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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): 18.0-999.0, Melanoma Brain Metastases Subjects must have provided written Informed Consent prior to any study procedure Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are scheduled for craniotomy Histologically confirmed, primary cutaneous melanoma, metastatic to the CNS (brain OR spinal cord OR carcinomatous meningitis) based on Pathologic confirmation (i.e. prior craniotomy) OR Radiography (brain MRI or CT scan with intravenous contrast) Patients must have no contraindications for lumbar puncture for CSF collection Hemoglobin level of 8g/dL or higher within the prior 30 days FFPE tissue block containing a biopsy from the primary site available for retrieval Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are not having a craniotomy and before they undergo external beam irradiation or stereotactic radiosurgery (patient's and/or neurosurgeon's preference) Histologically confirmed melanoma (unknown primary, mucosal, ocular are allowed), metastatic to the CNS (brain OR spinal cord OR carcinomatous meningitis) based on For study subjects, patients with extradural lesions, i.e. those that originate from the bone (calvarium or vertebrae), will not be considered Any significant psychiatric disease, medical intervention, or other conditions, which in the opinion of the Investigators, could impair proper discussion of the informed consent or compromise participation to the clinical trial Active systemic treatment for metastatic melanoma within 2 days from the collection of specimens (brain tumor tissue, peripheral blood, CSF). Corticosteroids, other immunosuppressive anti-inflammatory and anti-epileptic medications are allowed Patients who have undergone whole brain irradiation therapy within the last 30 days. Therefore neither CNS lesions nor CSF are considered suitable for collection Patients with growing CNS lesions at an area that has previously undergone radiosurgery within 3 months prior to enrollment in this study. Therefore CNS tumors from previously irradiated areas using radiosurgery are not considered suitable for collection although CSF is allowed for collection Brain abscess Other conditions that at the opinion of the investigator are contraindicated | 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, Leptomeningeal Metastasis Patient must have a previously diagnosed solid tumor malignancy originating from a visceral organ (i.e., outside of the CNS), and present with signs and/or symptoms consistent with carcinomatous meningitis (headache, vision dysfunction, hearing loss, cranial nerve deficit, cognitive dysfunction, focal weakness or numbness suggestive of cranial neuropathy or radiculopathy, cauda equine syndrome, meningismus, and/or bowel or bladder dysfunction). 2. Age ≥ 18 years. 3. Patients will meet accepted standard of care and follow FDA guidance for low molecular weight heparin use prior to lumbar puncture, specifically INR < 1.4 and PT within normal range for DHMC laboratory, and platelet count >50,000. For enoxaparin use, delay of Lumbar puncture to allow at least 12 hours after administration of prophylactic doses, such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily). A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after lumbar puncture. Aspirin and other antiplatelet therapy is permitted without timing constraints prior to or after lumbar puncture. 4. Patient must consent to provide up to additional CSF (10 mL) and blood (10 mL) when these fluids are drawn as part of clinically indicated procedures. 5. Patient must consent to permit genetic analysis of their cancer. 6. Patient capable of giving informed consent. 7. MRI of clinically symptomatic area (spine and/or brain) and/or head CT within the last 3 months to brain disease that would contraindicate lumbar puncture Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated. 2. Previous or current hematological malignancy. 3. Previous or current primary CNS malignancy. 4. Prior treatment for CNS metastasis. 5. Known CNS autoimmune or inflammatory disease (i.e., Multiple Sclerosis, neurosarcoidosis, chronic fungal, rickettsial or bacterial meningitis). 6. Patient is currently receiving treatment for LM. 7. Patient was previously diagnosed with LM | 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, Re-entrant Atrioventricular Node Tachycardia Age > 18 and <80 years 2. History of symptomatic PSVT 3. Signed informed consent 4. Documented AVNRT during EPS with at least 1 of the following Previous unsuccessful right-sided ablation attempt Ideal SP electrogram at XR < 10 mm in RAO 30° Right-sided ablation attempt with VA block during JB or A minimum of 7 unsuccessful RF energy deliveries, with no upper limit (to the 1st operator's discretion) Previous CVA Severe mitral or aortic valve disease Documented intra-cardiac thrombus | 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): 18.0-45.0, Lateral Epicondylitis Individuals who meet all of the following are eligible for enrollment into the study Adult between 18-45 years of age Pain over the lateral humeral epicondyle provoked by at least two of the following: gripping, palpation, stretching of forearm extensor muscles and resisted wrist or middle finger extension Persistent pain for at least 3 months despite conservative treatments including medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace application, or physiotherapy Patients with structural tendon changes at the origin of the extensors, demonstrated during musculoskeletal ultrasound Individuals who meet any of the following are disqualified from enrollment of the study Patients with a history of advanced cervical arthrosis in the C4-C6 segments Bilateral LE with central sensitization Symptoms compatible with posterior interosseous nerve entrapment Previous surgery, fractures, trauma or previous history of rheumatic disorders in the area of the lateral epicondyle History of corticosteroid injection at the lateral epicondyle within the last 3 months Two experienced professionals performed recruitment and examination of subjects in order to assess for criteria. All eligible patients provided written informed consent | 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, Acute Cholecystitis years of age or older Symptoms of right upper quadrant pain with ambiguous US (and/or CT) findings Standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis - Scheduled for emergent surgery, or is otherwise determined by the Investigator that the subject is clinically unsuitable for the study Glomerular filtration rate (GFR) below 60 mL/min/1.73m2 Total bilirubin above 3.0 mg/dL Inability to provide informed consent (altered or diminished mental status) Allergic to morphine Known or suspected hypersensitivity to gadolinium-based agents The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), penile implants, inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments Pregnant or breast-feeding - | 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 Chronic Lymphocytic Leukemia (CLL) Patients must have histologically or flow cytometry confirmed diagnosis of B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL) according to the IWCLL 2008 criteria. The malignant B cells must co-express CD5 with CD19 or CD20. Patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma. 2. Active disease meeting at least 1 of the following IWCLL 2008 for requiring treatment A minimum of any one of the following constitutional symptoms: Unintentional weight loss >10% within the previous 6 months prior to screening Extreme fatigue (unable to work or perform usual activities) Fevers of greater than 100.5ᵒF for ≥2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia Massive (i.e., >6 cm below the left costal margin), progressive or symptomatic splenomegaly Massive nodes or clusters (i.e., >10 cm in longest diameter) or progressive lymphadenopathy Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids 3. Patients with relapsed/refractory CLL defined as having received ≥2 treatment regimens that included A treatment regimen containing cytotoxic agents (eg, fludarabine, pentostatin, cladribine, cyclophosphamide, chlorambucil, bendamustine) AND A treatment regimen containing a therapeutic anti-CD20 antibody (e.g., rituximab, ofatumumab, obinutuzumab) AND A treatment regimen containing ibrutinib unless patient is not a candidate Recent therapeutic intervention including a) prior nitrosoureas or mitomycin C; prior radio or toxin-immunoconjugates within 6 weeks; b) therapeutic anticancer antibodies (including rituximab, ofatumumab and obinituzumab) within 4 weeks; and c) all other chemotherapy or radiation therapy within 2 weeks prior to initiation of study drug 2. The patient has not recovered from adverse events related to prior therapy to Grade ≤1 (excluding Grade 2 alopecia and neuropathy) 3. Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent 4. Patients who have been in the past enrolled on a study of a Cdk inhibitor 5. History of prior malignancy except: a) Malignancy treated with curative intent and no known active disease present for ≥2 years prior to initiation of current study; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated in situ carcinomas (e.g., cervical, esophageal, breast, etc.) without evidence of disease; d) asymptomatic prostate cancer managed with "watch and wait" strategy; e) myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening 6. Patients with uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis is not an exclusion) 7. Patients with known Richter's transformation which is progressive and is deemed to require immediate chemotherapy (history of Richter's transformation is not an exclusion); patients with prolymphocytic leukemia (prolymphocytes in blood >55%) 8. Patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with the absorption of study drugs 9. Patients with mean QTc interval >450 msec at screening and patients taking drugs known to prolong the QTc interval (see Section 9, Appendix D) who cannot be switched to an alternative drug 10. Nursing woman 11. Known history of Human Immunodeficiency Virus (HIV) or active Hepatitis B or C. Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and Hepatitis B DNA monitored periodically by the treating physician. 12. Any condition for which participation in the study is judged by the Investigator to be detrimental to the patient with inter-current illness including, but not limited to an uncontrolled active infection; unstable angina pectoris; uncontrolled cardiac arrhythmia; transient ischemic attack or pulmonary embolism during the previous 1 month or psychiatric/social situations that would jeopardize compliance with study requirements | 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): 80.0-999.0, Diffuse Large B Cell Lymphoma Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all age-adjusted International Prognostic Index (aaIPI). May also be included: De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell Infiltration in bone marrow or lymph node; or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma; or CD20+ Follicular lymphoma grade 3B (according to WHO classification); or CD20+ Aggressive B-cell lymphoma unclassifiable With a Cluster of Differentiation antigen 10 (CD10) immunostaining performed by the participating center pathologist Aged ≥ 80 years old Ann Arbor stage II, III or IV Patient previously untreated for DLBCL Lymphoma Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV serologies test within 4 weeks before (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative) Patient able to give his consent and having signed a written Informed consent Patient affiliated to social security system, if applicable Any other histological type of lymphoma, Burkitt included Any history of treated or non-treated small-B cell lymphoma Central nervous system or meningeal involvement by lymphoma Contra-indication to any drug contained in the chemotherapy regimens ; for anthracycline use, ejection fraction should be > 50% Any serious active disease (according to the investigator's decision) History of deep venous thrombosis or arterial thromboembolism events within the past 12 months before Poor renal function (creatinine clearance < 40 ml/min, according to Modification of Diet in Renal Disease (MDRD) formula) Poor hepatic function (total bilirubin level >30mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy | 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, Acute Cholecystitis Proved acute cholecystitis clinical, radiologic Evidence of peritonitis ASA III or IV Previous upper abdominal surgery 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): 20.0-75.0, Gallstones Cholecystitis Polyps Symptomatic gallstones Gallstones>3cm in diameter Fulfilled gallstones Acute or chronic cholecystitis Acalculous cholecystitis Gallbladder polyps >10mm in diameter Symptomatic gallbladder polyps Gallbladder stones associated with polyps Porcelain gallbladder Gallstone pancreatitis Suspicion of gallbladder cancer General condition is poor,inability to tolerate gallbladder cancer Important organ dysfunction Severe abdominal cavity adhesion Bleeding disorders,blood coagulation dysfunction Acute cholangitis with serious complications(gallbladder empyema,gangrene,perforation) Acute cholangitis Pregnancy(first or third trimester) Abdominal dysfunction or peritonitis | 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): 18.0-37.0, Polycystic Ovary Syndrome Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound 2. Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start 3. Subjects will be determined to be normal controls if they have a clinical history of regular periods Women with hemoglobin less than 11 gm/dl at screening evaluation 2. Women with untreated thyroid abnormalities 3. Pregnant women or women who are nursing 4. Women with BMI > 37 5. Women with known sensitivity to the agents being used 6. Women with diabetes, or renal, liver, or heart 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): 18.0-999.0, Kidney Transplantation Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol Age> 18 years Case group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013 patient with uncontrolled hypertension patient with diabetes mellitus - patient treated or who was treated with mTOR inhibitor recurrence of the initial glomerular pathology de novo glomerulopathy patient including in another study with an period still going | 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, B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma B-Cell Prolymphocytic Leukemia High Grade B-Cell Lymphoma, Not Otherwise Specified Post-Transplant Lymphoproliferative Disorder Recurrent Adult Burkitt Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Diffuse Large B-Cell Lymphoma Recurrent Follicular Lymphoma Recurrent Hairy Cell Leukemia Recurrent Lymphoplasmacytic Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma COH pathology review confirms that research participant's diagnostic material is consistent with recurrent/progressive/residual B cell lymphoproliferative neoplasms as listed below AND the research participant is not eligible for or declines COH IRB Protocol No. 13277; additionally, CD19 positivity must be documented in a pathology report if the research participant previously received CD19-targeted therapy; however, it is not a requirement that the CD19 testing be performed by a COH pathologist Disease stratum 1 (NHL): Unclassifiable high grade lymphoma, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma (DLBCL) and all its subtypes, Burkitt lymphoma (BL), marginal zone B-cell lymphoma, hairy cell leukemia, lymphoplasmacytic lymphoma, B cell lymphoma unclassifiable with features intermediate between DLBCL and BL, B cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, and those research participants who either declined or were not eligible for COH IRB Protocol No. 13277, or who collected autologous T cells for COH IRB Protocol No. 13277 but then became ineligible for autologous hematopoietic stem cell transplant (HSCT) or participants who have relapsed following prior T cell therapy on either COH IRB Protocol No. 09174 or 12224 may be enrolled on this study Disease stratum 2 (CLL/PLL/SLL): chronic lymphocytic leukemia (CLL), and B-cell prolymphocytic leukemia (PLL), and small lymphocytic lymphoma (SLL) Karnofsky performance status (KPS) of >= 70% Life expectancy >= 16 weeks at time of screening The effects of CD19R(EQ)28zeta/EGFRt+ TCM or CD19R(EQ)28zeta/EGFRt+ TN/MEM on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately All subjects must have the ability to understand and the willingness to sign a written informed consent Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed COH pathology review confirms that research participant's diagnostic material is consistent with a lymphoproliferative B-cell neoplasm Documentation of recurrence/progression/residual disease following prior therapy Research participants who received memory-enriched CD19R(EQ):CD28:zeta/EGFRt+ on IRB#13277 Research participants with any uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, poorly controlled pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of screening; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated within 2 years with curative intent and in a complete remission are eligible Pregnant and lactating women STUDY-SPECIFIC Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study Research participants with precursor B-cell acute lymphoblastic leukemia/lymphoma or plasma cell dyscrasias Any known contraindications to cyclophosphamide, fludarabine, etoposide, bendamustine, cetuximab or tocilizumab Dependence on corticosteroids | 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, Acute Cholecystitis With Chronic Cholecystitis Symptomatic chronic cholelithiasis patients, who were accepted to laparoscopic cholecystectomy Acute cholelithiasis patients, who were accepted to laparoscopic cholecystectomy in first 72-96 hours (from the onset of symptoms), Acute cholecystitis diagnosis was made according to; acute right upper quadrant abdominal pain with positive Murphy's sign, fever, leukocytosis and sonographically; distended GB, presence of gallstones or sludge, GB wall thickness of 3-mm or more, sonographic Murphy's sign Choledocholithiasis <18 years old | 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): 0.25-999.0, Meningoencephalitis Other Syndromes Requiring Lumbar Puncture in Emergency Department Age > or = 3 months old Receiving a Lumbar Puncture in the emergency department as part of their standard care No CSF 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): 18.0-65.0, Influenza with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained age younger than 18 or older than 65 years old. 2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) . 3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%. 4. Those have got suppurative tonsillitis or cough purulent sputum. 5. Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease（FEV1/FVC<70％，FEV1/ predicated value<50％； or respiratory failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal disease（Serum Creatinine>2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV) 7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more). 9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months. 10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization. 12. Two weeks before the test , those with acute respiratory Infection，otitis,or nasosinusitis . 13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion | 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, IVC Filters Patients will be male and female aged 18 years to 100 years old who were treated with either permanent or retrievable IVC filter placement and were referred to the Interventional Radiology or Vascular Surgery departments for IVC filter retrieval starting December 1, 2011 Patients have failed all other traditional methods/attempts at removal of their IVC filter Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter | 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): 20.0-35.0, Polycystic Ovary Syndrome Women willing to comply with study requirements and have signed an informed consent form. 2. Age 20-35 3. BMI ≥ 35 kg/m² 4. A history of failed IVF treatment cycle/s or resistance to ovulation induction with clomiphene citrate. 5. Documented negative pregnancy test. 6. Women agree to remain on contraceptives as long as the Endobarrier is intact. 7. PCOS as defined by at least two of the following A. Polycystic ovaries. B. Oligo and/or anovulation C. Clinical (i.e acne, hirsutism) and/or biochemical signs of hyperandrogenism (i.e high levels of Testosterone, Androstendione, 17-hydroxyprogesterone, DHEA-S) and of other etiologies (congenital adrenal hyperplasia androgen-secreting tumors, Cushing's syndrome). 8. IGT as defined by: the ratio of fasting glucose to fasting insulin <4.5, and/or 2-hour glucose level after a 75-g oral glucose tolerance test between 140-199 mg/dL. 9. Documented FSH levels below 12 IU/L, from any source taken no longer than 3 months before screening Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization 2. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to the Endobarrier insertion procedure (including GLP-1 analogs). 3. Known Diabetes as defined by: fasting plasma glucose ≥126 mg/dL or any plasma glucose ≥200 mg/dL or HbA1c level ≥6.5% . 4. Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant 5. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the Investigator, may impair implantation of the EndoBarrier device 6. Subjects with active GERD not taking a Proton Pump Inhibitor (PPI), which in the investigator's opinion might interfere with the Endobarrier. 7. Subjects with symptomatic kidney stones within 6 months prior to randomization. 8. Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions 9. Subjects with symptomatic gallstones within 6 months prior to randomization 10. Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities 11. Any documented history of acute or chronic pancreatitis 12. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent) 13. Subjects unable to discontinue Aspirin or any other NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect (i.e coumadin) during the study duration 14. Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 15. Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study 16. Subjects with poor dentition who cannot completely chew their food. 17. Subjects with thyroid disease unless controlled with a therapeutic dose of medication and have normal thyroid function tests for a minimum of 6 months prior to randomization 18. Subjects not residing within a 3 hour driving distance of the study center. 19. Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study 20. Subjects with known allergies or hypersensitivity to ceftrixone, cephalosporins or penicillin. 21. The investigator may decide to the participation of a subject due to medical, safety or any other reason (i.e; behavioral issues, etc.) at any point before the implantation procedure | 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, Pericardial Effusion Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation Hypersensitivity on Colchicine The existence of intra-cardiac thrombus on trans-esophageal echocardiography 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): 18.0-80.0, Crohn Disease Subject has provided informed consent. 2. Male or female subjects, 18 to 80 years of age, inclusive. 3. Prior diagnosis of CD confirmed by endoscopy or imaging for > 3 months prior to enrollment with active disease, defined as a Crohn's Disease Activity Index (CDAI) score >220 to <450 and at least one of either: fecal calprotectin >250 ug/g feces, or CRP >8 mg/L. 4. Patients will have evidence of ileocolonic, colonic, or ileal disease that is visualized either endoscopically or on MRI within the prior 6 months. 5. Patients must carry at least one G allele at rs2062305. 6. Patients will be eligible for the study if they are receiving any of the following mesalamine for >8 weeks with the dose remaining stable for 4 weeks prior to screening a maximum of 20 mg of prednisone per day (or steroid equivalent), with the dose remaining stable for 2 weeks prior to screening. Steroids must be held stable for the first 4 weeks of the study and then must be tapered by 5 mg per week, to be discontinued entirely by week 8 mercaptopurine, methotrexate or azathioprine for ≥3 months, with the dose remaining stable for 8 weeks prior to screening Monoclonal antibody or experimental agent use within 12 weeks before screening. 2. Use of non-approved drugs for CD. 3. Anticipated need for surgery within 12 weeks 4. Active sepsis, or use of antibiotics within two weeks prior to screening for the treatment of infection. 5. Pregnant, lactating or planning to become pregnant during the study 6. Inability to reliably use birth control for men and women during the course of therapy. 7. Known allergy to Denosumab or ingredients in formulation 8. Treatment of cancer within the last 5 years (except for non-melanoma skin cancers). 9. Recent jaw infection, invasive dental procedures (tooth extraction, dental implants or surgery), anti-angiogenic medications, or hypocalcemia within 1 month prior to screening. 10. Patients will also be excluded if they meet any of the following Proctocolectomy or total colectomy; stoma; a history of allergy to murine proteins; or treatment with parenteral corticosteroids or corticotropin within four weeks before screening. Serum Hg < 80 g/L, liver enzymes ≥ 2-fold elevated, or other serum biochemistry considered unsafe, or requiring treatment, in the opinion of the investigator | 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, Cardiovascular Diseases Any adult patient undergoing clinically indicated CMR scanning at the UHSM CMR Unit Age < 18 years, imprisonment, inability to provide informed consent | 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, Aseptic Meningitis clinical picture compatible with aseptic meningitis/meningoencephalitis age 18 years or older clear cerebrospinal fluid on macroscopic examination cerebrospinal pleocytosis (> 5 x 106 white blood cells per liter) younger than 18 years 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, Carcinoma, Hepatocellular Age > 18 Child-Pugh A or B cirrhosis ECOG performance status Grade 2 or below No serious concurrent medical illness No prior treatment (including surgery) for HCC Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion) Unresectable and locally advanced disease without extra-hepatic disease Massive expansive or nodular tumor morphology with measurable lesion on CT Size of largest tumor <= 15cm in largest dimension Number of main tumor <= 5, excluding associated small satellite lesions History of prior malignancy except skin cancer History of significant concurrent medical illness such as ischemic heart disease or heart failure History of acute tumor rupture Serum creatinine level > 180 umol/L Presence of biliary obstruction not amenable to percutaneous drainage Child-Pugh C cirrhosis History of hepatic encephalopathy, or Intractable ascites not controllable by medical therapy, or History of variceal bleeding within last 3 months, or Serum total bilirubin level > 50 umol/L, or | 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): 0.0-90.0, Neurological Diseases Criteria:All patients with neurological conditions, their siblings and parents. - 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): 18.0-999.0, Hypertension Diabetes Obesity Tobacco Dependence Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19143, 19145, 19146, & 19151 Has 2 or more of the following conditions: 1. Obesity: BMI30 2. HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2) 4. tobacco (from EPIC Social History/Vital Signs) Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI>=35); HTN (SBP >= 160); DM (HgBA1c >=9); Tobacco Use (>0 cigarettes)" Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance Has a scheduled appointment at a study clinic in the future Community Health Workers/CHWs/IMPaCT Partners involved in the care of patients of the three practices will be included in the qualitative portion of this study Will not provide informed consent for this study Does not have the capacity to provide informed consent for this study Previously enrolled in this study Currently enrolled in another study focusing on chronic disease management Currently has a CHW No one will be excluded on the basis of sex or race | 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 Kidney Disease hemodialysis patient over 18 years old that accepted to participate Patients with metal orthopedic implants, cardiac pacemakers, patients with amputated limbs, due to the failure of evaluation of these patients by bioelectrical impedance analysis (BIA) and patients who do not accept participate in the study or decide to leave during the period of study research | 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): 18.0-45.0, Preeclampsia Exposed cases African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded. Unexposed controls African American women obtaining prenatal care in our outpatient setting who meet matching as noted above Non-African American women and women who are not receiving care at our institution All women who do not speak English and who are unable to be consented will be excluded | 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): 35.0-85.0, Osteoarthritis, Knee Voluntary signature of the IRB approved Informed Consent 2. Unilateral osteoarthritic male or female ages 35-85 3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint 4. Physical examination consistent with osteoarthritis in one knee joint 5. Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension) 6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis 7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.) 8. Normal range of motion of the unaffected knee 9. No sign of pain, swelling, and/or functional disability of the unaffected knee 10. No history of acute injury in the unaffected knee 11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits Knee injections of any type within 6 months prior to the study. 2. Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) 3. Quinolone or Statin induced myopathy/tendinopathy 4. Symptomatic lumbar spine pathology (e.g. radicular pain) 5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam). 6. Contraindications for MRI 7. Tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site 8. Condition represents a worker's compensation case 9. Currently involved in a health-related litigation procedure 10. Is pregnant 11. Bleeding disorders 12. Currently taking anticoagulant or immunosuppressive medication 13. Allergy or intolerance to study medication 14. Use of chronic opioid 15. Documented history of drug abuse within six months of treatment 18) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment | 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 Subjects will be determined to have PCOS based on clinical such as history of irregular menses and clinical or laboratory evidence of hyperandrogenism Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start Women with hemoglobin less than 11gm/dl at screening evaluation Women with untreated thyroid abnormalities Pregnant women Women with BMI>37 Women with known sensitivity to the agent being used | 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): 20.0-999.0, Cholecystitis, Acute Common Bile Duct Calculi grade II or III acute cholecystitis met Tokyo 13 diagnostic a high suspicion of CBD stone based on laboratory and imaging study informed consent given bilo-pancreatic malignancy or surgically altered enteric anatomy subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class | 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, B-Cell Lymphoma Adults (aged ≥ 18 years) Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Adequate hematological, renal, hepatic, and coagulation laboratory assessments Must give written informed consent to participate in this study before the performance of any study-related procedure A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1 Treatment with proton pump inhibitors, H2 antagonists, or antacids Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures) Impaired cardiac function or clinically significant cardiac diseases, including any of the following Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug New York Heart Association Class III or IV congestive heart failure QTcF > 470 msec on the screening ECG Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded) A past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen) Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection) Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI 1205 Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-1205 Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-1205. Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-1205. Treatment with medications that are strong inhibitors of CYP3A4 Treatment with medications that are inducers of CYP3A4 enzymes Treatment with medications that are known to carry a risk of Torsades de Pointes Pregnant or lactating women Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter Patients unwilling or unable to comply with this study protocol | 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): 18.0-65.0, Blastoid Variant Mantle Cell Lymphoma CD20 Positive Mantle Cell Lymphoma Pleomorphic Variant Mantle Cell Lymphoma Patient has a confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy Patients with MCL must be symptomatic and need immediate therapy; symptoms and nature of MCL any of the following Blastoid variant Pleomorphic variant B symptoms Mantle Cell International Prognostic Score (MIPI) > 3 Ki-67 >= 30% Bulky tumors > 7 cm or in case of >= 2 tumors, each >= 5 cm in diameter Disease threatening organ function Elevated lactate dehydrogenase (LDH) Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form Pregnant or breast feeding females Known human immunodeficiency virus (HIV) infection Patients with active hepatitis B or C infection (not including patients with prior hepatitis B vaccination); these patients should be cleared by gastrointestinal (GI) consultation for hepatitis B and infectious disease consult for hepatitis C All patients with central nervous system lymphoma Significant neuropathy (grades 3 or grade 2 with pain) within 14 days prior to enrollment Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis unless due to lymphoma Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of ibrutinib Major surgery within 4 weeks of initiation of therapy; clearance letter from primary physician required | 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): 16.0-65.0, Lymphoma Patients with histologic diagnosis for one of the following histologies according to the World Health Organization: documented at initial diagnosis or at relapse Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma) Previous indolent lymphoma (follicular lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma, lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at most recent relapse (biopsy proof of transformation is mandatory) Unclassifiable B-cell lymphoma with indeterminate features between diffuse large B-cell lymphoma and Burkitt lymphoma Biopsy proof of disease at initial diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory. Participating centres must designate a local reference expert pathologist who will confirm the diagnosis for the patients enrolled at that centre Patients must be CD20+ in order to be eligible for the study Clinically and/or radiologically measurable disease (one site bidimensionally measurable). Measurements/ evaluations must be done within 28 days prior to randomization Prior FDG-PET scan, if done at baseline, must be positive (known FDG-avid lymphoma) Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy proven refractory disease, after 1 prior line of therapy (R-CHOP chemotherapy or equivalent). Patients with histological transformation from low grade lymphoma may have had up to 3 prior treatment regimens. Patients with transformed low grade lymphoma treated with a non-anthracycline regimen may be enrolled at investigator discretion Patient age is ≥16 years. Patients older than 65 years of age are not recommended for this study Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast, or localized excised prostate cancer, other solid tumours curatively treated with no evidence of disease for ≥ 3 years Active and uncontrolled central nervous system involvement, meningeal or parenchymal. Patients with CNS disease at initial presentation and who are in a CNS CR at the time of relapse are eligible. MRI scanning and / or lumbar puncture should be performed if there is clinical suspicion of active CNS disease Major surgery performed within 10 days of randomization Known history of human immunodeficiency virus (HIV), active Hepatitis C Virus infection, active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Patients with Hepatitis B serology suggestive of infection are eligible if they are HBV DNA negative and concurrently treated with anti-viral therapy. Patients with a past history of hepatitis C who have eradicated the virus are eligible Patients who have been vaccinated with live, attenuated vaccines within 4 weeks of randomization Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification Any serious active disease or co-morbid medical condition, including psychiatric illness, judged by the local investigator to preclude safe administration of the planned protocol treatment or required follow-up Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or preclude safe administration of the planned protocol treatment or required follow-up, including (for example) active, uncontrolled bacterial, fungal, or viral infection clinically significant cardiac dysfunction or cardiovascular 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): 18.0-999.0, Tick-borne Encephalitis years or older clinical picture compatible with tick-borne encephalitis clear cerebrospinal fluid cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus positive serum IgG antibodies against Lyme borreliae isolation of B.burgdorferi sensu lato from cerebrospinal fluid positive intrathecal borrelial antibody production index seroconversion of borrelial IgG antibodies presence of erythema migrans and/or borrelial lymphocytoma in the last month Bannwarth syndrome | 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, Lymphoma, Non-Hodgkin diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy patients refuse the therapy or have no tolerance for the therapy | 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): 18.0-55.0, Epilepsy All Cohorts 1. Is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations. 3. Is a healthy male or female aged 18 to 55 years inclusive, at the time of informed consent and first study medication dose. 4. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1. 5. Male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose. 6. Female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study, and for 30 days after the last dose. 7. Can complete the CogState Battery at Screening. Additional for Participants undergoing cerebrospinal fluid (CSF) Sampling (Part 2 only): 8. Agrees to spinal tap procedures for CSF collection All Cohorts 1. Has received any investigational compound within 30 days prior to randomization. 2. Has received TAK-935 in a previous clinical study or as a therapeutic agent. 3. Has a significant history of uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease or psychiatric disorder or endocrine disease or other abnormality or any significant results from physical examinations, or clinical laboratory results which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted. 4. Has a known hypersensitivity to any component of the formulation of TAK-935. 5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine. 6. Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table. Additional for Participants undergoing CSF sampling (Part 2) 7. Has CSF collection performed within 30 days prior to check-in (Day -3). 8. Has a known hypersensitivity to the anesthetic or its derivatives used during CSF collection, or any medication used to prepare the area of lumbar puncture. 9. Has significant vertebral deformities (scoliosis or kyphosis) which, in the opinion of the investigator, may interfere with lumbar puncture procedure. 10. Has a history of clinically significant back pain and/or injury. 11. Has local infection at the puncture site | 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, Interstitial Cystitis Female 2. Patients must be at least 18 years of age. 3. Patients must have been previously scheduled for a surgical procedure that includes cystoscopy under anesthesia or cystoscopy with hydrodistension under anesthesia. 4. Patients must be able to provide written informed consent pregnancy 2. planned cystotomy 3. incidental cystotomy during surgery patient not eligible for hydrodistention 4. patient's age > 90 5. history of pelvic radiation 6, Previous or newly diagnosed bladder tumor | 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, Microvascular Coronary Dysfunction Cardiovascular Disease For the new cohort n=120 women undergoing coronary angiography Symptomatic angina or anginal equivalent Age ≥ 18 Participant is willing to give written informed consent For the cohort n=100 women and men hospitalized for HFpEF (defined by ESC guidelines) Age ≥ 18 Signs and symptoms of heart failure Preserved ejection fraction, left ventricular ejection fraction (LVEF) ≥45% prior to study entry Structural evidence of cardiovascular abnormalities: elevated brain naturetic peptide, evidence of abnormal filling or relaxation, left ventricular hypertrophy, or an increased left atrial size Evidence of elevated filling pressures: LVEDP or PCWP at rest > 15 mmHg and/or with exercise ≥25 mmHg, exercise E/e' >13, elevated BNP, or use of diuretic Participant is willing to give written informed consent For the new cohort n=120 women undergoing invasive coronary angiography Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery STEMI within 3-7 days post MI, or Acute coronary syndrome/NSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC/AHA guidelines Primary valvular heart disease clearly indicating the need for valve repair or replacement Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or LVEF<45% Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis Non-cardiac illness with a life expectancy < four years Unable to give informed consent Chest pain which has an alternative non-ischemic etiology, i.e. pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema | 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): 8.0-17.0, Polycystic Ovary Syndrome Hyperandrogenism Puberty List of • Peripubertal girls, Tanner breast stages 1-5 List of Age < 8 or > 17 y Men and boys are excluded Inability to obtain proper consent/assent Atypical obesity Underweight: Underweight is defined as a BMI-for-age percentile < 5 Positive pregnancy test or lactation Assessment during the luteal phase as suggested by a serum progesterone ≥ 1.5 ng/ml Virilization or a total testosterone > 150 ng/dl Excessively elevated DHEA-S: This will be defined as a DHEA-S > 1.5 times the age-appropriate upper limit of normal Congenital adrenal hyperplasia (CAH) | 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, Cholecystitis, Acute Clinical and radiologic signs of acute cholecystitis First acute symptoms occurring within five days before surgery Anamnesis exceeding five days Any contraindication for laparoscopic surgery Allergy against beta-lactame antibiotics | 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, Anaemia Patients with anaemia (males Hb <130 g/L, females <120 g/L) undergoing elective cardiac surgery, and available to receive trial drug 1 weeks prior to surgery Pregnancy Known hypersensitivity to study drug (ferric carboxymaltose or equivalent) or its excipients Known or suspected haemoglobinopathy/thalassaemia Bone marrow disease Haemochromatosis Renal dialysis Erythropoietin or IV iron in the previous 4 weeks | 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): 18.0-73.0, Lymphoma, B-Cell Lymphoma, Non-hodgkins Malignancy Patients with the following malignancies are potentially eligible: any B-cell lymphoma, and chronic lymphocytic leukemia (CLL). Patients with indolent malignancies that have transformed to diffuse large B-cell lymphoma are eligible Clear CD19 expression must be uniformly detected on 75% or more of malignant cells from either bone marrow or a leukemia or lymphoma mass by flow cytometry or immunohistochemistry. These assays must be performed at the National Institutes of Health. It is preferable but not required that the specimen used for CD19 determination comes from a sample that was obtained after the patient s most recent treatment. If paraffin embedded unstained samples of bone marrow involved with malignancy or a lymphoma mass are available, these can be shipped to the NIH for CD19 staining; otherwise, new biopsies will need to be performed for determination of CD19 expression DLBCL patients must have received at least two prior chemotherapy-containing regimens at least one of which must have contained doxorubicin and a monoclonal antibody. Follicular lymphoma patients must have received at least 2 prior regimens including at least 1 regimen with chemotherapy. All other lymphoma and leukemia patients must have had at least 1 prior chemotherapy-containing regimen. All patients with CLL or small lymphocytic lymphoma must have had prior treatment with ibrutinib or another signal transduction inhibitor Patients must have measurable malignancy as defined by at least one of the below Lymphoma or leukemia masses that are measurable (minimum 1.5 cm in largest diameter) by CT scan is required for all diagnoses except CLL. All masses must be less than 10 cm in the largest diameter For a lymphoma mass to count as measurable malignancy, it must have abnormally increased metabolic activity when assessed by positron emission tomography (PET) scan For CLL and lymphoma with only bone marrow involvement no mass is necessary, but if a mass is not present, bone marrow malignancy must be detectable by flow cytometry in lymphoma and CLL Other Greater than or equal to 18 years of age and less than or equal to age 73 Patients that require urgent therapy due to tumor mass effects or spinal cord compression Patients that have active hemolytic anemia Patients with second malignancies in addition to their B-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 4 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias (active atrial fibrillation is not allowed, resolved atrial fibrillation not requiring current treatment is allowed (anticoagulants count as current treatment) ), active obstructive or restrictive pulmonary disease, active autoimmune diseases such as rheumatoid arthritis Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) Systemic corticosteroid steroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen. Corticosteroid creams, ointments, and eye drops are allowed History of severe immediate hypersensitivity reaction to any of the agents used in this study Patients with current CNS involvement by malignancy (either by imaging or cerebrospinal fluid involvement or biopsy-proven) | 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, Pericardial Effusion Age ≥ 18 years of age; 2. Confirmed large pericardial effusion on echocardiography (i.e., echo free space ≥1 cm anterior to the right ventricle of the heart in diastole); 3. Willingness to participate for the full duration of the trial (i.e., 12 months); and 4. Provision of written informed consent Age < 18 years; 2. Uraemic pericarditis (i.e., urea > 21.4 mmol/l); 3. Thrombocytopenia (i.e., < 100,000 platelets per µl); 4. Presence of a contra-indication to the administration of a fibrinolytic agent (i.e., major haemorrhage or major trauma; coincidental stroke; major surgery in the previous 5 days; blood pressure >200/100 mmHg) | 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, Diabetes Mellitus Type 2 in Obese Criteria:Type 2 diabetic obese pateints - patients age above 65 or below 18 years old, history of upper laparotomy, unfit for anesthesia or laparoscopy, major psychological instability and drug abuse. - | 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, Alzheimer's Disease (AD) Patients being evaluated for Alzheimer disease and related dementias according to the HAS recommendations (atypical dementia, early onset and rapid progressive dementia) Patients who have previously been evaluated for AD and related dementias to whom a CSF examination was recommended in the last 12 months, but lumbar puncture was contraindicated or refused or CSF results were ambiguous, or Patients currently being evaluated for AD and related dementias to whom a CSF examination is recommended but lumbar puncture is contraindicated or refused Patients have a study partner who is willing and able to accompany him/her to all clinic visits for the duration of the protocol Patients able to complete all clinical visits according to the protocol Patients able to tolerate a 20-minute FBB PET scan Patient or legal representative to provide informed consent for study participation, visits and data source verification The subject had a previous beta amyloid imaging scan Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol Is currently receiving any investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study For females of childbearing age, a positive pregnancy test | 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 Follicular Lymphoma Burkitt Lymphoma ≥18 y/o (no upper age limit) ECOG PS ≤2 Disease Histologically or cytologically documented newly diagnosed (stages II, III or IV) Myc-positive DLBCL, transformed follicular lymphoma, or high-grade unclassifiable with features intermediate between DLBCL and Burkitt lymphoma Myc Positive lymphoma is defined by Positive for Myc gene rearrangement by fluorescence in-situ hybridization (FISH) involving various breakpoints (e.g. 8-14, 8-22 and 2-8) AND concurrent gene rearrangements in bcl-2 and/or bcl-6 by FISH OR Myc and Bcl-2 overexpression defined by > 40% Myc and > 70% Bcl-2 expression by IHC. Patients may enroll in the study based on the local laboratory evaluation, but these should be confirmed by the UNC Hematopathology Laboratory retrospectively Positive for CD20 via immunophenotyping Prior Treatment: Previously untreated or who received a maximum of one cycle of combination chemotherapy (i.e. R-CHOP, R-EPOCH, or R-hyperCVAD) within 4 weeks of study entry except patients who require dose reduction after the first cycle of off-study R-EPOCH Measurable disease as assessed by 2 dimensional measurements by CT (≥ 1.5 cm) CNS involvement of DLBCL Major surgery within 4 weeks prior to entry Receiving any other concurrent cytotoxic, biologic agent(s) or investigational agent ; NOTE: Concurrent intrathecal chemotherapy for CNS prophylaxis allowed per institutional standards Receipt of investigational drugs within 14 days before D1 of alisertib Prior administration of an Aurora A kinase-targeted agent, including alisertib Patients with a "currently active" second malignancy other than non-melanoma skin cancers, non-invasive bladder cancer, "low risk" adenocarcinoma of the prostate and carcinoma in situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib and during the study Radiation therapy to more than 25% of the bone marrow (note: whole pelvic radiation is considered to be over 25%) Prior allogeneic bone marrow or organ transplantation Known GI disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease | 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): 18.0-60.0, Liver Transplantation First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O) Ages of 18 or older Patients receive liver transplantation due to benign end stage liver disease Patients or legal agent must be able to give informed consent Second or combined organ transplant recipient Combined transplantations such as simultaneous liver/kidney transplants Malignant disease Uncontrol bacterial, fungal, viral or parasitic infection Withdraw or unable to finish the follow-up Unwilling to sign informed consent | 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): 19.0-65.0, Opioid Use Disorder Chronic Pain Subject must provide written informed consent prior to the conduct of any study related procedures. 2. Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive. 3. Body mass index between 19 and 35 kg/m2, inclusive. 4. Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5) or past medical history of opioid use disorder currently being treated with SL BPN. 5. Subject must be taking SL BPN (Subutex® equivalent) 24 mg (Group 1 and Group 2) or ≥24 mg (Group 3) daily for at least 30 days prior to Screening. 6. Subject has a history of moderate to severe chronic non cancer pain. 7. Male and female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening visit to Follow-up phone call). 8. Subject must be willing and able to comply with all study procedures and requirements Individuals meeting DSM-V substance use disorder for alcohol, benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse (excluding caffeine, tobacco or THC/marijuana). 2. Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG; Fridericia's corrected QT interval [QTcF] ≥450 msec. for males or ≥470 msec. for females), and laboratory evaluations (including hematology, clinical chemistry, urinalysis at Screening), in the opinion of the Investigator. 3. Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study, including subjects who are at a risk for gastrointestinal obstruction or paralytic ileus or who have severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors. 4. Use (therapeutic or non-therapeutic) of opioids other than SL BPN. 5. Aspartate aminotransferase (AST) levels > 3 X the upper limit of normal, alanine aminotransferase (ALT), levels > 3 X the upper limit of normal, total bilirubin > 1.5 X the upper limit of normal, or creatinine > 1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in study. 6. Pregnant or lactating or planning to become pregnant during the study. 7. Diagnosis of, or currently under investigation for, fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness. 8. History of chemotherapy or confirmed malignancy (except basal cell or squamous carcinoma of the skin) within the past 2 years. 9. Clinically significant history of, or current evidence for, suicidal ideation or those who are actively suicidal, as based on the Columbia-Suicide Severity Rating Scale (C-SSRS; grade 4 or 5). 10. Clinically significant history of major depressive disorder that is poorly controlled with medication. 11. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038. 12. Exposure to any investigational drug within the 4 weeks prior to Screening. 13. Participants with a clinically significant history of risk factors of Torsades de Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy, heart failure, hypokalemia, family history of Long QT Syndrome. 14. On medications that have the potential for prolonging the QT interval or who may require such medications during the course of the study along with clinically significant abnormalities on screening electrocardiogram (ECG) readings as deemed by the investigator. 15. Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir). 16. Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff. 17. Is an employee of the Investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or is a family member of an employee or of the Investigator. 18. Any pending legal action that could prohibit participation or compliance 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): 18.0-65.0, Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis NAFLD proven by imaging Age 18-65 years Incompetent to understand and/or sign the informed consent Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis Not willing to be informed about unexpected findings by MRI and histopathologic evaluation of liver biopsy Unwilling to collect biosamples Pregnancy and breastfeeding Diagnosis of liver cirrhosis and/or hepatocellular carcinoma Current diagnosis of extrahepatic malignancie(s) or prior diagnosis within last 5 years Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFLD/NASH Chronic use of immunosuppressants (e.g. biologicals, prednisolone, azathioprine) | 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): 0.0-75.0, Acute Leukemia Acute Myeloid Leukemia Acute Lymphoblastic Leukemia/Lymphoma Burkitt's Lymphoma Natural Killer Cell Malignancies Chronic Myelogenous Leukemia Myelodysplastic Syndrome Large-cell Lymphoma Hodgkin Lymphoma Multiple Myeloma Relapsed Chronic Lymphocytic Leukemia Relapsed Small Lymphocytic Lymphoma Marginal Zone B-cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle-cell Lymphoma Prolymphocytic Leukemia Bone Marrow Failure Syndromes Myeloproliferative Neoplasms/Myelofibrosis Biphenotypic/Undifferentiated/Prolymphocytic Leukemias MRD Positive Leukemia Leukemia or MDS in Aplasia Relapsed T-Cell Lymphoma Relapsed Multiple Myeloma Plasma Cell Leukemia Age, Performance Status, and Graft <70 years of age with no matched 5/6 or 6/6 sibling donor patients ≥ 70 and ≤ 75 years of age may be eligible if they have a Co-Morbidity score ≤ 2 (http://www.qxmd.com/calculate-online/hematology/hct-ci) Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years) UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm Eligible Diseases All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following t(8,21) without cKIT mutation inv(16) or t(16;16) without cKIT mutation Pregnant or breast feeding. The agents used in this study Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy Untreated active infection Active HIV infection or known HIV positive serology Less than 3 months since prior myeloablative transplant Evidence of progressive disease by imaging modalities or biopsy persistent PET activity, though possibly related to lymphoma, is not an criterion in the absence of CT changes indicating progression CML in blast crisis Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy Active central nervous system malignancy | 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): 0.0-999.0, Meningitis any individual with culture-confirmed IMD in England from 01 September 2015 to 31 August 2019 written informed consent from the individual, the parent (for children aged <16 years) or next-of-kin (for non-survivors) any individual who does not fulfil the Temporary Critically-ill patients and/or their family member will be only approached when the patient starts recovering from their illness or after they are deceased, on the advice of their clinical team | 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): 3.0-75.0, Lymphoma Confirmed by pathological biopsy in patients with diffuse large B cell lymphoma by standard solution treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirmed the tumor cell surface expression positive intervention molecular targets, mainly for the CD19 (+) and/or CD20 (+). 2. Age 3 to 75 years old, both male and female; 3. Is expected to survive more than 3 months; 4. Physical condition is good: 0-2 score ECOG score; 5. In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET CT examination. 6. General requirements peripheral blood as basic, normal blood T lymphocytes in peripheral blood count must >= 0.2 x10^9 / L; 7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; 8. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form The recurrent or refractory patients with diffuse large B cell lymphoma. 2. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 3. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; 4. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 5. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution; 6. Coagulation abnormalities and severe thrombosis; 7. Pregnancy and lactation women; 8. Any other chronic disease patients who have been treated with immune agents or hormone therapy; 9. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 10. The Investigator believe the patients should not participate in this experiment | 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): 18.0-45.0, Polycystic Ovarian Syndrome Chinese; 2. 18-45 years old; 3. to meet the diagnostic for polycystic ovary syndrome; 4. no need for pregnancy in the next six months; 5. volunteering to join this research and give informed consent prior to receiving treatment hypertensive patients with blood pressure exceed 160/100 mmHg; 2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection; 3. having taken any pharmacological treatments affecting reproductive endocrine system; 4. having received acupuncture in the previous three months; 5. smoking more than 15 cigarettes per day; 6. having pacemakers, metal allergies or severe fear of acupuncture | 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): 14.0-75.0, Lymphoma, Large B-Cell, Diffuse CD19-expressing and CD20-expressing Diffuse Large B Cell Lymphoma(DLBCL) must be assured and must be relapsed or refractory disease after at least one standard chemotherapy and one salvage regimen. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time. 2. Patients enrolled must have an evaluated score above 60 with KPS. 3. Expected survival time of patients enrolled is over 3 months. 4. Gender is not limited, age from 14 years to 75 years. 5. Patients must have measurable or evaluable disease at the time of enrollment, which may any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis. 6. Patients are expected to survive for more than 3 months by their physicians at the time of enrollment. 7. Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts. 8. Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy: CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation) 9. Patients with isolated CNS relapse will be eligible if they have previously been treated with cranial radiation (at least 1800 cGy). 10. Ability to give informed consent. 11. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus. 12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO. 13. Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L. 14. Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. 15. Patients volunteer to participate in the research Subjects meeting any of the following are not eligible for participation in the study: 1. Patients are evaluated below 50 scores with KPS. 2. Evident signs suggesting that patients are potentially allergic to cytokines. 3. Frequent infection history and recent infection is uncontrolled. 4. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome 5. Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment. 6. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications. 7. Pregnancy and nursing females. HIV infection. 8. Active hepatitis B or active hepatitis C. 9. Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed. 10. Class III/IV cardiovascular disability according to the New York Heart Association Classification. 11. Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease. 12. Other situations we think not eligible for participation in the research | 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, Connective Tissue Diseases Pulmonary Hypertension Patients diagnosed as connective tissue diseases fulfilling ACR will be recruited non - | 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, Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis Stable angina, CCS FC II-IV "Right-dominance" coronary circulation according to coronary angiography Absence of other significant atherosclerotic coronary lesions (more than 65%) High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest) Signed, documented informed consent prior to admission to the study Acute coronary syndrome Contraindications for adenosine stress test Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest) | 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, Large B-Cell, Diffuse Burkitt Lymphoma Histologically confirmed DLBCL or BCLU Double hit lymphoma, defined by positive cytogenetic/ fluorescence in situ hybridization (FISH) analysis for translocations involving myc and bcl2 or a double hit score of 2 by immunohistochemistry as described by Johnson et al DLBCL without myc translocation or overexpression by the above methods 2. Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension. 3. Available prior CT or PET/CT scan done in the last 8 weeks for comparison 4. Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior. 5. Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation) 6. No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia) 7. Ability to sign a study-specific internal review board (IRB) approved consent prior to study entry. Patients must be able and willing to consent and undergo study procedures. 8. Age ≥18 years old Any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures 2. Body weight over 300 pounds 3. Female patients who are pregnant or breast-feeding 4. Prior MRI with gadolinium performed <24 hours before the study scan 5. No red blood cell transfusion or iron administration by any route in the last 7 days 6. Prior hypersensitivity or intolerance to gadolinium or gallium citrate | 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, Mesothelioma (All Cohorts) Histologically confirmed epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a more than or equal to 50% sarcomatoid component will be excluded. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI Archival sample or fresh biopsy or tumor effusion must be available for confirmation of diagnosis Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to10 mm with spiral CT scan Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin. There is no limit to the number of prior chemotherapy regimens received The last dose of previous therapy must have occurred at least 3 weeks prior to the start of study therapy. Palliative radiotherapy is allowed up to 2 weeks before the first LMB-100 infusion Patients for whom no standard curable therapy exists Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of LMB-100 in patients <18 years of age, children are excluded from this study All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to 1, except alopecia (any grade) and Grade 2 peripheral neuropathy ECOG performance status (PS) 0 or1 (All Cohorts): -Known or clinically suspected CNS primary tumors or metastases including leptomeningeal metastases. History or clinical evidence of CNS metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days. Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion) Active or uncontrolled infections HIV or active HBV or HCV infection. HIV positive patients will be excluded due to a theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection Patients with prior pneumonectomy Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug Major surgery or significant traumatic injury greater than or equal to 28 days prior to the first LMB-100 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment Dementia or altered mental status that would prohibit informed consent Live attenuated vaccinations 14 days prior to treatment Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LMB-100, breastfeeding should be discontinued if the mother is treated with LMB-100. These potential risks may also apply to other agents used in this study Known hypersensitivity to any of the components of LMB-100 | 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, Infective Pericarditis Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome Adult patient (= or > 18 years old) Patient who freely signed the informed consent form Patient affiliated to a health insurance regime Minor patient ( age <18 years) Pregnant, parturient or breastfeeding woman Adult patient incapable or unable to consent Patient deprived of liberty under judgment Person living in a health or social specialised structure Person in vital emergency situation | 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, Actinic Keratosis Males and females ≥18 years old 2. Clinical diagnosis of stable, clinically typical actinic keratosis 3. A define treatment area on the face or scalp 4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment 5. Males who have not had a vasectomy must agree to use barrier contraception 6. Participants who in the judgment of the Investigator, are in good general health 7. Willing to avoid excessive sun exposure 8. Able to comprehend and are willing to sign an informed consent form (ICF) Clinically atypical and/or rapidly changing AK lesions on the treatment area 2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence 3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1 4. Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1 5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1 6. A history of sensitivity and/or allergy to any of the ingredients in the study medication 7. A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation 8. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation 9. Females who are pregnant or nursing 10. Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing | 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, Meningitis Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a "POC meningitis kit." Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Pregnant woman, parturient or nursing Adult patient under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form | 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, Community-based Meningitis Meningo-encephalitis Patient is aged more than 18 years old Patient with clinical meningitis or meningo-encephalitis with community transmission Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis Patient who do not declined to have his medical records reviewed for research Patient with health insurance Minor Patient (age <18 years) Pregnant woman, parturient or breastfeeding Adult Patient under guardianship Patient deprived of liberty under court order Patient vital in emergency | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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): 18.0-59.0, AML Relapse Men and women whose age more than 18 and less than 59； Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease diagnosis standard Patients who relapsed after remission or who can not achieve remission after at least two cycle of systemic therapy (including chemotherapy, hematopoietic stem cell transplantation, etc.) ECOG performance status 0-3 Expected survival time ˃ 3 months Patients without serious hearts, lung, liver, kidney disease Patients have not received radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation and other treatment within 4 weeks prior to the enrollment Patients are able to understand and willing to sign informed consent Patients who allergy to the study drug or the drug with similar chemical structure Pregnancy, lactation women and women of childbearing age who do not want to practice effective methods of contraception Active infection Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of patients Patients with mental disorders or other conditions can not obtain informed consent, can not meet the requirements of the study treatment and procedures Patients have clinical significant QTc interval prolongation history (male > 450ms. Female >470ms), ventricular heart had tachycardia (VT) and atrial fibrillation (AF), II degree heart block, myocardial infarction attack (MI) within 1 year prior to the enrollment, congestive heart failure (CHF), patients of coronary heart disease who have clinical symptoms and need drug treatment Cardiac ultrasound showed that the diastolic pericardial fluid dark area width ˃ 10mm Patients have received organ transplantation Active bleeding Patients have new thrombosis, embolism, cerebral hemorrhage and other diseases or medical history of patients within 1 year prior to enrollment | 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, Cerebrovascular and Cardiovascular Diseases Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events Patients who are able to receive MRI Provision of written informed consent either directly or by a suitable surrogate MRI contraindication Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable 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): 18.0-80.0, Malignancy Pleural Effusion Pleural Diseases Ascites Males or females >18 years of age Have a serous effusion Scheduled for a diagnostic and/or therapeutic procedure to remove serous fluid ( Puncture of serous cavity) Females known to be pregnant | 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): 0.0-110.0, Encephalitis Meningitis Exclusions Patients on a 5150 or 5250 psychiatric hold Prisoners University of California employees / students or close associates of any of the key personnel on the study Outpatients and/or patients with chronic illness Demographic 1. Age: any (no age limit) 2. Language: any (with the use of interpreting services for obtaining consent) For the following, the infectious syndromes meningitis, encephalitis, fever, sepsis, and pneumonia: Clinical 1. Hospital admission or transfer with diagnosis of an presumed infectious syndrome or clinical presentation consisting with an infectious syndrome, as defined below Meningitis: fever >38°C and abnormal imaging or CSF pleocytosis (CSF white blood cell count (WBC) > 5 /mm^3) +/ stiff neck, +/ headache, +/ seizure Encephalitis: pleocytosis and at least one of the following: altered mental status, seizures, new onset of focal neurologic findings, abnormal EEG, acute brain abnormalities on neuroimaging 2. No known diagnosis of non-infectious etiology responsible for symptoms 3. Time of enrollment: within 7 days of onset of symptoms, either initial presentation or acute exacerbation of presumed infectious syndrome. Specimen 1. cerebrospinal fluid available within 7 days of symptom onset AND within 3 days of hospital admission or transfer unless evidence for acute exacerbation as defined by abrupt decline in clinical status, worsening pleocytosis or other laboratory parameters 2. Minimum of 600 microliters (uL) of clinical sample, stored at 4 degrees Celsius (C) no more than 5 days (ideally frozen in -70 degrees Celsius within 24 hours of collection) 3. No more than 3 freeze-thaw cycles | 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): 65.0-999.0, Frail Elderly Exercise Therapy Physical Therapy Techniques volunteers above the age of 65 who are community residents and classified as frail according to the established by Fried et al. will be selected for in the study previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury | 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, Idiopathic Parkinson Patients Age ≥18，≤75，idiopathic Parkinson's disease，both male and female 2. MMSE score ≥24 3. H-Y score ≥2.0 on the medicine off situation 4. UPDRS-III score≥30 on the medicine off situation 5. The duration of this disease ≥5 years 6. Ability to provide informed consent as determined by preoperative neuropsychological assessment 7. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients 8. Excellent responsiveness to levodopa 9. ≥6h in medicine off state Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment 2. Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia 3. Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases 4. Patients who are unable to follow verbal instructions 5. Other severe pathological chronic condition that might confound treatment effects or interpretation of the data | 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): 4.0-17.0, Autosomal Dominant Polycystic Kidney Disease (ADPKD) Key Male and female participants aged 4 to 17 years (inclusive) with a diagnosis of ADPKD as defined by the presence of family history and/or genetic AND who have at least 10 renal cysts, each of which measure at least 0.5 cm, confirmed upon magnetic resonance imaging (MRI) inspection; participants under the age of 12 years must have at least 4 cysts that are at least 1 cm in size, confirmed by ultrasound Weight ≥ 20 kg Participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 within 31 days prior to randomization (using the Schwartz formula, eGFR = 0.413 × height [cm]/serum creatinine mg/dL) Independent in toileting Ability to swallow a tablet. Key Liver function tests including aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 × the upper limit of normal (ULN) Nocturnal enuresis Need for chronic diuretic use Participants with advanced diabetes (eg, glycosylated hemoglobin > 7.5, and/or glycosuria by dipstick, significant proteinuria, retinopathy), evidence of additional significant renal disease(s) (ie, currently active glomerular nephritides), renal cancer, single kidney, or recent (within 6 months of screening) renal surgery or acute kidney injury Participants having disorders in thirst recognition or inability to access fluids Participants with critical electrolyte imbalances, as determined by the investigator Participants with, or at risk of, significant hypovolemia as determined by investigator Participants with clinically significant anemia, as determined by investigator Participants 12 years of age and older having contraindications to, or interference with MRI assessments (eg, ferro-magnetic prostheses, aneurysm clips, severe claustrophobia) Participants with a history of taking a vasopressin agonist/antagonist | 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, Precursor Cell Lymphoblastic Leukemia-Lymphoma Age ≥18 years at the time of signing the informed consent form 2. Subject must understand and voluntarily sign an Informed consent form (ICF) prior to any study-related assessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Diagnosis of B-cell Acute Lymphoblastic Leukemia (ALL) 5. Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy) 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 7. No contraindications to cyclophosphamide. This includes subjects with hypersensitivity to cyclophosphamide, any of its metabolites acute infections bone marrow aplasia or bone marrow depression prior to treatment urinary tract infection acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy urinary outflow obstruction obstruction 8. Adequate organ function, defined as: a. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m2 b. Alanine aminotransferase (ALT) ≤ 5 × ULN and direct bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with leukemic infiltration of the liver) c. Adequate pulmonary function, defined as ≤ Grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on room air d. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA) performed within 1 month of signing the informed consent form 9. Adequate central or peripheral vascular access for leukapheresis procedure. For subjects requiring central venous catheter (CVC) placement, a surgical consultation indicating subject for CVC placement is sufficient for enrollment. 10. Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals without recipient knowledge about exposure to a genetically modified organ by the donor and having been informed about the potential risks associated with it at any point after receiving JCAR015 infusion. 11. Females of childbearing potential (FCBP1) must: a. Have two negative pregnancy tests as verified by the Investigator (one negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of cytoreductive chemotherapy (Part A screening evaluation), and one negative serum or urine pregnancy test at the Part B screening evaluation prior to first JCAR015 infusion). She must agree to have another pregnancy test 90 days post final JCAR015 dose. This applies even if the subject practices true abstinence2 from heterosexual contact. b. Either commit to true abstinence2 from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must 1 highly effective and 1 additional effective (barrier) method of contraception from at least 28 days prior to JCAR015 initial infusion and during the study therapy including dose interruptions. Cessation of contraception after this point should be discussed with a responsible physician. Note: Highly effective methods are defined as those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. The following are examples of highly effective and additional effective methods of contraception Intrauterine device (IUD) Hormonal (birth control pill, injections, implants) Isolated extramedullary disease relapse 2. Concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome 3. Burkitt's lymphoma/leukemia or chronic myelogenous leukemia (CML) lymphoid blast crisis (p210 BCR-ABL+) 4. Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before signing the informed consent form, with the following exceptions: a. Subjects with Stage I breast cancer that has been completely and successfully treated, requiring no therapy or only anti-hormonal therapy b. Subjects with T1N0M0 or T2N0M0 colorectal cancer who have been completely and successfully resected and who are disease-free for > 2 years prior to screening c. Subjects with indolent prostate cancer, defined as clinical stage T1 or T2a, Gleason score ≤ 6, and prostate-specific antigen (PSA) < 10 ng/mL, requiring no therapy or only anti hormonal therapy d. Subjects with a history of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, fully resected, and with no evidence of active disease 5. Treatment with any prior gene therapy product 6. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of signing the informed consent form 7. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) at the time of signing the informed consent form 8. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of signing the informed consent form 9. Active C S involvement by malignancy, defined as CNS-3 per NCCN guidelines. Subjects with a history of Central nervous system (CNS) disease that has been effectively treated (defined as one documented negative CSF evaluation within 1 month prior to signing the informed consent form) will be eligible 10. History of any one of the following cardiovascular conditions within the past 6 months of signing the informed consent form: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease 11. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 12. Participation in an investigational research study using an investigational agent within 30 days of signing the informed consent form, with the exception of investigational antiinfective agents (eg, antibacterial, antifungal, antiviral) 13. History of treatment with a murine-derived biological product (unless subject has been shown to be negative for human anti-mouse antibodies [HAMA] prior to or during screening). Prior use of blinatumomab is permitted (provided there is evidence of CD19 expression per Part A Criterion #4). Chimeric biological products (eg, rituximab) are not considered murine for the purpose of this protocol. 14. Pregnant or nursing (lactating) women 15. Use of prohibited medications: a. Steroids: Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) are prohibited within 7 days prior to leukapheresis. Physiologic replacement dosing of steroids (≤ 12 mg/m2/day hydrocortisone or equivalent [≤ 3 mg/m2/day prednisone or ≤ 0.45 mg/m2/day dexamethasone]) is allowed. Topical steroids and intrathecal steroids for CNS relapse prophylaxis are permitted. b. Allogeneic cellular therapy: Donor lymphocyte infusions (DLI) are prohibited within 4 weeks prior to leukapheresis c. GVHD therapies: Any drug used for GVHD within 4 weeks prior to leukapheresis, eg, calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies (such as anti-CD20 [rituximab], anti-TNFα, anti-IL-6, or anti-IL-6R) d. Chemotherapies: Salvage chemotherapy (eg, cytosine arabinoside > 100 mg/m2/day, anthracyclines, and cyclophosphamide) must be stopped at least 1 week prior to leukapheresis 16. Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis 17. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol 4.3.2 (Part B) Subjects must not meet any of the following prior to Part B to be considered eligible: 1. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) 2. Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Subjects with a history of CNS disease that has been effectively treated (defined as one documented negative CSF evaluation within 1 month prior to signing the informed consent form) will be eligible 3. Presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD 5. Use of prohibited medications 6. Female subjects that have a positive serum or urine pregnancy test, or are pregnant | 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): 2.0-99.0, NOMID DIRA NLRC4-MAS SAVI CANDLE Be 2 to 99 years old for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years old for participants who participate remotely via a virtual protocol visit and will submit mail-in samples. Participants younger than 3 years will be seen in the outpatient clinic at the NIH CC if approved by the Pediatric Consult Service as per NIH CC policy and guidelines. 2. Is willing to allow storage of biological specimens for future use in medical research. 3. Is willing to allow genetic testing on collected biological samples. 4. Has a primary care or other physician who will manage all health conditions related or unrelated to the study objectives. 5. Fulfills one of the following Has a known disease-causing genetic mutation associated with NOMID/CAPS, DIRA, SAVI, or NLRC4-MAS Has clinical signs or symptoms not explained by any other disorder (eg, infections, malignancies) and are consistent with a possible IL-1 mediated autoinflammatory disease. Participants must meet both of the following Clinical characteristics strongly consistent with an IL-1 mediated autoinflammatory disease per the following and at the discretion of the principal investigator (PI). Individuals must have a past or present history of one of the following to be considered for study enrollment Recurrent fever that has gone undiagnosed after reasonable attempts, and that is consistent with the conditions under study in this protocol Neutrophilic urticaria, pustular dermatitis, erysipelas-like erythema, or urticarial rash Epiphyseal and/or patella enlargement, periostitis, myalgias, arthralgias, arthritis, or recurrent multifocal aseptic osteomyelitis Sensorineural hearing loss Chronic aseptic meningitis or CNS vasculitis Conjunctivitis, episcleritis, uveitis, papilledema, pleuritis, pericarditis, aseptic peritonitis, early onset enterocolitis, hepatosplenomegaly, or lymphadenopathies Presence of conditions that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study. 2. Oncological evaluation suggestive of lymphoma, leukemia or multiple myeloma, except for participants with a known primary diagnosis of an autoinflammatory disease who subsequently developed a malignancy. These patients will not be excluded from 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, Heterozygous Familial Hypercholesterolemia Men or women with heterozygous FH aged between 18 and 80 years FH patient carrying a documented mutation in the LDL receptor gene Subjects must be willing to give written informed consent and able to adhere to visit schedule Men or women < 18 or > 80 years Non-FH subjects History of alcohol or drug abuse within the past 2 years Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation 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): 35.0-55.0, Arterial Hypertension male and female 35-55 year old, 2. diagnosis of I-II grade essential AH, 3. patients with obesity (BMI ≥ 30 kg/m²), 4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy), 5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy), 6. written informed consent form (ICF) patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes), 2. patients with intolerance of ARB, thiazide diuretics, 3. secondary AH, 4. patients with contraindication to study drugs in accordance with Russian instruction, 5. patients currently enrolled in other clinical trials | 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, CLL/SLL Lymphomas Non-Hodgkin's B-Cell Diagnosis of B-cell NHL or CLL/SLL: Patients must be aged≥18 years with relapsed, refractory disease and no available curative options that meet clinical to initiate treatment. 2. Patients with B-cell NHL or CLL/SLL must have either CD19 or CD20 positive disease on most recent biopsy performed (a repeat biopsy is not mandatory for this study except as noted below). A minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry on prior or repeat biopsy is required. 3. Absolute CD3+ T cell count ≥50/mm3. 4. MRI brain and Lumbar Puncture with CSF analysis by cytology and flow cytometry without evidence of CNS involvement ONLY in patients with history of CNS involvement. 5. Measurable disease must have been documented within 4 weeks of the time of consent defined as the following by disease specific subtype: 1. B-cell NHL: Active disease defined as nodal lesions greater than 20 mm in the long axis or extranodal lesions >10 mm in long and short axis or bone marrow involvement that is biopsy proven. 2. CLL/SLL: Active disease by either bone marrow, peripheral flow cytometry, or CT and/or PET imaging with nodal disease. 6. Patients should have failed at least two lines of a standard treatment and meet disease specific detailed below: 1. CLL/SLL: measurable disease as defined above that has relapsed after at least one line of chemo-immunotherapy and progressed or intolerant to ibrutinib monotherapy. 2. CD19 or CD20 positive B cell NHL limited to the following histologies: Advanced Stage III or IV Follicular Lymphoma, Diffuse Large B cell Lymphoma and associated subtypes (e.g. aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone lymphoma, and Richter's transformation) and Mantle cell lymphoma. Specific Patients must have active, measurable disease after two lines of cytotoxic chemotherapy of which one must be anthracycline containing Must have received Rituximab or another CD20 antibody and at minimum two chemotherapy regimens appropriate for their disease Either failed autologous transplant or ineligible to receive autologous transplant 7. Karnofsky performance score ≥70. See Appendix A for scales. 8. Normal Baseline Neurological Evaluation: Mini-Mental Status Exam Score 24-30. 9. Adequate hepatic function, defined as AST and ALT <5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease. 10. Adequate renal function, defined as creatinine clearance>60 ml/min 11. Able to provide written informed consent. 12. Agree to practice birth control during the study. 13. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥35% (by cardiac ECHO or MUGA) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%. 14. Expected survival >12 weeks. 15. Negative urine or serum pregnancy test in females of child bearing potential at study entry and again within 48 hours' prior lymphodepleting chemotherapy. 16. Patients with prior blinatumomab treatment require repeat biopsy post-blinatumomab treatment that demonstrates CD19 or CD20 positive disease. 17. Meet for regarding fertility and contraception. 18. Central line access will be required for CAR-20/19-T cell infusion Positive beta-HCG in female of child-bearing potential. 2. Patients with known systemic allergy to bovine or murine products. 3. Known prior positive serology for human anti-mouse antibody (HAMA). 4. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. 5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy defined as >20 mg of prednisone or equivalent daily. 6. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease. 7. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of ≥4 weeks required from administration of any other investigational agents on other clinical trials prior to enrollment on this CAR-T protocol. 8. Refusal to participate in the long-term follow-up protocol. 9. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture. a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis. 10. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression. 11. Previous CAR-T cell therapy directed at either CD19 or CD20 within 100 days of planned CAR-20/19-T cell infusion (does not re-enrollment) a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry. 12. Anti-CD20 antibody treatment within 4 weeks of cell infusion. 13. Anti-CD19 antibody treatment within 4 weeks of cell infusion. 14. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion. 15. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells. 16. Patients post solid organ transplant who develop high grade lymphomas or leukemias. 17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin. Special for regarding Fertility and Contraception Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure [hysterectomy or bilateral oophorectomy]) must have a negative serum or urine pregnancy test performed as part of and again within 48 hours of initiation of lymphodepleting chemotherapy. Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol. Acceptable birth control includes a combination of two of the following methods Condoms* (male or female) with or without a spermicidal agent Diaphragm or cervical cap with spermicide Intrauterine device (IUD) Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy tubal ligation, salpingectomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception | 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, Hodgkin Lymphoma Cohort A overview: Patients age less than 60 with untreated stage III or IV classical Hodgkin lymphoma will be eligible for cohort A. In phase I, patients could enroll onto cohort A if they had have a baseline IPS ≥3 OR if their PET scan after 2 cycles of ABVD is positive (Deauville 4 or 5). Enrollment onto phase I has now ceased and enrollment will begin for phase II. In phase II, patients less than 60 years of age with stage III or IV HL are eligible. MSK patients may enroll anytime within the first 2 cycles of ABVD Non-MSK patients must enroll after positive PET-2 scan Cohort B overview: Patients 60 or older with untreated classical Hodgkin lymphoma (regardless of stage) will be eligible for cohort B. The following applies to both cohort A and B except when stated otherwise Histologic diagnosis of classical Hodgkin lymphoma FDG-avid disease by FDG-PET/CT Non-MSK patients ONLY: PET-2 positive disease (Cohort A only) Ann Arbor Stage III or IV disease (Cohort A only) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to the start of study drug. Women who undergo fertility preservation within 2 weeks of beginning chemotherapy are expected to have false-positive pregnancy tests and therefore testing may be waived for these patients WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women who undergo fertility preservation within 2 weeks of beginning chemotherapy are expected to have false-positive pregnancy tests and therefore testing may be waived for these patients Reliable methods of birth control a double barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, tubal ligation or total abstinence during the study Women must not be breastfeeding Subjects with active brain metastases or leptomeningeal metastases Subjects with nodular lymphocyte-predominant HL Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Subjects with a condition requiring systemic treatment with systemic corticosteroids (equivalent of >10mg/day of prednisone). Patients may receive steroid therapy if steroids are tapered down to 10mg or less by 4 weeks after initiating A(B)VD to control lymphoma-related symptoms Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug A left-ventricular ejection fraction < 50% Myocardial infarction within 2 years of randomization New York Heart Association (NYHA) Class III or IV heart failure | 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, Diffuse Large B-cell-lymphoma Classical Hodgkin Lymphoma Histologically confirmed diagnosis of classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma Age ≥18 years The need of anti-neoplastic treatment Written informed consent Carriers of cardiac pacemakers Carriers of metal mesh implants, tissue expanders (breast) Holders of metal implants, cochlear implants and stapedial prostheses, plates or screws, wires, nails, spinal-column distractors, ferromagnetic vascular clips, mechanical heart valves, Swan-Ganz catheter, endocorporal electrodes, neurostimulators, vascular filters, stents and metal spirals that they do not know the characteristics (the manufacturer, type and date of implant) and/or secure magnetic compatibility Holders of metal fragments in the eye, visceral or intracranial Tattoo holders executed by less than 6 months Claustrophobic patients Pregnant patients Patients with uncontrolled diabetes mellitus Patients who do not provide written informed consent to the study | 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): 18.0-73.0, Lymphoma, Large-Cell, Anaplasitc Enteropathy-Associated T-Cell Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Extranodal NK-T-Cell Lymphoma, T-Cell, Peripheral Malignancy Patients must have anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, grey zone lymphoma, enteropathy-associated T-cell lymphoma, or extranodal NK/T-cell lymphoma, nasal type Clear CD30 expression must be detected on 75% or more of malignant cells from either bone marrow or lymphoma mass by flow cytometry or immunohistochemistry. The patient s malignancy will need to be assessed for CD30 expression by flow cytometry or immunohistochemistry performed at the NIH. If unstained, paraffin-embedded bone marrow or lymphoma sections are available from prior biopsies, these can be used to determine CD30 expression by immunohistochemistry; otherwise, patients will need to come to the NIH for a biopsy to determine CD30 expression. The sample for CD30 expression can come from a biopsy obtained at any time before enrollment, unless the patient has received a prior anti-CD30 monoclonal antibody, in which case the sample must come from a biopsy following completion of the most recent anti-CD30 monoclonal antibody treatment Eligible patients with diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma must have received 2 prior treatment regimens at least 1 of which included an anthracycline and an anti-CD20 monoclonal antibody Patients must have measurable malignancy as defined by at least one of the below Lymphoma mass that is measurable (minimum 1.5 cm in largest diameter) by CT scan is required unless bone marrow lymphoma is detectable For a lymphoma mass to count as measurable malignancy, it must have abnormally increased metabolic activity when assessed by positron emission tomography (PET) scan For lymphoma with only bone marrow involvement, no mass is necessary, but if a mass is not present, bone marrow malignancy must be detectable by flow cytometry. Other Greater than or equal to 18 years of age and less than or equal to age 73 Able to understand and sign the Informed Consent Document Patients with Hodgkin lymphoma are no longer eligible for participation (as of amendment G, Protocol version: 08/12/2019) Patients that require urgent therapy due to tumor mass effects or spinal cord compression Patients with lymphoma masses 10.0 cm or larger in longest diameter will not be eligible Patients that have active hemolytic anemia Patients who are currently taking any medications for systemic anticoagulation other than aspirin will not be eligible Patients with second malignancies in addition to their lymphoma are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 4 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Women of child-bearing potential are defined as all women except women who are postmenopausal or who have had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when the intravenous antibiotics have been administered for less than 72 hours); active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system; history of myocardial infarction; history of idiopathic ventricular tachycardia or ventricular fibrillation in the past 12 months or history of ventricular tachycardia or ventricular fibrillation (VT/VF) associated with VT/VF risk factors (e.g., QT prolongation and cardiomyopathy); active cardiac arrhythmias (Active atrial fibrillation is not allowed, but resolved atrial fibrillation is allowed.); active obstructive or restrictive pulmonary disease; or active autoimmune diseases such as rheumatoid arthritis Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) , unless the immunodeficiency has been cured by allogeneic stem cell transplant | 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, Richter Syndrome Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per IW-CLL 2008 (Hallek et al, 2008) with biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome Age greater than or equal to 18 years. Because CLL and Richter's Syndrome are extremely rare in persons <18 years of age, children are excluded from this study ECOG performance status <2 (see Appendix A) Patients must meet the following hematologic at screening, unless they have significant bone marrow involvement of their malignancy confirmed on biopsy Absolute neutrophil count ≥1000 cells/mm3 (0.5 x 109/L). Growth factor allowed to achieve Platelet count ≥40,000 cells/mm3 (40 x 109/L) independent of transfusion within 7 days of screening Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min using 24-hour urine collection for creatinine clearance Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN Bilirubin ≤ 1.5 × ULN Patients with the Hodgkin variant transformation of CLL will be excluded History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to the chemotherapy drugs used in this study (see Appendix D), unless the antibody can be given through a desensitization program in consultation with an allergist Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of chemotherapy, or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: --Any anti-cancer therapy including chemotherapy, biologic agents for anti-neoplastic treatment (e.g. monoclonal antibodies) or radiotherapy, investigational therapy, including targeted small molecule agents. Patients who are currently receiving treatment with ibrutinib or acalabrutinib may continue this agent until the day prior to starting venetoclax, to reduce the risk of tumor flare on treatment cessation Received previous treatment with R-CHOP, R-EPOCH, or R-hyper-CVAD History of other malignancies, except Malignancy treated with curative intent and with no known active disease present before the first dose of study drug and felt to be at low risk for recurrence by treating physician Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Low-risk prostate cancer on active surveillance Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drug | 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, Cholecystitis, Acute Elderly Infection Drain Abscess clinical markers of acute cholecystitis diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US) clinical diagnosis was not confirmed with imaging | 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, Recurrent Adult Acute Lymphoblastic Leukemia Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma Refractory Adult Acute Lymphoblastic Leukemia Refractory B-Cell Non-Hodgkin Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma Recurrent Transformed Non-Hodgkin Lymphoma Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements Recurrent B Acute Lymphoblastic Leukemia Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Refractory B Acute Lymphoblastic Leukemia Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements FOR Diagnosis of R/R B-cell NHL or ALL as defined below Relapsed or refractory B-cell NHL meeting all of the following Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; LBCL transformed from any indolent histology; or primary mediastinal B-cell lymphoma (PMBCL) Prior treatment with an anthracycline and rituximab or another CD20-targeted agent (unless the disease is CD20-negative); transformed DLBCL (tDLBCL) must have failed treatment for DLBCL At least one of the following Refractory disease after frontline chemo-immunotherapy Not eligible for autologous hematopoietic stem cell transplant (auto-HSCT) Relapsed or refractory disease after at least 2 lines of therapy or after auto-HSCT Relapsed or refractory disease after allogeneic hematopoietic stem cell transplant (allo-HSCT) FOR For patients in stage 1 only, prior treatment with any CD19 CAR T-cell therapy is excluded Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection Pregnant or breastfeeding women Any known contraindication to leukapheresis Any known and irreversible contraindication to huJCAR014 therapy Medical, psychological, familial, sociological, or geographical condition that does not permit compliance with the protocol as judged by the PI or designee, or unwillingness or inability to follow protocol procedures FOR AND PRE-THERAPY History or presence of clinically relevant central nervous system (CNS) pathology that, in the opinion of the PI or designee, is a contraindication to lymphodepleting chemotherapy or huJCAR014 infusion History of another primary malignancy that has not been in remission for at least 2 years with the following exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, or other malignancy considered by the investigator to have a low risk of relapse or progression Active autoimmune disease requiring immunosuppressive therapy, unless considered by the PI or designee to be eligible | 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): 0.0-65.0, Lymphoma Histologically confirmed aggressive B cell lymphoma 2. Chemotherapy-refractory disease, defined as one or more of the following: No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy 3. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia) 4. Age 18 or older 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 6. ANC ≥1000/uL 7. Platelet count ≥75,000/uL 8. Absolute lymphocyte count ≥100/uL 9. Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min Serum ALT/AST ≤2.5 ULN Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50% ,no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation >92% on room air 10. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years 2. History of Richter's transformation of CLL 3. Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion 4. History of allogeneic stem cell transplantation 5. Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment 6. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy 7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides 8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the K Medical Monitor. 9. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing. 10. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted 11. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases 12. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 13. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement 14. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment 15. Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression 16. Primary immunodeficiency 17. History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment 18. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment 19. History of severe immediate hypersensitivity reaction to any of the agents used in this study 20. Live vaccine ≤ 6 weeks prior to start of conditioning regimen 21. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential 22. Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of CAR-C19 23. In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation 24. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years | 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, Hepatitis B HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia | 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): 0.0-75.0, Non-Hodgkin Lymphoma Hodgkin Lymphoma Eligible Diseases 1. Non-Hodgkin's Lymphoma (NHL) Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification Patients in partial or complete remission following cell therapy will also be eligible NHL patients with resistant or refractory lymphoma (no PR following up to three cycles of combination chemotherapy) will not be eligible for transplant in this trial Lymphoblastic Lymphoma: 1. All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR) 2. Patients with any high-risk features will be eligible in first complete remission 3. High risk features Stage IV, LDH >2 x upper limit of normal, ≥ 2 extranodal sites Mature B-cell Lymphoma 1. Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2 2. Diffuse Large B-Cell Lymphoma: in ≥ CR2 or ≥ PR1; a high intermediate or high IPI (≥ 2 for age-adjusted IPI or ≥3 for IPI) at diagnosis and double-hit or triple-hit lymphoma will be eligible in first CR; transformed lymphoma from FL (or other indolent lymphoma) or chronic lymphocytic leukemia will be eligible if chemosensitive and bone marrow is negative 3. Mantle Cell Lymphoma: in first or greater CR or PR 4. Burkitt's/Burkitt's like: all patients except localized lymphoma will be eligible any time after initial therapy (after achievement of first complete remission), or in partial remission if they fail to achieve CR; patients with localized (stage I or Ziegler stage A) will be eligible only if they fail to achieve CR1 or after relapse Mature T-Cell Lymphoma 1. Chemosensitive T-cell lymphomas including Primary T-cell not otherwise specified angioimmunoblastic, and ALK-positive anaplastic large cell, will be eligible after initial therapy, whether or not CR is achieved. 2. Mycosis fungoides/Sezary syndrome will be eligible in ≥CR2/PR2 2. Hodgkin Lymphoma (HL) Patients with histologically proven HL will be eligible for transplantation after failing prior therapy Patients with resistant disease (initial or at relapse): those who fail to achieve an objective partial response to three cycles of combination non-cross resistant chemotherapy will not be eligible for transplant in this trial For stage I/II patients treated with primary chemotherapy-radiation, they must have failed (no CR or progression after CR) at least one salvage combination chemotherapy treatment regimen Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy Eligible for any higher priority transplant protocols Chemotherapy resistant disease Unrelated active infection | 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): 5.0-75.0, Acute Leukemia Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Chronic Myelogenous Leukemia, BCR-ABL1 Positive Diffuse Large B-Cell Lymphoma Follicular Lymphoma Graft Versus Host Disease Hodgkin Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Myelodysplastic Syndrome Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Secondary Myelodysplastic Syndrome Patients with acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 10% blasts in the bone marrow Patients with myelodysplastic syndrome (MDS) with intermediate-2 or high risk per International Prognostic Scoring System (IPSS) (or intermediate, high, very high risk by Revised International Prognostic Scoring System [IPSS-R]) or myeloproliferative neoplasm; primary or secondary if high-risk features or refractory disease Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin lymphoma, or mantle cell lymphoma with chemosensitive disease at time of transplantation; all types of lymphoma are eligible High risk, or refractory and relapsed multiple myeloma No available human leukocyte antigen (HLA)-matched related donor Available matched unrelated donor Ejection fraction at rest >= 50% Karnofsky performance status (KPS) >= 70 Measured creatinine clearance more than 60 mL/min. The updated Schwartz formula should be used for pediatric patients (>=5 to 12 years old) Carbon monoxide diffusing capability test (DLCO) >= 50% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) >= 50% Prior allogeneic transplant Active central nervous system (CNS) involvement by malignant cells Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment Patients with transformed lymphoma (e.g., Richter's transformation arising in follicular lymphoma or chronic lymphocytic leukemia) Patients seropositive for the human immunodeficiency virus (HIV) Patients with active hepatitis B or C determined by polymerase chain reaction (PCR) Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiography (ECG) abnormality at screening must be documented by the investigator as not medically relevant Female patients who are lactating or pregnant Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [Stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear) | 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): 40.0-999.0, Stroke The for the participants included in this study involved both male and female of 40 year old or more of different body weights, and able to speak Arabic. Participants with at least one risk factor like hypertensive, diabetic, and dyslipidemia will be included in this study A family member of any participants will be excluded and will not participate in 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, Quality of Life years of age or older Patients undergoing EEA for resection of brain tumors Dural defect greater than 1cm Extensive arachnoid dissection Dissection into a ventricle or cistern Less than 18 years of age Spina Bifida | 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 Hyperplasia Lymphoid Reactive Adults 18 years and above Has condition related to lymphoma or reactive lymphoid hyperplasia Age below 18 years Known pregnancy lymph tissue cannot be accessed | 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): 0.0-999.0, Non Hodgkin Lymphoma Non hodgkin lymphoma patients of any age or sex healthy volunteers within the same range of age patients with any other haematological malignancy | 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): 0.0-18.0, Mature B-cell Non-Hodgkin Lymphoma Newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification124. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL, double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis) age at diagnosis < 18 years diagnostics and treatment in one of the participating centers of the trial no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma infiltration. Please contact the study center in case of unclear cases signed informed consent of patient and/or parents/guardians for treatment according to the protocol, participation and transfer of data follow-up of at least two years after initial diagnosis is expected Certificate of vaccination against hepatitis B or negative serology, defined as evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or patients with insufficient work up not allowing a correct stratification into the risk groups B-cell neoplasia as second malignancy any other medical, psychiatric or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.) participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc overt hepatitis B or history of hepatitis B hypersensitivity to rituximab or to murine proteins or to any of the other excipients of the Investigational Medicinal Product rituximab (MabThera®) or to ingredients of other IMPs lack of CD20 expression of the lymphoma cells pregnancy and lactation | 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, Venous Occlusion referred for placement of central venous access catheter have limited or diminishing upper body venous access have pathology impeding standard access methods willing to give written informed consent occlusion of the right femoral vein occlusion of the iliac vein occlusion of the inferior vena cava contraindicated by physician acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian diagnosed with active pericarditis diagnosed with active endocarditis suspected pericardial effusion known or suspected aneurysm or ectasia of ascending aorta innominate artery or subclavian artery | 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): 18.0-64.0, Lymphoma Aged 18-64 Within 2 years post-treatment completion for lymphoma English speaking Able and willing to provide informed consent Cancer treatment or follow-up for lymphoma at the MGH Cancer Center Unwilling or unable to participate in the study Unable to speak or read English Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI) Unwilling or unable to participate in group 3RP sessions delivered via the Partners Telehealth videoconferencing software Participation in qualitative interview during Phase 1 (DF/HCC 16-396) | 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, B Acute Lymphoblastic Leukemia CD19 Positive Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma of the Elderly Minimal Residual Disease Philadelphia Chromosome Positive Recurrent Diffuse Large B-Cell Lymphoma Recurrent Mediastinal (Thymic) Large B-Cell Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Mediastinal (Thymic) Large B-Cell Cell Lymphoma T-Cell/Histiocyte-Rich Large B-Cell Lymphoma For diffuse large B-cell lymphoma (DLBCL) Histologically confirmed aggressive B cell non-Hodgkin lymphoma (NHL) including the following types defined by World Health Organization (WHO) 2008 DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR Primary mediastinal (thymic) large B cell lymphoma Transformation of follicular lymphoma to DLBCL will also be included Subjects with DLBCL must have progressed, had stable disease (SD), or recurred after initial treatment regimens that an anthracycline and an anti CD20 monoclonal antibody; subjects who relapse >= 12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant For B acute lymphoblastic leukemia (ALL) Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of standard therapies (two induction regimens), or relapsed disease after 2 established induction regimens Subjects with persistent or relapsed minimal residual disease (MRD) / next generation sequencing (NGS) relapse require verification of relapse on two occasions at least 4 weeks apart Subjects with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs) History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years History of Richter?s transformation of chronic lymphocytic leukemia (CLL) Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment; known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (anti hepatitis C virus [HCV] positive); a history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement Subjects receiving anticoagulation therapy Any medical condition that in the judgement of the sponsor investigator is likely to interfere with assessment of safety or efficacy of study treatment History of severe immediate hypersensitivity reaction to any of the agents used in this study Women of child bearing potential who are pregnant or breastfeeding; females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential In the investigators judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation | 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, B Acute Lymphoblastic Leukemia CD19 Positive Minimal Residual Disease Philadelphia Chromosome Positive Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia 1 1. Diagnosis: ALL In view of the PI and the primary oncologist, there must be no available alternative curative therapies or subject has declined to pursue alternative therapy; and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment. 1. Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of therapies 2. Recurrence of disease after achieving a complete response (CR). 3. Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart. 4. Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs). 5. Subjects with recurrence of isolated CNS relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart. 2. Diagnosis: Lymphoma Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that an anthracycline and an anti CD20 monoclonal antibody. Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant. 3. CD19 expression CD19 expression is required at any time since diagnosis. If patient has received anti-CD19 targeted therapy (i.e. Blinatumomab), then CD19 expression must be subsequently demonstrated. CD19 expression. must be detected on greater than 50% of the malignant cells by immunohistochemistry or ≥ 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples. 4. Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other are met. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other they are at least 100 days post-transplant, they have no evidence of active GVHD and have been without immunosuppressive agents for at least 30 days. 5. Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if < 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry. 6. Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised IWG Response for Malignant Lymphoma[66] must be present. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. 7. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives. Exceptions: f. There is no time restriction with regard to prior intrathecal chemotherapy (incl. steroids) provided there is complete recovery from any acute toxic effects of such; g. Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; h. Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis. i. Subjects receiving steroid therapy at physiologic replacement doses (≤ 5 mg/day of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; j. For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port. 8. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities) 9. Age Greater than or equal to 1 year of age and less than or equal to 30 years of age at time of enrollment; must meet parameters for apheresis per institutional guidelines. NOTE: The first subject in the first dose cohort must be ≥ 18 years of age if an adult has not been treated at that dose cohort on the companion Stanford protocol "Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies" and undergone safety evaluation at Day 28 without evidence of DLT. 10. Performance Status: Subjects > 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50% (See Appendix B Section 14.2) 11. Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion) 1. ANC ≥750/uL* 2. Platelet count ≥50,000/uL* 3. Absolute lymphocyte count ≥150/uL* 4. Adequate renal, hepatic, pulmonary and cardiac function defined as Serum ALT/AST ≤10 ULN (unless elevated ALT/AST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient) Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation >92% on room air at rest creatinine: within age adjusted normal institutional limits (see table below) OR creatinine clearance ≥60 mL/min/1.73 m2 (as estimated by Cockcroft Gault Equation) for subjects with creatinine levels above institutional normal. Age (Years) Maximum Serum Creatinine (mg/dL) ≤5 0.8 5 < age ≤ 10 1.0 >10 1.2 * if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies. 12. CNS Status 1. Subjects with ALL Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs CNS 2, defined as presence of < 5/µL WBCs in CSF and cytospin positive for blasts, or > 5/µL WBCs but negative by Steinherz/Bleyer algorithm Subjects meeting any of the following are not eligible for participation in the study: 1. Recurrent or refractory ALL limited to isolated testicular. 2. Subjects with radiologically-detected CNS lymphoma or CNS 3 disease (presence of ≥ 5/µL WBCs in CSF and cytospin positive for blasts [in the absence of a traumatic lumbar puncture] and/or clinical signs of CNS leukemia). 3. Hyperleukocytosis (≥ 50,000 blasts/µL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy. 4. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years. 5. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing. 6. CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in the judgment of the investigator may impair the ability to evaluate neurotoxicity. 7. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement. 8. Subjects receiving anticoagulation therapy. 9. Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment 10. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 11. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning lymphodepletion chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. 12. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. 13. May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years | 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): 40.0-999.0, Hypertension Obesity Lived in Madafu or Markazi neighborhoods of Ukonga Ward in Tanzania Pregnant Mentally or physically disabled | 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, Infection, Bacterial Antibiotic Resistant Infection Diagnostic Self Evaluation Meningitis, Bacterial Nosocomial Infection all post neurosurgical patients with suspect infection or fever | 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, Breast Cancer Male or female patient ≥ 18 years-old, no age limit; 2. Histologically confirmed diagnosis of BC; 3. Hormone receptors and HER2 statuses of the primary tumor available; 4. Suspected LM based on clinical symptoms or signs, or radiological abnormalities; 5. Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient; 6. Patients must be affiliated to a Social Security System; 7. Patient information and written informed consent form signed prior to any study specific procedures History of other cancer(s) than the BC (except completely resected non-melanoma skin cancer or successfully treated in situ carcinoma). 2. Hormone receptors and/or HER2 statuses of the primary tumor not available; 3. Patients with a medical contra-indication to the realization of a lumbar puncture; 4. Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 5. Patients who are pregnant or breast-feeding. 6. Legal incapacity or limited legal capacity | 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, Thrombotic Microangiopathies Patients be scheduled to undergo HSCT; 2. Not received decitabine 6 month ago; 3. Without severe organ damage; 4. ECOG 0-2; 5. Informed consent were obtained Be sensitive to NAC; 2. Bronchial asthma； 3. Peptic ulcer； 4. Severe organ damage； 5. Pregnancy and breastfeeding 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): 18.0-75.0, Lung Cancer Brain Metastases Cerebrospinal Fluid Next-generation Sequencing Male or female, aged over 18 and less than 75 years old 2. The estimated survival period is greater than 12 weeks 3. ECOG score is less than 2 4. Histological diagnosis is non-small cell lung cancer, and there are enough tissue specimens for lung cancer related gene detection 5. The brain metastasis is confirmed by brain MRI, and the first line treatment of brain metastasis was considered as chemotherapy or target therapy 6. There must be at least one evaluable lesion based on the of 1.1 (maximum diameter at least 10mm on spiral CT and MRI) 7. Patients are tolerable for lumbar puncture with no contraindication 8. Patients are able to comply with the research requirements and follow-up procedures 9. Patients must sign the informed consent prior to the beginning of any substantive test procedure (informed consent is subject to approval of the independent ethics committee) Brain metastases were treated 2. Intracranial symptoms were obvious, and radiotherapy/surgery was considered in the first line treatment 3. Histological specimens are not enough to detect lung cancer related genes 4. Patients were suffering from other types of malignancy 5. Patients have any contraindications of lumbar puncture 6. Patients have any uncontrolled systemic disease, including active infection, uncontrolled high blood pressure, diabetes, unstable angina and congestive heart failure, myocardial infarction (1 year) before the start of treatment, severe arrhythmia that needs drugs therapy, coagulant function abnormality, liver or kidney or metabolic disease 7. Pregnant and lactating pregnant women 8. Patients were not willing to be followed up | 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, Obesity Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or mountain time zone) Access to DVD player or internet Able to participate fully in all study protocol/procedures including informed consent Inability to speak, read, or understand English Recent weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, bariatric surgery (or plans for during the study period) Expected weight loss because of alternate explanations such as from illness High variability in weight due to fluctuations in volume status (ascites liver disease, chronic heart failure) Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy <24 months Pregnant, lactating, or planning to become pregnant during the study period Participation in other intervention studies | 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): 20.0-70.0, Non-hodgkin Lymphoma Histologically confirmed Non-Hodgkin lymphoma Patients able to understand requirements of the study and provide written informed consent Previous radio or chemotherapy Other serious chronic diseases Statin therapy Presence of allergy on any seeds Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study | 2 |
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