 3. NYHA II IV for at least 45 of the last 60 days. 4. Last documented left ventricular ejection fraction ≤ 35% by any imaging modality. 5. Age 18 years. 6. Under the care of a cardiologist at study site. 7. On appropriate evidenced -based heart failure medications ACE inhibitor, ARB or sacubitril/valsartan [LCZ-696]; beta blocker; aldosterone antagonist; hydralazine/long-acting nitrate [required of African-American subjects only] for ≥ 3 months absent contraindications or intolerances. 8. Has ICD or CRT-D. If CRT-D, present for ≥ 3 months. 9. Demonstrated advanced heart failure, including any one of the following*: i. Serum sodium ≤ 135 mEq/L (obtained as an outpatient)** ii. Serum BNP ≥ 750 pg/mL or NT-proBNP ≥ 3000 pg/mL** (obtained as an outpatient) iii. Seattle Heart Failure Model (SHFM) one year predicted survival ≤ 85%** iv. Heart Failure Survival Score (HFSS) ≤ 7.19** v. Peak VO2 ≤ 55% of predicted for age by Wasserman equation or ≤ 14 ml/kg/min, with RER ≥ 1.05*** vi. VE/VC02 slope > 40*** vii. 6 minute walk test (6MWT) distance ≤ 350 m without significant non-cardiac limitation** viii. Currently listed as Heart Transplant Status II due to heart failure limitation Or History of one (1) hospitalization (≥ 24 hours) for acute or acute on chronic heart failure in the past year with additional history to i. Serum BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL** (obtained as an outpatient) Or History of two (2) hospitalizations (≥ 24 hours) for acute or acute on chronic heart failure in the past year. * Qualifying measure must be the most recent of that type of measure obtained (i.e., a BNP ≥ 1000 obtained 2 months prior would not qualify the heart failure subject if a more recent BNP was < 1000) **Using values obtained within the prior 90 days, except for peak VO2 within 365 days ***Obtained within the prior 365 days 10. Willingness to continue to receive heart failure care from the enrolling advanced heart failure clinic over the next two (2) years and to come for all scheduled study visits. 12. Written Informed consent given Known serious medical problem other than heart failure that would be expected to limit 2-year survival (≥50% mortality within 2 years from non-heart failure diagnosis). 2. Patient is not likely to be compliant with the protocol, in the opinion of the Investigator. 3. Currently hospitalized. 4. Current use of an intravenous inotrope. 5. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival. 6. Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment. 7. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality. 8. Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient. 9. Cardiac conditions that are amenable to surgical or percutaneous procedures (other than VAD or transplant) that would substantially improve prognosis and for which this subject is a reasonable candidate, regardless of whether the procedure will or will not be performed. 10. Uncorrected hyperthyroidism or hypothyroidism. 11. 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): 18.0-999.0, Pancreas Cancer Patients 18 or above will be included in the study. 2. Patients suspected of pancreatic mass or with a known pancreatic mass would be enrolled in the study. 3. Patients with suspected pancreatic pathology and scheduled for imaging study (CT vs. MRI) will be included if they had obstructive jaundice, with either a stricture in the lower common bile duct on magnetic resonance cholangiopancreatography (MRCP) or a pancreatic mass on ultrasound or other imaging study Patients with known advanced pancreatic tumors and those with previous pancreatic resection will be excluded. 2. Patients with renal insufficiency: increase Cr level or glomerular filteration rate (GFR) of less than 45 ml/min/1.73. 3. Patients who demonstrate increase in Cr level or patients with acute renal injury. 4. Claustrophobic or patients who are not able to tolerate MRI. 5. Patients with previous history of contrast allergies. 6. Pregnant patients | 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, Coronary Artery Disease Atherosclerosis Only patients with also Calcium Score ≥64-slice CT technology (or 16-slice CT technology with >4 year follow-up) Number of patients of at least 100 with complete clinical file and follow-up Minimum follow-up of 12 months Only patients with suspected Coronary Artery Disease renal failure (creatinine clearance <60ml/min) known previous reaction to iodinated contrast medium and pregnancy history of Myocardial Infarction previous revascularization (PCI and/or 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, Lymphoma Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008) Patients must have clinical stage IA, IB, IIA, or IIB disease Patients with "E" extensions will be eligible if all other have been met Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images Bone marrow biopsy is required ECOG performance status 0-2 ANC ≥ 1,000/μL Platelet count ≥ 100,000/μL Hemoglobin ≥ 10 g/dL Serum creatinine ≤ 2 mg/dL Nodular lymphocyte-predominant Hodgkin lymphoma Pregnant or nursing "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 Prior treatment (chemotherapy or radiation therapy) for Hodgkin 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): 18.0-999.0, Thyroid Cancer Metastases Patients with thyroid cancer and known measurable (>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan 2. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal 3. Age >18 years 4. Previous treatment with radioiodine more than 6 months before inclusion. 5. Serum TSH level <0.5 mU/L 6. Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula > 60 ml/ml 7. Effective means of contraception for female patient, at risk of pregnancy 8. Written informed consent Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake 2. Iodine excess (< 50 μg/dl) 3. Large or diffuse bone or brain metastases 4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs 5. Patients already included in a therapeutic trial with an experimental medicine 6. Pregnancy and breast feeding patients 7. Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures 8. Treatment with antivitamin k | 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, Pancreas Cancer Histologically documented pancreatic adenocarcinoma not previously treated with systemic therapy Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the pancreas with no evidence of malignant ascites, peritoneal metastases or distant metastases. Lack of recurrent and/metastatic disease must be confirmed radiologically with CT chest, abdomen, and pelvis prior to enrolment Adequate tissue available for IHC testing of hENT1. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute (CCI) is required. Paraffin block sufficient for preparing ≥ 6 unstained slides for central storage and testing if required by oncologist ECOG performance status of 0 (Appendix B) Age ≥ 18 years Life expectancy of at least 6 months based on discretion of treating Adequate hematologic function defined by the following laboratory parameters: Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5 Adequate hepatic and renal function defined by the following laboratory parameters: AST and ALT ≤ 2.5 X upper limit of institutional normal, bilirubin ≤ upper limit of institutional normal, and calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR ≥ 50 mL/min as determined Patients may have received prior curative radiotherapy for a different malignancy (unless radiation was curative therapy to ≥ 25% of bone marrow stores) and patients must have recovered from the toxic effects of this treatment Patients who have received prior chemotherapy or radiation delivered as parts of initial curative therapy for pancreas cancer (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are not permitted. Metastatic patients are not permitted Prior treatment for a different malignancy with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that Known dihydropyrimidine dehydrogenase (DPD) deficiency Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs Any other reason the investigator considers the patient should not participate in the study | 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, Aneurysm Men and women age ≥ 18 years. 2. Diagnosis of intracranial aneurysm secured by magnetic resonance angiography (MRA), computed tomographic angiography (CTA), or catheter-based cerebral angiography. 3. Diagnosis of subarachnoid hemorrhage diagnosed by head CT, brain MRI or lumbar puncture. 4. Provides written informed consent. 5. No know diagnosis of aortic aneurysm 6. No history of prior screening for aortic aneurysm 7. No condition like recent abdominal surgical scar that would preclude abdominal ultrasonography 8. No therapy like abdominal hypothermia pads that would preclude abdominal ultrasonography | 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): 30.0-999.0, Pancreatic Mass Peripancreatic Mass We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 Patients with unavailable data | 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 will all patients who consented to have both EUS and had biopsy taken for tissue diagnosis Will patients who are less than 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, Chronic Pancreatitis Patients who are eligible are individuals who have normal pancreas suspected chronic pancreatitis established chronic pancreatitis (by ERCP, MRI, previous EUS, CT) pancreatic cancer Patients who are not eligible are individuals who have: • an uncorrectable coagulopathy (platelet <50,000, INR>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed) | 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): 18.0-65.0, Hepatitis C Infection To be eligible for this trial, patients must have documentation of the following Male or female > 18 years old HCV genotype-1 infection Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years No previous treatment with any anti-HCV therapy (approved or investigational) For women of childbearing potential, a negative urine pregnancy test result documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during study treatment and for 6 months after treatment Willingness to give written informed consent and to participate in and comply with requirements of the study Patients with any of the following will not be eligible for participation Infection with HCV other than genotype 1 History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History or other evidence of decompensated liver disease (e.g., coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from esophageal varices) or a Child-Pugh score > 6 (see Appendix 1) Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM) antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab, or anti-HIV antibodies History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against HCV within 3 months prior to enrollment Pregnant or breastfeeding Male partners of females who are pregnant or breastfeeding Hemoglobin concentration < 12 g/dL in females or < 13 g/dL in males or any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic Absolute neutrophil count (ANC) < 1000 cells/mm3 | 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 Adenocarcinoma Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC Patient eligible for chemotherapy treatment Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted ECOG performance status 0-2 A minimum age of 18 years old Known to be HIV positive on antiretroviral therapy Prior organ allograft Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures | 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, Coronary Artery Disease Congestive Heart Failure Valvular Heart Disease Atrial Fibrillation Hypertension Pyelonephritis Acute Renal Failure Renal Failure Viral Hepatitis Alcoholic Hepatitis Steatohepatitis Cirrhosis Asthma COPD Bronchitis Emphysema Pneumonia Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Diverticulitis Peptic Ulcer Disease Irritable Bowel Syndrome Cholecystitis Pancreatitis Malabsorption Disorders Celiac Sprue Diabetes Five Diagnosis Group: 1. Sex: Male or Female 2. Age range: 18 to 85 3. Qualifying medical diagnoses (5 diagnosis groups) For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (Type 1 and Type 2) 4. The patient or legal representative is able to understand and provide signed consent for the procedure. 5. Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited. Control Group: 1. Sex: Male or Female 2. Age range: 18 to 85 3. Freedom from qualifying medical diagnoses (control group) For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V Patients < 18 years in age or > 85 years in age Inability or unwillingness to provide informed consent Patients with pacemakers or another electrical device implanted somewhere in their body Pregnant women Patients currently undergoing therapy for cancer of any kind | 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): 50.0-75.0, Colonic Diverticula Diverticulitis Age ≥ 50 years and ≤ 75 years Scheduled for colonoscopy Written informed consent Patient group: The presence of diverticulosis, diagnosed during the scheduled colonoscopy Control group: During the scheduled colonoscopy, diverticulosis or other gastrointestinal and liver diseases are absent. In other words, the colonoscopy is qualified as a 'normal' colonoscopy Age < 18 years Presence of gastrointestinal and liver diseases, such as inflammatory bowel disease Use of NSAID's and proton pump inhibitors, during the 5-day time period prior to endoscopy Alcohol intake above 14 consumptions per week for males and 7 consumption per week for females (Sub)total colectomy or hemicolectomy Refusal to participate in this study | 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, Surgery Pancreatitis Diverticulitis Appendicitis Infected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis) age over 18 years old intra-abdominal collections >5 cm in diameter with signs of infections on imaging pregnancy age< 18 years signs of peritonitis Intensive care unit 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): 18.0-95.0, Colonic Diverticulitis Adults (age above 18 years, acute abdominal pain (Duration< 3 days), abdominal tenderness, elevated inflammatory parameters, CT scan sign of uncomplicated diverticulitis(without sign of abscess or free air) diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons | 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): 3.0-17.0, Pediatric Solid Organ Transplant Patients Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral) Must be at least 6 months after transplant 17 years of age, inclusive Available for duration of study Parent or guardian able to be reached by phone History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein History of Guillian-Barre syndrome Receipt of rituximab within the past one year Rejection treatment with intravenous steroid bolus within 30 days Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol Have any condition that the investigator believes may interfere with successful completion of the study History of received 2011-2012 influenza vaccine Pregnant female History of proven influenza disease after September 1, 2011 | 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 Tumors Patient with pancreatic lesion undergoing EUS for diagnosis and pre-operative assessment Pregnant women, breastfeeding women and individuals with metastatic lesions on CT | 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, Diarrhea Fever Vomiting Abdominal Pain Patients with culture-positive stool sample with Campylobacter concisus Diarrheic patients ≥ 18 years symptoms of diarrhea defined as three or more watery stools per day or two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever Diarrheic symptoms for a minimum of 24 hours before enrollment Diarrheic symptoms for a maximum of 21 days before enrollment Informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient The patient must be willing and able to participate in the trial Hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics Pregnancy or breastfeeding (if relevant) Culture positive stool sample with a Co-pathogen Treatment with other antibiotics (in any stage 21 days before the first stool sample) Patients with severe liver disease Patients with severe renal impairment (GFR <10 ml / min) Patients with congenital or documented acquired QT prolongation Patients treated with other active drugs that prolong the QT interval such as: antiarrhythmics of classes IA and III, cisapride and terfenadine Patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia Patients with clinically relevant bradycardia, arrhythmia or severe heart failure | 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 Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form Exocrine pancreatic potentially resectable carcinoma, histologically confirmed Aged 18-75 years OMS functional state (FE) from 0-2 and Karnofsky functional state 70% Radiologically or measurable disease, defined as borderline resectability disease Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL; hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN Controlled biliary obstruction in all the patients before their in the study Absence of peripheral neuropathy grade 2 Life expectancy of at least 3 months Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment Administration of other experimental treatment during this study or in the previous 6 months Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months) Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications Patients with lack of physical integrity of the upper gastrointestinal tract or bad absorption syndromes or unable to ingest the tablets Other previous bad or concurrent diseases, with the exception of nonmelanoma skin cancer Medical or psychiatric pathologies that are severe or uncontrolled Distant metastases | 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 of the Colon diagnosis of diverticular disease diagnosed for the first time or established by previous colonoscopy symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior to study entry patients who have given their free and informed consent acute diverticulitis (both complicated and uncomplicated) diverticular colitis active or recent peptic ulcer chronic renal insufficiency allergy to salicylates patients with intended or ascertained pregnancy, lactation women of childbearing age not using contraceptives lactulose-lactitol use in the two weeks before the enrolment and during the study presence of diverticulitis complications (fistulas, abscesses, and/or stenoses) use of probiotic preparations either prescribed or over-the counter within two weeks prior to study entry | 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): 60.0-89.0, Osteoarthritis, Knee Adults aged 60 years of age primary unilateral TKA 10-21 days prior to the outpatient PT evaluation received inpatient rehabilitation at Helen Hayes Hospital Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing any other lower extremity joint replacement surgery diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes chest pain or shortness of breath on stair-climbing requirement of human assistance to walk in addition to the ambulation device inability to follow instructions to perform testing and/or exercise participants who stated that they would not be available to complete 12 exercise sessions individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period | 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 Adenocarcinoma Adults ≥ 18 years of age, male or female Histopathologically or cytologically confirmed adenocarcinoma of the pancreas ECOG performance status 0 to 2 Adequate bone marrow reserve Absolute neutrophil count > 1x10^9/L Total bilirubin <3 times the upper limit of the normal range Life expectancy ≥ 12 weeks Signed written informed consent form Prior malignant disease other than pancreatic cancer Patients suitable for surgical or locoregional therapies Patients who have prior anticancer therapy for pancreatic cancer Patients unable to swallow oral medications Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0) History of allergy to platinum compounds Patients who have chronic inflammatory bowel disease and/or bowel obstruction Patients who have severe bone marrow failure Patients undergoing renal dialysis | 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 Cyst Pancreatic Neoplasms Pancreatic Adenoma Pancreatic Cancer Pancreatic Islet Cell Tumors Lymph Node Lymphadenopathy Male or female > 18 years of age Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via Willing and able to comply with study procedures and provide written informed consent to participate in the study. Add for lymph nodes any lymph node reachable with EUS-FNA Add for pancreatic mass any size any location in the pancreas Subjects for whom EUS-FNA procedures are contraindicated Known allergy to fluorescein dye If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding Add for cysts Subject with multiple cysts size < 20mm in diameter previous EUS-FNA procedure performed less than 3 months ago Patients suffering chronic calcifying pancreatitis Add for lymph nodes size < 5mm in diameter If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure Add for pancreatic mass If patient present several pancreatic masses, only one of them will be imaged during the nCLE 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): 18.0-999.0, Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v7 Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past) Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization; any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration; the most recent procedure may be nephrectomy for a renal primary tumor Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1) Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence; recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease) Patient must have no evidence of disease on post-operative imaging A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated | 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, Haematopoietic Stem Cell Transplantation Patients after haematopoietic stem cell transplantation (HSCT) who are referred to our department for clarification of one of the following symptoms anorexia nausea vomiting abdominal pain diarrhoea intestinal bleeding To possible side effects of the conditioning therapy, GI symptoms must have occurred or persisted 20 days after the respective transplantation date [22] infection with CMV or HSV bacterial infection of the GI tract medication related symptoms patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE ) refusal to participate in the study patient's age below 18 years | 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, Community-Acquired Infections Common characteristics of cases and controls Patients aged of more than 18 years old Hospitalized patients, during the period of study, via the ICU of the participating hospital center, for a community infectious pathology lower respiratory infections (pneumonia) intra-abdominal infections (cholangitis, diverticulitis, peritonitis) urinary parenchymal infection (pyelonephritis complicated or without abscess, prostatitis, orchitis, epididymitis) infections of skin and soft tissue infections (cellulitis, fasciitis) meningitis, endocarditis, osteo-articular infections, salpingitis Definition of cases Patient included in the study and admitted to the emergency service either directly from ICU or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community. Definition of controls Patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital. Non Occurrence, during hospitalization, a severe sepsis or septic shock associated with a nosocomial superinfection | 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 Pancreatitis All adult patients >18y.o Diagnosis of acute pancreatitis (defined as an amylase >3 times the upper limit of normal and typical symptoms) Inability to provide informed consent Declines participation Uretheral catheterisation not required on clinical grounds | 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 Age >18 years old A clinical indication for diagnostic coronary angiography to evaluate possible CAD Pregnancy Known allergy to iodinated contrast Renal insufficiency (>1.5mg/dL) Cardiogenic shock Acute myocardial infarction within one week Prior coronary artery bypass graft treatment Prior percutaneous coronary intervention treatment | 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 Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible Patients must have distant metastatic disease; patients with macroscopic residual disease post-resection as the only site of disease are not eligible; patient must not have clinically significant ascites (defined as requiring paracentesis) or have brain metastases Patients must have received one line, and no more than one line, of prior gemcitabine-based chemotherapy for advanced/metastatic pancreatic cancer and must have documentation of metastatic disease progression while on this treatment; documented disease progression must occur within 42 days of the last treatment; OR For patients who received one line of gemcitabine-based chemotherapy for treatment in the adjuvant setting, recurrence to a metastatic site must be documented by imaging studies within 6 months of completing chemotherapy; chemoradiation as part of adjuvant treatment is acceptable; if the patient received one line of adjuvant gemcitabine-based treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of gemcitabine-based chemotherapy used to treat the metastatic disease Patients must have measurable and/or non-measurable disease; x-rays, scans. or physical examinations for assessment of measurable disease must have been completed within 28 days prior to registration; x-rays, scans, or other tests for assessment of non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered to =< grade 1 from any of the effects of prior therapies or procedures Patients must not plan to receive concurrent chemotherapy, radiotherapy, agents known to prolong corrected QT (QTc) interval, or agents known to be strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5) or cytochrome P450 1A2 (CYP1A2) Patient must not have received prior treatment with fluorouracil, irinotecan, leucovorin calcium, and oxaliplatin (FOLFIRINOX), oxaliplatin-based chemotherapy, mitogen-activated protein kinase (MEK) inhibitors, phosphoinositide-3-kinase (PI3K) inhibitors, or protein kinase B (AKT) inhibitors Zubrod performance status of 0-1 Leukocytes >= 3,000/mcL | 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): 30.0-999.0, Pancreatic Cancer Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened Patients at least 40 years old or 10 years younger than the youngest affected individual Peutz-Jeghers Syndrome (PJS) patients age>30 Hereditary pancreatitis patients Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM) Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA) Willingness to undergo surgical evaluation for abnormal EUS/FNA finding Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope Personal history of pancreatic adenocarcinoma Previous partial or complete resection of the pancreas for adenocarcinoma Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV) Life expectancy less than 5 years 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): 18.0-100.0, Pancreas Mass Diagnosis adult pancreas mass coagulopathy mass not approachable by endoscopic ultrasound biopsy | 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, Solid Lesions of the GI Tract or of Adjacent Organs Presence of a solid lesion in the GI tract or in one of the adjacent organs identified at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because unresectable or because tissue characterization is needed to decide further treatment modalities 2. Age greater than 18. 3. Absence of histological or cytological confirmation of malignancy. 4. Informed consent obtained Patients with active coagulopathy that cannot be corrected after administration of plasma. 2. Resectable lesions that does not need tissue characterization to decide treatment modalities. 3. Pregnancy. 4. Patients who cannot give inform consent | 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, Mitral Regurgitation Mitral Insufficiency Eligible patients must meet all the following 1. Signed Informed Consent Form. 2. Male or female aged ≥18 to ≤ 85 years on the day of screening. Females of childbearing potential (not surgically sterilized or more than one year post-menopausal) must have a negative pregnancy test (serum beta-human chorionic gonadotropin (beta-hCG) or urine) within 24 hours prior to mitral valve surgery. 3. Patient must meet one of the following indications for mitral repair surgery according to the European Society of Cardiology (ESC) and the American Heart Association (AHA) guidelines, and must have consented to have such surgery before undergoing the informed consent process for this study Symptomatic patient with chronic severe primary mitral regurgitation (MR), left ventricle ejection fraction (LVEF) > 30% and left ventricle end systolic diameter (LVESD) < 55 mm or Asymptomatic patient with chronic severe primary MR who either Has LV dysfunction (LVEF ≤ 60 % and/or LVESD ≥ 40 mm or Has a preserved LV function (LVEF> 60% and LVESD < 40 mm) together with a likelihood of a successful and durable repair of > 95 % and an expected mortality rate of < 1% or Has a flail leaflet and LVESD ≥ 40 mm together with a high likelihood of durable repair and a low surgical risk or Has a new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure > 50 mm Hg at rest) or Asymptomatic patient with chronic moderate or severe primary MR who is to undergo cardiac surgery for another indication when the mitral valve (MV) repair can be performed concomitantly Patient with chronic severe or moderate secondary MR and an LVEF > 30 % who is undergoing CABG concomitantly 4. Patient must have a life expectancy of more than 24 months at the time of screening, assuming they undergo mitral valve annuloplasty. 5. Patient must have a mitral valve diameter corresponding to MAR size 26 and leaflet thickness (smallest helix height Eligible patients must not meet any of the following Have had previous cardiac surgery, including but not limited to any of the following: minimally invasive surgery, mitral valve surgery or valvuloplasty, implantation of a prosthetic heart valve or cardiac defibrillator. 2. Have ejection fraction below 30%. 3. Plan to have any concomitant cardiac surgery or procedure other than CABG, tricuspid valve repair, correction of atrial septal defect, closure of auricular appendage, correction of patent foramen ovale and/or ablation therapy for correction of atrial fibrillation performed with the mitral valve repair, which may also leaflet resection and chordae replacement. 4. Have any structural hindrance or heart abnormality that would make use of the MAR technically infeasible, such as a mitral valve of an unusual size or leaflet thickness for which a suitable MAR is not available, or an obstruction or other abnormality that blocks positioning of the MAR. (Final determination to be made during surgery). 5. Show evidence of having had an acute myocardial infarction (MI) within the 30 days preceding the mitral valve repair surgery. 6. Have a history of stroke within the preceding 12 months or have had any stroke that is not completely clinically resolved and/or significant carotid artery disease (subjects with carotid stenosis ≥50% and/or ulceration). 7. Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy. 8. Have restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2. 9. Be in need of annular decalcification. 10. Have any comorbidities or conditions that would be a contraindication to open heart surgery or that would place the patient at an unacceptable surgical risk, such as: severe chronic obstructive pulmonary disease (COPD); hepatic failure; immunosuppressive abnormalities or other immunological deficiencies including being immunocompromised or having an autoimmune disease; chronic renal failure requiring dialysis; hematological abnormalities including a history of bleeding diathesis or coagulopathy; being unable to follow the locally recommended anticoagulant regimen; an intolerance or hypersensitivity to anesthetics; cancer that requires further radiation, chemotherapy or surgical treatment. 11. Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler. 12. Have any recent psychiatric disorder, including drug or alcohol abuse, that in the Investigator's opinion could impair the patient's compliance with study procedures. 13. Be currently or have in the preceding 30 days participated in any other study involving an investigational drug or device. 14. Be an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization or have an immediate family member who is | 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): 1.0-14.0, Complicated Appendicitis Children age 1-14 years CA that was defined by one of the followings: 1. Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess 2. Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3 Documented allergy to any of the study medications, acute or renal insufficiency at admission, and severe septic shock at admission | 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, Carotid Artery Disease Patient must meet one of the following regarding neurological symptom status and degree of stenosis Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days. 2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements). 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 4. Patient is greater or equal to 18 years of age. 5. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure. 6. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study. 7. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. 8. Patient meets at least one of the anatomic or clinical high-risk criteria Patient has chronic atrial fibrillation. 2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation. 3. Patient has an evolving stroke. 4. Patient has severe dementia. 5. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months. 6. Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure. 7. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days. 8. Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion. 9. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention. 10. Patient has had a recent GI bleed that would interfere with antiplatelet therapy. 11. Life expectancy of < 12 months post procedure. 12. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel. 13. Myocardial Infarction within 72 hours prior to the intervention. 14. Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site. 15. Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, moderate to severe dementia, or intracranial hemorrhage). 16. Patient with a history of major stroke (CVA or retinal embolus) with major neurological deficit likely to confound study endpoints within 1 month of index procedure. 17. Patient has Hgb <10 g/dl, platelet count <125,000/μl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia. 18. Patient has an intracranial tumor. 19. Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period. 20. Patient has inability to understand and cooperate with study procedures or provide informed consent. 21. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery. 22. Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery. 23. Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma). 24. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram. 25. Ostium of Common Carotid Artery (CCA) requires revascularization. 26. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device. 27. The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound. 28. Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure. 29. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion. 30. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings. 31. Patient has had a previous intervention in the ipsilateral proximal CCA. 32. Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure. 33. Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury. 34. Patient is otherwise unsuitable for intervention in the opinion of the investigator | 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, Stable Coronary Artery Disease CAD Coronary artery disease patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey Too ill to take survey Previously completed this survey Refused to participate | 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, Gastrointestinal Bleeding LVAD insertion as bridge to transplant or destination years of age or older Poorly controlled diabetes, A1C greater than 8% Poorly controlled hypothyroidism, TSH > upper limit of normal (5.5) End Stage Renal Disease (ESRD) requiring dialysis Cirrhosis Anemia (Hgb < 8) Acromegaly Hx of chronic diarrhea as determined by history of loose stool lasting longer than 2-4 weeks Pregnancy or breastfeeding 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, Coronary Artery Disease Patients referred for cardiac catheterization procedure with 3 out of the following 4 characteristics: age ≥70 years, female gender, hypertensive, and ≤64 inches in height Patients will be excluded if they 1) underwent prior CABG with utilization of an internal mammary artery, 2) have an abnormal Allen test, 3) require emergency cardiac catheterization, 4) are planned to undergo a staged PCI procedure, 5) do not consent or are unable to give consent, or 6) are participating in another competing 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, Recurrent Melanoma Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed) Patients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; one exception are patients treated with a curative intent and are continuously disease free for > 3 years; these patients would be considered eligible Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible Patients with prior history of basal or squamous skin cancer are eligible Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g, standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to 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): 18.0-100.0, Atrial Fibrillation Coronary Artery Disease Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease who will undergo catheterization X-ray angiography Critically ill patients, patients on ventilators patients with hypotension, asthmatics, and other patients whose medical care or safety may be compromised from undergoing an MRI examination will be excluded. 2. Patients with claustrophobia will also be excluded since MRI is conducted in a closed environment. 3. Patients with contraindications to MRI (pacemaker, metal implants). 4. Pregnant subjects (or women who may become pregnant), minors, and prisoners will be excluded from this study. 5. Subjects are over 60 or have any suspicion of abnormal kidney function (a blood test to determine Glomerular filtration rate (GFR) will be performed prior to imaging. Subjects with GFR<30 will be excluded from the study. This is standard practice for clinical scans in Radiology due to the extremely small but not negligible relationship between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with severely impaired renal function | 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, Wound Infection Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer) Subjects will be excluded from the study if: 1. The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion) 2. The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy) 3. A new stoma is created at a different site | 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): 20.0-999.0, Post ERCP Pancreatitis Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years Patients were excluded from study participation if they had a contraindication for diclofenac including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks renal failure (Cr > 1.4) those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable) those who developed acute pancreatitis during the 2 weeks before ERCP those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection | 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 Neoplasms CHRONIC PANCREATITIS Age > 18 years old, male or female Patients diagnosed with solid pancreatic masses with an indication for EUS-FNA Signed informed consent for EUS with FNA and nCLE examination Failure to provide informed consent Patients with a contraindication for EUS-FNA Known allergy to fluorescein Pregnant or breast-feeding 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): 15.0-999.0, Chemotherapy-Induced Nausea and Vomiting Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve Written informed consent and HIPAA authorization for release of personal health information Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this is met No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy No concurrent participation in a clinical trial which involves another investigational agent No use of agents expected to induce the metabolism of fosaprepitant which rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates No concurrent use of agents which may inhibit metabolism of fosaprepitant which cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir No concurrent use of warfarin while on study No known history of anticipatory nausea or vomiting No clinically significant infections as judged by the treating investigator | 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): 15.0-999.0, Advanced Malignant Solid Neoplasm C-KIT Tyrosine Kinase Protein Overexpression Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Gastrointestinal Stromal Tumor Metastatic Malignant Solid Neoplasm Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Unresectable Melanoma Unresectable Solid Neoplasm For dose escalation study, patients must have histological confirmation of solid tumors that is metastatic or unresectable. For expansion cohorts, patients must have metastatic or unresectable gastrointestinal stromal tumor (GIST), melanoma, or uncategorized tumors with tumor biopsies that are positive for c-KIT mutations by polymerase chain reaction (PCR) or immunohistochemistry (IHC). For patients enrolled in the melanoma expansion cohort, only select KIT mutations will be eligible. Patients with mutations in exon 13 V654X, 14 T6701, 17 D816X and all exon 18 mutations will not be eligible for enrollment Patients who have completed previous therapies 4-weeks prior to (or within 5 drug half lives) enrollment on study. Radiation therapy wash out period will be 2 weeks. This includes an exception of patients with metastatic GIST tumors who are taking maintenance imatinib mesylate therapy. These patients are allowed to remain on imatinib mesylate therapy up to enrollment in this study Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%) Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL Total bilirubin < or = 2.0 mg/dL. (Does NOT apply to patients with Gilbert's syndrome) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal (patients with liver involvement will be allowed < or = 5.0 X institutional upper normal limit) Serum creatinine < 2.0 mg/dL Patients MUST have recovered from all treatment related toxicities to grade 1 National Center Institute (NCI) Common Terminology for Adverse Events (CTCAE) (version [v] 4.0) in severity Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus or autoimmune vasculitis [e.g., Wegener's granulomatosis] are excluded from this study History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab) Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses) Patients who do not agree to practice appropriate birth control methods while on therapy Pregnant women are excluded from this study. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician | 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, Ampullary Tumors Adenoma with at least low grade dysplasia (LGD) was required for Two other were needed in asymptomatic patients with LGD an ampullary size > 1 cm at endoscopy in case of Familial Adenomatous Polyposis (FAP) two series of positive biopsies in case of sporadic tumors uT1N0 lesion at EUS (tumor without invasion of the muscularis propria (MP) of the duodenum and no suspicious lymph nodes) without intraductal growth (pancreatic and/or common bile duct) were previously treated ampulloma metastatic disease at CT-scan advanced tumor at duodenoscopy (ulceration or induration involving the duodenal roof of the papilla) advanced tumor (uT2 = invasion of the MP without invasion of the pancreas ; uT3 = invasion of pancreas and/or N+ suspicious lymph nodes) and/or intraductal invasion at EUS absence of adenoma on the resected specimen adenoma not confirmed | 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): 21.0-65.0, Obesity Measured BMI of 35.0-55.0 kg/m2 at time of screening. 2. 21 years of age (inclusive) at time of screening. 3. Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs). 4. Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening). 5. Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit. 6. Willing and able to provide informed consent in English and comply with the protocol Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement 2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease 3. History of refractory gastric ulcers 4. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination. 5. History of radiation therapy to the chest or abdomen 6. Uncontrolled hypertension (blood pressure >160/100). 7. Diabetes treated with insulin or sulfonylurea medications 8. Any change in diabetes medication in previous 3 months 9. Hemoglobin A1C >9.5% 10. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure (defined below): Class III: patients with marked limitation of activity and who are comfortable only at rest Class IV: patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity 11. Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5) 12. Anemia (Hemoglobin <11.0 g/dL in women and <12.5 g/dL in men) 13. Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal 14. Thyroid Stimulating Hormone (TSH) >1.5 x upper limit of normal at screening. 15. Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values). 16. History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma) 17. Pregnant or lactating 18. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria) 19. Night Eating Syndrome (diagnosed by EDE) 20. Serum potassium < 3.8 mEq/L 21. Chronic abdominal pain that would potentially complicate the management of the device 22. Taking a GLP-1 agonist < 6 months. 23. Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 24 months. 24. Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids) 25. Self reported history of substance abuse in last 3 years. 26. Malignancy in the last 5 years (except for non-melanoma skin cancer). 27. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy. 28. At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction, such as cirrhosis or renal dysfunction (GFR <60 mL/min/1.73 m2 at screening, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) | 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, Pancreas Adenocarcinoma Pancreas Neoplasms Gastrointestinal Stromal Tumor Lymphoma Adult patient 18 years or older Able to read and write English Undergoing EUS for the evaluation of: i) pancreas mass ii) intra-abdominal mass iii) suspected submucosal tumor iv) esophageal cancer staging v) other lymph node assessment No detectable lesion lesion inaccessible to EUS guided biopsy Lesion determined to not require tissue sampling Pancreas lesion is predominantly cystic coagulopathy with a known clotting factor deficiency or an uncorrectable INR > 1.5, PTT > 40, platelet count < 50,000 | 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, Adenocarcinoma Pancreas Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas including tumors in the pancreatic head, uncinate process, neck, body and tail that are potentially resectable by pancreatico-duodenectomy (Kausch-Whipple procedure). Patients with islet cell or other neuroendocrine neoplasms are excluded Definition of localized, potentially resectable disease Staging by intravenous contrast-enhanced thin section helical abdominal computed tomography (2.5 mm cuts or less) or MRI (for patients with an IV contrast allergy) using pancreatic protocol. Endoscopic ultrasound is required for tissue acquisition and staging confirmation No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein/portal vein (SMV/PV) with < 180-degree abutment and no evidence of invasion Clear fat plane between the SMA and celiac axis No extension to celiac axis and hepatic artery Patent superior mesenteric vein and portal vein No evidence of distant disease Male or non-pregnant and non-lactating female, and ≥ 18 years of age If a female patient is of childbearing potential, she must have a negative serum pregnancy test documented within 72 hours of the first administration of study drug Patient has borderline resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the distal pancreatic body or tail are ineligible. Patients with endocrine tumors, lymphoma of the pancreas, or ampullary cancer are also ineligible Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Patient has known infection with HIV 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 Patient has a history of allergy or hypersensitivity to the study drugs Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy Patients requires chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine) No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before randomization Patient is unwilling or unable to comply with study 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, Breast Cancer Bone Metastasis Pain The patient must be 18 years of age or older 2. The patient must have histologically proven breast adenocarcinoma 3. Radiographic evidence of bone metastasis is required .Acceptable studies plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging 4. The patient must have pain that appears to be related to the radiographically documented metastasis 5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket) 6. Patients must have an estimated life expectancy of 3 months or greater 7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites 8. Signed study specific informed consent 9. Karnofsky Performance Status > 40 10. Calculated Creatinine Clearance > 50 ml/min 11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00 Prior radiation therapy or prior palliative surgery to the painful site 2. Impending fracture of the treatment site or planned surgical fixation of the bone 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration | 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 Stable angina Cadmium-zinc-telluride gamma camera SPECT with dual isotope imaging Coronarography Pregnant woman Patient with terminal illness Terminal Renal failure Allergy to iodine | 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 Pancreatitis Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis Presentation within 48 hours of symptom onset Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis The presence of organ failure by the Atlanta on the first day of presentation The presence of clinical signs and/or symptoms of sepsis Alcoholic acute pancreatitis A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications Coagulopathy (international normalized ratio >1, and/or platelet count <50,000/mm3 Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease) | 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): 19.0-89.0, Pancreatitis Pancreatic Carcinoma All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreas will be included Age <19 years Unable to safely undergo EUS for any reason | 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, Advanced Malignant Solid Neoplasm HIV Infection Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm Unresectable Solid Neoplasm Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 12 weeks Leukocytes >= 3,000/mcL (within 1 week of study entry) Absolute neutrophil count >= 1,500/mcL (within 1 week of study entry) Platelets >= 100,000/mcL (within 1 week of study entry) Total bilirubin=< 1.5 x upper limit of normal (ULN) (within 1 week of study entry) (if, however, the participant has Gilbert's disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal (within 1 week of study entry) Creatinine =< 1.5 x ULN (within 1 week of study entry) Prior treatment with cabozantinib (XL184) The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment The participant has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 4 weeks or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; note: participants with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents The participant has received any other type of investigational agent within 28 days before the first dose of study treatment The participant has not recovered to baseline or Common Terminology for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) The participant has a primary brain tumor The participant has active brain metastases or epidural disease; participants with brain metastases previously treated with whole brain radiation or radiosurgery or participants with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; participants with treated brain metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2 weeks of registration, though non-enzyme inducing anticonvulsive drugs such as levetiracetam are allowed; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for participants with known brain metastases is required to confirm The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted The participant requires chronic concomitant treatment with the following strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers OTHER than antiretroviral agents: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, primidone, modafinil, and other enzyme inducing anti-convulsant drugs (EIACD), and St. John's wort; use of efavirenz or etravirine is permitted for participants considered for the CYP3A4-inducer based antiretroviral therapy (ART) regimen arm (Stratum B) of the trial; because the lists of CYP3A4 inducers are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product | 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, Peritonitis Diverticulitis Patients who have had an episode of sigmoid diverticulitis as a result of pelvic or purulent peritonitis (Hinchey stage II and III) complications and treated by conservative treatment such as per cutaneous radiological drainage or laparoscopic-assisted per cutaneous drainage Male and female individuals aged from 18 to 65 years old (both ages included) Absence of contra-indication for surgery ASA Score ≤3 Participants must have signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions Patients will sign an informed consent after haven been informed of the results of the previous medical visit Patients must be affiliated with, or a beneficiary of a social security system Subjects in the period (haven participated in a previous trial or an ongoing trial ) Contra indication to surgery ASA Score >3 Past history of evolutive neoplasm Subjects unable to consent (case of emergency, subjects having difficulties in understanding) Patients for which consultation visits will not be possible (e.g. tourists and people who cannot stay above 18 months in France) Pregnant and breastfeeding women Subjects under tutorship or curator ship Subjets under judicial protection | 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, Type 1 Diabetes Mellitus Male or female of age 18 years or older with a history of T1DM for at least 12 months 2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results 3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL) 4. Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant 5. Current treatment at the time of screening with insulin <300 units per day (U/day) 6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average CGM use 5 or more days per week over the preceding 3 months) and those who do not routinely used CGM are both eligible for in the study. Intermittent use of CGM is also acceptable but will not be a criterion use for stratified randomization. 7. Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol Type 2 diabetes 2. Known or suspected allergy to any component of any of the study drugs in this study 3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator 4. History of transmural myocardial infarction, congestive heart failure and uncontrolled hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury [mmHg]) are exclusionary 5. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures 6. History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant 7. As judged by the Investigator, clinically significant findings in routine laboratory data at screening 8. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis. 9. Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator. 10. Current addiction to alcohol or substance abuse as determined by the Investigator. 11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study. 12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this 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): 18.0-999.0, Lateral Epicondylitis Elbow Pain The duration of symptoms over 3 months Primary conservative treatment (physiotherapy, NSAID, ...) has been tried Significant systemic diseases Any surgical operation of the particular elbow | 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, Active C. Difficile Colitis Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin <3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB treatment with major immunosuppressive agents including prednisone >10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine >4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be >1 yr. - | 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, Relapsing Forms of Multiple Sclerosis Key Decision to treat with DMF must precede enrollment Naïve to DMF or fumaric acid esters Resides in the US and has a confirmed diagnosis of a relapsing form of MS Satisfies the approved therapeutic indication(s) for DMF. Key Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies Is participating in any other interventional clinical trial. NOTE: Other protocol-defined inclusion/ | 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): 20.0-80.0, Left-sided Pancreatic Cancer Ductal Adenocarcinoma Ductal adenocarcinoma 2. Age ≥20 and ≤80 3. General performance status: the Karnofsky score> 70% or ECOG 0-1 4. Potentially Curative resection 5. Tumor size < 3cm 6. Pancreatic cancer located on neck or body portion 7. No invasion to spleen or spleen hilum 8. No combined resection except Lt. adrenal gland 9. Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum Unresectable or locally advanced, metastatic case 2. Patients who do not want surgery 3. ASA (American society of anesthesiologists' physical status classification) score: ≥3 4. Patients with drug or alcohol addiction 5. Patients showing low compliance 6. Patients who not want to involve the clinical trial 7. Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, 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): 0.0-999.0, Abdominal Aortic Aneurysm Male patients with coronary artery disease Patient's denial to participate Female Gender Already diagnosed or treated abdominal aortic aneurysm | 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 Histology-proven adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater 2 cm (≥cT2) and/or close contact to the superior mesenteric vessels (≤3 mm in preoperative staging) No evidence of metastasis to distant organs (liver, peritoneum, lung, others) For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should the pelvis. Imaging derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association [1] are applied for preoperative assessment of local resectability Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV) Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA < 180°, GDA encasement up to the origin of the hepatic artery, or colonic/mesenteric root invasion Karnofsky performance status ≥ 80% Serum creatinine level ≤ 3.0 mg/dl Serum total bilirubin level ≤ 3.0 mg/dl in the absence of biliary obstruction (In the event of biliary obstruction, patients allocated to the CRT group must undergo interventional endoscopy or percutaneous drainage for biliary decompression. Post-interventionally, bilirubin levels should be ≤ 3.0 mg/dl before patients are subjected to CRT. In control patients undergoing upfront surgery, serum total bilirubin levels ≤ 10.0 mg/dl are tolerated, unless clinical and laboratory signs of severe cholangitis take place. Patients with serum total bilirubin level > 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy) White blood cell count ≥ 3.5 x 109/ml, platelet count ≥ 100 x 109/ml Ability to understand and willingness to consent to formal requirements for study participation Age ≤ 18 years Neuroendocrine, acinar cancer Cancers of the pancreatic body or tail, i.e. lesions left to the SMV Recurrent disease Infiltration of extrapancreatic organs (except duodenum and transverse colon) Persistent cholestasis/cholangitis despite adequate biliary stenting Gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa Tumor specific pre-treatment History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper 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, ANEMIA Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis Patients starting anemia treatment (naïve) after six months of the last recommendations of the European Anemia Working Group ERBP (January 2011) Patients in treatment who changed from previous ESA treatment since January 2011 (converted patients Patients in Erythropoiesis Stimulating Agents (ESA) dose adjustment period Kidney transplant 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): 3.0-12.0, Laceration Abscess Minor Procedure Age 3 years Behavioral Disorders Anxiety Score <10 | 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, Pancreatic Adenocarcinoma Colorectal Cancer Histological proven adenocarcinoma of the pancreas 2. Histological/radiological verified colorectal liver metastases 3. Consent capable patient 4. Signed written, informed consent Patient'history of other malignancy | 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, Hypothyroidism Suspected hypothyroidism subject Willing to comply with the trial protocol Signed informed consent document Menstrual period, bleeding hemorrhoids, hematuria Drinking or taking aspirin within 48 hours Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability Subjects who are unwilling or unable to complete the trial Subjects who do not sign informed consent form | 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 Cancer Periampullary Carcinoma Below 80 years old CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer, with or without obstructive jaundice/chronic abdominal pain Liver Metastasis Metastasis in common bile duct and hepatic duct Extensive lymph node metastasis, metastasis at hepatic portal or above pancreas Pancreatic head or periampullary has tight adhesion with postcava or aorta Distant metastasis Poor physical condition to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders) | 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, Other Impaired Renal Function Disorder Normal Renal Function Abnormal Renal Function Renal metastasis | 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): 30.0-80.0, Breast Cancer Stereotactic Directional Vacuum-assisted Breast Biopsy Female Adult Patients The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy | 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): 20.0-999.0, Abdominal Pain Care Resident physicians will be included if they provide care to adult patients in the Icahn School of Medicine at Mount Sinai's ED. Patients will be enrolled for survey and/or medical record review if All adult (≥20 years) patients seen in the Icahn School of Medicine at Mount Sinai's ED with severe pain (≥10 on a verbal pain scale of 0-10, 0=none, 10=severe) and chief complaints of abdominal pain will be eligible for retrospective and/or medical record review and prospective survey at ED discharge | 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 Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded. 2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0. 3. Subject should be able to start treatment no later than 12 weeks postsurgery. 4. ≥18 years of age at the time of signing the informed consent form (ICF). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Acceptable hematology parameters Absolute neutrophil count (ANC) ≥1500 cell/mm^3 Platelet count ≥100,000/mm^3 Hemoglobin (Hgb) ≥9 g/dL 7. Acceptable blood chemistry levels Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN) Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN) Alkaline phosphatase ≤ 2.5 x ULN Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead 8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization 9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%) A subject will not be eligible for in this study if any of the following apply: 1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma 2. Presence of or history of metastatic pancreatic adenocarcinoma 3. Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization) 4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment 5. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications 6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients 7. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These but are not limited to: 1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder | 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): 45.0-999.0, First Recently-diagnosed Colorectal Cancer CASES Patients aged ≥ 45 years with a first recently-diagnosed colorectal cancer due to undergo elective surgical resection with curative intent (in practice, stage I, II, III or IV if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: CHU de Dijon, CHU de Nancy, CHU de Strasbourg, CHU de Reims et CHU and Besançon who have given their informed consent Patients aged ≥ 45 years due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia …) matched for abdominal site with cases for age (± 3 years), sex and hospital Who have given their informed consent CASES pre-operative anticancer treatment (chemo or radiotherapy) existence of visceral metastases except a single hepatic nodule resected with curative intent familial adenomatous polyposis and HNPCC syndrome (when suspected: after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of DNA mismatch repair proteins known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease) personal history (recent or not) of colorectal cancer emergency treatment for the presenting complication (perforation, occlusion…) significant modification in dietary habits during the previous three months other evolving neoplastic disease psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship) | 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): 20.0-999.0, Vomiting Patients receiving pancreaticoduodenectomy Peritonitis history Previous abdominal operation pregnancy Gastroesophageal reflux 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): 18.0-90.0, Diverticulitis older than or equal to 18 history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol the diagnosis confirmed by colonoscopy Signed informed consent Prior episode of diverticulitis Right sided diverticulitis Failure of recovery from first episode, defined as recurrence within one month Cancer found at the site on screening colonoscopy Comorbidities prohibiting surgery (as measured by colorectal score) Immunosuppressed patients Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm) Patients who are unable to sign the 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): 18.0-65.0, Gastroparesis Age 18 to 65 years of age Diagnosed gastroparesis patients with symptoms of gastroparesis for at least 3 months Symptoms of nausea and vomiting of at least moderate severity using the GCSI Prior history of delayed gastric emptying as determined by scintigraphy Gastroparesis from either diabetic or idiopathic etiologies Symptoms of nausea and vomiting that have not responded adequately to conventional antiemetic agents (Compazine®, Tigan®) Post-surgical gastroparesis Prolonged QTc on EKG Prior intolerance to 5HT3 antagonists (ondansetron or granisetron) Known hypersensitivity to granisetron or to any of the components of the patch Current treatment with ondansetron or granisetron. Patients may stop these medications for one week to enter the study. Patients will not be allowed to take ondansetron or oral granisetron during the study. Use of ketoconazole, a medications with known drug-drug interactions with granisetron Women known to be pregnant, as determined on enrollment by a urine pregnancy test Women of childbearing potential who do not agree to use a medically approved form of contraception Nursing mothers | 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 Adenocarcinoma Living in France Pancreatic adenocarcinoma histologically or cytologically proven primary diagnosis Agreed to participate Suspected pancreatic adenocarcinoma histologically or cytologically unproven Refused to participate | 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): 20.0-999.0, Vomiting Patients receiving pancreaticoduodenectomy Peritonitis history Present obstruction evidence or symptoms Previous abdominal operation Pregnancy Gastroesophageal reflux disease Disease causing vomitus prior to operation | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 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 Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 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 Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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, Complications Elective surgery patients (adults) scheduled to undergo hepatectomy at FMC from May 2013 to May 2015 Patients will be excluded if they are unable to give informed consent | 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, Acute Pancreatitis Diagnosis of pancreatitis Typical pain Increase in serum lipase or amylase Onset of abdominal pain within <=72h before admission 2. The diagnosis of Severe Acute Pancreatitis is according to Atlanta revisited in 2012 3. no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on 4. Age from 18 to 65 years old Besides above, the patient should also satisfied one of these CBP 1. Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine > 1.5 times baseline，26.5umol/L increase, or urine output < 0.5ml/kg.h for 6 hours 2. Systemic Inflammatory Response Syndrome: temperature >38℃ or<36℃；heart rate respiratory rate White blood cell count >12*10^9/L，or< 4*10^9/L 3. Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective Pregnancy 2. Chronic pancreatitis 3. Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell < 0.5*10^9/L for 10 days | 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): 18.0-70.0, Pancreatitis Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection - Pregnancy 2.Heart function: NYHA >II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy < 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure>25cmH2O 9.At least one organ'S newly emerged dysfunction - | 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): 45.0-75.0, Spinal Cord Injury Males 45-75 years old with at least 5 yrs of SCI Females 50-75 years old with at least 5 yrs of SCI; females 40-50 years old with at least 10 yrs of SCI Stable SCI (regardless of level of lesion or completeness of injury) Ability to sign consent form. For Optional Fat Meal Test Only Must have completed initial risk factor assessment as previously described Acute medical illness Pregnancy Chronic debilitating disease (i.e., severe pulmonary disease, stage IV pressure ulcers, etc.) Atrial fibrillation History of percutaneous coronary angiography with stent placement. For Optional Fat Meal Test Only Known diabetes Lactose-intolerance or dairy allergy Allergy to chocolate | 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): 70.0-90.0, Femoral Neck Fracture Patients 70 Years of Age - Dementia, Infection Not Suitable for Hemiarthroplasty - | 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 Ovarian Cancer Platinum Sensitive Ovarian Cancer Participants must have histologically or cytologically confirmed ovarian cancers for which carboplatin is an acceptable treatment option. In addition, participants must be candidates for systemic chemotherapy as determined by their treating physician Participants must have received a carboplatin-containing regimen at initial diagnosis. Retreatment is permitted in second or greater line with carboplatin-based chemotherapy Age ≥ 18 years of age Eastern Cooperative Oncology Group performance status <2 (see Appendix A) Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating chemotherapy on trial and must agree to practice an effective method of birth control, such as an intrauterine device, tubal ligation, or oral contraceptives, during the study and for six months after their last treatment. Women should not breast-feed while on this study Ability to understand and the willingness to sign a written informed consent document Patients must be willing to comply with study design and requirements for participating on the study Laboratory for The following are laboratory for baseline absolute neutrophil count, platelet count, and creatinine for on this study Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements | 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): 45.0-999.0, Breast Cancer General 1. Age > 45 years 2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 (AJC Classification) 3. Invasive ductal carcinoma and / or DCIS Intra-operative 1. Negative sentinel node assessment 2. Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound Post procedure 1. Negative microscopic surgical margins** **If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis. General Scleroderma, systemic sclerosis and active lupus 2. Participation in an investigational drug or device study 3. Previous ipsilateral radiation to the thorax or breast Intra-operative Intra-operative positive sentinel lymph node biopsy 2. Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image) 3. Skin spacing less than 1-cm via intraOp ultrasound. 4. A cavity size that is not appropriate for a 40 -70 cc balloon. 5. Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy | 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, Atrial Fibrillation Able to sign Informed Consent and Release of Medical Information forms Age ≥ 18 years Clinical indications for mitral valve surgery for organic mitral valve disease Note: May need for surgical management of functional tricuspid regurgitation or patent foramen ovale. Surgical intervention may be performed via sternotomy or minimally invasive procedure a) Persistent atrial fibrillation (AF) within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion. Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization. b) Longstanding persistent AF is defined as continuous AF of greater than one year duration. Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR left atrial diameter > 65mm Able to use heart rhythm monitor AF is paroxysmal AF without indication for mitral valve surgery Concomitant coronary artery bypass grafting (CABG), aortic arch or aortic valve procedure Previous catheter ablation for AF Redo cardiac surgery Left ventricle ejection fraction (LV EF) < 35% Life expectancy of less than one year Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study | 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, Infectious Diseases All age groups and both sexes Initial serum samples must be collected within 1 days of onset of symptoms consistent with Dengue virus infection Information must be available about symptoms, age, and sex of patient from which samples are collected The location of sample collection must be recorded Archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for as test specimens in this study. If these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection Archived samples with linked personal identifiers or any sample for which personal information can be discovered Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen | 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, Cardiometabolic Disease Group 1 : metabolic syndrome As defined by the IDF Central obesity: defined as waist circumference > 94 cm for European men and > 80 cm for European women (with knowledge on ethnicity for other groups) plus 2 of the following out of 4 Elevated blood pressure with systolic ≥ 130 mmHg and/or diastolic ≥85 mmHg (or patients receiving anti-hypertensive drug treatment) Triglycerides ≥1.50mg/dl (1.71mmol/l) (or patients receiving drug treatment for elevated triglycerides) HDL-c<40mg/dl (1.03 mmol/l) in males or HDL-c<50mg/dl (1.29mmol/l) in females (or patients receiving drug treatment that reduces HDL-c) Elevated fasting glucose: Glycemia ≥100mg/dl Aged 18 to 75 years old To avoid overlapping with the other groups (in particular group III): only patients with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c < 6.5 % will be included in this group. Group II: severely Obese patients Aged 18 to 75 years old BMI ≥35kg/m² Definitive <18 or >75 years old Past history of abdominal cancer+/ radiation therapy on the abdomen past history of intestinal resection except for appendicectomy Participants with acute or chronic inflammatory or infectious diseases (including VHC, VHB and HIV) Organ transplantation Patient on Immunosuppressive therapy Patients with severe kidney failure and or patients on dialysis therapy or eGFR < 50 ml/min per 1.73 m2 body surface area) Non affiliated to social security | 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): 19.0-89.0, Pancreatic Cancer Pain Abdominal pain typical for pancreatic cancer ( pain score ≥ 3/10) 2. Abdominal CT consistent with diagnosis of pancreatic cancer 3. Pancreatic cancer confirmed by EUS-FNA 4. Inoperable pancreatic cancer as determined during EUS or prior CT Age under 19 years 2. Unable to safely undergo EUS for any reason 3. Coagulopathy (Prothrombin time > 18 secs, platelet count < 80,000/ml) 4. Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy 5. Another cause for abdominal pain such as pseudocyst, ulcer or other intrabdominal disorder 6. Noncompliance such that the patient would not return for subsequent follow-up 7. Active alcohol or other drug use or significant psychiatric illness 8. Unable to consent 9. Non-English speaking | 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, Postoperative Pain Female ASA physical status 1-3 Scheduled for open abdominal hysterectomy Age 18-80 years old Able to participate personally or by legal representative in informed consent in English or Spanish History of relevant drug allergy Age less than 18 or greater than 80 years Chronic opioid use or drug abuse Significant psychiatric disturbance Inability to understand the study protocol Refusal to provide written consent | 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, Hereditary Pancreatitis Hereditary Pancreatic Cancer fold higher risk to develop pancreatic cancer Obtained informed consent age less than 18 yrs No consensus obtained | 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, Granulomatous Disease, Chronic Participant (Part 1 Longitudinal Analysis) CGD Patients Undergoing Transplant 1995 to Present with Birth Year In or After 1988 1. CGD Patients will be Defined by both Defective Neutrophil NADPH Oxidase Function and by Clinical History Consistent with CGD Patients must have both of: A functional assay demonstrating abnormal NADPH oxidase function (see A below); AND Clinical history consistent with CGD (see B below). ************************************************************************* Patients must have both "A" and "B": A. Function: Assays of NADPH Oxidase Function I. Dihydrorhodamine (DHR) Assay Blood sample was obtained at a time when patient was clinically stable and not critically ill, with control samples performed simultaneously indicating a qualified assay; and Assay unequivocally demonstrates CGD with an stimulation index (SI) SI < 35 or equivalent. Assay report, including mean fluorescence intensity (MFI) from unstimulated and stimulated samples and gating strategy, must be de-identified and provided. OR II. Nitroblue Tetrazolium Oxidation Test (NBT): o Diagnostic of CGD (reported as reduced granulocyte oxidative response). Report must be de-identified and provided. AND B. Clinical History: One or More of the Following Severe and/or recurrent infection (liver, perirectal or lung abscess; pneumonia; adenitis; or osteomyelitis) due to, for example, Staphylococcus aureus, Burkholderia sp, Serratia marcescens, non-albicans Candida sp, Aspergillus sp or other mold; or Nocardia sp or other deep tissue infection characteristic of CGD Sterile granulomatous disease in respiratory, gastrointestinal or urogenital tracts; or Crohn's disease-like colitis A family history consistent with either X-linked or autosomal recessive CGD In cases where either functional assay (A) or history (B) is equivocal, one or more of the following may be used to confirm a diagnosis of CGD: C. Absent or significantly reduced in expression or abnormal size of any of the 5 phox components (gp91 phox, p47 phox, p22 phox, p67phox, and p40phox) of NADPH oxidase, by either Western blot Northern blot OR D. Mutation in a gene encoding one of the 5 phox components (gp91 phox, p47 phox, p22 phox, p67 phox, and p40 phox) of NADPH oxidase that is predictive of a decreased or absent oxidative burst. (Nonsense, frameshift, or previously described missense mutation associated with CGD). Molecular Diagnosis is Desirable In addition, molecular diagnosis (gene sequencing and expression analysis) of CGD is desirable and should be performed when possible. 2. Further Characterization of Oxidase Level, Longitudinal Study, Prospective Cohort Patients who are to undergo transplantation during the study period must be further characterized as oxidase-null or oxidase positive by level of oxidase production by either Participant (Longitudinal and Cross Sectional Analyses) Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory for CGD Rac2 Deficiency Myeloperoxidase Deficiency (MPO Deficiency) Glutathione deficiency Leukocyte adhesion deficiency syndrome Non-transplant subjects The above exclusions pertain | 0 |
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