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70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, KRAS NP_004976.2:p.G12R Stage III Pancreatic Cancer AJCC v6 and v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Patients must have histologically confirmed locally advanced or metastatic pancreas cancer Patients must have received at least 6 months fluorouracil (5-FU) or gemcitabine-based treatments for pancreas cancer (fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin [FOLFIRINOX], fluorouracil, leucovorin calcium and oxaliplatin [FOLFOX], 5-FU+ nal-IRI [MM-398; nanoliposomal irinotecan], or 5-FU [including capecitabine], gemcitabine-based gemcitabine plus abraxane, gemcitabine monotherapy among others) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic Kirsten rat sarcoma (KRAS) G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70% Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 75,000/mcL Patients who have received prior treatment with tyrosine kinase inhibitors (e.g. erlotinib), or anti-Epidermal growth factor receptor (EGFR) agents (e.g. cetuximab, panitumumab) Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous Patients with active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial; no additional workup is needed to brain metastases if the patient is asymptomatic or has no history of brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib (AZD6244) or other agents used in study Previous Mitogen-activated protein kinase kinase (MEK), RAS, or Rapidly Accelerated Fibrosarcoma (RAF) inhibitor use Patients with the following cardiac conditions are excluded | 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, Shock Adult patients aged ≥18 years a NEWS≥3 requiring a trolley • <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): 70.0-999.0, Impaired Cognition Quality of Life Surgery Delirium Colorectal Carcinoma Bladder Carcinoma Abdominal Hysterectomy (& Wertheim) Prostatic Neoplasms Colon Carcinoma Renal Carcinoma Patients undergoing major body cavity surgery Male and Female patients Age greater than 70 years Patients undergoing neo-adjuvant chemotherapy will be included Participation in a formal exercise regime A BMI > 35 kg·m2 Active cardiovascular disease: uncontrolled hypertension (BP > 180/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event Taking beta-adrenergic blocking agents Cerebrovascular disease: untreated aneurysm (large vessel or intracranial) Respiratory disease including: pulmonary hypertension Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease Musculoskeletal or neurological disorders Family history of early (<55y) death from cardiovascular disease Severe rheumatoid arthritis limiting ability to perform any part of the assessment process | 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, Knee Osteoarthritis Knee Arthroplasty patients requiring primary total knee replacement patients willing and able to comply with follow-up requirements and self-evaluations patients willing to sign an IRB approved informed consent form English fluency (printed instructions are provided in English only) varus arthropathy osteoarthritis ASA less than or equal to 3 home/cell phone access adult to accompany patient home post-operatively and to stay with patient for a minimum period of 1-2 days patients with inflammatory arthritis patients with a BMI greater than 40 or less than 18 patients who are skeletally immature patient with an active infection or suspected latent infection in or about the joint bone stock that is inadequate for support or fixation of the prosthesis hardware precluding intramedullary instrumentation prior osteotomies of the femur or tibia patients living greater than 1.5 hours from the hospital patients without access to caregivers, or unable to go to their home after surgery cognitive or neuromotor conditions | 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 Cyst EUS-FNA Adult subjects over the age of 18 Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts Able to give written informed consent Capable of safely undergoing endoscopy with deep sedation or general anesthesia Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma) Known or suspected pancreatic cancer or pathologic lymphadenopathy Cysts with the following high-risk features: main pancreatic duct dilation of > 5mm, epithelial type mural nodules (> 2mm)33, pathologically thick wall/septation (> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity. (Of note, the following higher-risk features ARE eligible: recent growth in size, atypical cells on cytology, and symptoms referable to the pancreas.) Septated cysts with > 4 compartments Confirmed pancreatitis within the last 3 months Baseline lab values (must be within 6 months of consent date) in the following ranges: white blood cells > 14 or < 2 K/uL, hematocrit <30%, platelets <30 K/uL, non-pharmacologic INR >1.7, CA19-9 >2x ULN, lipase >2x ULN, creatinine >3.0 mg/dl (unless stable on renal replacement therapy), ALT >500 U/L, total bilirubin >2.5 mg/dl Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst) Pregnancy, breastfeeding, or incarcerated individual | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-999.0, Gynecologic Cancer Chemotherapy Gynecologic cancer patients under chemotherapy aged 20 and above Patients who had been enrolled for other investigational drug trials within the data collection period of 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): 14.0-999.0, Stress Fracture Ultrasound Therapy Musculoskeletal Ultrasound age 14 years and up suspected acute stress fracture of the lower extremity symptoms < 4 weeks x-ray ordered by clinician to which subjects originally present with suspected stress fracture age < 14 unable to provide consent unable to undergo MRI (implantable pacemaker or other device not compatible for MRI) previous diagnosis of acute stress fracture in the location of interest previous XR or MRI obtained at an outside clinic/facility prior to presentation previously implanted hardware (ex. orthopedic screws or plates) at location of interest symptoms > 8 weeks depth from skin surface to bone surface that exceeds the capability of ultrasound for visualization Pregnant (self-reported) Subject is known to all clinicians who would be completing the diagnostic ultrasound component of the study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases Diagnosis of ischemic or non-ischemic cardiomyopathy 2. Symptomatic functional (secondary) mitral regurgitation defined as both (Moderate), 3+ (Moderate/Severe), or 4+ (Severe). Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study. 3. NYHA Class II, III, or IV 4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters 5. Left Ventricular Ejection Fraction ≤ 50% 6. LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory. 7. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1500 pg/ml, or one or more heart failure hospitalizations within one year prior to consent 8. Guideline directed heart failure medication regimen. 9. Age ≥ 18 years old 10. implant can be sized and placed in accordance with the IFU 11. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days 2. Heart failure hospitalization within the past 30 days 3. Anticipated need of left ventricular assist device within twelve (12) months 4. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months 5. Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis 6. Heart transplant candidate or prior orthotopic heart transplantation 7. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device. 8. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 9. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory 10. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) 11. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the Imaging Core Laboratory 12. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory 13. Severe mitral annular calcification 14. Severe aortic stenosis 15. Not a candidate for right internal jugular venous cannulation 16. Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina 17. Cerebral vascular event within the past 30 days 18. Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant 19. Pulmonary embolus or deep vein thrombosis within the past six (6) months 20. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year 21. Expected to require any percutaneous coronary intervention within 30 days of the index procedure. 22. Hemodynamic instability defined as sustained systolic blood pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device 23. Presence of left atrial appendage (LAA) clot or presence of LAA occluder 24. Anemia defined as hemoglobin < 9.0 mg/dL 25. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints 26. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically 27. Active infections requiring current antibiotic therapy 28. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months 29. Female subjects pregnant or planning to become pregnant in the next five (5) years 30. Subjects unable to perform the required study assessments (e.g., 6 minute walk test) 31. Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study 32. Subjects belonging to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with the 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): 18.0-80.0, Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Phase I: 1. Male and female patients (≥18 years of age to 80) 2. Eligible for care at Brooke Army Medical Center Phase II: 1. Met the for qualification for a percutaneous liver biopsy and completed Phase I 2. Eligible for care at Brooke Army Medical Center Phase I: 1. Patients with excessive alcohol use will be excluded as defined as >21 units of alcohol/week for men and 14 units of alcohol/week for women over a 2 year time frame. One drink "unit" or one standard drink is equivalent to a 12-ounce beer, a 4-ounce glass of wine, or a 1-ounce shot of hard liquor. 2. Patients with prior history of liver disease to chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, or prior documentation of NAFLD. 3. Patients on medications known to cause fatty liver disease: tamoxifen, corticosteroids, amiodarone, methotrexate, valproic acid 4. Patients carrying an implantable active medical device such as a pacemaker or a defibrillator 5. Pregnant women Phase II: 1. CCTA/CAC only: GFR <60 mls/min/1.73m2 or IV contrast dye allergy 2. CCTA/CAC only: contraindications to atrioventricular (AV) nodal blocking agents (high degree AV block without permanent pacemaker, asthma, allergy to nodal blocking agents). 3. Known CAD defined as previous PCI or CABG (Note: Subjects with CCTA within the past 12 months will not be excluded from study and repeat scan will not be needed but the results of that previous scan will be included in the prevalence and severity analysis.) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Uncomplicated Diverticular Disease Age ≥ 18 and < 90 years old 2. Capable of giving informed consent 3. Lower abdominal pain and/or tenderness 4. Confirmed affection of left colon, including descending and sigmoid colon 5. Confirmed episode of acute uncomplicated diverticulitis on computed tomography (CT) scan defined as wall edema with or without fat stranding. Limited pericolic air with bubbles less than 5 mm in size, and less than 5cm from the colon wall, will be included as uncomplicated diverticulitis. Scan must be performed prior to enrollment and assessment for illegibility. The initial scan is not a study-specific procedure CT scan shows complicated diverticulitis as defined by the presence of intraperitoneal free perforation (i.e. intraperitoneal contrast extravasation if intra-rectal contrast given, free air under diaphragms, disseminated intraperitoneal air), abscess, obstruction, fistulisation, and phlegmon. 2. Suspicion of colorectal cancer on CT scan 3. Immunosuppression (including but not exclusively insulin-dependent diabetes mellitus, chronic liver disease, ongoing chemotherapy, chronic renal failure with hemodialysis, corticosteroid and immunosuppressive medication) 4. Pregnancy and breastfeeding 5. Any comorbid infection requiring 6. High fever (≥ 38.5 ºC) 7. Significant leukocytosis (> 15 g/dL) 8. Abdominal pain worsening in the emergency, impeding ambulation and/or eating 9. Evidence of generalized peritonitis on physical exam 10. Intolerance to oral intake and/or persistent vomiting 11. Marked abdominal distension and/or signs of ileus on CT scan 12. Noncompliance/unreliability for return visits/lack of support system 13. Failed outpatient treatment not previously included in study within last 30 days 14. Cognitive, social or psychiatric impairment 15. For patients aged 65 years or older, a Charlson Comorbidity Score ≥ 5 as calculated on the following website: https://www.thecalculator.co/health/Charlson-Comorbidity-Index-(CCI)-Calculator-765.ht ml 19-20 | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 19.0-999.0, Pancreatic Carcinoma Metastatic Pancreatic Adenocarcinoma Pancreatic Neoplasms Pancreatic Cancer Pancreatic Cancer, Adult Age ≥ 19 years 2. The subject is capable of understanding and complying with protocol requirements. 3. The subject is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures. 4. Abdominal pain typical for pancreatic cancer 5. Cross-sectional imaging findings consistent with pancreatic cancer 6. Pancreatic cancer confirmed by EUS-FNA in patients referred for suspected pancreatic cancer OR Patients with known diagnosis of pancreatic cancer 7. Inoperable pancreatic cancer as determined during EUS or prior CT Age <19 years 2. Unable to obtain consent for the procedure from the patient 3. Unable to safely undergo EUS for any reason 4. Irreversible coagulopathy (Prothrombin time > 18 secs, platelet count < 50,000/ml) 5. Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy 6. Another cause for abdominal pain such as pseudocyst, ulcer or other intraabdominal disorder 7. Pregnant women will be excluded. This will be confirmed by self-report. Pregnancy in females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin (HCG) testing | 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 Pulmonary Hypertension Patients listed for surgery for severe primary mitral regurgitation +/ concomitant coronary artery bypass grafting for bystander disease +/ tricuspid valve surgery +/- atrial fibrillation surgery Secondary mitral regurgitation. Significant history of ischaemic heart disease eg. angina. Age <18 years or >85 years. Critical preoperative status with multi-organ dysfunction. Emergency cardiac surgical intervention. Pregnancy. Unable to give informed consent or unwilling to participate in research. Patients with definite contraindication for MRI would be excluded from the cardiac MRI element of the study. Patients we are unable to take adequate biopsies due to technical difficulties would be excluded from the myocardial biopsy element of 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): 20.0-70.0, Essential Hypertension Dyslipidemia Voluntarily provided a written consent to participate in this clinical study 2. Male or female adults aged 19-70 years 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1) 4. Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy 5. Subjects who meet the following of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC) 6. Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3) 7. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms 2. Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1) 3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease) 4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2)) 5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1) 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis 8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1) 9. Pregnant or lactating women 10. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.) | 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 Subjects must satisfy the following to be enrolled in the study: 1. ≥ 18 years of age at the time of signing the informed consent form. 2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures conducted. 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas. 4. Performance status or Comorbidity condition not currently appropriate (but potentially reversible) for a major abdominal operation. Acceptable hematology parameters: 1. Absolute neutrophil count (ANC) ≥ 1500 cell/mm3 2. Platelet count ≥ 100,000/mm3 without transfusion support. 3. Hemoglobin (Hgb) ≥ 9 g/dL Acceptable blood chemistry levels: 1. Hepatic transaminases (ALT and AST) less than 2.5× the upper limits of normal (ULN) 2. Total bilirubin level less than 1.5 × the upper limits of normal (ULN) or in patient with Biliary stenting less than 2 mg/dL 3. Serum creatinine level less than 1.5 × the upper limits of normal (ULN) or creatinine clearance (Ccr) ≥ 40 mL/min. 4. Alkaline phosphatase ≤ 2.5 x ULN 5. Serum albumin > 3 g/dL Absence of poorly controlled comorbid conditions: 1. Congestive heart failure (CHF) 2. Chronic obstructive pulmonary disease (COPD) 3. Uncontrolled diabetes mellitus (DM) 4. Neurologic disorders (not acutely related to pancreatic cancer) or limit function 5. Radio-graphically suspicious but not diagnostic for extra-pancreatic disease, 1. Superior mesenteric vein and portal vein confluence that can be reconstructed even if short segment venous occlusion is present (i.e. a suitable portal vein above, and a suitable Superior mesenteric vein below the area of occlusion); 2. Tumor abutment of the Superior mesenteric artery of ≤180⁰, 3. Short segment encasement of the hepatic artery amenable to resection and reconstruction (this is usually at the origin of the gastroduodenal artery and reconstruction may or may not require interposition grafting with a short segment of reversed saphenous vein). 6. Cancer antigen 19-9 level (in absence of jaundice) ≥ 100u/ml suggestive of disseminated disease. 7. Preoperative treatment is recommended as an alternative for patients with potentially curable pancreatic cancer who meet all of the following no clinical evidence for metastatic disease, a performance status and comorbidity condition appropriate for a major abdominal operation, no radiographic interface between primary tumor and mesenteric vasculature on imaging, an acceptable Cancer antigen 19-9 level The presence of any of the following will a subject from enrollment: 1. Pancreatic tumors of endocrine or mixed origin. 2. Prior anticancer therapy for pancreatic carcinoma. 3. Presence of or history of metastatic pancreatic adenocarcinoma. 4. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the prostate (Gleason score ≤ 7), cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment). 5. Active 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. 6. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelo-suppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications. 7. History of allergy or hypersensitivity to study regimen or any of their excipients. 8. Peripheral sensory neuropathy Grade > 1. 9. Clinically significant ascites. 10. Plastic biliary stent. (Metal biliary stent is allowed.) 11. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the integrity of the study data. These but are not limited to: 1. History of connective tissue disorders (e.g., 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 treatment 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 12. Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures. 13. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 14. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 15. Any condition that confounds the ability to interpret data from the study. 16. Unwillingness or inability to comply with study procedures. 17. Pregnant or breast feeding | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis, Chronic Age 18 or over Patients referred for EUS for investigation of abdominal pain without a cause found on assessment with MRI and FEL-1 Patients referred for EUS for chronic pancreatitis assessment based on MRI and/or FEL-1 testing Patients with known solid pancreatic lesions Patients under the age of 18 Patients who decline EUS examination Patients referred for EUS with indications other than epigastric pain or suspicion of chronic pancreatitis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Granulomatosis With Polyangiitis Greater than or equal to 18 years of age Stenotic Airway Disease (laryngeal, subglottic, distal tracheal or bronchial) <18years of age Patients without capacity to consent for themselves History of significant laryngotracheal traumatic injury Endotracheal intubation 2 years prior to presentation Major anterior neck surgery History of neck irradiation History of caustic or thermal injury to the laryngotracheal complex | 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, Gestational Diabetes (women with a history of GDM) Pregnancy with diagnosis of GDM, within the last 5 years No other previous pregnancies Complete resolution of GDM after delivery No evidence of T2D at the time of BMI between 17 and 30 Signed informed consent (women without a history of GDM) Pregnancy without problems in glucose homeostasis, within the last 5 years No other previous pregnancies No evidence of T2D at time of Previous treatment (within 6 months) with synthetic exendin Breast feeding Current pregnancy Renal dysfunction Liver 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): 18.0-999.0, Pancreatic Adenocarcinoma Metastatic A subject must fully meet all of the following to be eligible for the study: 1. The subject has a biopsy-proven diagnosis of adenocarcinoma of the pancreas (or recurrence of previously resected disease) with metastatic disease that is measurable per 1.1; 2. The subject must have tumor that is amenable to fine needle biopsy via computerized tomography (CT) guided approach OR an archived tissue sample such as a prior surgical sample or biopsy sample that is adequate for testing; 3. The subject must have EGFR and c-Met overexpressed in tumor as determined by immunohistochemistry (IHC) test score of 2+ for both markers; 4. The subject has demonstrated radiographic progression after front-line treatment for locally advanced or metastatic disease (prior adjuvant therapy allowed if ≥ 6 months elapsed between end of adjuvant therapy and metastatic relapse); 5. The subject is ≥ 18 years old on the day of consent; 6. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. The subject has recovery to baseline or ≤ Grade 1 CTCAE v.4.03 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy; 8. The subject has organ and marrow function and laboratory values as follows within 7 days before the first dose of study treatment: 1. The ANC ≥ 1500/mm3 without colony stimulating factor support; 2. Platelets ≥ 100,000/mm3; 3. Hemoglobin ≥ 9 g/dL; 4. Bilirubin ≤ 1.5 x the ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL; 5. AST/ALT ≤ 3 x the ULN; 6. Serum albumin ≥ 2.8 g/dl; 7. Serum creatinine ≤ 1.5 x the ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: i. Male: CrCl (mL/min) = (140 age) × wt (kg) / (serum creatinine × 72); ii. Female: Multiply above result by 0.85; h. UPCR ≤ 1; i. Serum phosphorus, calcium, magnesium and potassium ≥ LLN; j. Prothrombin time (PT)/INR or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatment; 9. The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document; 10. The subject has a life expectancy of 12 weeks or greater; 11. The subject is able to tolerate oral medications and no evidence of ongoing malabsorption; 12. All sexually active subjects of reproductive potential must agree to use both a medically accepted barrier method (e.g., male or female condom) and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s); 13. Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy or bilateral oophorectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons A subject who meets any of the following is ineligible for the study: 1. The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; 2. Prior treatment with cabozantinib or erlotinib; 3. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible; 4. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment; 5. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment; 6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment; 7. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel); Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low-dose LMWH are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor. 8. The subject has experienced any of the following: 1. clinically-significant GI bleeding within 6 months before the first dose of study treatment; 2. hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment; 3. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment; and 4. clinically confirmed history of interstitial lung disease (ILD). 9. The subject has radiographic evidence of cavitating pulmonary lesion(s); 10. The subject has tumor invading or encasing any major blood vessels; 11. The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib; 12. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders including: i. Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening; ii. Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; iii. Any history of congenital long QT syndrome; iv. Any of the following within 6 months before the first dose of study treatment unstable angina pectoris clinically-significant cardiac arrhythmias stroke (including transient ischemic attack (TIA), or other ischemic event) myocardial infarction. b. GI disorders particularly those associated with a high risk of perforation or fistula formation including: i. Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction ii. Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before first dose of study treatment Note: Complete healing of an intra-abdominal abscess must be confirmed prior first dose of study treatment c. Other clinically significant disorders that would preclude safe study participation; 13. Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible; 14. QTcF > 500 msec within 1 month before the first dose of study treatment: a. Three ECGs must be performed for determination. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets in this regard. 15. Pregnant or lactating females; 16. Active smoker; 17. Inability to swallow intact tablets; 18. Previously identified allergy or hypersensitivity to components of the study treatment formulations; 19. Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy; malignancy felt by investigator to potentially affect subject survival or ability to evaluate disease response | 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, Unresectable Stage III Melanoma Stage IV Melanoma Histologically or cytologically confirmed unresectable stage III or IV cutaneous or mucosal melanoma Presence of BRAF V600E or V600K mutation in tumor tissue prior to enrolment as per local assessment Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. This can be an archived sample if obtained at maximum 3 months prior to randomization and if the patient did not receive treatment since then Measurable disease per 1.1 by computed tomography (CT) or Magnetic Resonance Imaging (MRI) of Chest/Abdomen/Pelvis CT and brain CT/MRI performed within 28 days prior to randomization Patients ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Patients must be able to swallow and retain oral tablets Adequate organ function within 14 days prior to randomization Patients with hyperthyroidism or hypothyroidism but that are stable on hormone replacement can be included Adequate cardiac function Uveal melanoma Any symptomatic brain or leptomeningeal disease. Subjects with brain metastases are eligible if these have been locally treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment and treatment is completed within 28 days prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration Any prior treatment for advanced disease including treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody, anti-LAG-3, anti-TIM-3, anti-IDO, etc or BRAF or MEK inhibitors History of hypersensitivity to study drugs or any excipient (refer to Investigator's brochures for binimetinib and encorafenib and SmPCs for ipilimumab and nivolumab) Prior adjuvant melanoma therapy with IFN, anti-PD1, anti-PDL1 or anti-CTLA-4 or any other systemic treatment is permitted if completed at least 1 year prior to randomization and all related adverse events have either returned to ≤ 1 Concomitant administration of strong inducers and inhibitors of P-gp, glucuronidation, CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [hypericin]) Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin) Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine Current participation or treatment with other investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment Child-Pugh B/C and patients with history of acute or chronic pancreatitis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 40.0-80.0, Mitral Valve Disease Coronary Artery Disease Tricuspid Valve Disease Aortic Valve Disease Atrial Fibrillation Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other) Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation Signing of the informed consent Age below 40 and over 80 years of age Left ventricular ejection fraction below 25% Left atrium diameter over 60mm Permanent atrial fibrillation Polymorbidity (Euroscore II over 10) Emergency surgery Renal insufficiency (creatinine over 200 umol/l) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 16.0-80.0, Acute Pancreatitis patients with acute pancreatitis admitted at Assiut university hospital and the diagnosis of acute pancreatitis is confirmed if at least two of the following three features present: 1. abdominal pain characteristic of acute pancreatitis. 2. serum amylase and/or lipase greater than 3 times the upper limit of normal . 3. radiographically demonstrated acute pancreatitis on CT scan or abdominal ultrasound Patients are excluded from the study if they do not meet the for acute pancreatitis 2. Patients who are under the age of 16. 3. Patients with chronic pancreatitis. 4. Patients with recurrent acute pancreatitis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Type2 Diabetes Coronary Artery Disease T2DM as defined by American Diabetes Association (ADA) Adult patients with T2DM who are indicated to receive liraglutide, not as first-line therapy, in addition to diet and exercise to improve glycemic control Hemoglobin A1c (HbA1c) ≤ 9% Age ≥ 18 years old Body mass index (BMI) ≥ 27 Kg/m2 and/or waist circumference ≥ 102 cm (40 inches) in men and 88 cm (35 inches) in women, respectively Clinically and angiographically stable CAD who requires CABG as part of the standard medical care, as CAD does not represent a contraindication for using liraglutide. The stability of the CAD further warranties that study patients will not be exposed to higher risk by using liraglutide Patients with a personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2 Patients with a prior serious hypersensitivity reaction to liraglutide Other contra-indications to liraglutide in accordance with risks and safety information included in the latest updated prescribing information Type 1 diabetes, as defined by ADA Current use of other GLP-1A, dipeptidyl peptidase 4 (DPP4) or Sodium Glucose transporters 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), pramlintide and fixed prandial insulin Patients with unstable CAD, assessed by the Cardiology team and defined as new onset angina, rest angina, rapidly increasing or crescendo angina History of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; acute or chronic infective diseases, cancer or chemotherapy, history of pulmonary, renal or liver diseases, and drug abuse Patients with chronic and acute inflammatory conditions such as sepsis, rheumatoid arthritis, ectopic dermatitis, asthma, ulcerative colitis Current use of systemic corticosteroids in the 3 months prior this study Pregnant or breast-feeding women | 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, Acute Diverticulitis Abdominal Pain informed consent obtained patients with abdominal pain presenting to the Emergency Department with a suspicon of diverticular disease, in whom the tutor physician orders an imaging study (abdominal CT or abdominal US performed by the Radiologist) no ultrasonographer physician who can perform bedside abdominal US is present the patient does not undergo imaging study clinical conditions of the patient are particularly severe, preventing an adequate enrollment | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Coronary Artery Disease Coronary Arteriosclerosis Atrial Fibrillation Left Atrial Abnormality Severe Aortic Stenosis symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement diagnosis of acute coronary syndrome in the last 3 months prior history of persistent or permanent atrial or flutter fibrillation coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve left ventricular dilatation [end-diastolic volume index >75 mL/m²] left ventricular ejection fraction <55% chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated by Cockcroft-Gault formula adjusted for body surface area < 30 mL/min/1.73m² moderate to severe chronic obstructive pulmonary disease defined as forced expiratory volume in one second <50% according to the 2011 Global Initiative for Chronic Obstructive Pulmonary Disease guidelines active malignancy (i.e. With no evidence of recurrence and no longer receiving active treatment) | 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 Breast Carcinoma Locally Advanced Breast Carcinoma Metastatic Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 PRE-REGISTRATION Women who have disease that is amenable to biopsy and agree to undergo a standard of care and /or research biopsy Note: If a standard of care biopsy was recently obtained =< 2 months of pre-registration, eligible patients should agree to a research biopsy of recurrent or metastatic breast cancer prior to the start of protocol treatment to collect additional core samples for research purposes Patients must satisfy one of the following for prior therapy First line setting: No prior endocrine therapy in the metastatic setting with no more than one prior line of chemotherapy in the advanced/metastatic setting Second line setting: Progression on one prior line of endocrine based therapy monotherapy either in the adjuvant or advanced/metastatic setting; either one or two prior lines of chemotherapy in the advanced setting are allowed Note: Patients receiving bisphosphonate or denosumab therapy prior to registration may continue at the same intervals used prior to study registration First line therapy setting only: The intention to begin palbociclib and letrozole as treatment for locally advanced or metastatic breast cancer Second line therapy setting only: The intention to begin palbociclib and fulvestrant as treatment for metastatic breast cancer (after progression on first line endocrine therapy) Note: Patients who are to receive second line endocrine therapy are allowed to remain on their most recent treatment (tamoxifen or an aromatase inhibitor during the pre-registration period as well as after registration while awaiting insurance approval for the use of palbociclib PRE-REGISTRATION History of metastatic ER negative or HER2 positive breast cancer Prior treatment in the metastatic setting with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway Uncontrolled intercurrent illness including, but not limited to Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Uncontrolled symptomatic cardiac arrhythmia Uncontrolled hypertension (defined as blood pressure > 160/90) Other active second malignancy other than non-melanoma skin cancers =< 3 years of pre-registration; Note: a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for =< 3 years prior to pre-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): 0.0-18.0, Perforated Appendicitis Postoperative Infection Postoperative Perforated Appendicitis (documented by intraoperative photo) Postoperative Laparoscopic Appendectomy Nonperforated Gangrenous Appendicitis Nonperforated Purulent Appendicitis Open Appendectomy | 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 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Negative HER2/Neu Negative Metastatic Malignant Solid Neoplasm Pancreatic Ductal Adenocarcinoma Progesterone Receptor Negative Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Lymphoma Refractory Lymphoma Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Triple-Negative Breast Carcinoma Unresectable Solid Neoplasm Non-pregnant Subjects must have histologically confirmed malignancy that is metastatic or unresectable and for which there is no available therapy likely to convey clinical benefit Subjects must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options are also eligible. a) Subjects with relapsed and/or refractory lymphoma must have had at least 2 prior lines of systemic therapy and are not candidates for high dose therapy/autologous stem cell transplant Subjects must have evaluable disease for the dose escalation, and measurable disease for the dose expansion Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Subjects must have a life expectancy >= 12 weeks Absolute neutrophil count >= 1,500/mcL Hemoglobin >= 9 g/dL Platelets >= 100,000/mcL Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) Subjects who have had chemotherapy or radiotherapy within 3 weeks (4 weeks for immunotherapy; 6 weeks for nitrosoureas or mitomycin C) prior to starting the study agent Subjects with active brain metastases Subjects may not be receiving any other investigational agents or have participated in any other clinical trial involving another investigational agent for treatment of advanced solid tumors or lymphoma within 3 weeks prior to cycle 1, day 1 of the study Subjects who had major surgery or radiation therapy within 4 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IACS-010759 Subjects receiving metformin or other agents known to increase risk of lactic acidosis Subjects who previously received IACS-010759 or oxidative phosphorylation (OXPHOS) inhibitors Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active serious bacterial, fungal or viral infection or psychiatric illness/social situations that would limit compliance with study requirements Subjects with a history of significant cardiac disease including: congestive heart failure requiring therapy; history of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment; clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block); left ventricular ejection fraction (LVEF) < 50% evaluated by echocardiogram (ECHO) or multigated acquisition scan (MUGA); increased Fridericia's correction formula (QTcF) (> 450 for men and > 470 for women) Women who are breast-feeding or pregnant as evidenced by positive serum or urine pregnancy test performed within 72 hours of first dosing. (Pregnant women are excluded from this study because it is not known whether IACS-010759 has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IACS-010759 breastfeeding should be discontinued if the mother is treated with IACS-010759.) | 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): 4.0-999.0, Fibrodysplasia Ossificans Progressiva Key Written, signed, and dated informed subject/parent consent; and for subjects who are minors, age-appropriate assent (performed according to local regulations) Males or females at least 4 years of age Previous participation in Clementia's natural history study (NCT02322255); clinically diagnosed with FOP, with the R206H ACVR1 mutation or other FOP variants reported to be associated with progressive HO (who have not participated in any Clementia-sponsored study); participants in Clementia's Phase 2 studies (NCT02279095 and NCT02979769) who cannot currently receive the chronic/flare-up regimen due to country of residence or those traveling long distances to participate in the Phase 2 studies No flare-up symptoms within the past 4 weeks, including at the time of enrollment Abstinent or using two highly effective forms of birth control Accessible for treatment and follow-up; able to undergo all study procedures including low-dose WBCT (excluding head) without sedation. Key Weight <10 kg Concomitant medications that are strong inhibitors or inducers of cytochrome P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib Amylase or lipase >2x above the upper limit of normal (ULN) or with a history of chronic pancreatitis Elevated aspartate aminotransferase or alanine aminotransferase >2.5x ULN Fasting triglycerides >400 mg/dL with or without therapy Female subjects who are breastfeeding Subjects with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease Simultaneous participation in another clinical research study (other than palovarotene studies) within 4 weeks prior to Screening; or within five half-lives of the investigational agent, whichever is longer Any reason that, in the opinion of the Investigator, would lead to the inability of the subject and/or family to comply with the protocol | 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): 40.0-100.0, Pancreatic Cyst Patients of all ethnic groups older than 40 years old Cystic pancreatic lesions larger than 1 cm documented by MR Scheduled for surgery (Group 1) or undergoing surveillance (Group 2) for a pancreatic cyst by a hepatobiliary surgeon at UHN (University Health Network) Patients with contraindication for contrast-enhanced CT or MRI Pregnancy Patients who do not consent to the study Patients younger than 40 years old or with pancreatic cysts less than 1 cm | 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, Diverticulum, Colon Diverticulitis All consecutive patients satisfying the following are recruited: 1. Acceptance to sign the Informed Consent form 2. Age >18 3. Instrumental evidence (endoscopic or radiological) of diverticula in the colon Refusal to sign the Informed Consent form 2. Inability to comply with the study 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): 19.0-70.0, Essential Hypertension, Dyslipidemia Voluntarily provided a written consent to participate in this clinical study 2. Male or female adults aged 19-70 years 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1) 4. Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre baseline visit (V2) after wash-out period 5. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms 2. Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1) 3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease) 4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2)) 5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis 8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1) 9. Pregnant or lactating women | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-70.0, Low Back Pain Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation). 2. Low back pain of greater than three months' duration. 3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture). 4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels. 5. At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture, and manual therapy Patient refusal. 2. More than four painful lumbar facet-joints. 3. Patient has not completed at least two components of NICE-recommended best non-invasive care. 4. 'Red flag' signs ('Red flag' signs are possible indicators of serious spinal pathology, and thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia). 5. Hypersensitivity to study medications or X-ray contrast medium. 6. Radicular pain (Radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band). 7. Dominantly midline tenderness over the lumbar spine. 8. Any other dominant pain. 9. Any major systemic disease or mental health illness that may affect the patient's pain, disability and/or their ability to exercise and rehabilitate. 10. Any active neoplastic disease, including primary or secondary neoplasm. 11. Pregnant or breastfeeding patients. 12. Previous lumbar facet-joint injections. 13. Previous lumbar spinal surgery. 14. Patients with morbid obesity (body mass index of 35 or greater). 15. Major trauma or infection to the lumbar spine. 16. Participation in another clinical trial in the past thirty days. 17. Patients unable to commit to the six-month study duration. 18. Patients involved in legal actions or employment or benefit tribunals related to their low back pain. 19. Patients with a history of substance abuse | 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): 17.0-999.0, Testing a Computational Model to Estimate Patient Size Adult Referred to Ninewells Hospital for an anterior-posterior abdomen x-ray examination Patients unable to give consent Patients who have had a contrast injection in the previous 24 hours Patients suffering abdominal pain at the time of the examination | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 16.0-999.0, Pancreatitis, Acute All patients treated at Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis will be recruited where possible. For the potential clinical diagnosis of acute pancreatitis an appropriate clinical history based on compatible clinical features, will be required (i.e. abdominal pain, nausea and/or vomiting), supported by the finding of elevated serum amylase greater than 3x the upper limit of the reference range for the laboratory (currently 300 U/L). For the radiological diagnosis, if applicable, computerised tomography (CT) and/or ultrasound scan (USS) evidence of acute pancreatitis will be accepted The following will be adhered to: i. Patients under the age of 16 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity. Additional exclusions will apply only to those patients being considered for the nested cohort study: iv. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker) v. Patients with a known allergy to salbutamol | 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, Intra Abdominal Infections Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures. 2. Adult patients ≥18 years of age 3. a. Intra-operative/post-operative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis including at least 1 of the following diagnosed during the surgical intervention: i. Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall ii. Diverticular disease with perforation or abscess iii. Appendiceal perforation or peri-appendiceal abscess iv. Traumatic perforation of the intestines, only if operated on >12 hours after perforation occurs v. Secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites) vi. Intra-abdominal abscess (including of liver or spleen provided that there was extension beyond the organ with evidence of intraperitoneal involvement). OR: b. Pre-operative enrollment where one of the following surgical procedures are planned within 24 hours prior to the first dose of study drug: i. Open laparotomy, percutaneous drainage of an intra-abdominal abscess, or laparoscopic surgery. 4. Evidence of systemic inflammatory indicators, with at least one of the following: i. Fever (defined as body temperature >38°C) or hypothermia with a core body temperature <35°C ii. Elevated white blood cell count (>12,000 cells/mm3) iii. Drop in blood pressure (systolic BP must be <90 mmHg without pressor support) iv. Increased heart rate (>90 bpm) and respiratory rate (>20 breaths/min) v. Hypoxia (oxygen saturation ≤90 percent on room air) 5. Physical findings or symptoms consistent with intra-abdominal infection, with at least one of the following: i. Abdominal pain and/or tenderness, with or without rebound ii. Localized or diffuse abdominal wall rigidity iii. Abdominal mass iv. Nausea/vomiting v. Altered Mental Status 6. Specimen/s from the surgical intervention were sent for culture Patient diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which the primary etiology was not likely to be infectious. 2. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation. 3. Patient has simple cholecystitis or gangrenous cholecystitis without rupture, or simple appendicitis, or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic abscess. 4. Patient whose surgery included staged abdominal repair, or "open abdomen" technique, or marsupialization. 5. Patient known at study entry to have a complicated intra-abdominal infection caused by pathogens resistant to the study antimicrobial agents. 6. Patient needed effective concomitant systemic antibacterials (oral, IV, or intramuscular) or antifungals in addition to those designated in the 2 study groups, except vancomycin, linezolid, or daptomycin if started for known or suspected methicillin-resistant Staphylococcus aureus (MRSA) or Enterococcus spp. as per clinical study protocol (CSP). 7. Patient has perinephric infections or an indwelling peritoneal dialysis catheter. 8. Patient has suspected intra-abdominal infections due to fungus, parasites (e.g., amoebic liver abscess), virus, or tuberculosis. 9. Patient has a known history of serious allergy, hypersensitivity or any serious reaction to carbapenem antibiotics, or to other β-lactam antibiotics 10. Patient known to have any of the following laboratory values as defined below: 1. Hematocrit <25% or hemoglobin <8 g/dL 2. Absolute neutrophil count <1000/mm3 3. Platelet count <75,000/mm3 4. Bilirubin >3 x the upper limit of normal (ULN), unless isolated hyperbilirubinemia was directly related to the acute infection or known Gilbert's disease 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN values at Screening. Patients with elevations of AST and/or ALT up to 5 x ULN will be eligible if these elevations are acute and directly related to the infectious process being treated. This must be documented 6. Alkaline phosphatase (ALP) >3 x ULN. Patients with values >3.0 x ULN and <5.0 x ULN are eligible if this value is acute and directly related to the infectious process being treated. This must be documented. 7. Estimated creeatinine clearance <50 mL/min 11. Patient has a body mass index >45 kg/m2. 12. Patient has II score >30. 13. Patient considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness, including septic shock that was associated with a high risk of mortality. 14. Patient unlikely to respond to 10-14 days of treatment with antibiotics. 15. Patient received systemic antibacterial agents within the 72-hour period prior to study entry, unless either of the following pertained: a. Patient has a new infection (not considered a treatment failure) and both of the following were met: i. Patient received no more than 24 hours of total prior antibiotic therapy ii. Patient received ≤1 dose of a treatment regimen post-operatively and antibiotics were not received more than 6 hours post-procedure. b. Patient considered to have failed the previous treatment regimen i.e., pre-operative treatment of any duration with non-study systemic antimicrobial therapy for peritonitis or abscess permitted provided that all of the following are met: i. The treatment regimen had been administered for at least 72 hours and was judged to have been inadequate ii. The patient had an operative intervention that was just completed or was intended no more than 24 hours after study entry iii. Findings of infection were documented at surgery iv. Specimens for bacterial cultures and susceptibility testing were taken at operative intervention v. No further non-study antibacterials were administered after randomization. 16. Patient has a concurrent infection that may interfere with the evaluation of response to the study antibiotic. 17. Patient receiving hemodialysis or peritoneal dialysis. 18. Patient has a history of acute hepatitis in the recent past (3 months prior to study entry), chronic hepatitis, cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure. 19. Patient has past or current history of epilepsy or seizure disorders excluding febrile seizures of childhood. 20. Patient immunocompromised as evidenced by any of the following: 1. Human immunodeficiency virus infection, with either a recent (in the past 6 months) acquired immune deficiency syndrome-defining condition or a CD4 + T lymphocyte count <200/mm3 2. Systemic or hematological malignancy requiring chemotherapeutic or radiologic/immunologic interventions within 6 weeks prior to randomization, or anticipated to begin prior to completion of study 3. Immunosuppressive therapy, including maintenance corticosteroid therapy (>40 mg/day equivalent prednisolone) for 5 days or more. 21. Patient participating in any other clinical study that involved the administration of an investigational medication at the time of presentation, during the course of the study, or who had received treatment with an investigational medication in the 30 days prior to study enrollment, or had previously been enrolled in this study or had been treated with sulopenem. 22. Patient is in a situation or has a condition that, in the investigator's opinion, may interfere with optimal participation in the study. 23. Patient unlikely to comply with protocol e.g., uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study. 24. Patient has known inflammatory bowel disease (ulcerative colitis or Crohn's disease) or Clostridium difficile-associated diarrhea. 25. Patients with a history of blood dyscrasias 26. Patients with a history of uric acid kidney stones 27. Patients with acute gouty attack 28. Patients on chronic methotrexate therapy 29. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours of study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant. 30. Male subjects who do not agree to use an effective barrier method of contraception during the study and for 14 days post treatment | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Resectable Pancreatic Cancer Major for the Study the Following Patient has an ECOG performance status PS 0-1. No prior chemotherapy or radiation for pancreatic cancer and no prior exposure to gemcitabine and/or nab-paclitaxel Patient has the following blood counts at baseline ANC ≥1.5 × 109/L (1500 /mm3) Platelets ≥100 × 109/L; (100,000/mm3) Hgb ≥10 g/dL Patient has the following blood chemistry levels at baseline AST (SGOT), ALT (SGPT) ≤ 3.0 × upper limit of normal (ULN) Alkaline phosphatase (AP) ≤3.0 X ULN Total bilirubin ≤1.5 or ≤ULN Serum creatinine ≤1.5mg/dL or calculated clearance ≥50 mL/min/1.73 m2 for patients with serum creatinine levels >1.5 mg/dL Patient has acceptable coagulation status as indicated by a PT within normal limits (± 15%) and PTT within normal limits (± 15%) Major the Following: 1. Patient has locally advanced unresectable pancreatic cancer. 2. Patients aged >75. 3. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible. 4. Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT. 5. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 6. Patient has known infection with HIV, hepatitis B, or hepatitis C. 7. 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. 8. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or nab-paclitaxel. 9. Patient has a history of allergy or hypersensitivity to the study drugs. - - | 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, Pregnant Women Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center All others fetal diagnosis | 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 Necrotizing Pancreatitis All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis will be considered Age <18 years Pregnancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 16.0-999.0, Pilonidal Abscess Pilonidal Sinus With Abscess Pilonidal Sinus Infected Pilonidal Disease All patients with acute pilonidal abscess Patients under the age of 16 years will be excluded Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive medication) patients will be excluded | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Coronary Artery Disease Subject must be ≥ 18 years of age 2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed 3. Subject is eligible for percutaneous coronary intervention (PCI) 4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia 5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG) 6. Subject is willing to comply with all protocol-required follow-up evaluation Angiographic (visual estimate): 7. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤3.50 mm 8. Target lesion(s) must be able to be treated with a single stent and the target lesion length must be ≤27 mm (by visual estimate). NOTE: Only lesion lengths that have both the control and comparable investigational stent lengths available at the same time are eligible for enrollment. 9. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: 1. Stenosis ≥70% or; 2. Abnormal fractional flow reserve (FFR) defined as <0.80 or; 3. Abnormal stress or imaging stress test or; 4. Elevated biomarkers prior to the procedure 10. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s) 11. The first lesion treated must be successfully predilated/pretreated Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) 2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina 3. Subject has received an organ transplant or is on a waiting list for an organ transplant 4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure 5. Planned PCI (including staged procedures) or CABG after the index procedure 6. Subject previously treated at any time with intravascular brachytherapy in the target vessel(s) 7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., Cobalt-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin) 8. Subject has one of the following (as assessed prior to the index procedure): 1. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months 2. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) 3. Planned procedure that may cause non-compliance with the protocol or confound data interpretation 9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome 10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3 11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3 12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis 13. Subject is on dialysis or has baseline glomerular filtration rate (GFR) of <30 ml/min 14. Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions 15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months 16. Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) <30%)) 17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint 18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure 19. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure) 20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) Angiographic (visual estimate): 21. Planned treatment of a single lesion with more than 1 stent 22. Planned treatment of more than 3 lesions 23. Planned treatment of lesions in more than 2 major epicardial vessels 24. Planned treatment of more than 2 lesions in a single major epicardial vessel 25. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) 26. Target lesion(s) is located in the left main or unprotected left 27. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate 28. Target lesion(s) is located within a saphenous vein graft or an arterial graft 29. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft 30. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing 31. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent) 32. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent 33. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure 34. Significant thrombus, present in the target vessel (by visual estimate) | 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, Gastrectomy Atrial Fibrillation Age >18 English-speaking Planned for either a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) or catheter-based atrial fibrillation ablation Participant is willing and able to read and sign consent and participate in study Participant has an email account and a mobile device (smartphone or tablet) able to download the necessary applications Participant is willing to use the mobile health platform and syncable devices (e.g. Fitbit Charge 2) Attending bariatric surgeon or electrophysiologist (as appropriate) concurs that patient is a candidate for enrollment Healthy patients Patients who refuse participation | 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): 50.0-999.0, Diverticulitis Over the age of 50 Clinically suspected acute diverticulitis Low abdominal pain WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L Pregnancy Previous allergy to intravenous contrast Renal failure or other reasons that the patient cannot undergo CT with iv contrast Unable to give informed consent Dementia Language barrier | 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): 40.0-80.0, Chronic Obstructive Pulmonary Disease Age 40-80 years Patients hospitalized with a primary diagnosis of an acute exacerbation of COPD Body mass index (BMI) ≤ 35 kg/m2 Cognitively and linguistically able to follow instructions given in English and provide informed consent To be discharged to home following the hospitalization Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust in a home environment deemed safe by the investigators to perform home assessments Previous home PAP (CPAP or NIV) therapy use within the past year, or post-discharge Allergies to latex, metals or local anaesthetic agents Wound or inflamed skin at parasternal location (2nd intercostal space) History of skin allergies or sensitivity to cosmetics and lotions Psychological and social factors that would impair compliance with study protocol and schedule Any major non-COPD chronic disease or condition, such as severe heart failure (LVEF<30%), malignancy (active treatment and palliation), end stage renal failure/dialysis, significant neuromuscular disease (e.g. NMD, MD) determined by review of medical history and / or patient reported medical history that may contribute significantly to risk of readmission, as determined by PI Length of stay ≤ 24 hours Planned travel away from home within the 30 day post discharge 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, Atrial Fibrillation Coronary Artery Disease Aortic Valve Stenosis Aortic Valve Disease Mitral Valve Disease Cardiac Arrythmias Cardiac Tumor Cardiac Surgery Any open-heart cardiac surgery Written informed consent All-comers design No informed 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): 0.0-999.0, Cancer, Metastatic Cancer Cancer of Pancreas Cancer of Liver Cancer of Stomach Cancer Liver Cancer of Rectum Cancer of Kidney Cancer of Esophagus Cancer of Cervix Cancer of Colon Cancer of Larynx Cancer, Lung Cancer, Breast Cancer, Advanced Cancer Prostate Cancer of Neck Cancer of Skin Neuroendocrine Tumors Carcinoma Mismatch Repair Deficiency BRCA Gene Rearrangement Non Hodgkin Lymphoma Leukemia Non Small Cell Lung Cancer Cholangiocarcinoma Glioblastoma Central Nervous System Tumor Melanoma Urothelial Carcinoma Bladder Cancer Ovarian Cancer Endometrial Cancer Testicular Cancer Breast Cancer COVID Pts with solid and hematological malignancies Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, Tumor mutational burden/load (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX, AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4, CDK6, CDKN1A/B, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1/2, DNMT3A, EGFR, ERBB2, ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR (VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, ROS1, RPTOR, SDHA/B/C, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1, ZNF217, ZNF703, among others. These biomarkers should be determined by local laboratory, external vendor, or next generation sequencing platform Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider and/or patient ECOG PS > 2 Abnormal organ function Hospice enrollment | 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, Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Male and female ≥18 years Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement Rheumatoid arthritis Correction of functional deformity Voluntary written Informed Consent obtained Pre-operative Prospect for recovery to independent mobility compromised by known coexistent medical problems Requiring revision hip replacement Requiring bilateral hip replacement Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points Likely post-operative leg length inequality >5cm Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity) Primary or metastatic tumour involving this hip Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint Previous organ transplant | 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, Aortic Valve Stenosis Mitral Regurgitation Heart Murmurs Valvular Heart Disease Able to provide consent Undergoing a complete echocardiogram Refusal 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): 18.0-75.0, Nephrolithiasis Adult patients who present to the ED with flank or abdominal pain for whom ED provider orders a CT scan for suspected nephrolithiasis Previous enrollment into the study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Diverticulosis, Colonic Microbiota Suspected symptomatic uncomplicated diverticular disease Requires colonoscopy for investigation of symptoms Under 18yo Previous bowel resection Antibiotics use in the last 6 months Medical condition precluding colonoscopy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Diverticulitis Key Men and women aged 18-80 years at screening Female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception A previous documented episode of diverticulitis between 30 and 180 days prior to screening Clinical remission from acute diverticulitis at screening Key History of two or more acute diverticulitis episodes or history of any diverticular complication Any documented current organic disease of the gastrointestinal tract other than diverticulosis Laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications Diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract) Patients with positive Clostridium difficile toxin stool assay Use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis Severe hepatic impairment Severe kidney impairment Any other current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures History of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients. NOTE: Other protocol defined Inclusion/ | 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, Pancreas Adenocarcinoma Age ≥ 18 years at the day of consenting to the study Patient with a potential pancreatic adenocarcinoma whatever the TNM/UICC stage Systematic treatment not initiated Signed and dated informed consent document Pregnant or breastfeeding woman Geographical, social or psychiatric reason preventing the patient from completing the study follow-up | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 6.0-999.0, Crohn Disease Group 1 Males or females 6-18 years of age Current weight >10 kg (or 22 lb) Ability to swallow pills Normal kidney function Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase Active CD or IBDU defined as PCDAI ≥ 30 C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)>350mcg/g (within one month of enrollment) Have been treated with one of the following therapies for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages Known allergy or intolerance to aminoglycosides or any of the medications used in this study Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole Known diagnosis of diabetes mellitus Known or suspected structuring disease producing obstructive symptoms Active Clostridium difficile infection Prolonged QTc interval as seen on enrollment EKG Current use of antibiotics Starting or increasing the dose of an IBD related medication within 4 weeks of screening Group 2 Males or females 10 years of age and older Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA) | 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, Abdominal Abscess Intra-abdominal abscess drained with catheter/drain Treatment with systemic antibiotics Able to consent Abscess(es) not amendable for an image guided drain placement | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Management of Obstructed Infected Kidney Adult Patients with infected hydronephrosis. 2. Infected hydronephrosis due to ureteric stone or ureteric stricture. 3. Uremic and non uremic patients Patients with a contraindication to either form of drainage (uncorrected coagulopathy, urethral stricture disease, bladder outlet obstruction, pregnancy, ureteral stone greater than 15 mm., or Steinstrasse) | 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, Bone Loss, Alveolar Dental Implant Failure Nos Any healthy patient scheduled for an implant-supported restoration will be considered for in this study, independently of the implant and prosthetic protocols used general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV) patients <18 years of age smoking habit (>10 cigarettes/day) sites with acute infection or requiring regenerative procedures Full Mouth Plaque Score Full Mouth Bleeding Score >25 % pregnant and lactating | 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): 22.0-75.0, Walled Off Pancreatic Necrosis Age between 22 and 75 years old Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous) Well defined wall Location-intrapancreatic and/or extrapancreatic Infected WON or symptomatic sterile WON Note: WON-related symptoms may pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight Imaging suggestive of greater than 30% necrotic material WON ≥ 6cm in size Eligible for endoscopic intervention Pseudocyst Cystic neoplasm Untreated Pseudoaneurysm > 1cm within the WON More than one WON clearly separated and requiring drainage WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access) Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON Abnormal coagulation INR > 1.5 and not correctable presence of a bleeding disorder platelets < 50,000/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, Diverticular Disease of Colon Quality of Life patients, scheduled for elective sigmoidectomy for diverticular disease (Indication: foregoing acute diverticulitis with pericolic or pelvic abscess >1cm, ongoing complaints after acute uncomplicated diverticulitis, recurrent uncomplicated disease (three or more diverticulitis episodes in combination with the patients wish for surgery), recurrent complicated disease (three or more diverticulitis episodes+complications: stenosis, fistula, chronic pain), urgent wish of patients for surgery after uncomplicated disease Age >18 years ASA 1-3 informed consent Age <18 years ASA 4 acute diverticulitis with free perforation acute or forgoing diverticular bleeding colorectal malignancies (current or foregoing) immunosuppression (corticoids > 20 mg prednisolon/d, status post transplant) advanced malignancy with systemic 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, Pancreatic Adenocarcinoma Able to understand and provide written informed consent. 2. ≥ 18 years of age. 3. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas. 4. Patients must have measurable disease in the pancreas, with no evidence of metastatic disease on imaging of the chest, abdomen and pelvis (contrast-enhanced CT or MRI abdomen with contrast instead of abdominal CT); PET scans alone will not be adequate alternatives. 5. The primary tumor must be surgically resectable, defined as: 1. no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or superior mesenteric artery); 2. no involvement or <180° interface between tumor and vessel wall of the portal vein, superior mesenteric vein and/or portal vein/splenic vein confluence. 6. Adequate hepatic, renal and hematological function Serum total bilirubin ≥2 x ULN (biliary drainage is allowed for biliary obstruction). 2. Severe renal impairment (CLcr ≤ 30 ml/min). 3. Inadequate bone marrow reserves as evidenced by: 4. ANC ≤ 1,500 cells/μl; or Platelet count ≤ 100,000 cells/μl; or Hemoglobin ≤ 9 g/dL 5. KPS < 60 6. Patients who received previous chemotherapy or radiotherapy for pancreatic disease. 7. Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment. 8. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2. 9. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months. 10. NYHA Class III or IV congestive heart failure, ventricular | 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 Pancreas Neoplasm, Benign Chronic Pancreatitis Pancreas Adenocarcinoma Adult patients 18 years and above with a solid pancreatic mass of any size, needing to Undergo the EUS examination to collect sample for diagnosis will be recruited for the study. The definition of a solid pancreatic mass will be based on an ultrasound or a CT scan result or based on the findings of a EUS examination done prior Patients should have the ability and be willing to give informed consent Cysts that do not have a significant solid component will be excluded Any contraindication to pancreatic biopsy | 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): 0.0-30.0, Childhood Hepatocellular Carcinoma Childhood Malignant Liver Neoplasm Fibrolamellar Carcinoma Hepatoblastoma Hepatocellular Malignant Neoplasm, Not Otherwise Specified Patients in Group F must have a body surface area (BSA) >= 0.6 m^2 Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2 For Groups B, C and D, rapid review is required if patients are either >= 8 years of age or have an alphafetoprotein (AFP) =< 100 at diagnosis For all Groups E and F patients, rapid central pathology review is required In emergency situations when a patient meets all other and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy Clinical situations in which emergent treatment may be indicated but are not limited to, the following circumstances Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.) Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible Patients who are currently receiving another investigational drug Patients who are currently receiving other anticancer agents Patients with uncontrolled infection Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma Patients with hypersensitivity to any drugs on their expected treatment arm Group C: Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD) Group D Patients with chronic inflammatory bowel disease and/or bowel obstruction Patients with concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-85.0, Diverticulitis, Colonic Colonic Neoplasms All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion Patient refusal to participate in the study. 2. Impossibility of obtaining informed consent by the patient or guardian. 3. Age <18 years and> 85 years 4. Impossibility of performing a diagnostic CT of AD. 5. Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis | 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): 70.0-999.0, Pancreatic Adenocarcinoma Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas. 2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination. 3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible. 4. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. 5. Baseline ECOG performance status is 2. 6. Patients have life expectancy of at least 12 weeks. 7. Patients have age 70 years. 8. Patients have adequate organ function. 9. Patients with biliary obstruction which is adequate drained before enrollment are eligible. 10. Patients agree to have an indwelling venous catheter implanted. 11. Women or men of reproductive potential should agree to use an effective contraceptive method. 12. All patients must be informed of the investigational nature of this study and must sign written informed consents Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. 2. Patients with metastatic lesion in central nervous system. 3. Patients with active infection. 4. Patients with active cardiopulmonary disease or history of ischemic heart disease. 5. Patients who have peripheral neuropathy > grade I of any etiology. 6. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. 7. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately | 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 Cyst IPMN Mucinous Cyst Pancreatic Adenocarcinoma Patients 18 years old or above Able to provide informed consent Pancreatic cyst with a diameter of 15 mm or above OR pancreatic cyst of any size with any one of either high-risk stigmata or worrisome features (obstructive jaundice in patients with a cyst in the head of the pancreas, solid component/mural nodule, thickened/enhancing cyst wall, main pancreatic duct ≥ 10 mm or abrupt change of main pancreatic duct diameter with distal atrophy) Lactating and pregnant females Cystic lesions with a predominantly solid component, suspected of malignancy Patients with uncorrected coagulopathy (international normalized ratio > 1.5 or platelet count < 50 109/L) Patients with previous history of pancreatic cancer Patients with a history of major stomach surgery (e.g. Billroth 1 and 2, gastrectomy, gastric bypass, esophagectomy, resection of the liver or pancreas) Patients with disseminated malignant disease Patients unfit for surgery Patients where EUS-guided puncture of the lesion is not presumed technically feasible and/or safe Patients with systemic immunosuppressive disease or receiving systemic immunosuppressive treatment Patients with a history of recent pancreatitis (within 3 months) | 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, Serious Bacterial Infection All Subjects 1. Subject must be ≥18 years of age. 2. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study. 3. Subjects must have a confirmed diagnosis of serious bacterial infection, specifically cIAI, HAP/VAP, cUTI, or BSI requiring administration of IV antibacterial therapy. 4. Subjects must have an MBL positive Gram negative bacteria (an Enterobacteriaceae and/or Stenotrophomonas maltophilia for which the imipenem or meropenem MIC is ≥ 4 µg/mL), that was isolated from an appropriate specimen obtained within 5 days prior to screening. 5. Female subject of childbearing potential must have a negative serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL. 6. Subjects who have received appropriate prior systemic antibiotic[s] for a carbapenem non-susceptible pathogen must meet the following (Note: antibiotic[s] is considered appropriate if microbiological susceptibility test results show that all carbapenem non-susceptible pathogens are susceptible to the systemic antibiotic[s] received): 1. Worsening or lack of improvement of objective symptoms or signs of infection after at least 48 hours of antibacterial therapy Note: Symptomatic subjects (see 3 and 4) with an isolated causative pathogen that was not susceptible to the prior systemic therapy are eligible for this trial. 7. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Additional cIAI Subjects 1. Subject must have a specimen obtained from an abdominal source during a surgical intervention within 5 days prior to screening from which a study qualifying pathogen was isolated upon culture. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery. 2. The subject has at least 1 of the following diagnosed during the surgical intervention Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall Diverticular disease with perforation or abscess Appendiceal perforation or peri-appendiceal abscess Acute gastric or duodenal perforations, only if operated on >24 hours after diagnosis Traumatic perforation of the intestines, only if operated on >12 hours after diagnosis Other secondary peritonitis (not primary/ spontaneous bacterial peritonitis associated with cirrhosis or chronic ascites) All Subjects 1. Subject has an Acute Physiology and Chronic Health Evaluation (APACHE) II score >30. 2. Subjects unlikely to respond to up to 14 days of study treatment. 3. History of serious allergic reaction (anaphylaxis, angioedema, bronchospasm, hypersensitivity) to any systemic antibacterial allowed per protocol. 4. Subject has previously been treated with ATM-AVI Subject with known Clostridium difficile associated diarrhea. 5. Subjects with perinephric infection. 6. Colonization with an MBL-producing Gram-negative bacteria without signs or symptoms. 7. Estimated CrCL ≤15 mL/min or anticipated requirement for dialysis during the study. 8. Hepatic disease as indicated by ALT or AST >3 x ULN at Screening. Exception: AST and/or ALT up to 5 x ULN if these elevations are acute and directly related to the infectious process. 9. Bilirubin >2 x ULN, unless related to the acute infection or due to known Gilbert's disease. 10. Alkaline phosphatase (ALP) >3 x ULN. Exception: up to <5 x ULN if this value is acute and related to the infectious process. 11. Absolute neutrophil count <500/mm3. Additional cIAI Subjects 1. Subject has infections limited to the hollow viscous, such as simple cholecystitis, gangrenous cholecystitis without rupture, and simple appendicitis, or has acute suppurative cholangitis, infected necrotizing pancreatitis, or pancreatic abscess. 2. Subject has abdominal wall abscess or small bowel obstruction without perforation or ischemic bowel without perforation. 3. Subject has a cIAI managed by staged abdominal repair (STAR), or "open abdomen" technique, or marsupialization. This criterion is intended to subjects in whom the abdomen is left open, particularly those for whom re operation is planned. 4. Subject who has prior liver, pancreas or small bowel transplant. Additional HAP/VAP Subjects 1. II score <10. 2. Subjects with lung abscess, pleural empyema, or post obstructive pneumonia. 3. Subject is a recipient of a lung or heart transplant. 4. Subjects with myasthenia gravis. Additional cUTI Subjects 1. Subjects with suspected or confirmed complete obstruction of any portion of the urinary tract, perinephric or intrarenal abscess, or prostatitis, or history of any illness that, in the opinion of the investigator, may confound the results of the study or pose additional risk in administering the study therapy to the subject. 2. Subjects with renal transplantation. 3. Subjects with a permanent urinary diversion (eg, with ileal loops, cutaneous ureterostomy or vesicoureteral reflux). 4. Subjects who are likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (eg, subjects with vesico-ureteric reflux). 5. Any recent history of trauma to the pelvis or urinary tract. 6. Subjects with uncomplicated urinary tract infections (generally female subjects with urinary frequency, urgency, or pain or discomfort without systemic symptoms or signs of infection). Additional BSI Subjects 1. Subject has a prosthetic cardiac valve or synthetic endovascular graft. 2. Subject has a suspected or documented medical condition with well-defined requirement for prolonged antibiotic treatment (eg, infectious endocarditis, osteomyelitis/septic arthritis, undrainable/undrained abscess, unremoveable/unremoved prosthetic associated infection) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis - Diagnosis of acute pancreatitis according to the following: the presence of two of the three following abdominal pain consistent with the disease serum amylase and or lipase greater than three times the upper limit of normal characteristic findings from abdominal imaging Contrast-enhanced computed tomographic (CECT) and or magnetic resonance imaging (MRI) of the pancreas | 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, Mitral Valve Prolapse Mitral Regurgitation Mitral Valve Disease Patients undergo mitral valve repair with either surgery of MitraClip techniques Over 18 years old Unable to place TEE probe Refuse 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): 18.0-999.0, Pancreatitis Pancreas Divisum Pancreatitis, Acute Pancreatitis Idiopathic Pancreas Inflamed Patient must consent to be in the study and must have signed and dated an approved consent form. 2. >18 years 3. Two or more episodes of acute pancreatitis, with each episode meeting two of the following three abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal characteristic findings of acute pancreatitis on CECT, MRI or transabdominal ultrasonography 4. At least one episode of acute pancreatitis within 24 months of enrollment 5. Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site. 6. By physician assessment, there is no certain explanation for recurrent acute pancreatitis. 7. Subjects must be able to fully understand and participate in all aspects of the study, including completion of questionnaires and telephone interviews, in the opinion of the clinical investigator Prior minor papilla therapy (endoscopic or surgical) 2. Calcific chronic pancreatitis, defined as parenchymal or ductal calcifications identified on computed tomography or magnetic resonance imaging scan that is reviewed by an expert radiologist at the recruiting site. 3. Main pancreatic duct stricture* 4. Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging* 5. Presence of a local complication from acute pancreatitis which requires pancreatogram 6. Regular use of opioid medication for abdominal pain for the past three months 7. Medication as the etiology for acute pancreatitis by physician assessment 8. TWEAK score ≥ 4 | 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): 40.0-999.0, Lumbar Facet Syndrome Adult patients aged > 40 capable of understanding and providing consent in English and capable of complying with the outcome instruments used Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also referred lower limb pain day worst numeric pain rating score (NPRS) for back pain of 5/10 or greater at baseline evaluation Positive responses to dual comparative diagnostic MBN blocks using 0.5mL of 0.5% bupivacaine and 4% lidocaine, on respective encounters on separate days, at each of the appropriate MBNs. The blocks are administered in a double-blind fashion so that neither the subject nor the independent assessor is aware of the local anesthetic used Focal neurologic signs or symptoms Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis Active systemic or local infections at the site of proposed needle and electrode placement Coagulopathy or other bleeding disorder Receipt of remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation) History of prior spine surgery Grade 2 Spondylolisthesis at an affected or adjacent level BMI >35 Incarceration Cognitive deficit affecting ability to complete the assessment instruments | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis, Acute Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase > 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding Patients with severe pancreatitis as defined by the Revised Atlanta Classification will be excluded. Severe pancreatitis is defined by the Revised Atlanta Classification as those with a Modified Marshall score of >2 for their cardiovascular renal, or respiratory system will be excluded (Figure 2).13 Practically this includes patients with systolic blood pressure <90, serum creatinine >1.9, and PaO2/FiO2 <300 (Figure 3). Since blood gases are unlikely to be drawn on those with mild pancreatitis we will patients with an oxygen saturation <92% on room air and certainly any patients which require intubation for respiratory failure due to pancreatitis Patients who cannot tolerate increased doses of fluids for other reasons will also be excluded. This consists of those with cardiac insufficiency (CI, >NYHA Class II heart failure), pulmonary edema, dialysis requirement, or severe liver dysfunction (albumin < 3mg/dL, known cirrhosis) Pregnant women will also be excluded as they are prone to retain sodium and water, which puts them at increased risk of pulmonary congestion, ascites or peripheral edema Patients who are incarcerated, younger than eighteen, or unable to give informed consent will be excluded Individuals who present with clinical signs of edema or anasacra, including pulmonary congestion, peripheral swelling, and ascites, will also be ineligible for the study Administration of fluids prior to the enrollment in the study will not be an criterion as this reflects actual clinical practice (hydration during evaluation period) however all fluids given prior to the study will be meticulously recorded | 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, Post-ERCP Pancreatitis Pancreatitis, Acute Necrotizing Age over 18 years old,gender is not limited; Preoperative blood amylase is normal; PEP risk factors during surgery:difficulty in intubation,needle knife incision,intraoperative intubation into the pancreatic duct more than 3 times,the contrast agent in the pancreatic duct is filled; The research procedure is willing to be followed and the informed consent is signed Myocardial infarction occurred within 3 months; Insufficiency of renal function; Conventional gastrectomy; Preoperative state of shock,such as hypotension(systolic blood pressure less than 90mmHg); Pregnancy and lactation; Allergic to NSAIDs drugs; Partially or completely restricted in the ability to exercise consciousness,without self-determination ability; Are participating in other clinical observation trials or have participated in other clinical trials within 60 days; Cases considered unsuitable by the 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): 18.0-79.0, Pancreatitis Stent Dislodgement patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis age 18-79 signed informed consent any disease that rules out study participation patient not legally competent to sign informed consent chronic pancreatis as indication for pancreatic stenting | 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, Mitral Regurgitation Mitral Valve Disease Mitral Valve Failure Mitral Disease Valve Heart Disease Valve Disease, Heart Has severe mitral regurgitation New York Heart Association (NYHA) Class II, III, IVa or heart failure High risk for cardiovascular surgery Excessive calcification or thickening of mitral valve annulus Severe mitral stenosis, fused commissures, valvular vegetation or mass Left ventricular end diastolic dimension > 7cm Left ventricular outflow tract obstruction Severe right ventricular dysfunction Stroke within 90 days; transient ischemic attack or myocardial infarction within 30 days of the index procedure | 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 A patient will be eligible for the study if all the following are met: 1. Must be 18 years of age or older. 2. Must have histologically confirmed pancreatic adenocarcinoma. 3. Must have Stage III or IV disease. 4. Must have received one line of systemic chemotherapy in the advanced setting with or without targeted agents, immunotherapy, or radiotherapy for treatment of advanced pancreatic adenocarcinoma. 5. Must have radiological evidence of disease progression following most recent prior treatment, defined as appearance of any new lesion or increase of >20% of one or more existing lesions. 6. Must have measurable lesion(s) per version 1.1 by CT scan with contrast (or MRI, if the patient is allergic to CT contrast media). NOTE: Bone disease consisting of blastic lesion only is not measurable. 7. Archival or fresh tumor tissue must be available for evaluating relevant biomarkers. Formalin-fixed paraffin-embedded [FFPE] block preferred, or a minimum of 10 unstained FFPE slides of one archived block is required. NOTE: Cytology samples from fine needle aspirates or brushing biopsies are not sufficient. If archival tissue is unavailable and an elective biopsy can't be scheduled due to COVID, this will be waived. 8. Must have adequate performance status: 1. ECOG Performance Status (PS) score of 0, or 2. ECOG PS score one and score ≥80 on Karnofsky Performance Status (KPS) scale. NOTE: Must have body mass index (BMI) ≥18.5 kg/m2 (obtained <14 days prior to randomization. 9. Must have life expectancy of >12 weeks according to the investigator's clinical judgment. 10. Females of childbearing potential must have a negative pregnancy test at screening and additional negative pregnancy test prior to first dose. Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose of study treatment. 11. Must have adequate laboratory parameters at baseline (obtained <14 days prior to randomization). Laboratory parameters outside of these ranges that are deemed clinically insignificant should be discussed with the medical monitor: 1. Absolute neutrophil count ≥1.5 x 109/L. 2. Hemoglobin ≥9 g/dL. Patients with a baseline Hemoglobin ≥13 g/dL should be discussed with the medical monitor. 3. Platelet count ≥100,000/mm3 (100 x 109/L). 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN in presence of liver metastases). 5. Total bilirubin ≤ 1.5 x institutional ULN. 6. Serum creatinine within normal limits or calculated clearance >60 mL/min/1.73 m2 for patients with serum creatinine levels above or below the institutional normal range. 7. Acceptable coagulation parameters: plasma antithrombin III >70% and fibrinogen ≥1.5 g/L 8. Serum albumin ≥3.0 g/dL. 12. Patients requiring biliary stent placement must have the biliary stent placed >7 days prior to screening and must have normalization of bilirubin level after stenting. 13. Must not be receiving therapy in a concurrent clinical study and must agree not to participate in any other interventional clinical studies during their participation in this trial while on study treatment. Patients taking part in surveys or observational studies are eligible to participate in this study. 14. Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent A patient is not eligible to participate in the study if any of the following are met: 1. Resectable or borderline resectable pancreatic adenocarcinoma at the time of signing the informed consent. 2. Histology other than pancreatic adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous, etc.). 3. More than one line of prior treatment in advanced or metastatic setting. 4. Patient has experienced medically significant acute decline in clinical status including 1. Decline in ECOG PS to >1 (or KPS <70) between baseline visit and within 72 hours prior to randomization. 2. Weight loss of ≥10% during screening. 5. Presence of active or symptomatic untreated central nervous system (CNS) metastases. NOTE: Patients with asymptomatic or stable CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable, and the patient is off high-dose steroid treatment for at least one month prior to randomization. 6. Prior radiotherapy to the only area of measurable disease. NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of the first dose of eryaspase or chemotherapy. 7. Bone as the only site of metastatic disease from pancreatic cancer (bone only disease). 8. History of recent clinical pancreatitis, according to revised Atlanta within 3 months of randomization. NOTE: The revised Atlanta classification [1] requires that two or more of the following be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level ≥3 x ULN, or (c) characteristic imaging findings using CT or MRI. 9. Neurosensory neuropathy > Grade 2 at baseline. 10. Pregnancy or breastfeeding. 11. History of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C. NOTE: Patients with unknown status of hepatitis B or C must be tested and declared negative before randomization. 12. Hypersensitivity to any of the components of the chemotherapy or ASNase. 13. Patients who have received live or live attenuated vaccines within 3 weeks of randomization. 14. History of other malignancies NOTE: Adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix may be eligible. NOTE: Patients successfully treated for other malignancies and are disease-free for at least 5 years may be eligible. 15. Any other severe acute or chronic condition/treatments that may increase the risk of study participation including: 1. History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months prior to randomization. 2. Current or history within 6 months prior to randomization of medically significant cardiovascular disease including symptomatic congestive heart failure >New York Heart Association (NYHA) Class II, unstable angina pectoris, clinically significant cardiac arrhythmia. 3. Patients with pre-existing coagulopathy (e.g. hemophilia). 4. Psychiatric illness/social situations or any other serious uncontrolled medical disorders in the opinion of the Investigator that would limit compliance with study requirements | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-100.0, Abdominal Abscess patients who underwent standard dose CT for suspected intraabdominal abscess 2. patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol pregnancy 2. patients with poor renal function (GFR < 30 mL/min/1/73m2) 3. Patients who have allergy to CT contrast media 4. Patients who are not cooperative (e.g., dementia) | 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 Neoplasms Prostate Neoplasms Neoplasms, Squamous Cell Melanoma Mesothelioma Pancreatic Neoplasms Colorectal Neoplasms Carcinoma, Renal Cell Liver Neoplasms For Part 1A: Histological or cytological diagnosis of a solid tumor that is advanced/metastatic, patients are intolerant to standard treatment, resistant to standard therapy or for which no standard therapy is available for the following tumor types: Breast cancer; Prostate cancer (mCRPC testosterone less than 50 ng/dL); Squamous cell cancer of the head and neck; Melanoma; Mesothelioma; Pancreatic cancer; Colorectal cancer; Renal cell carcinoma; Hepatocellular cancer. 2. For Part 1B, Part 2A, and Part 2B Histologically or cytologically confirmed prostate adenocarcinoma metastatic disease Effective castration with serum testosterone levels 0.5 ng/mL (1.7 nmol/L) Having received 3 or more cycles of prior docetaxel therapy (before or after abiraterone) Having PD while receiving abiraterone acetate within 12 months of abiraterone treatment initiation Progressive disease (PD) by: 1. Progression in measurable disease per 1.1 criteria. Patient with measurable disease must have at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) (CT scan thickness no greater than 5 mm) or magnetic resonance imaging (MRI). Lymph nodes should be greater than or equal to 15 mm in short axis. As defined by PCWG2, if lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to 20 mm in diameter when measured by spiral CT or MRI. Previously irradiated lesions, primary prostate lesion, and bone lesions will be considered non-measurable disease, or 2. Appearance of 2 or more new bone lesions (PCWG2). They must be confirmed by other imaging modalities (CT; MRI) if ambiguous results, or 3. Rising PSA defined (PCWG2) as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1) taken at least 1 week apart. • Prior abiraterone acetate must be stopped at least 2 weeks before study treatment. 3. Patients must have recently obtained archival tumor tissue available for submission to the sponsor (except for Part 2A monotherapy dose expansion). Patients enrolled in Part 1 and Part 2 should have access to their archival formalin-fixed paraffin-embedded material, collected within 6 months of screening, containing tumor that is of diagnostic quality and representative of their diagnosed malignancy or whenever possible, consent to undergo a biopsy during screening. The sponsor should be contacted if obtaining a new biopsy is not medically feasible for approval to enroll, prior to initiating screening activities. 4. Patients entering the study in the subgroup(s) requiring mandatory pre and on treatment tumor biopsies in Part 2A and 2B must have a tumor amenable to biopsy and consent to these planned biopsy procedures. The sponsor should be contacted if obtaining a pre-treatment and on treatment biopsies is not medically feasible for approval to enroll, prior to initiating screening activities. 5. Age 18 years or older 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 7. Adequate bone marrow function (see Appendix 3), including Absolute Neutrophil Count (ANC) greater than or equal to 1,500/mm3 Platelets greater than or equal to 100,000/mm3 12. For Part 1A monotherapy dose escalation: serum pregnancy test (for females of childbearing potential) negative at screening. 13. For Part 1A monotherapy dose escalation: female patients of nonchildbearing potential must meet at least 1 of the following Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and must have a serum follicle stimulating hormone level confirming the postmenopausal state Have undergone a documented hysterectomy and/or bilateral oophorectomy Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential. 14. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 15. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures Patients with any of the characteristics/conditions listed below will not be included in the study: Any labs may be repeated for confirmation. Only the lab result requiring confirmation must be repeated, not the entire panel. 1. For Parts 1B, 2A, and 2B Prior chemotherapy other than docetaxel for prostate cancer, except estramustine, adjuvant/neoadjuvant treatment completed more than 3 years ago Less than 28 days elapsed from prior treatment with chemotherapy, immunotherapy, radiotherapy, or surgery to the time of study enrollment. 2. Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by baseline brain MRI (or CT with contrast if MRI is medically contraindicated), clinical symptoms, cerebral edema, and/or progressive growth. If contrast is medically contraindicated, a non-contrast CT scan may be performed. 3. Patients with a history of CNS metastases or cord compression. 4. Liver metastases at baseline as evidenced by CT scan or MRI that may be at risk for bleeding, such as those that are greater than 1 cm, 5. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement). Note: Patients with indwelling catheter for drainage, or requirement for drainage no more frequently than monthly will be allowed. 6. Any other active malignancy within 3 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. 7. Patients with a history of clinically significant tumor bleeding (except for bleeding in a post-operative setting), coagulopathy or arterio-venous malformations (AVM) or aneurysms in the CNS, liver, lung or other major organ of the body. Patients with known Osler-Weber-Rendu disease, Hemophilia A, Hemophilia B (Christmas Disease), Von Willibrand's Disease, Factor 13 deficiency and Factor 7 deficiency, antibodies to Factors 8 and 7, history of other bleeding diatheses and abnormal INR values. 8. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the investigator is likely to bleed. 9. Major surgery within 4 weeks prior to first dose. 10. Prior organ transplantation including heart and allogeneic stem cell transplantation. 11. Radiation therapy within 4 weeks prior to study entry. Note: Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting. 12. Last anti cancer therapy including investigational drug(s) within 28 days (or 5 half-lives, whichever is shorter) prior to study entry excluding hormonal therapy. 13. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. In equivocal cases, with positive serology, those patients with a negative viral load are potentially eligible provided the other entry are met. Note: of patients with well controlled HIV, HBV or HCV can be discussed with sponsor on a case by case basis. • COVID-19/SARS-CoV2: Refer to Appendix 8 for further information. 14. Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; deep venous thrombosis (DVT); arterial occlusive disease; ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE Grade 2 or higher , atrial fibrillation of any grade that is uncontrolled, or QTcF interval greater than 470 msec at screening. Note: There is an exception where a cardiac rhythm device/pacemaker is fitted and results in QTcF greater than 470 msec. 15. Anticoagulation therapy with heparin, low molecular weight heparin, vitamin K antagonists, anti-platelet agents, or factor Xa inhibitors throughout the study and for at least 28 days post the last dose of study treatment. (If anticoagulation therapy is medically indicated on trial, patients should stop treatment with PF-06952229. For those requiring temporary anticoagulant therapy, resumption of PF-06952229 treatment may be permitted after discussion with the Sponsor. In any other case, study treatment should be permanently discontinued, and the patient should enter the follow-up portion of the trial.) 16. Moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation. 17. Evidence or history of septal aneurysm, other heart aneurysm, or any aneurysm of the major vessels. 18. Grade 3 or higher cardiac troponin I at baseline. 19. Left ventricular ejection fraction (LVEF) of less than or equal to 50% or significant valvular regurgitation. 20. Hypertension that cannot be controlled by medications (greater than 150/90 mmHg despite optimal medical therapy) or requiring more than 2 medications for adequate control. 21. Clinically significant non healing or healing wounds. 22. For patients entering the combination with enzalutamide arm, history of seizures other than isolated febrile seizure in childhood. 23. Has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago. 24. Known or suspected hypersensitivity to active ingredient/excipients of PF 06952229 or enzalutamide. 25. Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 26. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study. 27. For Part 1A Monotherapy Dose Escalation: Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product. 28. For Part 1B Combination Dose Escalation, Part 2A Monotherapy Expansion, and Part 2B Combination Dose Expansion: fertile male patients and female partners of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose for monotherapy (Part 2A) or for at least 3 months after the last dose for combination therapy (Part 1B and Part 2B). 29. Inability to consume or absorb study drug, including but not limited to: • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery. Impairment of gastro intestinal function or GI disease that may significantly alter the absorption of PF 06952229, such as history of GI surgery with may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE Grade greater than 1. 30. Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer, prior to first dose of investigational product. 31. Current use or anticipated need for drugs that are known strong and moderate CYP3A4/5 inducers, including their administration within 10 days or 5 half lives of the CYP3A4/5 inducer, whichever is longer, prior to the first dose of investigational product (See Section 5.7). 32. Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa B ligand (RANK L) targeted agents (for example, denosumab) less than 14 days prior to study entry, unless there is agreement with the medical monitor. 33. Active, known suspect suspected autoimmune diseases including inflammatory bowel disease (including ulcerative colitis and Crohn's disease), rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus (SLE), autoimmune vasculitis (eg, Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (eg, Gullian Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis) | 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): 50.0-75.0, Coronary Artery Disease Subjects with clinically and angiographically established CAD Controls: subjects with have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care Patients with heart failure, kidney failure or liver failure, infective disease or cancer will be excluded from the study. Subjects taking glucocorticoids or estrogens or patients currently smoking will be excluded from the study. Patients with mental disorders will also not be included | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-999.0, Colorectal Neoplasms Neoplasm Metastasis Colonic Neoplasms Rectal Neoplasms <Inclusion Criteria> Patient-related consideration 1. Have provided written informed consent prior to any study specific procedures 2. Willing and able to comply with the protocol 3. ≧ 20 years of age at the time of signing Informed Consent Form 4. Eastern Cooperative Oncology Group (ECOG) status of ≤1 Disease-related consideration 1. Histologically diagnosed colorectal adenocarcinoma 2. Liver metastases from colorectal adenocarcinoma confirmed through biopsy 3. Liver metastatic lesions should be considered to be potentially resectable after conversion chemotherapy by multi-disciplinary team and should meet one of the following Number of metastatic deposit ≧ 4 Possibility of resection margin could be involved Involvement of major hepatic vessels Presence of extrahepatic metastases (if they are supposed to be treated with curative aim and not to alter a plan for hepatic metastasectomy) High likelihood of insufficient residual hepatic volume after surgery 4. Measurable by 1.1. 5. One or more hepatic lesions should be accessible for biopsy 6. Archival tumor tissue from the metastatic liver lesion obtained at the time of the initial diagnosis must be available. 7. Adequate major organ functions as following Hematopoietic function: Absolute neutrophil count(ANC) ≧ 1,500/mm3, Platelet ≧ 100,000/mm3 Hepatic function: serum bilirubin ≦ 2 x Upper limit of normal(ULN), Aspartate aminotransferase(AST)/Alanine aminotransferase(ALT) ≦ levels 5 x ULN Renal function: serum creatinine ≦ 1.5 x ULN 8. International normalised ratio(INR) < 1.5 or Activated partial thromboplastin(aPTT) < 1.5 x ULN within 14 days prior to the start of study treatment for patients not receiving anti-coagulation. For patients receiving anticoagulants, INR and aPTT must be within the medical standard of enrolling institution. Other considerations 1. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment after the last dose of study treatment i. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≧12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). ii. Examples of contraceptive methods with a failure rate of < 1% per year bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 2. For men, they must practice abstinence or condom use, and abstain from sperm donation during the treatment period and for 6 months after their last dose of study treatment during the treatment period and for 6months after the last dose of study treatment. < > Patients who meet any of the following will be excluded from study entry: 1. Extrahepatic metastases that are not candidates for treatment of curative aim (e.g. resection, radiation or radiofrequency ablation) 2. Presence of central nervous system (CNS) metastases 3. Concurrent or previous history of another primary cancer within 3 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanomatous skin cancer, superficial bladder cancer (pTis or pT1) and curatively treated thyroid cancer of any stage. Concurrent, histologically confirmed, unresected thyroid cancer without distant metastasis could be allowed with the agreement of the principal investigator. 4. Chronic alcoholic hepatitis or cirrhosis 5. Chronic hepatitis B, defined as HBV DNA (> 2,000 IU / mL) and ALT> upper limit of normal range, must be treated with antiviral drugs before enrollment to reach appropriate viral suppression (HBV DNA <2000 IU / mL), and the antiviral drugs must be maintained during the study treatment period and for 6 months after the last dose of study treatment. 6. Prior chemotherapy for metastatic disease 7. Uncontrolled medical illness congestive heart failure, myocardial infarction within 6 months including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months 8. Prior adjuvant chemotherapy 9. Prior adjuvant chemotherapy, if administered within 6 months before study entry 10. Current or recent (within 10 days of start of study treatment) use of aspirin (>325mg/day), clopidogrel (>75mg/day), therapeutic or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (therapeutic anticoagulation on a stable dose for at least 2 weeks prior to the start of study treatment is allowed) 11. Known alcohol or drug abuse 12. Active infection requiring intravenous antibiotics at the start of study treatment 13. Inadequately controlled hypertension (defined as systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg) 14. Prior history of hypertensive crisis or hypertensive encephalopathy 15. History or evidence upon physical or neurological examination of CNS disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy 16. Uncontrolled chronic peripheral neuropathy ≥ CTCAE grade 2 17. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of start of study treatment 18. Any previous venous thromboembolism > CTCAE Grade 3 within 12 months prior to start of study treatment 19. History of haemoptysis ≥ Grade 2 (defined as ≥ 2.5 mL bright red blood per episode) within 1 month of start of study treatment 20. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation) 21. Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to start of study treatment, or anticipation of need for major surgical procedure (other than hepatic metastasectomy) during the course of the study 22. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to start of study treatment 23. Serious, non-healing wound, active ulcer, or untreated bone fracture 24. Known hypersensitivity to any component of any of the study medication 25. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins 26. Known dihydropyrimidine dehydrogenase deficiency 27. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the last dose of study treatment 28. Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study treatment. 29. Known hypersensitivity or allergy to Chinese hamster ovary cell products 30. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met Rash must cover 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months 31. Prior allogeneic bone marrow transplantation or prior solid organ transplantation 32. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.) 33. Positive test for human immunodeficiency virus (HIV) 34. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening The HCV RNA test will be performed only for patients who have a positive HCV antibody test Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 35. Active tuberculosis 36. Administration of a live, attenuated vaccine within 4 weeks prior to start of study maintenance treatment or anticipation that such a live attenuated vaccine will be required during the study 37. Prior treatment with Cluster of differentiation(CD)137 agonists, anti-cytotoxic T-lymphocyte-associated antigen(CTLA)4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents 38. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to start of study maintenance treatment 39. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-Tumour Necrosis Factor agents) within 2 weeks prior to start of study maintenance treatment, or requirement for systemic immunosuppressive medications during the 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): 18.0-999.0, Atrial Fibrillation Stroke Bleeding Male or Female ≥ 18 years At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures Two or more episodes of New Onset Atrial Fibrillation (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours (Or for >18 hours over a 24-hour interval) If female of child-bearing age, use of adequate contraception Pre-existing paroxysmal atrial fibrillation before cardiac surgery Pre-existing indications for therapeutic anticoagulation (Including but not limited to PE, DVT, mechanical valve) Moderate-to-severe mitral valve stenosis not surgically corrected Pre-existing allergy to study medications Recent (< 1 year) or ongoing pregnancy (Urine pregnancy test will be obtained for women of child bearing age at the time of enrollment into the study) Stroke within 1 month prior to surgery or postoperatively prior to initiation of study drugs Postoperative bleeding episode prior to initiation of study drug Severe dysfunction of another organ system including GFR < 30 ml/min, baseline INR > 1.7, ileus or other gastrointestinal pathology hindering ability to absorb oral medications, and known coagulation pathway deficiencies Postoperative need for non-aspirin anti-platelet therapy that cannot be discontinued when therapeutic anticoagulation is initiated Patient taking medications with known major interactions with study drugs with no therapeutic alternatives) | 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): 0.0-999.0, Colorectal Neoplasms Anastomotic Leak Surgery--Complications Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra and extra-corporeal), including planned Hartmann's reversals. 2. American Society of Anesthesiologists' (ASA) class I, II or III 3. Elective or delayed urgency surgery 4. Patients' written acceptance to be included in the study American Society of Anesthesiologists' (ASA) class IV-V 2. Patients with stoma before or at operation 3. Simple stoma closure 4. Transanal procedure 5. Pregnancy 6. Hyperthermic intraperitoneal chemotherapy for carcinomatosis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Pancreas Pancreas Cancer Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas 2. CT w/ contrast or MRI of the abdomen and pelvis with contrast within 6 weeks prior to registration 3. CT chest or PET/CT within 6 weeks prior to registration 4. Clinically determined to be resectable based on NCCN 3.2017: No arterial tumor contact (celiac axis, superior mesenteric artery or common hepatic artery) and no tumor contact with the superior mesenteric vein or portal vein, or < 180 degrees contact without vein contour irregularity 5. No evidence of metastatic disease and/or non-regional lymph node metastases 6. Adequate cardiopulmonary reserves to tolerate surgery 7. ECOG performance status 0-2 8. Adequate bone marrow function defined as follows: White blood cell> 3000cells/mm^3, Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 9.0 g/dl 9. Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year 10. Patient must sign study specific informed consent prior to study entry 11. Anticipated life expectancy ≥ 12 weeks; - Prior surgical resection of any pancreatic malignancy 2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years 3. Any prior systemic or radiation treatment, including investigational treatments, of the patient's pancreatic tumor. 4. Prior radiotherapy to the region of pancreatic cancer that would result in overlap of radiation therapy fields 5. Severe, active comorbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 2. Transmural myocardial infarction within the last 6 months 3. Clinically significant ECG abnormalities e.g. QTcF >450msec 4. Acute viral, bacterial or fungal infection requiring intravenous antibiotics at the within 4 weeks of registration 5. Known active HIV, HBV or HCV infections 6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration. 7. Uncontrolled diabetes or hypertension 8. Serious psychiatric illness or altered mental status 6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure 7. Any evidence of distant metastases (M1) 8. (ONLY applies for Group 1 patients taking CCX872-B )Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks prior to Day 1 dosing; these atazanavir, boceprevir, clarithromycin, conivaptan, gemfibrozil, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, rifampin, and carbamazepine; use of these drugs must be avoided during the study and until 2 weeks after stopping CCX872-B 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): 16.0-999.0, Abdominal Trauma Abdominal Injury Abdominal Infection Abdominal Sepsis Abdominal Abscess Abdominal Aneurysm Abdominal Compartment Syndrome Peritonitis Mechanically ventilated patients, managed with the OA strategy years of age or older Patients who are pregnant Loss of any portion of the abdominal wall that could preclude primary closure Burn patients BMI greater than 40 kg/m2 | 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, Chronic Kidney Diseases Seen on a regular base in one of the participating outpatient clinics of renal care with a previous consultation within the last year Having a chronic kidney disease (including having a transplant kidney for more than 3 years) with a CKD stage 2, 3A or 3B ( i.e. with estimated glomerular filtration rate (eGFR) between 30 and 90 ml/min/1.73m2) at the time of the baseline visit showing a decline of eGFR between 2.0 and 20.0 ml/min/year determined using at least three determinations of eGFR (CKD-Epi formula) whereby the oldest one should be from more than 1 year ago and the most recent will be the one of the baseline visit. For transplant patients the decline will be based on serum creatinine values determined during the preceding 24 months. For all other patients, the decline will be based on values determined within the last five years Illiteracy: patients not knowing how to read or write 2. Patients not able to communicate in Dutch or French 3. Patients with mental deterioration, incapable to give informed consent and to understand the safety instructions of the study (at the discretion of the treating nephrologist) 4. Patients with one of the following clinical problems Patients with nephrotic syndrome Patients showing a fast decline of renal function (more than 20 ml/min/year) during the preceding five years Diabetes mellitus (any type: 1, 2, Maturity Onset Diabetes of the Young (MODY), New Onset Diabetes After Transplantation (NODAT)) confirmed by a glycemia level > 125 mg/dl (7.0 mmol/L) after a fasting time of 8 hours Patients with a renal transplantation for less than 3 years Patients with multi-organ transplantation History of solid organ transplantation Chronic obstructive pulmonary disease ( COPD) stage Gold IV (Oxygene-dependency) Congestive heart failure (NYHA stage IV) Inflammatory bowel disease (IBD) | 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, Malnutrition Patients (>18 years) who are able to communicate clearly Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement Patients expected to require oral nutritional supplementation for at least 2 further weeks Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement Informed assent/consent obtained Patients with cow's milk protein allergy requiring a milk free diet Patients with inherited metabolic conditions Patients requiring enteral tube feeding or parenteral nutrition Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list) Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis) Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Thyroid Cancer Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who underwent total thyroidectomy +/ neck lymph node dissection as clinically indicated are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced or presenting with distant metastases; or are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size >4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and/or lateral neck), detectable/increasing baseline/suppressed thyroglobulin (Tg) level or detectable/increasing anti-Tg antibody titers if anti-Tg antibodies are present are either RAI-naive or requiring repeated RAI therapy for locally advanced disease or distant metastases Underwent imaging with MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases Age greater than or equal to 18 years of age hour urine iodine excretion of less than or equal to 150 micro grams/24 hour -Patients with non-RAI avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096 Pregnant or lactating women Adults who are incapable of providing 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): 70.0-999.0, Sarcopenia Aged 70 years or older at time of recruitment Expected to undergo an elective major colorectal surgery procedure Aged 70 years or older at time of recruitment Emergency admission Expected to undergo emergency abdominal procedure during admission, or emergency abdominal procedure performed within previous 48 hours Aged 70 years or older at time of recruitment Emergency admission for acute bacterial infection or presumed acute bacterial infection Unable to provide written informed consent at time of recruitment Unable to understand verbal English Life expectancy less than 30 days Unable to provide written informed consent at time of recruitment and no consultee available Unable to understand verbal English Life expectancy less than 30 days Unable to provide written informed consent at time of recruitment and no consultee available Unable to understand verbal English Life expectancy less than 30 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): 18.0-999.0, Coronary Artery Disease Subject group enrolled in trial | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-80.0, Hypertrophic Obstructive Cardiomyopathy Age >18 years Signed informed consent to participate in the study For patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient >50 mmHg, NYHA class III-IV For patients with arterial hypertension only: hystory of arterial pressure increase >140/90 mmHg, increased left vantricular wall thickness (>10 mm) and myocardial mass indexed to BSA (>95 g/m2 for women and >115 g/m2 for men), as assessed by 2D transthoracic echocardiography Age < 18 years Persistent form of atrial fibrillation Intrinsic mitral or aortic valve disease Coronary artery disease Reduced left ventricular ejection fraction For control group only: presence of any structural heart disease | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-70.0, Renal Impairment Tuberculosis Subject for Patients with Renal Impairment (Groups 2-5) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB 2. Agree to abide by the study restrictions. 3. Are between the ages of 18 and 70, inclusive, at the time of enrollment. 4. Must have mild, moderate, severe or end stage renal disease but are not on dialysis. 5. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 6. Have QTc interval on electrocardiogram (ECG) < 500 msec. 7. Have a body mass index of 18 to 35 kg/m^2. 8. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study. **Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year has passed since the last menses if menopausal. ***Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 9. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #8, and/or abstinence from sexual intercourse with women. 10. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Healthy Subjects (Groups 1A-1D) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB. 2. Agree to abide by the study restrictions. 3. Are healthy male or non-pregnant female, between the ages of 18 and 70, inclusive, with normal GFR > / = 90 at screening. 4. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 5. Have a normal QTc interval < 500 msecs on electrocardiogram (ECG). 6. Have a body mass index of 18 to 35 kg/m^2. 7. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 8. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #7, and/or abstinence from sexual intercourse with women. 9. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Patients with Renal Impairment (Groups 2-5) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)). 5. Any clinically significant ECG abnormality at screening* *Note: the following can be considered not clinically significant Heart rate < / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) Right or left axis deviation Incomplete right bundle branch block Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects 6. History of or screening results show a QTc interval > / = 500 msecs. 7. Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death ***such as known coronary artery disease or congestive heart failure (CHF) or terminal cancer. 8. Inability to swallow tablets. 9. History of fever or documented fever (oral temperature > 100.4 degrees Fahrenheit) in the 48 hours prior to admission to the hospital. 10. Resting pulse rate <50 or > 100 bpm at Screening. 11. At Screening blood pressure > / = 20 mm Hg systolic or 10 mm Hg diastolic above baseline**** (sitting). ****Baseline is most recent blood pressure in the last 3 months if not similar to control group. 12. Current hypokalemia or hypomagnesemia. 13. Positive result of urine drug screen or blood alcohol screen prior to hospital admission. 14. Significant history of drug and/or food allergies (as deemed by the PI). 15. For women, subject is pregnant (positive test for urine HCG at Screening or Check-in), breastfeeding or planning to conceive for the duration of the study. 16. Women who are breastfeeding or lactating. 17. Any contraindication to the use of nitromidazoles, or prior treatment with pretomanid or delamanid. 18. Treatment with strong CYP450 enzyme inducers or inhibitors***** within 7 days prior to admission or during the study, unless****** the substance would not likely impact the validity of the study results. *****except hormonal contraceptives ******in the opinion of the site investigator 19. Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine, etc.) within 30 days prior to dosing and during the entire study. 20. Use of St. John's Wort within 7 days prior to admission and during the entire study. 21. Consumption of products containing grapefruit within 5 days prior to dosing until discharged from the hospital. 22. Donation of whole blood or blood products > 500 mL within 30 days and plans to donate during the study or up to 14 days after dosing. 23. Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit. 24. Hemoglobin < 9.0 g/dL in both men and women at the screening visit. 25. Positive Screening test for HCV, HBV, or HIV. 26. Renal transplant. 27. Scheduled for hemodialysis or peritoneal dialysis 28. Presence of any condition or finding******* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments. *******In the opinion of the investigator 29. Semen donation for the duration of the study. 30. AST and ALT > 2.0 x ULN. 31. Hyperbilirubinemia > 1.5 x ULN. Subject for Healthy Subjects (Groups 1A-1D) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI). 5. Any clinically significant ECG abnormality at screening*. *Note: the following can be considered not clinically significant Heart rate > / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) | 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 Kidney Diseases Subclinical Hypothyroidism • Patients older than 18 years Patients with chronic kidney disease G2-G5 without renal replacement therapy) who attend a renal health clinic Presence of proteinuria in a test strip, 24 hours urine collection (greater than 150mg / dl in 24hrs urine) TSH <9.9uiml / L and TSH> 2.4 0uiml / L Take an IECA or ARA-2 Patients with weight> 50 kg and <80kg Accept informed consent Chronic dialysis (peritoneal dialysis or hemodialysis) Primary hypothyroidism or preexisting thyroid disease Use of levothyroxine TSH> 10uiml / L and TSH <2.5 0uiml / L Positive thyroid antibodies Ischemic heart disease in less than 6 months Cardiac arrhythmia Use Medications (Levothyroxine synthesis, see Table 2) Anxiety disorder Pregnancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Portal Vein Thrombosis Patients with liver cirrhosis and PVT which don't fulfill of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either With or without hepatic mass Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up Uncooperative or excessively apprehensive patient Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses) Inhibition of platelet aggregation by clopidogrel and other thienopyridines Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents) Patients fulfilling of malignancy by triphasic CT on abdomen Extra hepatic metastasis of HCC Child-Pugh classification stage C | 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, Hepatocellular Carcinoma Cirrhosis Liver Failure Have been diagnosed with HCC and deemed a candidate for nonsurgical local therapy (TACE and/or percutaneous ablation) Have a Child-Pugh score < 6 Are at least 18 years of age or older Otherwise healthy adults Provide written consent to participate Have a diagnosis of renal failure Have a Child-Pugh score > 6 Consume > 60g alcohol intake per day Have been diagnosed with branched-chain ketoaciduria (maple syrup urine disease) Have hepatic encephalopathy Have been diagnosed with a medical condition that warrants a low-protein diet Are currently taking insulin or metformin Pregnant women Younger than 18 years of age Are unable to provide 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): 0.0-999.0, Candiduria patients with Candiduria patients without Candiduria | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 12.0-90.0, Tuberculosis; Abdomen Both sexes and age between years and 90 years Patients presenting with acute abdomen and who underwent exploratory laparotomy Patients who diagnosis confirmed on biopsy (caseating granulomas) Peritoneal tuberculosis Other causes of acute abdomen (Typhoid perforation) Patients diagnosed with abdominal tuberculosis and on conservative management | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Diverticular Disease Confirmed symptomatic diverticular disease (5 or more diverticula) Age range 18-90 years Retains capacity and medically fit for colonoscopy Does not meet Unable to give informed consent Patients with severe co-morbidities and substance misuse | 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): 10.0-35.0, Aortomesenteric Angle Aortomesenteric Distance Retroperitoneal Adipose Tissue With age range of 10-35 years old Chinese ethnicity With abdomen contrast CT Any patients with diagnosis of SMAS will be excluded from the Non-SMAS group Patients who had undergone more than one CT scan during the research period Previous retroperitoneal, abdominal surgery Conditions causing significant weight loss, e.g. anorexia nervosa, malabsorption Presence of abdominal masses or pathology that will affect the anatomy of aorta- superior mesenteric artery and the retroperitoneal structures Presence of severe scoliosis and/or history of spinal fixation that may increase incidence of SMA syndrome Presence of free intraperitoneal or retroperitoneal fluid that may affect fat measurement, e.g. following trauma, or ascites | 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, Colonic Polyp Colonic Neoplasms Colonic Diseases Colon Adenoma Colon Disease Colon Adenocarcinoma Colon Cancer Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy 2. Subject willing to undergo colon preparation bowel cleansing 3. Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60). 4. Subject is able to understand and willing to sign informed consent form Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC). 2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 4. History of colonic resection 5. Clinically significant cardiovascular or pulmonary disease. 6. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk. 7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study) 8. Pregnancy 9. Previous radiation therapy to the abdomen 10. Morbid Obesity (BMI > 40 kg/m2) 11. Drug abuse or alcoholism 12. Subject is bed-ridden and/or unable to adequately communicate 13. Subject is under custodial care 14. Subject has a history of psychiatric disorders which would prevent compliance with study instructions 15. Participation in a clinical study within the previous 30 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): 18.0-999.0, Pancreatic Carcinoma The histologically or cytologically confirmed, or the clinically diagnosed by clinical diagnosis criterion proposed by Pancreatic Cancer Committee of Chinese Anti-Cancer Association [15], which was based on evidences of (1). Typical symptoms of abdominal and/or back pain; (2). CA19-9 increased over the normal up limit; (3). A pancreatic mass shown on CT or MRI; and (4). SUV of PET-CT in mass increased compared to that in normal pancreas; 2. Unresectable LAPC defined by the of (NCCN) guidelines (Version 1. 2013), or refusal to surgery; 3. Gastrointestinal tract (GI) not invaded; 4. ECOG Performance Status 0-1 within 30 days prior to registration; 5. Age of ≥ 18 years old; 6. Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L); 7. Enough liver and kidney functions (creatinine <110gmol/L; urea nitrogen <7.1mmol/L; bilirubin < 1.5 x ULN, ALT and AST ≤ 2.5 x ULN); 8. No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration; 9. Informed consent form obtained No pathological evidence of malignant tumor; 2. ECOG>=2； 3. Liver, kidney and bone marrow function are poor and not adequate for treatment; 4. Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month; 5. Prior radiation therapy to the abdomen or radioactive particle implantation; 6. cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume; 7. Dose constrain of normal liver, digested system and other OAR could not reach the expecting safe dose constrain; 8. The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion; 9. Comitant diseases or affecters which could affect the proton or heavy ion radiotherapy; 10. Pregnancy（blood or urine β-HCG certified）or lactation; 11. Drug or alcohol abused; 12. HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage; 13. HBV positive, hepatitis B virus replication stage, need to be treated with anti-virus treatment, but could not receive anti-virus treatment because of comitant disease; 14. Psychiatric history, possibly affecting the completion of treatment; 15. patients with serious complications that might affect radiotherapy， including 1）unstable angina pectoris requiring hospitalization in the last 6 months，congestive heart failure，myocardial infarction； 2）acute bacterial or systemic fungal infections； 3）exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratory system disease requiring hospitalization 4）hepatic function insufficiency or renal function insufficiency 5） immunosuppressed patients 16. patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy 17. patients can't understand treatment goal or unwilling/unable to sign up inform consent form； 18. no civil capability or limited civil capacity | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-90.0, Small Bowel Disease Signed informed consent 2. Patients with small bowel disease indicated for deep enteroscopy Age under 18 years 2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period 3. Any contraindication to standard enteroscopy 4. Concurrent participation in another competing clinical 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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
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