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This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 65.0-999.0, Fall Patients Elderly Patients Chronic Disease Sleep Quality Cardiovascular System Tai Chi Eurythmy Therapy To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for into ENTAiER main study for Substudy Cardiac pacemaker Atrial fibrillation (documented in medical reports) To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for into ENTAiER main study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Hypophosphatasia HPP (CASES) Clinical diagnosis of HPP (with or without previous genetic test confirmation) Evidence of burden of disease (HPP) including abnormal gait, muscle weakness, pain, recurring fractures, slow healing fractures and/or bone deformities Age ≥ 18 years Able and willing to participate in the study Able to give written informed consent (CONTROLS) Healthy men and women with normal bone mineral density (defined as a DXA bone mineral density T score at the lumbar spine or total hip greater than -1) Age ≥ 18 years Able and willing to participate in the study HPP (CASES) Individuals with BMI<18, or BMI>30 kg/m2 Other conditions known to affect serum ALP and PLP Coeliac disease, B12 deficiency, untreated hypothyroidism, Wilson's disease Taking nutritional supplements containing vitamin B6 within past two weeks History of, or current: Severe ischaemic heart disease, rheumatoid arthritis, ankylosing spondylitis, cancer (concurrent) History of, or current neurological diseases affecting the neuromuscular system including Parkinson's disease, CVA, muscular dystrophy, myasthenia, cerebral trauma, peripheral neuropathy Treatment for more than 3 months in a year or under treatment with oral corticosteroids History of any long term immobilization (duration greater than three months) Conditions or surgery which prevent the acquisition or analysis of musculoskeletal images | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Oropharyngeal Squamous Cell Carcinoma Proven squamous cell carcinoma of the oropharynx p-16 immunohistochemistry analysis Tumour lesion of at least 1.0 cm in diameter Planned chemoradiotherapy as primary treatment Ability to provide written informed consent Contra-indications for PET Contra-indications for administration of iodine-containing contrast agents Other serious illness that can affect the scans | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Mantle Cell Lymphoma Follicular Lymphoma Splenic Marginal Zone Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Nodal Marginal Zone Lymphoma Indolent Non-hodgkin Lymphoma Note: During the period of cell procurement and CAR.κ.28 T cell production, subjects are allowed to receive additional standard of care chemotherapy to stabilize their disease if the treating physician feels it is in the subject's best interest. For subjects requiring bridging chemotherapy while awaiting manufacture of their CAR.κ.28 T-cells, details regarding treatment(s) administered including dose, frequency, number of cycles, etc. will be collected. for the Study Unless otherwise noted, subjects must meet all of the following to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Adults ≥18 years of age. 3. Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma OR histologically confirmed B-cell NHL, including the following types defined by WHO 2016: Aggressive Lymphomas DLBCL not otherwise specified (NOS) T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma Primary mediastinal (thymic) large B-cell lymphoma High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade B-cell lymphoma, NOS B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma Transformation of indolent lymphoma or CLL to DLBCL will also be included Burkitt lymphoma Indolent Lymphomas Follicular lymphoma grade 1-3b Splenic marginal zone lymphoma for the Study Subjects meeting any of the following will not be able to participate in this study (procurement, lymphodepletion and cell infusion): 1. A diagnosis of lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia or multiple myeloma. 2. A history of intolerance to bendamustine or fludarabine. Note: subjects with known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide and fludarabine at the discretion of the clinical investigator. 3. Subject is pregnant or lactating. 4. Tumor in a location where enlargement could cause airway obstruction. 5. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10 mg daily may be enrolled at discretion of investigator. 6. Active infection with HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy as well as no history of HIV. Subjects are required to have negative HIV antibody, negative HTLV1 and HTLV2 antibodies, negative hepatitis B surface antigen, and negative HCV antibody or viral load. 7. Subjects who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded. Subjects who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline (when tested during screening for procurement). Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. to be Met Prior to Procurement 1. Subject has signed a consent to undergo cell procurement. 2. Evidence of adequate organ function as defined by Hemoglobin ≥ 8.0 g/dL (transfusion independent for 2 weeks prior to enrollment) Total bilirubin <1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5 × ULN) AST and ALT < 5x ULN Pulse oximetry of >90% on room air Creatinine ≤1.5x ULN or Creatinine Clearance (CrCl) >60 mL/min per Cockcroft and Gault (see Appendix F). 3. Imaging results from within 120 days prior to procurement to assess presence of active disease. 4. Confirmed kappa-positive expression on lymphoma or CLL/SLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology. 5. Subject has adequate cardiac function, defined as No ECG evidence of acute ischemia No ECG evidence of active, clinically significant conduction system abnormalities Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Diffuse Large B-cell Lymphoma Each potential subject must satisfy all of the following to be enrolled in the study. 1. Male or female, age ≥ 18 years and ≤80 years. 2. No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy) 3. Histological or cytological confirmation of DLBCL 1. CD20-positive DLBCL; 2. Myc≥40% as well as Bcl-2≥50% through immunohistochemistry; 3. Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH. The verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation. 4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT). 5.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry): (1)Hematology values:Hemoglobin (Hb)≥90g/L ; Absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN); Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT,AST≦5×ULN if liver involved). 8.Expected survival≥6 months. 9.All patients must have signed an informed consent document Any potential subject who meets any of the following will be excluded from participating in the study. 1. Presence of CNS involvement. 2. Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL. 3. Patients with transformed lymphoma. 4. History of organ transplantation or hematopoietic stem cell transplantation. 5. Patients planned for autologous or allogeneic transplant as consolidation in first line. 6. Patients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible. 7. Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle 1. 8. Prior use of any monoclonal antibody within 3 months of the start of Cycle 1. 9. Any investigational therapy within 3 months prior to the start of Cycle 1. 10. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products. 11. Contraindication to any of the individual components of CHOP. 12. Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control: 1. Patients receiving corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization (Cycle 1, Day 1). 2. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 5 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment. 13.Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy. 14.Have uncontrolled or significant cardiovascular disease, including: 1. Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) < 50% during screening stage. 2. Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al). 3. History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening. 4. Symptomatic coronary heart disease requiring treatment. 5. Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment. 15.History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening. 16.Patients with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy. 17.History of deep vein thrombosis or pulmonary embolism. 18.History of active bleeding within 2 months prior to the start of Cycle 1;or patients receiving anticoagulation therapy; or patients with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). Patients with bleeding led by lymphoma according to investigators' judgment are eligible. 19.6 weeks or less from the last major surgery that involved crucial organs, or with any other factors impede postoperative recovery according to investigators' judgment. 20.Known active infection, or active and uncontrolled hepatitis B infection(HBV), hepatitis C Virus(HCV), human immunodeficiency virus (HIV)/AIDS (Acquired Immune Deficiency Syndrome), or any other serious infection. (active infection defined as any major episode of infection requiring systemic treatment; Patients with occult or prior HBV may be included if HBV DNA is undetectable.) 21.Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements/ treatment. 22.Drug or alcohol abuse. 23.Women of childbearing potential and men who are sexually active not willing to practice a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.These restrictions apply for 12 months after the last dose of rituximab or 12 weeks after the last dose of study drug, whichever is later. Pregnancy or lactation. 24.Any other condition which is inappropriate for the study according to investigators' judgment | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Crohn's Disease Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130) If female, participant must meet the contraception requirements Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Hypertension Diabetes Mellitus, Type 2 Gastrostomy Morbid Obesity Weight Loss LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity Have not undergone any further bariatric surgical procedures since the index operation Still be alive at the time of the study Have correct be contactable with the contact details present available in the electronic database Missing data Uncontactable Unwilling to participate | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 25.0-85.0, Coronary Artery Bypass, Off-Pump Patients are planned for undergoing off-pump coronary artery bypass surgery BMI greater than 28 2. trauma, surgical or radiotherapy history of left chest 3. EF less than 40% 4. Simultaneous other cardiac surgery or planned cardiopulmonary bypass 5. Preoperative critical situation: acute myocardial infarction, heart failure and other conditions require emergency surgery. Preoperative nitrate drugs are difficult to control angina and needs IABP implantation. 6. Respiratory function: severe hypoxemia (pO2 less than 60 mmHg without Oxygen inhalation), carbon dioxide retention (pCO2 > 50 mmHg), severe chronic obstructive pulmonary disease (FEV1/forced vital capacity less than 70% and FEV1 less than 50%) 7. Aortic lesions: patients with ascending aorta calcification confirmed by preoperative CT 8. Peripheral vascular lesions:By the preoperative assessment with ultrasound or CT，LIMA and left subclavian artery stenosis>70% ,or bilateral femoral artery calcification, stenosis>50% 9. Drug therapy: Preoperative antiplatelet or anticoagulant therapy (except aspirin and clopidogrel) 10. Others and contraindications of CABG | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Effusion Pleural Ascites Pericardial Effusion all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, High Grade B-Cell Lymphoma, Not Otherwise Specified Recurrent Burkitt Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Refractory Burkitt Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Relapsed/refractory DLBCL defined as any of the following Confirmed DLBCL/Burkitt lymphoma (BL)/B-cell lymphoma, unclassifiable (BCLU) by World Health Organization (WHO) 2016 classification Double hit lymphoma (DHL) phenotype as confirmed by FISH (fluorescent in-situ hybridization) or IHC (immunohistochemistry) Relapsed or progression of disease after at least one prior line of standard rituximab-cyclophosphamide-hydroxydaunorubicin-oncovin-prednisone (R-CHOP), rituximab-etoposide-prednisone-oncovin-cyclophosphamide-hydroxydaunorubicin (R-EPOCH) or other R-CHOP-like therapy Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 No prior treatment with a proteasome inhibitor or prior BCL2 inhibitor No cytotoxic chemotherapy within 2 weeks prior to study treatment Patients who are not candidates for salvage stem cell transplant or patients who are not candidates for CAR-T (chimeric antigen receptor T-cell) therapy, patients who have progressed or relapsed after a salvage transplant or CAR-T therapy are eligible Patients must give informed consent Prior radiation therapy allowed to < 25% of the bone marrow and patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Patients treated with standard postoperative adjuvant radiation therapy for other cancers are allowed. Prior radiotherapy must be completed 14 days before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy Patients who have had prior proteasome inhibitor therapy or prior therapy with venetoclax Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator Patients with history of hepatitis B with negative viral load are eligible (including latent carriers and patient with history of active disease who required treatment) History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax and bortezomib or other agents used in the study Subjects with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) which is not well controlled on antiviral therapy Patients who have received autologous hematopoietic stem cell transplantation within 12 months Subject has received the following within 7 days prior to the first dose of study drug: Steroid therapy for anti-neoplastic intent, strong and moderate CYP3A inhibitors and/or strong and moderate CYP3A inducers The effects of combination venetoclax and bortezomib may cause fetal harm. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 12 weeks after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma New diagnosis of High grade Diffuse large B cell Lymphoma Signed written informed consent Any other malignancy within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA) | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-46.0, Preeclampsia Pregnancy Complications Insemination; Complication Immune Tolerance Paternal Exposure Age 18-45 women for each group Primigravid or first insemination from a new partner/sperm donor (group I) Women exposed to sperm (from the same donor/partner ≥ 2 times) (Group II) Singleton gestation Obtained verbal/written consent to participate in study o Multiple gestation Multifetal gestation Chronic hypertension Chronic renal disease Autoimmune disease (antiphospholipid syndrome, systemic lupus erythematosus) Vascular disease Pregestational diabetes mellitus | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Relapsed/Refractory Large B-cell Lymphoma Key Individuals with large B-cell lymphoma, including Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, Primary mediastinal large B-cell lymphoma (PMBCL), High-grade B-cell lymphoma (HGBL), and DLBCL arising from Follicular lymphoma (FL) Individuals must have relapsed disease after 2 or more lines of systemic therapy, or chemorefractory disease defined as the following No response to first-line therapy, including the following Progressive disease (PD) as best response to first therapy Stable disease (SD) as best response after ≥ 4 cycles of first-line therapy (eg, 4 cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP)), with SD duration no longer than 6 months from the last dose of therapy No response to ≥ 2 lines of therapy, including the following PD as best response to most recent therapy SD as best response after ≥ 2 cycles of last line of therapy Individuals must have received adequate prior therapy including at a minimum History of Richter's transformation of chronic lymphocytic leukemia Autologous stem cell transplant (SCT) within 6 weeks of planned axicabtagene ciloleucel infusion History of allogeneic stem cell transplantation Prior CD19 targeted therapy or prior CAR T cell therapy History of pulmonary alveolar proteinosis (PAP) History of severe, immediate hypersensitivity reaction attributed to aminoglycosides Known history of human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive) or hepatitis C (HCV) (anti-HCV positive) infection. A history of hepatitis B or hepatitis C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing Individuals with detectable Cerebrospinal fluid (CSF) malignant cells, or brain metastases, or with a history of CNS lymphoma, CSF malignant cells or brain metastases History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement Note: Other protocol defined Inclusion/ | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Autoimmune Encephalitis Anti NMDA Receptor Encephalitis Herpetic Encephalitis Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF Without age limit No respect of | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, Auto-immune Encephalitis Auto-immune encephalitis proved by biological results (blood and/or CSF sample) No MRI available | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Diffuse Large B-Cell Lymphoma 75 years old, male or female Patients diagnosed as CD20-positive diffuse large B-cell lymphoma after histopathological or cytological examination and untreated ECOG score ≤ 2 when enrolled Echocardiography measured LVEF ≥ 50% The laboratory indicators during the screening period shall meet the following White blood cell count (WBC) ≥ 4.0 × 109/L or the lower limit of normal of the local laboratory; patients with bone marrow invasion, WBC ≥ 3.0 × 109/L; Absolute neutrophil count (ANC) ≥ 2.0 × 109/L or the lower limit of normal of the local laboratory; in the patients with bone marrow invasion, ANC ≥ 1.5 × 109/L; Hemoglobin (HB) ≥ 90 g/L; in the patients with bone marrow invasion, HB ≥ 80 g/L; Platelets (PLT) ≥ 100 × 109/L; in the patients with bone marrow invasion, PLT ≥ 75 × 109/L; Total bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 1.5 × ULN in the patients without bone marrow invasion; Serum creatinine level ≤ 1.5 × ULN Patients having at least one two-dimensional measurable lesion as the basis for evaluation: for intra-nodal lesions, ≥1.5 cm in the long diameter and ≥1.0 cm in the short diameter; for extra-nodal lesions, ≥1.0 cm in the long diameter Patients with lymphoma International Prognostic Index (IPI) score of 0-2, with stage I to IV Female at the childbearing age who show negative in the pregnancy test, and agree to take effective contraceptive measures during the study period and within 12 months after the last dose; male patients who agree to take effective contraceptive measures during the study period and within 3 months after the last dose Patients with the expected survival period of greater than 6 months Patients voluntary to sign the Informed Consent Form Patients with primary central nervous system lymphoma and secondary central nervous system invasion, gray zone lymphoma between Burkitt and DLBCL, gray zone lymphoma between DLBCL and HL, primary mediastinal DLBCL, primary exudative lymphoma, plasmablastic lymphoma, primary skin DLBCL, ALK-positive DLBCL or transformed lymphoma Patients with double hit (BCL-2 and c-MYC gene rearrangement) or triple hit (BCL-2, BCL-6 and c-MYC gene rearrangement) diffuse large B-cell lymphoma diagnosed by the FISH test method; or patients with the pathological immunohistochemical test results as follows: BCL-2 ≥70% positive and c-MYC≥40% positive and tumor cells judged to be the source of germinal center according to Han's evaluation but without exact FISH test result Patients with history of malignant tumors other than cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma and cervical carcinoma in situ within 5 years prior to enrollment Patients with major surgery (excluding diagnostic surgery) within 2 months prior to enrollment Patients treated for non-Hodgkin's lymphoma: Chemotherapy and immunotherapy; Radiotherapy or local radiotherapy for DLBCL; Monoclonal antibody therapy (including Rituxan® and biosimilars of Rituxan®) Surgery (except biopsy) Patients previously receiving cytotoxic drugs or anti-CD20 antibodies to treat other diseases (e.g. rheumatoid arthritis) Patients receiving any monoclonal antibody within 3 months prior to enrollment Patients who participated in other clinical trials and used other trial-related drugs within 3 months prior to enrollment Those vaccinated within 1 month prior to enrollment Those receiving hematopoietic cytokines, e.g. granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to enrollment | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 40.0-70.0, Laparoscopy Age: any age Sex: Male and Non pregnant female Patients with cardiopulmonary diseases Patients who diagnose acute cholecystitis not improving on medical treatment for 48 hours Patients with biliary colic, mucocele of gall bladder and pyocele of gall bladder American Society of Anesthesiologist's (ASA) score: grade I, II, III ASA grade IV Patients refuse surgery Documented neurological, renal and Liver disease Previous percutaneous cholecystostomy Cases not tolerated CO2 insufflation from the start Other associated problems as acute cholangitis, pancreatitis, gastro-intestinal cancer or bile duct diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Atrial Fibrillation sustained AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2, not suitable for long-term oral anticoagulant drugs Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 17.0-999.0, Dysphagia, Esophageal Dysphagia, Oral Phase Dysphagia Comes and Goes Thyroiditis Thyroid Cancer Thyroid Neoplasms Thyroid Goiter Thyroid Nodule (Benign) Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma) Patients with total thyroidectomy (TT) indication Patients over 17 year-old Patients without thyroid disease Patients with thyroid disorder, but prepared for surgery other than TT Healthy volunteers Patients below 17 y/o | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Anxiety Chemotherapy Effect Breast Cancer Head Cancer Neck For all patients Patient Study Information and written informed consent Social Security Affiliation For breast cancer cohort Adult patient (>18 years) Histological or cytological proven breast cancer Eligible to an adjuvant or neo-adjuvant IV chemotherapy with the protocol doxorubicin- cyclophosphamide Therapeutic strategy validated in multidisciplinary meeting First chemotherapy cure (C1D1) with doxorubicin cyclophosphamide not initiated yet Patients with a complete healing after resection (for adjuvant chemotherapy) Patient with a consciousness disturbance or a spatio-temporal disturbance Claustrophobic patient Patient with a non-stabilized psychiatric pathology Patient with seizure crisis background Patient with a visual or hearing disturbance that is not compatible with video watching and sound listening Patients with out-of range clinical parameters (arterial pressure, cardiac frequency,..) Patients with out-of range blood parameters that are not compatible with chemotherapy or an invasive act Patient with a life expectancy below 3 months Impossibility to track and follow patient (any reason) Patient deprived of liberty or subjected to guardianship | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.5-75.0, CD19 Negative B-cell Malignancies Age older than 6 months. 2. B cell malignancies relapsed after anti-CD19 immunotherapy. 3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20. 4. The KPS score over 80 points, and survival time is more than 1 month. 5. Greater than Hgb 80 g/L. 6. No contraindications to blood cell collection Complications with other active diseases, and difficult to assess patient response. 2. Bacterial, fungal, or viral infection unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers. 6. Under systemic steroid use within a week of the treatment. 7. Judged difficult to cooporate for continued evaluation | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-60.0, DLBCL Untreated MYC Gene Rearrangement Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 excluding PMBCL, PCNSL, HIV-associated lymphoma. 2. ECOG PS 0-2 3. Age 18-60 years old 4. Expected survival ≥ 12 weeks 5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm) 6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures 2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons 3. Previous exposure to any anti-tumor therapy 4. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma 5. History of DVT or PE within past 12 months 6. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration 7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia 8. CNS or meningeal involvement 9. Known sensitivity or allergy to investigational product 10. Major surgery within three weeks 11. Patients receiving organ transplantation 12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer 13. Presence of Grade III nervous toxicity within past two weeks 14. Active and severe infectious diseases 15. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment 16. In any conditions which investigator considered ineligible for this study 17. Patients with histological transformation | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Metabolic Syndrome Obesity Inflammation Having body mass index ≥30 kg/m2 Manifest heart disease ( coronary heart disease, cardiac failure, cardiac valve disease or arrythmia) Renal failure Hepatic failure Infection Chronic systemic inflammatory disease Pulmonary disease Malignancy Inadequate transthoracic echocardiographic images | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-60.0, Coronary Artery Disease Left Main Age between 18 and 60 years LV ejection fraction between 30 and 50% left main stem CAD mitral or aortic valve disease associated with ischemic heart disease Double valve disease or other valve disease mitral or aortic valve disease associated with congenital heart disease patients subjected to prior heart surgery emergency operation poorly controlled diabetes mellitus | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, T-LGL Leukemia Clpd-Nk The gender of the patient is not limited, and the age is ≥18 years old; 2. Must meet diagnostic of T-LGLL or CLPD-NK according to WHO 2016 version; 3. The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate. 4. With LGLL treatment indications, it mainly includes (meets at least one of the following conditions): 1. ANC <0.5 × 10^9 / L 2. HGB <100g / L or need red blood cell infusion to maintain 3. PLT <50 × 10^9 / L 4. Combining autoimmune diseases that require treatment 5. symptomatic splenomegaly 6. Severe B symptoms 7. Pulmonary hypertension. 5. ECOG performance status score is 0-2; 6. The patient's expected survival time is ≥ 6 months Unable to understand or follow the research procedure; 2. Co-occurrent malignant tumors that has to be treated or course the symptom; 3. Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A; 4. ALAT / ASAT or alkaline phosphatase> 3 times the normal value; 5. Creatinine clearance <60ml / min; 6. Serological evidence of active infection of HIV, hepatitis C or hepatitis B; 7. Ineffective contraception; 8. Positive pregnancy test; 9. Pregnant women | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Encephalitis PCR SARS COV2 positive or CT Scan Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection Contraindication to performing an MRI scan Minor Pregnant woman No follow-up possible at 6 months | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma Primary Mediastinal Large B Cell Lymphoma Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma Chronic Lymphocytic Leukemia Indolent Non-Hodgkin Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Burkitt's Lymphoma Primary CNS Lymphoma Age ≥ 18 years of age Creatinine ≤2.0 mg/100 ml, direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN) Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry. Dose Escalation Phase Histologically confirmed DLBCL and large B cell lymphoma, including DLBCL, not otherwise specified (NOS), or Transformed DLBCL from follicular lymphoma, or High-grade B cell lymphoma (excluding Burkitt's lymphoma), or Primary mediastinal large B cell lymphoma AND Chemotherapy refractory disease, defined as a failure to achieve at least a partial response or disease progression within 6 months to the last therapy, OR Disease progression or recurrence in ≤12 months of prior autologous stem cell transplant (ASCT), OR ECOG performance status ≥2 Patients with active CNS disease Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan Patients with the following cardiac conditions will be excluded New York Heart Association (NYHA) stage III or IV congestive heart failure Myocardial infarction ≤6 months prior to enrollment History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment Patients with HIV or active hepatitis B or hepatitis C infection are ineligible Patients with prior allogeneic hematopoietic stem cell transplant are eligible, if more than 3 months from transplant and if patients have no active graft versus host disease (GvHD) and not on systemic immunosuppressive therapy | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Pericardial Effusion Malignant Patients with confirmed active malignancy AND Presence of at least moderate (>10cm) pericardial effusion on CT or Echocardiography Patients unable to give an informed consent Previous history of open-heart surgery Previous history of pericardial window or pericardial instillation of sclerosing therapy Scheduled thoracic or cardiac surgery within the next 3 months Patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia Patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 25.0-55.0, Dental Implant Failed the residual bone height at the site of implant placement was 8 mm or less. All patients were in a good health, non-smokers with no systemic, immunologic or debilitating diseases that could affect normal bone healing. Their edentulous ridges were covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue and sufficient inter arch space was adequate for future prosthesis smokers bad oral hygiene systemic disease | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-120.0, Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors Locally advanced, unresectable, or metastatic disease based on most recent imaging The respective cohorts for patient are Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer Progressed following prior treatment or who have no satisfactory alternative treatment option Uncontrolled intercurrent illness History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Renal Insufficiency, Chronic History of primary glomerulonephritis eGFR between 60 ml/min and 30 ml/min age between 18-65 years old secondary GMN severe heart failure (NYHA IV) ongoing infectious diseases ongoing neoplasia hepatic diseases COPD inflammatory bowel disease history of stroke history of acute coronary disease less than 3 months pregnancy | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-70.0, B-cell Lymphoma Burkitt Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Transformed Non-Hodgkin Lymphoma Richter Syndrome Hodgkin Lymphoma Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having attained a CR, PR, or stable disease post reinduction therapy Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score Life Expectancy Patients must have a life expectancy of > 6 weeks Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea). 2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent Organ Function Requirements Adequate Renal Function Defined As Creatinine clearance or radioisotope GFR > 60 mL/min/1.73 m2 or A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4 years 1.7 1.4 Patient may not have had a prior stem cell transplant Patients must not have active CNS lymphoma Other concurrent investigational agents for treatment of B-cell lymphoma Pregnancy and/or active Breast Feeding Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation Patient must not have an uncontrolled infection Patient must not have ≥ Grade 3 neuropathy | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, Pulmonary Arterial Hypertension Subjects must meet all of the following 1. Male or female, aged 18 to 75 years inclusive 2. WHO Group 1 PAH related to one of the following conditions: 1. Idiopathic 2. Heritable 3. Drugs or toxins-induced 4. Associated with connective tissue disease 5. Associated with congenital heart disease if subjects underwent surgical correction more than 12 months before Screening 3. Symptoms due to PAH are consistent with WHO functional class II III; 4. Have not taken endothelin receptor antagonists (ERAs) within 3 months before randomization. 5. Has been taking at least one oral PAH targeted drug that has been approved by local guidelines for at least 3 months before screening with stable dosage and the disease did not worsen during this period. 6. Right heart catheterization (RHC) result meets below when screening. 1. Mean pulmonary arterial pressure (PAP) ≥25 mmHg 2. Pulmonary vascular resistance (PVR) >3 Woods units 3. PA wedge pressure (PAWP) ≤15 mmHg * if a subject has undergone RHC within 3 months before screening, the waveform results will serve as baseline data if they meet entry criteria; and the RHC at Screening will not be repeated. 7. Has a six-minute walk test (6MWT) with distance between 150 to 450 meters at Screening. 8. The dosage of digitalis drugs or L-arginine supplementation must be stable for at least 1 month before Screening, if applicable. 9. No new use of an IV diuretic, cardiotonic or vasoactive drug within 30 days before screening. 10. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent signing to 90 days after last dose, if the possibility of conception exists. Medically acceptable methods of contraception oral, implantable, or injectable contraceptives (starting 2 months before dosing); diaphragm with vaginal spermicide; intrauterine device; condom and partner using vaginal spermicide; and surgical sterilization (6 months after surgery). Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 90 days after the last dose of study drug. 11. Body weight no less than 40 kg at Screening. 12. Able to understand and willing to sign the Informed Consent Form (ICF) and comply with the study procedures Subjects who meet any of the following will not be allowed to participate in this study: 1. Diagnosed with WHO Group II, III, IV, V of PH; 2. Using calcium channel blockers when Screening; 3. BP>160/100mmHg at Screening; 4. Systolic BP <90 mmHg at Screening; 5. Pulmonary function test: FEV1<60% of predicted, TLC<60% of predicted, DLCO<60% of predicted; 6. One of the following tests with confirmed pulmonary embolism and/or chronic thrombo-embolic pulmonary hypertension (CTEPH) following initial diagnosis of PAH: 1. Pulmonary ventilation/perfusion scan 2. CT pulmonary angiogram 3. Contrast dye pulmonary angiogram 7. History of sleep apnea. 8. Limited full participation in the 6MWT due to arthritic, neuromuscular, vascular or other diseases unrelated to PAH. 9. History of acute cardiovascular and/or cerebrovascular events within 6 months before screening. 10. Echocardiogram (ECHO) demonstrating at least one of the following: 1. LVEF <50% 2. Mean end-diastolic left ventricular septal and posterior wall thickness of >12 mm 3. Left atrial (LA) area on apical 4 chamber view >20 cm2 4. LA volume by biplane modified Simpsons or area-length methods >55 mL 5. LA volume index >29 mL/m2 6. Significant valvular heart disease including moderate or severe mitral or aortic stenosis with an aortic valve area <1.0 cm2 or mitral valve area <1.5 cm2), greater than moderate aortic or mitral regurgitation, greater than moderate tricuspid or pulmonic stenosis 11. Restrictive, dilated or hypertrophic cardiomyopathy or constrictive pericarditis 12. Using non-oral prostacyclin when screening; 13. Laboratory parameters during screening: 1. Baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN) or total bilirubin ≥1.5 times ULN 2. Estimated glomerular filtration rate (eGFR) <60 mL/min by Cockcroft-Gault formula 3. Hemoglobin concentration ≤100 g/L at screening 14. QTc interval by Fridericia's (QTcF) ≥500 msec at screening 15. Malignancy within 5 years before screening visit (with the exception of localized non-metastatic basal cell carcinoma of the skin, non-metastatic carcinoma of the prostate or in-situ carcinoma of the cervix excised with curative results) 16. Alcohol or drug abuse within 1 year before screening 17. A psychiatric, addictive or other disorder that compromises the ability to give informed consent for participating in this study 18. History of organ transplantation 19. Pregnant or nursing females 20. History of HIV 21. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-ab). 22. Enrolled in another interventional study within 30 days before screening. 23. Any condition that, in the opinion of the investigator, prevents a potential subject from safely participating in the study | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Central Nervous System Lymphoma ECOG Performance Status of 0, 1, or 2 2. Previously untreated patients with primary central nervous system lymphoma with pathologically confirm 3. At least one bi-dimensionally measurable lesion, defined as >1.0 cm in its longest dimension as measured by MRI 4. Signed written Informed Consent Form 5. hematologic function,defined as follows Hemoglobin ³ 9.0 g/dL without packed RBC transfusion during 14 days before first treatment ANC ³ 1,000/µL Platelet count ³ 80,000/µL 6. Adequate liver and kidney function function,defined as follows: Serum AST and ALT≤ 2.5 *ULN ，Total bilirubin ≤ 1.5 * ULN Serum creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula) Evidence of extracranial involvement (such as testis and breast) and secondary CNS involvement 2. Evidence of pleural fluid, ascites and pericardial effusion 3. History or presence of prolonged QTc interval in ECG, QTc interval>470ms in female and >450ms in male 4. History of other malignancy in 5 years 5. Positive test results for hepatitis C, HIV and RPR. 6. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology) Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is less than 10E4 at the time of screening. 7. Pregnancy or lactation or intending to become pregnant during study 8. Prior organ transplantation 9. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1. 10. Evidence of significant, uncontrolled, epilepsy | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Tuberculous Pericarditis HIV Status Aged >18 years 2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole) 3. Consent to study participation including testing for HIV-1 (if HIV status is unknown) 4. Microbiologically detected Mtb in PCF or diagnosis of probable PCTB. Probable PCTB (in the absence of a positive pericardial fluid culture) will be defined as per Mayosi et al.4: 1. Evidence of pericarditis with microbiologic confirmation of Mtb infection elsewhere in the body and/or 2. Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L) 5. Participant will undergo pericardiocentesis (as per clinical indication) 6. Within 5 days of ATT initiation Glomerular filtration rate <30ml/min or renal failure requiring dialysis 2. Rifampin-resistant TB 3. Severe concurrent opportunistic infection 4. Contraindication to placement of intra-pericardial catheter 5. Failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter 6. Any disease or condition in which the use of the standard anti-TB drugs (or any of their components) are contraindicated. This includes, but is not limited to, allergy to any TB drug or their components. 7. In females: a positive urine pregnancy test result 8. Confirmed autoimmune disorders (e.g. systemic lupus erythematosus) Additional Exclusions for Gadolinium contrasted CMR 1. Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.) 2. Claustrophobia 3. Gadolinium allergy 4. Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure) 5. Breastfeeding | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 14.0-999.0, Cryptococcal Meningitis Patients with HIV-associated cryptococcal meningitis, admitted to inpatient department of SHW, SHM and SHT during the study period 2. Patients of both sexes 3. Age above 14 years 4. Patients or caregivers who will give informed consent to participate in this study Pregnancy | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-100.0, Cholecystitis, Acute Cholecystitis; Gangrenous Cholecystitis Suppurative Covid19 All patients presenting acute cholecystitis during COVID 19 pandemic, aged >=18 yo Patients presenting with acute cholecystitis aged <18 yo | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Refractory Non-Hodgkin Lymphoma Burkitt Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Primary Mediastinal Large B Cell Lymphoma Diffuse Large B Cell Lymphoma Small Lymphocytic Lymphoma Transformed Lymphoma Patients must have a diagnosis of relapsed or refractory B-cell NHL DLBCL, Mantle Cell, Follicular Lymphoma, Lymphoplasmacytic lymphoma, Small Lymphocytic Lymphoma, Primary Mediastinal B-Cell Lymphoma, Burkitt Lymphoma, transformed lymphoma Subjects with small lymphocytic lymphoma (SLL) must have progressed after at least 2 prior therapies and prior treatment with or intolerance of both ibrutinib and venetoclax Subjects with DLBCL, primary mediastinal B Cell lymphoma, Burkitt lymphoma and transformed lymphoma must have relapsed or failed to respond to >= 2 prior lines of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline Subjects with indolent lymphomas (follicular lymphoma and lymphoplasmacytic lymphoma) must have relapsed after or been refractory to >=2 prior lines of multi-agent chemoimmunotherapy including prior exposure to rituximab and at least 2 other chemotherapy agents For subjects with Mantle cell lymphoma, previous lines of therapy may multiagent chemotherapy including alkylating agent or anthracycline and anti CD20 antibody therapy and Bruton's tyrosine kinase (BTK) inhibitor therapy Positron Emission Tomography (PET) -positive disease according to "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification" At least one of the following Primary refractory or early relapse (first remission < 12 months) and not eligible for stem cell transplant Autologous transplant within 6 weeks of planned CAR-T cell infusion 2. Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol 3. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast). 4. HIV seropositivity 5. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) 6. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements. 7. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with 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 CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test. 8. Patients with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease. 9. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months. 10. Body weight <40 kilograms(kg) for Infusion of Investigational Product: Subjects will undergo a second evaluation of on day -2 or -1 prior to infusion of antiCD19 CAR-T cell product. This criterion will the and required for enrollment with the following exceptions and additions exceptions: 1. Hematologic function parameters will not be included as a pre-infusion criterion (because lymphodepletive chemotherapy is expected to cause pancytopenia). 2. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition additions: 1. Use of corticosteroids within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy). 2. Neurologic symptoms suggestive of an active central nervous system condition. 3. Signs or laboratory markers of active infection or systemic inflammatory response | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse 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 must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Thoracic Spine Neoplasm Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.) All diagnoses are eligible Vertebral body site to be treated located from T2 to T12 Signed informed consent Requires open spinal procedure or a percutaneous procedure without the use of image guidance Unable to tolerate general anesthesia and prone position Unable to undergo MRI scan of the spine | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-90.0, Subarachnoid Hemorrhage Ventriculo-Peritoneal Shunt Infection Hydrocephalus patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils patients in whom EVD was inserted in the other hospital patients were successfully weaned from EVD with 7-10 days of EVD insertion patients who died during hospitalization | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome Overweight Obesity Age ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS Taking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-90.0, Coronary Artery Disease Patients presenting to cathlab for elective PCI along one year duration patients who have significant main vessel lesion subtending large, sizable (≥2mm) side branches (Medina 1,0,0 / 1,1,0 / 0,1,0) acute myocardial infarction previous CABG LV EF<50% baseline SWMA in the territory of the vessel to be stented totally occluded main vessel small (<2mm) side branch any ostial, mid or distal significant side branch disease at baseline true bifurcation lesions (Medina 1,0,1 / 1,1,1 / 0,1,1) with upfront 2-stent strategy advanced renal impairement | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma Lymphoma Cns Cohort 1 Patients with relapsed/refractory active primary or secondary CNS lymphoma, histologically proven aggressive B cell lymphoma, including DLBCL, HGBL, PMBL, or tFL, and defined by the following categories Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy. There is no restriction on the number of recurrences Secondary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy for prophylaxis or treatment of CNS lymphoma Measurable CNS disease by MRI of the brain (longest diameter >1cm on gadolinium enhanced MRI) No evidence of active systemic lymphoma (treated systemic lymphoma in remission is allowed) Cohort 2 Patients with relapsed and/or refractory systemic aggressive B cell lymphoma, including DLBCL, HGBL, PMBL or tFL, with active or treated secondary CNS lymphoma R/R systemic lymphoma with concurrent CNS disease R/R systemic lymphoma with history of CNS disease Primary vitreoretinal lymphoma and intraocular PCNSL without evidence of brain disease. Patients with prior history of intraocular involvement treated only with intraocular methotrexate and no prior systemic therapy are excluded PCNSL patients who cannot undergo magnetic resonance imaging assessments Patients with brain stem lesions Patients with leptomeningeal disease only without brain parenchymal involvement Bulky leptomeningeal disease and or CSF protein ≥100 mg/dL History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years History of Richter's transformation of CLL History of allogeneic stem cell transplant Prior CD19 targeted therapy Treatment with systemic immunostimulatory agents (including but not limited to interferon and IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel or SOC | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 19.0-70.0, Cholecystitis, Acute among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II) 2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging 3. Gallbladder with surrounding organs due to gallbladder inflammation 4. Patients over 19 years of age, under 70 years of age patients with elective gallbladder surgery (chronic cholecystitis) 2. gallbladder disease not inflammatory disease (GB cancer, GB polyp) 3. pregnant women, patients under 18 years of age, over 70 years of age 4. patients with simultaneous surgery due to other organ diseases 5. immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients 6. patients with hemorrhagic tendency, or with hematologic diseases 7. Patients who underwent percutaneous cholecystectomy (PTGBD) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, Diffuse Large B Cell Lymphoma CD79A Gene Mutation CD79B Gene Mutation Age between 18 to 70 years old (including 18 and 70) 2. Diagnosed as diffuse large B cell lymphoma 3. CD79A/CD79B genetic abnormality 4. Subjects must be untreated or R/R and either a or b (a: medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ b: Immunohistochemical staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%) 5. Having at least one measurable lesions 6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1 7. Life expectancy no less than 3 months 8. enough main organ function 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. Agreeing to sign the written informed consents Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike 2. Diagnosed as grey-zone lymphoma 3. Diagnosed as primary mediastinal large B-cell lymphoma 4. Diagnosed as CD20 negative diffuse large B-cell lymphoma 5. Active malignant tumor need be treated at the same time 6. Other malignant tumor history 7. Serious surgery and trauma less than two weeks 8. Systemic therapy for serious acute/chronic infection 9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 10. Vaccination with live attenuated vaccine less than 4 weeks 11. HIV-positive, AIDS patients and untreated active hepatitis 12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 13. Patients with a history of mental illness 14. Researchers determine unsuited to participate in this trial | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-38.0, Infertility, Female Polycystic Ovary Syndrome Age:18-38 years old Diagnosis of PCOS according to compliance with the Rotterdam BMI >= 25 Hormonal contraceptive, insulin sensitizers such as metformin, inositols, antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugs or others with anti-inflammatory properties, antibiotics, probiotics, laxatives use in the 3 months prior to recruitment Tobacco consumption in last 12 months Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatory diseases, systemic immune diseases, other endocrine diseases or dysfunctions except for PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (eg congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease or without evidence of complete remission for at least 5 years Active participation in an active weight reduction program or hypocaloric diet during the study period. No change in habits will be taught during the study period Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 6.0-99.0, Nervous System Diseases all patients with neurological disorders, with known or probable autoimmune involvement. This includes adults and children and peripheral and/or central nervous system symptoms Social coverage up to date Patients with neurological damage from which the autoimmune character can be excluded Known anemia and hemoglobin <10 g / dl Patients under protective supervision (guardianship, curators) Pregnant or breastfeeding woman | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cardiac Disease Age ≥ 18 years old Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty) Registered in Cardiovascular Rehabilitation at the Mitterie Clinic Number of rehabilitation sessions at least equal to 30 Ejection fraction ≥ 45% Signed written consent of the patient Affiliation to a social security scheme Cardiac decompensation Severe functional limitation Unstable acute coronary syndrome Decompensated heart failure Severe ventricular rhythm disorders Presence of an intracardiac thrombus with high embolic risk Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound) Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism Severe and/or symptomatic left ventricular ejection obstruction Any progressive inflammatory and/or infectious disease | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 3.0-70.0, CAR Only subjects meeting all of the following conditions were included in the study The subjects who voluntarily participated in the study and signed the written informed consent The age at the time of signing the informed consent is 3-70 years old, regardless of gender or race The patients with CD19 / CD20 positive hematological malignancies without other effective treatment options those who are not suitable for allogeneic stem cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases; Other contraindications, such as total body irradiation (TBI) contraindications (TBI is one of the important treatment measures before allogeneic stem cell transplantation in all patients); Lack of suitable donors Expected survival > 12 weeks Relapse after any stem cell transplantation (no matter what previous treatment plan); and Patients who relapsed after previous allogeneic SCT (myeloablative or non myeloablative) and met all other 1. There was no active GVHD and no immunosuppression was required; 2. Transplantation lasted more than 4 months Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl Serum AST and alt ≤ 5 x upper limit of normal value (ULN) It is necessary to have indicators for disease detection or evaluation, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR Pregnant or lactating female patients Participate in another clinical trial within 4 weeks before the study, or intend to participate in another clinical trial during the whole study period Uncontrolled active infection The history of human immunodeficiency virus is known Active hepatitis B or hepatitis C infection The systemic steroid treatment is needed during cell infusion or cell collection, or there are some diseases that researchers think may need steroid treatment during blood collection or infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone for physiological replacement therapy in patients with adrenocortical insufficiency are also allowed There are grade 2-4 acute or systemic chronic GVHD There is GVHD under treatment Patients with cns3 disease progression or central nervous system parenchymal lesions that may increase central nervous system toxicity; patients with active central nervous system leukemia or lymphoma infiltration Absolute neutrophil count < 750 / μ L or platelet count < 50000 / μ l caused by non primary diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma Non-Hodgkin Lymphoma Diffuse Large B-Cell Lymphoma Burkitt Lymphoma Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as high-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s) Indolent B-cell lymphoma: with the following exceptions MCL is excluded given increased risk of tumor lysis syndrome (TLS) with venetoclax compared to other non-Hodgkin lymphomas and need for venetoclax ramp-up, dose-escalation CLL/SLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed CLL/SLL and increased risk of TLS with CLL/SLL compared to other non-Hodgkin lymphomas. NOTE: Patients with known active CNS lymphoma are not eligible Relapsed and/or refractory disease after at least 1 prior treatment regimen, as follows Aggressive B-cell lymphoma: relapsed after and/or refractory to at least 1 prior anthracycline-containing regimen Indolent B-cell lymphoma: relapsed after and/or refractory to at least 1 prior anti CD20 antibody-containing regimen Patients must have evaluable disease by clinical exam (i.e., palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e., lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and/or imaging (measurable lymph nodes or masses on CT or MRI and/or evaluable FDG-avid lesions on PET). NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy. -Age greater than or equal to18 years NOTE: Because no dosing or adverse event data are currently available on the use of polatuzumab in combination with venetoclax, ibrutinib, obinutuzumab, prednisone and Revlimid in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials The following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug Patients who are actively receiving any other investigational agents Any chemotherapy or anti-cancer antibodies within 2 weeks. NOTE: Short courses of corticosteroids or palliative XRT prior to enrollment are permitted within the 2- week washout period Radio or toxin-immunoconjugates within 10 weeks Previous treatment with polatuzumab or more than one of the other study agents (i.e., venetoclax, ibrutinib, or Revlimid ), excluding prior prednisone or anti-CD20 antibody treatment Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia) Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin Patients requiring the following agents to the first dose of venetoclax or ibrutinib are excluded, as noted | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Septic Arthritis of the Native Hip Failure of Initial Debridement All microbiology reports for cases of septic arthritis of the native hip joint concerning synovial fluid or solid tissue cultures obtained from arthrocentesis/debridement of the hip, collected from January 1st 2010 to January 1st 2020 Patients are at least 18 years of age Cases with positive cultures in patients of which the initial diagnosis, treatment and follow-up was conducted at UZ Leuven Gasthuisberg History of arthroplasty of the hip in the affected joint | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Postpartum Pregnancy-Induced Hypertension Postpartum Preeclampsia Hypertension, Pregnancy-Induced Hypertension Postpartum women No antenatal diagnosis of hypertensive disorder of pregnancy at the time of admission for delivery, defined as existing chronic hypertension diagnosis or documented blood pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions at least 4 hours apart prior to delivery admission who do not go on to get magnesium for seizure prophylaxis by the time of delivery At least 18 years of age English or Spanish speakers One or more high risk factors for development of de novo postpartum hypertension Non-English or Spanish speakers Women with a contraindication to diuretic therapy Women who have used diuretics in the two weeks prior to delivery | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 20.0-80.0, Inguinal Hernia all patients with confirmed groin hernia of both sexes none | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Intracranial Hemorrhage Patient is between 18 and 80 years of old Patients with ICH rupture into the ventricle in the primary basal ganglia region or non-aneurysmal subarachnoid hemorrhage confirmed by skull imaging examination Patient is admitted to hospital within 72 hours after onset Informed consent of the patients or their family members, and signed informed consent for CSF replacement treatment Non-spontaneous intracranial hemorrhage Time from onset to admission is longer than 72 hours The patient who needs surgical treatment Contraindication of lumbar puncture, such as: cerebral hernia, severe intracranial hypertension, puncture site inflammation, blood system diseases, etc Patient has other serious diseases, such as heart failure, kidney failure, liver failure, etc Patient or his/her relatives refuse to accept the above research plan | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Waldenstrom Macroglobulinemia (WM) Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Follicular Lymphoma (FL) Diffuse Large B-cell Lymphoma (DLBCL) Patients must be ≥ 18 years of age Patients must have measurable disease per disease-specific response Patients with indolent forms of NHL must meet the requiring systemic treatment (i.e., iwCLL, IWG, or Lugano Classification of Lymphoma response criteria) Patients with transformed lymphoma are eligible for the study with the exception of those who have Richter's transformation, prolymphocytic leukemia, or blastoid lymphoma prior to planned start of study drug Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ and bone marrow function, in the absence of growth factors Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol for Patients in Phase 1a Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL(grade 1 ), and DLBCL (High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma NOS) Received at least 2 prior systemic therapies and have no other therapies known to provide clinical benefit History of CNS lymphoma/leukemia in remission for less than 2 years Autoimmune hemolytic anemia or autoimmune thrombocytopenia History of known/suspected other autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.) Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug Bleeding diathesis, or other known risk for acute blood loss Patients requiring ongoing treatment with chronic, therapeutic anticoagulation with warfarin Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation) Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy or hematologic parameters meeting criteria) Active known second malignancy with the exception of any of the following Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Atrial Fibrillation AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2 and HAS-BLED score ≥3, not suitable for long-term oral anticoagulant drugs Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Bariatric Surgery Candidate Obesity Obesity, Morbid body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) a positive evaluation by our BMDT Presence of H. Pylori, resistant to eradication therapy chronic diarrhoea history of previous bariatric or extensive abdominal surgery | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-35.0, Polycystic Ovary Syndrome (PCOS) Age of 18 to 35 years Overweight and obese PCOS patients (overweight defined as body mass index (BMI) 25-29.9 kg/m2 and obesity defined as BMI ≥ 30 kg/m2) History of amenorrhea or oligomenorrhea with or without hirsutism. Amenorrhea was defined as absence of menstruation for six or more months. Oligomenorrhea was defined as cycle interval of more than 35 days but less than 6 months PCOS diagnosed according to the 2004 Rotterdam ESHRE/ASRM Consensus workshop, with presence of at least 2 out of 3 oligo and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology identified by ultrasound with more than 12 small antral follicles in an ovary Prediabetes defined by the American Diabetes Association 2014, as fasting plasma glucose (FPG) levels of 100 to 125 mg/, or impaired glucose tolerance (IGT) defined as 2-hour readings of 140 to 199 mg/dL in the oral glucose tolerance test (OGTT). Also, patients who had their Glycosylated Hemoglobin A1C levels between 5.7% and 6.4% were Lean or average weight PCOS with BMI < 25 kg/m2, morbidly obese patients with BMI ≥ 35 kg/m2 Patients suffering from any other metabolic disorders History of receiving any hormonal treatment or any drug affecting carbohydrate metabolism 3 months prior to the beginning of the study Inability to attend the regular follow up visits Already known and recently diagnosed diabetic patients. According to the American Diabetes Association 2014 (16), diabetes mellitus was defined as Glycosylated Hemoglobin A1C levels ≥ 6.5% or FPG ≥ 126 mg/dL or 2-hour plasma glucose readings ≥ 200 mg/dL during 75 g OGTT, or presence of classic symptoms of hyperglycemia with random plasma glucose levels ≥ 200 mg/dL Thyroid diseases Hyperprolactinemia | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Advanced Solid Tumors and Hematological Malignancies Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 2. Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma. 3. Solid tumors or hematological malignancies that failed from standard therapy, or lymphoma patients who have had at least two regimens of systemic therapy failures, or who refused other systemic therapy. 4. At least 1 measurable lesion according to tumor-appropriate response criteria. 5. Must have adequate organ and bone marrow function. 6. Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 per CTCAE v5.0 except for AEs not constituting a safety risk by investigator judgment. 7. Serum pregnancy test (for females of childbearing potential) negative within 7 days before enrollment. 8. Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for at least 90 days (180 days if required by local regulation) after the last dose of assigned treatment. 9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures Patients with known symptomatic brain metastases requiring steroids. 2. Concurrent secondary malignancy. 3. Uncontrolled pleural effusion or pericardial effusion with clinical significance and requiring repeated drainage as assessed by the Investigators. 4. Prior treatment with monospecific or bispecific antibodies or fusion proteins targeting CD47 or signal regulatory protein alpha (SIRPα). 5. Therapeutic or experimental monoclonal antibodies within 28 days prior to enrollment. 6. Immunosuppressive regimens involving systemic corticosteroids (except <10 mg daily prednisone equivalent) within 14 days before the first dose of study treatment. 7. Prior allogeneic hematopoietic stem cell transplant. 8. Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment. 9. RBC transfusion dependence, defined as requiring more than 2 units of RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during screening and prior to enrollment to meet the hemoglobin criteria. 10. Vaccination within 4 weeks prior to enrollment except for administration of inactivated vaccines (for example, inactivated influenza vaccines) 11. Active and clinically significant bacterial, fungal or viral infection including tuberculosis, hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 12. History of hemolytic anemia or Evans syndrome within 3 months. 13. Autoimmune hemolytic anemia (AIHA) assessed by Positive Direct Antiglobulin Test (DAT). 14. Autoimmune disorders (e.g., Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system. 15. Unstable or serious concurrent medical conditions in the previous 6 months. 16. Significant medical diseases or conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study. 17. Other severe 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 | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-79.0, Cardiovascular Diseases Carotid Stenosis Cerebral Arteriosclerosis Cerebrovascular Disorders Heart Diseases Vascular Diseases Men and women with early carotid atherosclerosis and moderately elevated LDL cholesterol between the 60th and 90th percentiles | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Stroke Cerebral Infarction Atherosclerosis Constriction, Pathologic TIA or non-severe stroke within 90 days prior to randomization (including day 90) Modified Rankin score of < 3 High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90) TIA or stroke is attributed to high grade intracranial stenosis Age > 40 years Patient is able to follow an outpatient protocol(requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms) Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (SGOT > 3x normal*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine > 3.0* Indication for intravenous heparin beyond randomization A severe neurological deficit that renders the patient incapable of living independently Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably Co-morbid conditions that may limit survival to less than five years Pregnancy or female in age range of childbearing potential who is not using contraception | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Atherosclerosis Stroke Carotid Stenosis Cerebral Infarction Myocardial Infarction Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 70% by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) are eligible for randomization Asymptomatic patients with no recent (in the last 6 months) neurological events referable to the study with artery and carotid stenosis (patients with symptoms beyond 180 days are considered asymptomatic) greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 80% by CTA or MRA are eligible for randomization Conditions that: (1) interfere with the evaluation of endpoints, (2) are known to interfere with the completion of CEA or CAS, or (3) affect the likelihood of survival for the study period (4 years). Chronic atrial fibrillation and/or anti-coagulation or episodic atrial fibrillation within the last 6 months | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 35.0-75.0, Cardiovascular Diseases Heart Diseases Coronary Disease Atherosclerosis Carotid Artery Diseases Diabetes Mellitus, Non-insulin Dependent Diabetes Mellitus Patients with type 2 diabetes mellitus (DM), defined by medical record diagnosis, fasting glucose >140 mg/dl, or the use of diabetes medications Had a myocardial infarction (MI) any time in the past, a coronary angiogram within the previous year, or an exercise perfusion scan (stress thallium study) within one year Patients with CAD group, defined by the following documented prior MI, PTCA/stent, CABG, or >75% stenosis in any vessel by coronary angiography Patients without CAD group, defined as: the absence of a prior MI and <50% stenosis in all vessels by coronary angiography within the past year, or the combination of a normal exercise perfusion scan and the absence of a prior MI or any interventional cardiac procedures MI or cardiac procedures within the past 3 months Diagnoses of cancer, severe congestive heart failure (ejection fraction < 20%), kidney or liver disease, pancreatitis, other gastrointestinal conditions Laboratory values of creatinine levels > 1.3, abnormal liver function tests, abnormal CBC, fasting TG > 400 mg/dl, urine protein > 2+ on urinalysis or > 1000 mg/24 h, abnormal thyroid function tests, body mass index (BMI) > 34 for men and > 37 for women or BMI < 20 for both sexes Age < 35 or > 75 years | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Carotid Stenosis Case: Either had a history of surgical carotid endarterectomy or carotid or CT angiogram showing greater than or equal to 80% stenosis in one or more internal carotid artery. Control: An ultrasound documenting internal carotid artery stenosis less than 15% bilaterally | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Hepatitis C Vasculitis Diagnosis of HCV-CV: must have all of the following HCV infection documented by serology and/or plasma HCV RNA. One or more organ system with objective evidence of active vasculitis such as: Palpable purpura; Glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria); Acute peripheral neuropathy. Detectable cryoglobulins and/or RF. Failure of treatment with IFN-alpha and ribavirin to control manifestations of HCV-CV OR intolerance to IFN-alpha/ribavirin regimen. Patients must have a personal physician responsible for the care of their HCV. Ages of 18 and 75 years Willingness to use effective contraception during and for 12 months following Rituximab treatment. Effective contraception methods abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception Recent (within 4 weeks) initiation of or increase in immunosuppressive therapy. Active systemic infection (other than hepatitis C). Pregnancy or breast feeding. Prior treatment with Rituximab. Known allergy to murine proteins. Significant renal insufficiency (creatinine clearance less than 30 ml/min). Presence of life-threatening HCV-CV; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), CNS vasculitis, cardiac disease due to active vasculitis, or GI vasculitis (defined by ischemic bowel, perforation, or infarction). Significant hepatic insufficiency as manifested by Child-Pugh classification of B or C. History of variceal bleeding, encephalopathy. History of liver transplantation. Co-infection with either HBV or HIV. Any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Disease Age 18 years or greater 2. Neurologically and cognitively independent prior to surgery (mRS less than 2) 3. Patients with stable or unstable angina pectoris (Braunwald Class I-II, B) and/or documented ischemia due to single or multivessel disease and a normal, mild or moderately impaired global left ventricular function 4. Patients who are a candidate for CABG 5. Patients who are eligible for on-pump and off-pump CABG: Patients with single or multi-vessel disease in which one or more significant stenosis(es) in at least one major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery, or the combination of one of the former and a side branch providing different myocardial territories) History of CABG 2. Need for concomitant major surgery (e.g., valve replacement, resection ventricular aneurysm, congenital heart disease, vascular surgery of the carotid artery or thoracic-abdominal aorta) or salvage or emergency CABG 3. Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure) 4. Q-wave myocardial infarction in the previous 6 weeks 5. Overt congestive heart failure 6. Hemorrhagic diathesis or hypercoagulability 7. Any contraindication for off-pump CABG (i.e., thoracic deformities) 8. Patients whose procedure requires no clamps (i.e., LIMA to LAD) 9. Patients with hemodynamic instability, severe left ventricular dysfunction (ejection fraction less than 25%), significant cardiac enlargement, frequent arrhythmia or respiratory instability 10. Carotid stenosis (greater than or equal to 60%) by magnetic resonance angiography or carotid Doppler 11. Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder 12. Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc) 13. Unable to give informed consent 14. Patients with the following intraoperative findings such as 1) hemodynamic instability with positioning, 2) inadequate visualization, 3) inappropriate vessels (i.e., small, intramyocardial), or 4) heavily calcified aorta by palpation FOR THE STUDY 1. Age 65 years or greater 2. Neurologically and cognitively independent prior to surgery (mRS less than 2) 3. Patient scheduled for CABG or aortic or mitral valve replacement within one week FOR THE STUDY 1. Need for concomitant carotid endarterectomy 2. Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure) 3. Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder 4. Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc) 5. Patient unable to give informed consent 6. Participation in other research studies | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Atherosclerosis Cardiovascular Diseases Hypertension, Renovascular Renal Artery Obstruction Either 1. Documented history of hypertension on two or more anti-hypertensive medications OR 2. Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula) 2. One or more severe renal artery stenoses by any of the following pathways: a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation Unable to provide informed consent 2. Unable or willing to comply with study protocol or procedures 3. Must be greater than 18 years of age 4. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization 5. Pregnancy or unknown pregnancy status in female of childbearing potential 6. Participation in any drug or device trial during the study period, unless approved by the Steering Committee 7. Prior enrollment in the CORAL study 8. History of stroke within 6 months, if associated with a residual neurologic deficit* 9. Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry* 10. Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization* 11. Hospitalization for heart failure within 30 days* 12. Comorbid condition causing life expectancy of less than or equal to 3 years* 13. Allergic reaction to intravascular contrast, not amenable to pre-treatment 14. Allergy to stainless steel 15. Allergy to all of the following: aspirin, clopidogrel, ticlopidine 16. Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.* 17. Previous kidney transplant 18. a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side) 19. Kidney size less than 7 cm. supplied by target vessel 20. Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis 21. Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery 22. Local lab serum Cr greater than 4.0 mg/dl on the day of randomization* 23. Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization 1. The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length) 2. The placement of a stent will necessitate covering a renal artery branch renal artery with a stent 3. The stenosis is in an artery less than 3.5 mm. in diameter 4. The stenosis involves a segmental renal artery branch 24. Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with abrupt vessel closure or dissection as a result of diagnostic angiography will not be randomized but will undergo stent revascularization, receive optimal medical therapy and will be followed for the full study period] *Roll-in patients do not need to meet these inclusion/ | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Unstable Angina Myocardial Infarction Acute Disease Be aged >=18 years at the time of randomization. 2. Have symptoms which at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled). 3. Meet at least one of the following for UA/NSTEMI: 1. All of the following four features: *Age >= to 65 years; *aspirin taken within the last 7 days; *two or more episodes of angina in the last 24 hours; *three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR 2. ECG changes: New or presumably new ST-segment depression >=0.1 MV (>=1mm), or transient (<30 minutes) ST-segment elevation >=0.1MV (>=1mm) in at least 2 contiguous leads, OR 3. Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR 4. History of coronary artery disease with documentation of one of the following: *prior angiography (coronary stenosis of >50%); *prior PCI or Coronary Artery Bypass Grafting (CABG); *prior definite, documented myocardial infarction. 4. Provide written informed consent before initiation of any study related procedures Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization. 2. ST segment elevation of >1 mm in 2 contiguous ECG leads lasting for >30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy. 3. Cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump). 4. Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks. 5. Platelet count <100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia 6. Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is < 1.5 times control. 7. Allergy to pork or pork products. 8. Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled. 9. Patients who have been started on bivalirudin in the 6 hours prior to randomization 10. Thrombolytic therapy or abciximab use within the last 24 hours. 11. Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued. 12. Patients on Arixtra (fondaparinux). 13. Absolute contraindication or allergy to any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin both abciximab and eptifibatide both eptifibatide and tirofiban iodinated contrast which cannot be pre-medicated 14. Contraindications to angiography, including but not limited to severe peripheral vascular disease. 15. Angina from secondary causes. 16. Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment. 17. Calculated serum creatinine clearance < 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x [Creatinine in mg/dL]). For women, multiply by 0.85. 18. Previous enrollment in this study. 19. Patients currently enrolled in another investigational drug study that has not completed the follow-up phase | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 55.0-999.0, Cardiovascular Disease Myocardial Infarction Stroke Cancer Women and men 55 years of age or over with established CVD and at high risk for future fatal and nonfatal CV events, defined as: 1. Documented coronary artery disease (CAD); 2. Documented peripheral vascular disease (PVD); 3. Documented cerebrovascular disease; 4. Diabetes with one of the following; additional cardiovascular risk factors: i) hypertension (BP >160 mmHg systolic or >90 mmHg diastolic or on treatment); ii) total cholesterol >5.2 mmol/L (>200 mg/dl); iii) HDL cholesterol <0.9 mmol/L (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease Provision of informed consent Current use of any vitamin supplements containing folic acid >200 micrograms/day. The patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree, they can be randomized to the study following a one month wash-out period Known previous adverse reactions to folic acid and/or vitamin B6 and/or B12 Planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months Hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve) Constrictive pericarditis Complex congenital heart disease Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not criteria Uncontrolled hypertension Cor pulmonale Heart transplant recipient | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-79.0, Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis The subject must be > 18 and < 80 years of age. 2. Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure. 3. Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack [(TIA);(hemispheric or ocular)] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status. 4. Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure. 5. The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB). 6. The subject must agree to return for all required follow-up visits. 7. Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved. 8. Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis. 9. Target ICA vessel diameter must be visually estimated to be: > 2.5 mm and < 7.0 for the Emboshield Pro or for the Emboshield NAV6, > 2.8 mm and < 6.2 for the Emboshield Gen 3 And > 4.0 mm and < 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate. 10. Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.). 11. De novo target lesion that can be treated with a single stent Each potential subject must be screened to ensure that they do not meet any of the following This screening is to be based on known medical history and data available at the time of determination and enrollment. 1. Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon. 2. Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure. 3. Subject has inability to understand and cooperate with study procedures or provide informed consent. 4. Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure. 5. Subject has dementia or has a neurological illness that may confound the neurological evaluation. 6. Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications. 7. Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine. 8. Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count <100,000/mm3 or >500,000/mm3, or known heparin associated thrombocytopenia. 9. Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions. 10. Subject has had a GI bleed that would interfere with antiplatelet therapy. 11. Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated). 12. Subject has had an myocardial infarction (MI) within the previous 30 days. 13. Subject has any condition that limits their anticipated survival to less than 3 years. 14. Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions: 1. Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization. 2. Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher. 3. Unstable angina, defined as angina at rest with ECG changes. 4. On a list for major organ transplant or is being evaluated for such. 5. Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted). 6. Chronic renal insufficiency (serum creatinine >2.5 mg/dL). 7. Uncontrolled diabetes defined as fasting glucose > 400 mg/dL. 8. Concurrent requirement for any invasive procedure 30 days pre or post-procedure. 9. Age ≥ 80 years. 15. Subject may be considered a non-surgical candidate for CEA as a result of one or more anatomic conditions or features which preclude normal surgical access or a high surgical risk because of the presence of any one or more anatomic conditions that present an increased potential for adverse events. These subjects are not eligible for enrollment. 1. Subject has had radiation treatment to the neck. 2. Subject has had a radical neck dissection. 3. Surgically inaccessible lesions (i.e., lesions extending above the level of C2). 4. Spinal immobility inability to flex neck beyond neutral or kyphotic deformity. 5. Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel. 6. Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle. 7. Presence of tracheostomy stoma. 8. Contralateral laryngeal nerve paralysis. 9. Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis. 10. Severe hypertension (defined as blood pressure > Systolic of 180 mm Hg and/or a diastolic of 110 mm Hg) not adequately controlled by anti-hypertensive therapy at the time of study entry. 16. Severe vascular disease including tortuosity and/or occlusive disease that would preclude the safe introduction of a guiding catheter/sheath, cerebral protection device, balloon catheter, stent delivery system or stent placement. Severe tortuosity is defined as 2 or more >90 degree bend points within 3cm of the target stenosis. One of these bends will be considered to be present if the ICA branches from the CCA at a 90 degree angle. This includes aortic arch anatomy that is unacceptable for carotid stent placement. 17. Intraluminal filling defect thought to represent thrombus. 18. Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque. 19. Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery. 20. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement. 21. Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off. 22. Presence of a previously placed intravascular stent in the ipsilateral carotid distribution. 23. Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature. 24. Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Stroke, Acute Eligible for study treatment within 3-9 hours after onset of stroke symptoms Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke. from diagnostic imaging screening Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm Rapidly improving neurological symptoms Pre-stroke MRS score of > 1 (including previous disability) Suspected acute vertebral or basilar artery occlusion Current use of anticoagulants and a prolonged prothrombin time Uncontrolled hypertension Baseline hematocrit of < 0.25 Baseline platelet count < 100,000/mm3 | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Mellitus Type 2 Diabetes Mellitus, Type 1 Primary Care Provider Current prescription of insulin or an oral hypoglycemic agent A1c > 7.0% fasting glucose levels > 130 mg/dl referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included A Primary Care Provider for a Cleveland CBOC primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months) documented dementia, aphasia, and psychosis | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 35.0-85.0, Peripheral Vascular Diseases Cardiovascular Diseases Intermittent claudication with objective evidence of PVD (e.g. ankle-brachial index [ABI] < 0.90) Ischemic rest pain of the lower limbs Ischemic non-healing ulcers or focal gangrene Amputation for vascular causes Previous peripheral vascular revascularization (angioplasty or bypass surgery) Blue toe syndrome Other significant peripheral arterial disease (e.g. carotid stenosis) Vascular disease and evidence of asymptomatic peripheral arterial disease [PAD] (i.e. ABI < 0.90) Temporary Potential subjects will be temporarily excluded if they need to undergo vascular diagnostic (angiography) or interventional procedures (arterial bypass graft surgery or angioplasty); or limb amputation for vascular insufficiency. Permanent Subjects will be excluded for the following active bleeding or high risk bleeding clear indication for long-term warfarin use (i.e. atrial fibrillation) previous allergy or intolerance to warfarin stroke in the last 6 months renal failure requiring dialysis | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Stroke Stenosis Age at least 18 years Presence of symptoms of an ischemic stroke with a baseline National Institutes of Health Stroke Scale (NIHSS) scale of one up to 20 or due to an ipsilateral atherosclerotic >50% stenosis of the extracranial internal carotid artery (ICA) as shown by ultrasonography Latency between the onset of stroke symptoms and intended administration of the study drugs is not more than 24 hours Latency between the intended administration of the study drugs and intended carotid endarterectomy is at least three days Documented peptic ulcer disease within the preceding 30 days Septicemia or severe localized infection Severe illness (active cancer or significant liver or renal disease) or disability Alcohol or illicit drug abuse Pregnancy Need for chronic anticoagulant therapy (e.g. atrial fibrillation, deep venous thrombosis) Need for long-term daily nonsteroidal antiinflammatory drugs Contraindications for platelet therapy such as severe bleeding disorder within the past three months prior to randomization (coagulopathy, platelet disorder including history of heparin-induced thrombopenia, hemorrhage) or significant retinopathy with hemorrhages and exudates Hypersensitivity to abciximab, murine monoclonal antibodies or aspirin Any preexisting intracranial neurological disease such as tumor or multiple sclerosis | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Aneurysmal Subarachnoid Hemorrhage Adult patients (>= 18 years) Aneurysmal subarachnoid hemorrhage Uncontrolled systemic hypertension (systolic blood pressure > 220 mmHg) Erythrocytosis vera Concurrent erythropoietin therapy Negative angiography Subarachnoid hemorrhage more than 7 days | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-95.0, COPD Subject is able to ambulate. Defined as a 6MWD greater than 110 meters Subject is diagnosed with COPD years-old and older Currently or previously smoking with a smoking history of at least 10 pack-years Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70% No previous diagnosis of asthma, left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction), terminal disease, dementia or uncontrolled psychiatric illness Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long term care facility Subject understands and is able to read and write French or English MRC dyspnea scale of at least 2 The need for supplemental oxygen at rest or during exercise will not be an criterion | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Stenosis To participate in this study, the subject MUST have all of the following for in the study: • The subject (male or non-pregnant female) must be > 18 years of age. • The subject should have a stenosis in the common or internal carotid artery of at least 70% determined by one of the modalities listed below. • The subject should be considered a relatively high risk for carotid endarterectomy. This determination has to be made and documented by two physicians, at least one of who must be a vascular surgeon acting as an investigator on this trial. High risk considerations should at least one of the following: 1. Cardiac dysfunction. NYHA class III or above, compensated or active congestive heart failure (CHF), incomplete coronary revascularization, ejection fraction of <35%, pulmonary hypertension, or recommendation of a cardiologist against open CEA. 2. Pulmonary dysfunction, history of respiratory failure, severe chronic obstructive pulmonary Disease (COPD) on bronchodilators or recommendation of a pulmonary specialist against open CEA. 3. Multi-system dysfunction, defined as any combination of medical problems in three distinct systems. 4. Anatomic issues: previous CEA or neck dissection, neck irradiation, inaccessible lesions, neck fusion or other anatomic considerations increasing the risk of CEA. 5. Age >80 AND symptomatic (defined below) 6. General debilitation documented by the subject's primary physician. 7. Increased anesthetic risk as documented by an anesthesiologist Subjects can be either clinically symptomatic or asymptomatic (less than 80 years of age). Symptomatic subjects will have experienced an event within the previous 120 days in the ipsilateral carotid artery distribution. The event will be classified as either 1) one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or 2) one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event). **Patients with major non-hemorrhagic strokes will be included if their clinical status has been stable for 5 days (based on an exam performed by a neurologist participating as a Co-Investigator in this trial) If an angiogram is performed to qualify the subject, it should be as recent as feasible and will not be acceptable if done > 120 days from study entry. Angiograms from other institutions will be acceptable Other non-invasive qualifying imaging modalities 1. Duplex ultrasound (DU) performed at UPMC Presbyterian or Shadyside hospitals. 2. Magnetic Resonance Angiography (MRA) performed at UPMC Presbyterian or Shadyside hospitals. 3. Computed Tomographic Angiography (CTA) performed at UPMC Presbyterian or Shadyside hospitals The degree of stenosis from these non-invasive studies has to be confirmed on the pre-deployment diagnostic angiography prior to proceeding with stent deployment However, if two of the non-invasive studies listed above report a stenosis of >70%, AND the pre-deployment angiogram reveals a 50 -70% stenosis, the patient will be randomized and entered into the trial as the angiogram can on occasion underestimate the stenosis Female subjects of childbearing potential must have a documented negative pregnancy test during the index hospitalization The subject must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board or Medical Ethics Committee If a patient's creatinine is 3.5 or greater, their nephrologist must clear them to participate in the trial To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study The subject has had an intracranial hemorrhage, hemorrhagic stroke, or any stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure The subject has a persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry) The subject has an intracranial mass lesion (i.e., abscess, tumor, or other infection) The subject has known allergies to heparin, to both ticlopidine and clopidogrel or to metals used in stents There is any visual angiographic evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization The subject has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful results The subject, if female, has a positive pregnancy test The subject has an arterio-venous malformation in the territory of the target carotid artery Subjects with highly calcified lesions resistant to predilation by PTA | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Stenosis Subjects will be eligible if the following are met Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >18 years Diagnosis of >75% asymptomatic carotid artery stenosis by ultrasound or angiographic evaluation No contraindication to Abciximab or anticoagulation Ability to insonate an adequate window for Transcranial Doppler Imaging pre-operatively In women of childbearing capacity a negative pregnancy test Signed authorization of release of protected health care information Inability to insonate an ipsilateral window; bilateral monitoring will be performed when possible CT or MRI positive CVA within past 12 weeks Active internal bleeding Recent within six weeks gastrointestinal or genitourinary bleeding of clinical significance Bleeding diathesis Administration of oral anti-coagulants within seven days unless prothrombin time is less than or equal to 1.2 times control History of CVA within two years or CVA with a significant residual neurological deficit Thrombocytopenia (<100,000 cells/uL) Recent (within six weeks) major surgery or trauma Intracranial neoplasm, AVM, or aneurysm Severe uncontrolled hypertension | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Atherosclerosis Carotid Artery Disease Patient age >=18. 2. Symptomatic patient: Transient ischemic attack (TIA), amaurosis fugax, or minor/non-disabling stroke (in the hemisphere supplied by the target vessel) within 180 days of enrollment; asymptomatic patient: meets angiographic and clinical criteria. 3. Patient has no childbearing potential or a negative pregnancy test within 30 days of study procedure. 4. Patient or legally authorized representative, and the patient's physician, agree to have the patient return for all required clinical contacts following study enrollment. 5. Patient or legally authorized representative has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. (Sample consent Appendix A-2). 6. Patient must meet two or more of the listed in a-e OR one or more of the listed in f-q below: 1. Knowledge of two or more proximal or major diseased coronary arteries with >=70% stenosis that have not, or cannot be revascularized; 2. Unstable angina defined as rest angina with ECG changes; 3. MI within the previous 30 days and current need for carotid artery revascularization 4. Concurrent requirement for aortocoronary bypass or cardiac valve surgery within 30 days; 5. Contralateral occlusion of the ICA; 6. Currently on a list for major organ transplantation (i.e. heart, lung, liver, kidney) or is being evaluated for such; 7. Ejection fraction <30% or New York Heart Association (NYHA) Functional Class III or higher; 8. FEV1 <30% (Predicted); 9. Dialysis-dependent renal failure; 10. Uncontrolled diabetes defined as fasting glucose >400 mg/dl and ketones >2+; 11. Restenosis after previous CEA (defined as >=50% by angiography for symptomatic patients or >=80% by angiography for asymptomatic patients); 12. Patient is status/post radiation treatment to the neck; 13. Patient is status/post radical neck surgery; 14. Surgically inaccessible lesions (e.g. lesions above the level of C2 or below the clavicle, lesions obstructed by tumors in the neck); 15. Spinal immobility inability to flex neck beyond neutral or kyphotic deformity; 16. Presence of tracheostomy stoma; 17. Contralateral laryngeal nerve paralysis. Anatomic NOTE: Angiographic measurements must be made utilizing either on-line quantitative carotid angiography (QCA) or electronic calipers with magnification correction. 1. Patient has a discrete lesion located in the ICA (with or without involvement of the contiguous CCA). 2. Carotid stenosis must be >= 50% by angiography (symptomatic patient) or >= 80% by angiography (asymptomatic patient). 3. Target ICA vessel reference diameter must be >=4.0 mm and =<9.0 mm by angiography. NOTE: Patients with bilateral carotid stenosis are eligible. Management of the non-study stenosis may be done in accordance with local Principal Investigator recommendation. Treatment of the non-study artery must take place either >30 days before or >30 days after the study procedure is completed. Specific for the System 4. Expected ability to deliver the System distal to the lesion (absence of excessive tortuosity) and an available straight or mildly angulated segment >= 4 cm, by angiography, in the distal ICA (prior to the petrous portion of the vessel) in which to place the embolic protection device. 5. The diameter of the straight or mildly angulated segment, in the distal ICA prior to the petrous portion of the vessel, must be >= 3.25 mm and =< 7.5 mm by angiography Candidates will be ineligible for enrollment in the study if any one of the following conditions apply: 1. Patient has an evolving stroke. 2. Patient has history of intolerance or allergic reaction to any of the study medications or materials, including heparin, aspirin, baby aspirin, nitinol, or x-ray contrast. 3. Patient has history of intolerance or allergic reaction to both ticlopidine and clopidogrel. 4. Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusions. 5. Patient has a history of major ipsilateral stroke likely to confound study endpoints. 6. Patient has severe dementia. 7. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months. 8. Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure. 9. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days. 10. Patient has Hgb < 8 gm/dl (unless on dialysis), platelet count < 50,000, uncorrected INR > 1.5, or heparin-associated thrombocytopenia. 11. Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g. morbid obesity, sustained SBP > 180 mm Hg.). 12. Patient has had neurologic illness within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures; complicated or classic migraine; tumor or other space-occupying brain lesions; subdural hematoma, cerebral contusion or other post-traumatic lesions; intracranial infection; demyelinating disease; moderate to severe dementia; or intracranial hemorrhage). 13. Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period. Patients may be enrolled only once in the ARCHeR clinical trial and may not participate in any other clinical trial during the ARCHeR follow-up period. 14. Patient or patient's legally authorized representative is unable to understand and cooperate with study procedures or provide informed consent. 15. Patient has a life expectancy less than two years. 16. Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the targeted carotid artery 17. Knowledge of cardiac sources of emboli (e.g. left ventricular aneurysm, atrial fibrillation, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, cardioversion of atrial fibrillation within 30 days prior to intervention, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect (ASD), atrial septal aneurysm, or left atrial myxoma). 18. Patient has had a recent GI bleed that would interfere with antiplatelet therapy. Anatomic Exclusions 1. Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, guide sheath, embolic protection system, or stent system. 2. Presence of previously placed intravascular stent or intravascular graft in the ipsilateral distribution. (Patch grafts are not an criterion.) 3. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch and proximal common carotid artery that would preclude the safe introduction of a guide catheter or guide sheath. 4. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion 5. Other abnormal angiographic findings such as: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm >= 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, AV fistula, or other confounding intracranial lesion. 6. Bilateral carotid stenosis if the intervention is planned within the 30-day ARCHeR periprocedure period. 7. Occlusion [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] or "string sign" >1 cm of the ipsilateral common or internal carotid artery | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Mellitus type 2 diabetic patients in women> 60 yo or men > 55 yo, with high risk of coronary artery disease (EF < 40%, ECG abnormalities, renal failure , 2 others risk factors of atherosclerosis) previous documented CAD acute coronary syndrome | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-18.0, Multivessel Pulmonary Vein Stenosis Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins Must give written informed consent according to institutional guidelines Mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-999.0, Breast Cancer Lung Cancer age ≥ 65 years breast or lung cancer patients to receive docetaxel therapy as per protocol corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events performance status ECOG 0-2 peripheral neuropathy ≤ 1 adequate kidney and liver functions signed study-specific informed consent Patients who have received an investigational drug within 4 weeks of registration Prior or concurrent malignancies (other than surgically treated carcinoma in situ Serious medical or psychiatric illness which would prevent informed consent Life expectancy < 3 months Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 55.0-999.0, Atherosclerosis Cardiovascular Disease Criteria:Women and Men aged ≥ 55 years at high risk for CV events with: (a) Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v) Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i) Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2) Provision of informed consent.(3) Adequate baseline carotid US examination Current use of folic acid supplements > 200 mg/day. 2. Known previous adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or cerebrovascular. - | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Carotid Artery Disease The patient must be > 18 years of age. 2. The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis >50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a >80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms. 3. To be entered into the study, the patient must have one or more of the following conditions: · congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30% open heart surgery within six weeks recent MI (>24 hours and <4 weeks) unstable angina (CCS class III/IV) synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization severe pulmonary disease to any of the following: 1. chronic oxygen therapy 2. resting PO2 of 60 mmHg 3. baseline hematocrit 50% 4. FEV1 or DLCO 50% of normal. · contralateral carotid occlusion · contralateral laryngeal palsy · post-radiation treatment · previous CEA recurrent stenosis · high cervical ICA lesions · CCA lesions below the clavicle · severe tandem lesions abnormal stress test. 4. The qualifying ultrasound or angiogram was performed less than 30 days prior to study entry. · Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec · Stenosis >80%: PSV>220 cm/sec; EDV <135 cm/sec · PSV ICA/PSV CCA ratio 4.0 5. The target vessel is in the native common or internal carotid artery. The arterial segment to be treated has a diameter between 4 mm and 9 mm as the largest diameter either proximal or distal to the lesion The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours. 2. There is any visual angiographic or ultrasound evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization. 3. There is total occlusion of the target carotid artery treatment site. 4. The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel cannot be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm. 5. The patient has any intracranial aneurysm (> 9 mm) | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-80.0, Cardiovascular Diseases Heart Diseases Coronary Disease Diabetes Mellitus Atherosclerosis Cerebral Arteriosclerosis Hypertension Currently receiving medical care at Johns Hopkins University African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years A serious physician-recorded psychiatric morbidity that would interfere with the study Sufficient neurological impairment that would interfere with the study | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Stroke Coronary Artery Disease Arrhythmia Coronary artery stenosis >50% and either carotid or brain artery stenosis > 50% Creatinine > 2.0 mg/dL Co-morbidity A letter of authorization is not given | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-21.0, Congenital Disorders patients who received RFA for treatment of EAT between August 2992 and August 2003 Treatment at Children's Healthcare of Atlanta those who do not meet | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Disease >18 years of age Patient must be: Symptomatic with lesions >/= to 50% stenosis, or Asymptomatic with lesions of >/= to 75% stenosis in at least one carotid artery, specific to the internal carotid artery, common carotid artery or bifurcated region; documented through acceptable ultrasound studies, completed within 30 days of recruitment For patients with bilateral carotid disease procedures need to be staged greater than 30 days apart. The lesion that has a greater degree of stenosis will be considered as the index procedure Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment The patient is able to give informed consent The patient is experiencing a new (acute) neurologic event or has experienced a stroke within the last 30 days prior to enrollment The patient has intracranial tumors, arterial vascular malformations >5mm, aneurysms or severe intracranial stenosis distal to the target lesion Presence of thrombus at the target site or loose 'floating' debris as determined by duplex analysis and/or angiography Existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site The patient has an allergy to, or is unable to tolerate, heparin, concomitant medications (clopidogrel or ticlid, aspirin) or to nitinol metal The patient has a history of or known reaction to radiocontrast agent (radiopaque dye) and is unable to be premedicated Coumadin treatment that has continued during the 48 hours prior to enrollment and an INR above hospital normals (i.e. in the event of atrial fibrillation or prosthetic valve replacement) Hemodynamic instability at the time of intervention Severe chronic renal insufficiency (plasma/ serum creatinine> 2.5 mg/dL) at the time of intervention, except in patients on dialysis | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis Subjects who agree to participate in this study and have signed the IRB approved informed consent form Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature There are no for this study | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Carotid Artery Diseases Stroke Cerebral Arteriosclerosis Key General Patient must meet for either A or B: A. Symptomatic: Carotid stenosis of greater than or equal to 50% via angiography with associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure, which are determined to have occurred in the cerebral hemisphere or eye ipsilateral to the target carotid artery lesion and to be reasonably attributable to that lesion; or B. Asymptomatic: Carotid stenosis greater than or equal to 80% via angiography without associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure Target lesion is in the native common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation Target arterial segment to be stented has a diameter of greater than or equal to 4.0 mm to less than or equal to 9.0 mm Vessel diameter distal to the target lesion is greater than or equal to 3.5 mm and less than or equal to 5.5 mm as an optimal "landing zone" for placement of the FilterWire EZ System with visual angiographic recommendations as described in the instructions for use (IFU). Key High-Risk Patients must qualify in at least one high-risk category. The high-risk categories are defined as Anatomical conditions [one (1) criterion qualifies] Co-morbid conditions Class I [one (1) criterion qualifies] Co-morbid conditions Class II [two (2) qualify] Patient has experienced an evolving, acute, or recent stroke within 21 days of study evaluation A total occlusion of the ipsilateral carotid artery. (Only for Roll-In and Pivotal patients.) A total occlusion of the contralateral carotid artery. (Only for Bilateral Registry patients.) Pre-existing stent(s) Roll-In and Pivotal Patients: located within the ipsilateral carotid distribution; a stent was placed in a contralateral vessel within the previous 30 days of the study enrollment Bilateral Registry Patients: located within the carotid distribution A target lesion which is expected to require more than one stent Known cardiac sources of emboli of a type likely to be associated with cerebral ischemic events [e.g. endocarditis, intracardiac thrombus, embolic-associated cardiovascular lesions, or any current arrhythmia (e.g. atrial fibrillation, atrial flutter, etc.)] Myocardial infarction (MI) within 72 hours prior to the index procedure, defined as creatine kinase (CK)-MB > 2 X the local laboratory's upper limit of normal (ULN) Any surgery requiring general anesthesia (e.g. coronary artery bypass graft [CABG], valve replacement, or abdominal aortic aneurysm) less than or equal to 30 days preceding the stent procedure | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Cardiomyopathy Heart Failure, Congestive Thoracic Surgery Age > 18 years Planned CABG and/or valve surgery LVEF < 30% Able to give written informed consent Enrollment in other research protocols Inability to give written informed consent Pregnancy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-999.0, Cataract Eyes with significant cataract and suitable for phacoemulsification and primary implantation of posterior chamber intraocular lens. 2. Cataract as the only ophthalmic pathology causing significant visual impairment. 3. Axial length less than 22mm or more than 25mm, as measured by Zeiss IOL Master. 4. Evidence of a personally signed and dated informed consent document indicating the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 5. Patient is willing and able to comply with scheduled visits and other study procedures Presence of other ophthalmic pathology causing visual impairment: amblyopia, glaucoma, optic neuropathy, age related macular degeneration, macular oedema, retinal detachment, proliferative diabetic retinopathy, ocular inflammation. 2. Previous intraocular or corneal surgery (including refractive surgery). 3. Corneal opacities or irregularities: previous scarring, dystrophy, ectasia 4. Corneal astigmatism greater than 1.5 dioptres. 5. Axial length unable to be measured by the Zeiss IOL master. 6. Other ocular surgery at time of cataract extraction. 7. Uncontrolled diabetes. 8. Any neurological condition which may interfere with performance of required tests. 9. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Surgical The patient will not be included in the study if any of the following complications are encountered during surgery: 1. Inability to achieve secure 'in-the-bag' placement of the IOL (i.e. due to posterior capsule rupture, radial tear in capsulorhexis, vitreous loss, zonular rupture) 2. Use of corneal sutures. 3. Multiple operative procedures at the time of IOL implantation. Post-implantation Haptic not in the capsular bag. 5. Decentration of the IOL of more than 1.0mm. 6. Other ocular pathology causing visual impairment that were not apparent prior to surgery (e.g. age related macular degeneration, macular oedema, glaucoma, retinal detachment) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Disease Myocardial Infarction Cerebrovascular Stroke adults ≥ 18 years able to give informed consent patients prepared to undergo long-term follow-up patients with and without significant coronary artery disease (CAD) who have undergone coronary angiography just before patients who are not available for follow-up patients who have previously participated in this study patients with known alcohol abuse or serious mental illness patients with known active malignant disease patients who have undergone coronary angiography for specific reasons, i.e. assessment for cardiac transplantation, kidney donor, heart donor, diagnostic assessment of cardiomyopathy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Low Back Pain Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months. - Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Low Back Pain Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting low back pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Low Back Pain At least 18 years of age History of chronic, function-limiting low back pain of at least 6 months duration Able to give voluntary, written informed consent to participate Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up No recent surgical procedures within last three months Cauda Equina symptoms and/or compressive radiculopathy Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine Uncontrolled major Depression or uncontrolled psychiatric disorder Uncontrolled or acute medical illnesses Chronic severe conditions that could interfere with outcome assessments Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis Inability to achieve proper positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Peripheral Vascular Diseases Hemodynamically significant PAD, as documented by an ankle-brachial index less than 0.9; control group participants will not have PAD Received a referral for an elective coronary angiogram Suspected CAD History of radiation treatment History of organ transplant History of viral diseases (i.e. HIV, hepatitis) | 2 |
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