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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): 3.25-3.833, Pneumococcal Disease Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study. 2. Aged 39-46 months (inclusive) at time of enrolment. 3. Available for entire study period and whose parent/legal guardian can be reached by telephone. 4. Healthy children as determined by medical history, physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator. 5. Parent/legal guardian must be able to complete all relevant study procedures during study participation Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007). 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Contraindication to vaccination with pneumococcal conjugate vaccine. 4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. Known or suspected immune deficiency or suppression. 6. History of culture-proven invasive disease caused by S pneumoniae. 7. Major known congenital malformation or serious chronic disorder. 8. Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. 9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, synagisB). 10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable. 11. Child who is a direct descendant (child, grandchild) of the study site personnel | 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, Non Hodgkin's Lymphoma NHL Aggressive NHL Diffuse Large B-cell Lymphoma Male or female, >18 years old Histological diagnosis of CD20+ B-cell NHL, with DLBCL or other aggressive lymphomas by WHO lymphoma including mantle cell lymphoma and transformed follicular lymphoma Failed at least one prior standard treatment regimen for NHL If DLBCL, either received, ineligible for or refused high-dose chemotherapy with stem cell transplant Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension Adequate performance status (>70 Karnofsky scale, 0-1 ECOG)* with an estimated life expectancy of at least 6 months Laboratory parameters Adequate hematology (Hemoglobin >/= 10 g/dL, ANC >/= 1.5 ´ 109/L, platelets >/=100 x 109/L) without ongoing transfusional support Adequate renal and liver function (creatinine and bilirubin </= 1.5 x IULN; AST and ALT </= 2.5 x IULN) Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 3.0 Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test NCI CTC Grade 3 or 4 infusion reaction to prior anti-CD20 antibodies (rituximab, veltuzumab, etc.) A known anti-antibody response to prior antiCD20 antibodies (HACA positive, HAHA positive, etc) Prior radioimmunotherapy, including Zevalin or Bexxar Prior high-dose chemotherapy with peripheral blood stem cell transplant Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis Rituximab or veltuzumab resistant, defined as having progressed during or within 6 months of any prior rituximab or veltuzumab treatment Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter Bone marrow involvement ≥25% | 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): 60.0-80.0, Lymphoma Diffuse Large B-cell Lymphoma Ages Eligible for Study: Between 60 and 80 years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No For patients registered at the time of initial diagnosis Patient with histologically proven CD20+ diffuse large B cel (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included 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 Or CD20+ Aggressive B-cell lymphoma unclassifiable previous untreated with chemo or radiotherapy For patients registered after response evaluation to first line treatment with R-CHOP Patient with histologically proven CD20+ diffuse large B cell (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included 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 Or CD20+ Aggressive B-cell lymphoma unclassifiable Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimens and up to 8 cycles of R-CHOP21 Previously untreated with Radiotherapy For all patients aged from 60 to 80 years at time of registration Ann Arbor stages II-IV at time of initial diagnosis aaIPI> 1 at time of initial diagnosis 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 Contraindication to any drug contained in the chemotherapy regimen Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV Uncontrolled hypertension Uncontrolled diabetes mellitus as defined by the investigator Active systemic infection requiring treatment previously known HIV positive serology Active hepatitis B or C Prior history of malignancies other than lymphoma within 3 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, Cholecystitis, Acute Patients aged 18 Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of cholecystitis Surgical indication for laparoscopic cholecystectomy ASA class I-III Informed consent <72 hours from onset of symptoms Informed consent refusal Choledocholithiasis Pre surgical generalized peritonitis (clinical evaluation) ASA class > III Peripheral artery disease Active or past history of malignant systemic disease Pregnant or lactating females Known allergy to components Floseal including bovine allergy (bovine gelatin) Known drug or alcohol abuse Patients with known diabetes, chronic renal disease and other metabolic diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-80.0, Follicular Lymphoma Patients older than 18 years of age Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens Relapse of disease must be greater than 6 months after last chemotherapy Stages II, III or IV Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator Patient signed written informed consent Adequate renal function defined as a glomerular filtration rate (GFR) > 60 ml/min Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow No known allergies to the chemotherapeutic agents No other major disabling co morbidities Stage I follicular lymphoma ECOG performance status ≥ 2, unless due to lymphoma Patient refuses to sign written informed consent Poor renal function defined as GFR <60ml/min Abnormal liver function as assessed by study investigator Poor bone marrow reserve (absolute neutrophil count <1,500 and/or platelets < 100,000) not attributable to lymphomatous involvement of the bone marrow Hypersensitivity to the chemotherapeutic agents Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed <5 years prior Central nervous system 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): 18.0-75.0, Non-Hodgkin's Lymphoma Age ≥ 18 and ≤ 75 years. 2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL. 3. Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy). 4. ECOG ≤ 2. 5. Signed written informed consent Clinical suspicion or documentation of histological transformation. 2. Have received prior chemotherapy scheme, first line without Rituximab. 3. Prior autologous or allogeneic. 4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis). 5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA) 6. HCV infection. HIV infection or other conditions of serious immunosuppression. 7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. 8. Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%. 9. Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma. 10. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma. 11. Women who are nursing or pregnant. Women of childbearing potential will be included prior pregnancy test serum / urine negative. Use effective contraception to be kept for 1 year after cessation of rituximab. 12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. 13. Severe acute or chronic infection in activity. 14. Any other concurrent medical or psychological comorbidity that might interfere with participation 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): 0.5-75.0, Lymphoma Leukemia Myelodysplastic Syndrome First-degree related donor who is at minimum HLA haploidentical Eligible diagnoses: 1. Low-grade non-Hodgkin's lymphoma or plasma cell neoplasm that has progressed during multiagent therapy, failed at least two prior therapies (excluding single agent rituximab and single agent steroids), or in the case of lymphoma undergone histological conversion Follicular grade 1 or 2 lymphoma Follicular lymphoma not otherwise specified Marginal zone (or MALT) lymphoma Lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia Hairy cell leukemia Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) Prolymphocytic leukemia Low grade B-cell lymphoma, unspecified Pregnant or breast-feeding Uncontrolled infection Note: Infection is permitted if there is evidence of response to medication. of HIV infected patients will be determined on a case-by-case basis Any previous BMT within 3 months prior to start of conditioning Active extra-medullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted | 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, Crohn's Disease Ulcerative Colitis Age 18 or above Informed consent given by patient or family Case group (IBD patients) Diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology Control group (non-IBD cases) Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy No consent Controls will be excluded if they have previously been diagnosed with IBD or if they have a first or second degree relative with IBD | 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, Kidney Donation Kidney Failure Kidney Transplantation Underwent unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005 at Mayo Clinic or University of Minnesota Alive at the time of study recruitment Underwent GFR measurement before and early after donor nephrectomy (Mayo Clinic participants only) Underwent GFR measurement late after donor nephrectomy and 3 or more years prior to the invitation to participate in this study (UMN participants only) Self reported black race (UAB participants only) Negative serum pregnancy test (Total Beta Human Chorionic Gonadotropin (HCG) <5) for women of child-bearing potential Less than 5 years out from time of kidney donation Inability to contact donor Inability or unwillingness to provide informed consent Iodine or iodinated contrast allergy Pregnant or breast feeding 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): 20.0-35.0, Polycystic Ovarian Syndrome Healthy subjects and PCOS patients at ages 20-35 will be recruited for the study Those with any metabolic or endocrine problems other than PCOS will 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): 18.0-65.0, Spinal Cord Injury Age 18 to 65 American Spinal Injury Association Impairment Scale A Clinical evidence of lesions located below c-spine 5 (C-5) Confirmation by MRI of injury level Time between injury and enrollment greater than 2 weeks Ability to provide informed consent Platelet count greater than 100 Thousand/uL at screening INR equal to or less than 1.5 Hematocrit less than 30% prior to bone marrow aspiration Spinal cord injury within 60 months of screening Anoxic brain injury Inability to provide consent Sepsis Neurological deficits attributed to lesions above C-5 Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased Multiple sclerosis Amyotrophic lateral sclerosis Cerebral Palsy Evidence of cancer over the last 3 years prior to enrollment Immunosuppressive diseases | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-35.0, Polycystic Ovarian Syndrome Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus Female subjects suitable for IVF/ICSI, undergoing first or second attempt 35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0) Normal FSH value (less than 10 international unit per liter [IU/L]) on Day 3 of spontaneous cycle within 12 months prior to the trial Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter [ng/mL]) of a spontaneous cycle within 12 months prior to the trial or at least at V0 No history of active genito-urinary infection Normal thyroid function (or adequate substitution for at least 3 months) Negative cervical papanicolaou test within the last 12 months prior to study entry No gonadotropins, for at least one month prior to the trial No metformin therapy for at least one month prior to Visit 1 (V1) Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term Drilling 3 months prior to V0 Uterine malformation, diethylstilbestrol syndrome, synechia Female subjects with World Health Organization (WHO) Type I or III anovulation Female subjects with hyperprolactinemia Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons) Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner Abnormal gynecological bleeding of undetermined origin History of major thromboembolic disease Endometriosis (Grade III or IV) | 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, Diffuse Large B-cell Lymphoma Newly diagnosed patients with diffuse large B cell lymphoma 2. > 20 years 3. life expectancy more than 6 months 4. Written informed consent Refusal to informed consent 2. Lymphomas other than diffuse large B cell lymphoma 3. Primary CNS lymphoma | 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): 18.0-34.0, Polycystic Ovarian Syndrome 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form. 2. A diagnosis of PCOS by their primary MD 3. An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion 4. A day 3 FSH level of <8 IU/mL 5. In good general health off of current medications which may confound response to study medications. 6. Desire to seek pregnancy actively during the study period by IVF-ICSI. 7. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study. 8. Male partner able to provide adequate semen sample by ejaculation (no TESE) Current pregnancy 2. Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry. 3. Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL). 4. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol. 5. Patients with significant anemia (Hemoglobin < 10 mg/dL). 6. Patients enrolled simultaneously into other investigative studies that would interfere with this research study. 7. have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) - | 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): 18.0-95.0, Osteoarthritis History of mild to moderate OA OA grade II Intraarticular injections in the affected knee Oral application of glucosamine and chondroitin sulphate during the last 6 months prior to the beginning of the study Clinically significant knee joint effusion Neoplasm Diabetes mellitus Osteonecrosis Rheumatoid arthritis or any other inflammatory arthritis diagnosed by American College of Rheumatology criteria | 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 patients with recent cardiac surgery admitted for cardiac rehabilitation pericardial effusion > grade 2 (corresponds to a loculated effusion > 10 millimeters or a circumferential effusion of any size)on the first trans thoracic echocardiography performed more than 7 days after surgery patients who do not give written consent to participate pregnancy colchicine allergy renal failure, which we define as a serum creatinine level > 250micromol/l or clairance < 30 ml/mn heart transplantation,or correction of congenital heart anomalies cardiac surgery more than 30 days before their first trans thoracic echocardiography pericardial effusion that requires immediate drainage | 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): 35.0-999.0, Chronic Total Occlusions Candidates for this study must meet ALL of the following Subject is willing and able to provide an informed consent Subject is willing and able to comply with the study procedures and follow-up Subject is 35 years of age or older Women who are non-reproductive, or reproductive women who are willing and able to practice effective birth control methods. A urine pregnancy test should be done at the screening/Day0 on all reproductive women of child bearing ability Subjects with CTO (older than 6 weeks or unknown duration based on the investigator's assessment of appropriateness for the study) with a clinical indication for revascularization. In subjects with occlusions of unknown duration, there must be absence of any identifiable ischemic event in the 6 weeks prior to enrolment in the study At least 1 previously failed attempt to cross the CTO Absence of pericardial effusion on 2D Echocardiogram Candidates for this study who meet any of the following at the time of the screening visit are NOT eligible to be enrolled in this study Culprit vessel is a saphenous vein graft occlusion True ostial LAD, LCX or RCA occlusions (since collagenase delivery will be unreliable) Presence of moderate or large pericardial effusion on echocardiogram within 2 weeks of the procedure Major side branch (1.5 mm diameter) within 3 mm proximal to the occlusion. (This is to prevent the infusate being diverted through a side branch and to prevent ischemia during the prolonged period of time during the infusion) Renal dysfunction (creatinine greater than 2 x ULN) Severe calcification (collagenase can not degrade calcium) based on consensus of 2 interventional cardiologists after review of coronary angiogram Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure Subject is a pregnant or lactating female (women of childbearing potential must have a negative serum beta-HCG within 24 hours prior to the inclusion) Subject is or has been partaking in another investigational product clinical study within 30 days of Screening/Day0 | 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): 19.0-50.0, Pregnancy Complications Obesity Obese pregnant women with BMI>35 Informed written consent Diabetes at booking Presence of contra-indication to metformin(renal, liver, heart failure) moving out of study area for pregnancy management Participants who suffer with hyperemesis Participants who are 18 years and below Participants with significantly raised creatinine Participants with high alcohol intake | 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, Ann Arbor Stage III Grade 1 Follicular Lymphoma Ann Arbor Stage III Grade 2 Follicular Lymphoma Ann Arbor Stage III Grade 3 Follicular Lymphoma Ann Arbor Stage IV Grade 1 Follicular Lymphoma Ann Arbor Stage IV Grade 2 Follicular Lymphoma Ann Arbor Stage IV Grade 3 Follicular Lymphoma Grade 3a Follicular Lymphoma Histologically confirmed follicular non-Hodgkin lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present) Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies Fine-needle aspirates are not acceptable Failure to submit pathology within 60 days of patient registration will be considered a major protocol violation Patients must have at least one of the following indicators of poor risk disease >= 3 risk factors by the Follicular Lymphoma International Prognostic Index, or 2 risk factors by the Follicular Lymphoma International Prognostic Index and at least one bulky mass or lymph node > 6 cm in size Follicular Lymphoma International Prognostic Index (FLIPI score) Age > 60 years Involvement of > 4 nodal sites Stage III-IV 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): 6.0-999.0, Transplantation Infection HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml 2. Age >/= 6 years 3. Patient must sign the informed consent document Creatine clearance < 55 ml/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation 2. Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside 3. Use of cidofovir for bladder instillation 4. Use of formalin or hyperbaric oxygen treatment | 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): 1.0-29.0, Meningococcal Disease Cases: i)consent to participate; ii) Laboratory confirmed serogroup A meningococcal disease established by examination of the CSF (turbid CSF or a white cell > 10 per ul) and evidence of a serogroup A meningococcal infection established by (a) culture of serogroup A meningococci from the cerebrospinal fluid, blood or other normally sterile fluid, (b) a positive CSF latex test for serogroup A meningococcal antigen, (c) a positive serogroup A dipstick assay or (d) a positive CSF PCR for serogroup A meningococcal infection; iii) 1 to 29 years old. iii) In target 1-29 year age group at the time of vaccination with MenAfriVac Hospital controls: i)consent to participate; ii)patients admitted to the hospital with an acute illness other than meningitis, matched to cases for age and sex -Community controls: i)consent to participate; ii)Healthy members of the community, matched to cases for age and sex Case: i)Refusal to participate in the study; ii) infants<1 year old and adults>29 years old Hospital controls: i)Refusal to participate in the study; ii)Previous history of meningitis; iii) Presence of symptoms that could indicate meningitis Community controls: i)Refusal to participate in the study; ii)Previous history of meningitis; iii) Presence of symptoms that could indicate meningitis | 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, Metastatic Melanoma CNS Metastases 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 and be able to undergo lumbar puncture for CSF collection Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable if documented from a previous visit within the prior 30 days Subjects must have provided written, informed consent (ICF) prior to any study procedures Subjects must provide a FFPE tissue block containing a biopsy from the primary site 2. 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 Pathologic confirmation (i.e. prior craniotomy) and/or 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 Patients with new focal findings on neurological examination Infected skin over the lumbar puncture needle entry site 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): 16.0-29.0, Adrenal Hyperplasia Polycystic Ovarian Syndrome Oligomenorrhea Obesity Hyperandrogenism FOR Women 16-24 years old with PCOS defined as biochemical hyperandrogenism with associated findings of either menstrual irregularity and /or polycystic ovaries on ultrasound; hyperandrogenism defined as elevation of any of the following androgens: free testosterone, total testosterone, DHEAS, DHEA, 17 0H progesterone, androstenedione, 17OH pregnenolone; a polycystic ovary on ultrasound should either have 12 follicles measuring 2-9 mm in diameter, or have an increased ovarian volume of 10 CC or greater; menstrual irregularity defined as: Amenorrhea refers to absence of bleeding for at least three usual cycle lengths; oligomenorrhea refers to bleeding that occurs at an interval greater than 35 days. We would like patients to have oligomenorrhea for at least six usual cycle lengths. Patients have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study FOR Women 18-25 years old with normal menstrual function; they have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study FOR Patients who have hyperandrogenism due to 21 hydroxylase deficiency non classic adrenal hyperplasia androgen secreting neoplasms Women with known or suspected androgenic/anabolic drug use Women with severe insulin resistance-acanthosis nigricans syndrome; Fasting insulin levels are obtained to rule out syndromes of severe insulin resistance and hyperandrogenism; if insulin is above 80 mU/mL in the fasting state, and/or >300 mU/mL following a 2 or 3-hour oral glucose tolerance test (obtained elsewhere), patients are not eligible. Women with thyroid dysfunction, hyperprolactinemia, (defined as prolactin level greater than or equal to 3 times the upper reference limit), less than 2 years post menarche, and patients on medications that alter steroidogenesis such as oral contraceptive pills, for less than a month prior to the date of in the study. (see above: patients have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study) Women with prior history of pregnancy FOR Young women with hyperandrogenemia, hirsutism or known adrenal tumors or other endocrine diseases, patients on multiple medications, known insulin resistance, or any other chronic or acute illness are not eligible as controls for 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, Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Lymphoplasmacytic Lymphoma Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Burkitt's Lymphoma Diagnosis: Group 1: Histologically confirmed indolent NHL, including follicular (any grade), small lymphocytic lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphomaGroup 2: histologically confirmed diffuse large B-cell, mantle cell, Burkitt, Burkitt-like, and diffuse large B-cell transformed from indolent non-Hodgkin's lymphoma. 2. Prior treatment: Group 1: (indolent histologies): Patients must have demonstrated relapsed or refractory disease to 1 prior treatment regimen. The maximum number of prior regimens used for treatment is not specified. Group 2: (aggressive histologies): Patients must have demonstrated relapsed or refractory disease to at least 1 prior treatment regimen. In the case of de novo diffuse large B-cell lymphoma, prior treatment must R-CHOP or R-CHOP-like therapy, as well as second line autologous stem cell transplantation unless the patient is not eligible. The maximum number of prior regimens is not specified. 3. At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response for Malignant Lymphoma. 4. ECOG Performance Status 0-2. 5. No clinical or laboratory evidence of central nervous system disease. 6. Adult (age 18 years or older). 7. Projected life expectancy >4 months. 8. If female, neither pregnant (negative pregnancy test required at screening) nor lactating. 9. If of child-bearing potential, must be able to use and agree to use medically acceptable contraception for the duration of the study. For female subjects who are neither post-menopausal nor surgically sterilized, this includes oral or injectable hormonal methods, barrier methods such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Male subjects must also agree to use an acceptable method for contraception for the duration of the study. 10. No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery. 11. No evidence of other concurrent active malignancy. 12. At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy. 13. Prior radiotherapy to less than an estimated 25% of the bone marrow. In addition, the target lesion(s) must not have been previously irradiated. 14. Clinical laboratory values within the following limits: 1. Hgb >/=10.0 g/dL 2. Absolute neutrophil count ANC >/=1,500/mm3 3. Platelets >/=75,000/mm3 4. Serum creatinine </=2.0 times upper limit of normal 5. Serum bilirubin </=2.0 times upper limit of normal 6. Serum AST and ALT </=3 times upper limit of normal 15. G6PD level >/= lower limit of normal 16. Able and willing to render informed consent and to follow protocol requirements Diagnosis of lymphoma based on fine needle aspirate. 2. Curative therapy is indicated or possible. 3. Absence of a measurable target lesion, or the only target lesion was previously irradiated. 4. Symptoms, exam findings, or laboratory findings to suggest central nervous system disease involvement. 5. Age < 18 years 6. Projected life expectancy <4 months. 7. Pregnant or lactating. 8. Unable or unwilling to use medically acceptable contraception, if of childbearing potential. 9. Evidence of major infection or other serious uncontrolled concomitant illness. Not fully recovered from prior major surgery. 10. Evidence of other active malignancy. 11. Prior radiotherapy, antibody therapy, or cancer chemotherapy within 4 weeks before start of treatment (2 weeks for corticosteroids). Prior radiotherapy to >25% of the bone marrow. 12. Clinical laboratory values outside of permitted ranges. 13. Respiratory insufficiency requiring oxygen therapy; angina at rest, or myocardial infarction in previous 3 months; history of life threatening ventricular arrhythmia; uncompensated CHF or NYHA Grade 3 or 4 cardiac disease. 14. Unable or unwilling to give informed consent and to follow protocol requirements. 15. Failure to meet any of the criteria | 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): 16.0-999.0, Heart Disease Dyspnea Aortic Disease Kidney Disease Liver Disease Patients admitted to Dep. of Medicine at Levanger Hospital Not able to give 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): 18.0-65.0, Hematologic Neoplasms Age between 18 and 65 years Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor Informed consent Patients with ECOG < 2 Patients with blood creatine > 2 mg/dl or with transaminase or cholestase index > 5 times compared to normality upper limits Patients with Cardiac Fraction Ejection < 40% Patients with DLCO < 60% or Diffusing Lung Capacity of carbon monoxide attesting a severe pulmonary insufficiency Patients with peripheral blast cell count over 10% Second neoplasia diagnosed no more than 2 years before Patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing HIV positive patients HCV-RNA and HBV-DNA positive patients Pregnant or lactating 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, Coronary Artery Disease Atherosclerosis Only patients with also Calcium Score ≥64-slice CT technology (or 16-slice CT technology with >4 year follow-up) Number of patients of at least 100 with complete clinical file and follow-up Minimum follow-up of 12 months Only patients with suspected Coronary Artery Disease renal failure (creatinine clearance <60ml/min) known previous reaction to iodinated contrast medium and pregnancy history of Myocardial Infarction previous revascularization (PCI and/or CABG) | 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 Ovarian Syndrome Must be 18 to 40 year old female with Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl Mentally competent Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months Long-term or chronic use of oral antibiotics Hysterectomy FSH >15 Pregnancy/lactation Consumption of flaxseed within the last month Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period | 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): 21.0-999.0, Breast Cancer Female Age 21 years or greater. Both pre and postmenopausal women will be included in this study. Postmenopausal status will be defined as the absence of menses for > 12 months, serum FSH > 20 mIU/ml, or history of bilateral oophrectomy Hispanic descent and fluent in Spanish History of histologically-confirmed stage 0, I, II, or III (see Appendix I for TNM staging system) invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry Minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. Current use of hormonal therapy is permitted No uncontrolled diabetes mellitus, defined as Hgb A1C >7 No uncontrolled comorbidities (i.e., hypertension) Currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns) Consumes <5 servings of fruits and vegetables per day, as assessed by the Block Fruit and Vegetable Screener Evidence of recurrent or metastatic breast cancer Uncontrolled diabetes (type 1 or 2), defined as Hgb A1C >7 Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements Previously participated in Cook For Your Life! classes Currently active in a dietary change program | 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, Common Bile Duct Gallstones The patients were treated with CBD stone removal during therapeutic ERCP after finding CBD stones with CT, ultrasound or MRCP The patients were treated with CBD stone removal during diagnostic ERCP because of cholangitis or cholecystitis Hemodynamic instability Younger than 18 Mental illness Received previous CBD stone removal Hemolytic anemia, IHD stone, parasites in hepatobiliary system Genetic, autoimmune, congenital biliary disorder Liver or biliary surgery except cholecystectomy Pancreatic cancer, cholangiocarcinoma, ampulla of vater cancer | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, GTP Cyclohydrolase Deficiency established diagnosis of GTPCH deficiency, supported by appropriate family history, CSF neurotransmitter studies, skin fibroblast enzyme assay and/or mutation analysis minimum age 18 years identified by self or others to have symptoms of anxiety, depression, fatigue, or other neurocognitive dysfunction (trouble concentrating, memory loss, etc) willingness to undergo at least 2 CSF evaluations for BH4 and neurotransmitter levels over an 8 to 12 week period age < 18 years old unwillingness to undergo repeated CSF analysis lack of supporting diagnostic concomitant medical problems or medications which would increase risk of Kuvan® concomitant psychiatric state, such as severe depression with suicidal ideation that requires immediate referral and alternative treatment intervention prior history of back surgery, abnormality or chronic pain that in the opinion of the investigator would increase risks associated with lumbar puncture significant obesity that might increase difficulty or risk in performing lumbar puncture if female, unwillingness to use birth control during the period of study drug administration | 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, Facioscapulohumeral Muscular Dystrophy Affected participants must have a clinical diagnosis of FSHD, including the presence of all of the following features based on review of medical records and/or direct examination Onset of symptoms involving the facial or shoulder girdle muscles Autosomal dominant inheritance in familial cases Contraction of the D4Z4 repeat array from 1-10 (10 kb) copies in the 4q35 subtelomeric region, based on established molecular genetic techniques Symptomatic cardiomyopathy or severe cardiac arrhythmia which may limit the ability to complete the study protocol Maternal/mitochondrial mode of inheritance Evidence of an alternative diagnosis based on muscle biopsy or other available investigations | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal information Eastern Cooperative Oncology Group (ECOG) =< 2 In vitro dasatinib sensitivity (IC 50 =< 50 nm per MTS assay) Diagnosis of CLL and must meet one of the following Relapsed CLL in all patients who have failed at least one prior treatment, regardless of risk group OR De novo (treatment-naïve) patients age >= 65 who are not candidates for or do not want to pursue aggressive chemotherapy treatment Have indications for treatment or evidence of progressive disease defined as follows (1996 NCI working group) Massive or progressive splenomegaly Massive lymph nodes (>= 10 cm), nodal clusters (>= 10 cm), or progressive lymphadenopathy Symptomatic anemia and/or thrombocytopenia (Rai stages III or IV disease) Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy Pleural or pericardial effusion of any grade Uncontrolled angina, > New York Heart Association (NYHA) class III congestive heart failure or myocardial infarction (MI) within 6 months prior to study enrollment Diagnosed congenital long QT syndrome Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) Subjects who are detained or imprisoned are not eligible History of significant bleeding disorder unrelated to cancer, including Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 17.0-60.0, Scleroderma, Systemic Age 17 years old at the time of pretransplant evaluation 2. An established diagnosis of scleroderma 3. Diffuse cutaneous scleroderma with involvement proximal to the elbow or knee and a Rodnan score (see Appendix V) of > 14 AND Scleroderma with any one of the following: 1. DLCO < 80% of predicted or decrease in lung function (DLCO, DLCO/VA or FVC) of 10% or more over 12 months. 2. Pulmonary fibrosis or alveolitis on CT scan or chest X-ray (CXR) (ground glass appearance of alveolitis). 3. Abnormal EKG [non-specific ST-segment and T-wave (ST-T) (pattern in electrocardiogram) wave abnormalities, low QRS (a pattern seen in an electrocardiogram that indicates the pulses in a heart beat and their duration) voltage, or ventricular hypertrophy], or pericardial effusion or pericardial enhancement on MRI 4. Gastrointestinal tract involvement confirmed on radiological study. Radiologic findings of scleroderma are small bowel radiographs showing thickened folds with dilated loops, segmentation, and flocculation +/ diverticula, or pseudodiverticula. A hide-bound appearance due to valvulae packing i.e. dilated and crowded circular folds may be present. GI involvement may also be confirmed by D-xylose malabsorption, patulous esophagus on HRCT, or esophageal manometry. OR 4. As published in New England Journal of Medicine (NEJM), 2006, 345:25 2655-2709. Limited or diffuse Systemic Sclerosis with (SSCL) with lung involvement defined as active alveolitis on Bronchoalveolar Lavage (BAL) or ground-glass opacity on CT, a DLCO < 80% predicted or decrease in lung function (DLCO/VA, DLCO, FVC) of 10% or more in last 12 months Significant end organ damage such as: 1. Left Ventricular Function (LVEF) < 40% on echocardiogram. 2. Untreated life-threatening arrhythmia. 3. Active ischemic heart disease or heart failure. 4. End-stage lung disease characterized by TLC<45% of predicted value, or DLCO hemoglobin corrected < 30% predicted . 5. Pulmonary arterial hypertension defined on right heart catheterization as: 1. a resting Mean Pulmonary Artery Pressure (mPAP) > 25 mmHg; 2. a mPAP > 30 mmHg following a 500-1000 ml normal saline bolus; 3. pulmonary vascular resistance (PVR) > 240 dynes*s/cm5 (> 3 Wood units) ; or 4. a decrease in cardiac output with fluid challenge (500 cc Normal Saline (NS) in 10 minutes) If fluid challenge cannot be done because right atrial (RA) pressure > 12mm Hg or pulmonary capillary wedge pressure (PCWP) > 15 m Hg at rest or must be stopped due to safety concerns, patient is excluded as candidate. 6. Serum creatinine > 1.4 mg/dl. 7. Liver cirrhosis, transaminases > 3x of normal limits or bilirubin > 2.0 unless due to Gilbert's disease. 8. Pericardial effusion > 1 cm on cardiac MRI unless successful pericardiocentesis has been performed 9. Occult or clinical constrictive pericarditis 10. On echocardiogram tricuspid annular peak systolic excursion (TAPSE) ≤ 1.8 cm or, grade II or worse Right Ventricular (RV) or Left Ventricular (LV) diastolic dysfunction 11. On cardiac MRI, a diastolic septal bounce or diastolic septal flattering (D-sign), or diffuse myocardial gadolinium enhancement, or diffuse hypokinesis (patchy late gadolinium myocardial enhancement are not ) 12. Ventricular tachycardia (sustained or non-sustained, multifocal or unifocal) on EKG or 24 hour Holter 2. HIV positive. 3. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment. 4. Prior history of malignancy 5. Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy. 6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible. 7. Inability to give informed consent. 8. Major hematological abnormalities such as platelet count < 100,000/ul or absolute neutrophil count (ANC) < 1000/ul. 9. Hepatitis B or C positive | 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 C Infection To be eligible for this trial, patients must have documentation of the following Male or female > 18 years old HCV genotype-1 infection Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years No previous treatment with any anti-HCV therapy (approved or investigational) For women of childbearing potential, a negative urine pregnancy test result documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during study treatment and for 6 months after treatment Willingness to give written informed consent and to participate in and comply with requirements of the study Patients with any of the following will not be eligible for participation Infection with HCV other than genotype 1 History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History or other evidence of decompensated liver disease (e.g., coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from esophageal varices) or a Child-Pugh score > 6 (see Appendix 1) Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM) antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab, or anti-HIV antibodies History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against HCV within 3 months prior to enrollment Pregnant or breastfeeding Male partners of females who are pregnant or breastfeeding Hemoglobin concentration < 12 g/dL in females or < 13 g/dL in males or any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic Absolute neutrophil count (ANC) < 1000 cells/mm3 | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Cardiac Magnetic Resonance Imaging Adult patients, age greater than or equal to 18 Undergoing medically necessary diagnostic or therapeutic pericardiocentesis Cardiogenic shock (sustained systolic blood pressure less than or equal to 80 mm Hg despite volume repletion on physical examination or requiring catecholamine support) Women who are pregnant or nursing Unable to undergo magnetic resonance imaging Cardiac pacemaker or implantable defibrillator Cerebral aneurysm clip Neural stimulator (e.g. TENS-Unit) Any type of ear implant Ocular foreign body (e.g. metal shavings) Metal shrapnel or bullet Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-60.0, Hypertension Obesity BMI > 40 kg/m2 or BMI 35-40 with major comorbidities Age between 18-60 years Obesity evolving for more than 5 years Failure of medical treatment Elimination of hormonal causes Uncontrolled hypertension (SBP > 160 mmHg and DBP> 100 mmHg) History of cardiovascular disease or signs of clinical atheroma: stroke, myocardial infarction and coronary heart disease (angina), peripheral arterial disease (no pulse, claudication), aortic aneurysm (anterior abdominal palpation or imaging ), carotid bruit Plasma creatinine > 130 micromol/L and/or proteinuria > 300 mg/24 h and/or dipstick hematuria | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.5-999.0, Cystic Fibrosis With Gastrointestinal Manifestation patients with cystic fibrosis | 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, Diffuse Large B-Cell Lymphoma Age ≥ 18 < 65 years. 2. Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like and primary CNS lymphomas and cases with leptomeningeal lymphoma involvement. Morphologically discordant lymphomas (most often follicular lymphoma and diffuse large cell B-cell lymphoma in different biopsy specimens, e.g. lymphatic gland and bone marrow) and transformed lymphomas are not to be included Follicular lymphomas grade III The diagnosis made by the local pathologist of the participating centre will be accepted for registration 3. Patients in at least stage II with age adjusted IPI score of 2 or 3: Stage III /IV and elevated LDH and/or WHO performance status 2 Stage II and elevated LDH and WHO performance status 2 4. Previously untreated. 5. Performance status < 4 (Appendix 2). 6. Written informed consent Severe cardiac disease: cardiac function grade 3-4 (Appendix 2) or Left Ventricular Ejection Fraction (LVEF) < 45% (based on MUGA scintigraphy or echo Doppler cardiography). 2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. 3. Pregnancy. 4. Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment. 5. Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons. 6. Known HIV positivity. 7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ. 8. Uncontrolled infectious disease. 9. Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol | 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 Gall Stone Pancreatitis patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis patients undergoing planned elective cholecystectomy | 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): 13.0-19.0, Type 1 Diabetes Children (diabetes exposed) from the national diabetes birth registry born between 1993 and 1999 (approximately n = 450) The same number of controls from the Central Person Register matched according to gender, age and postcode Offspring with major handicaps or chronic disease will be registered, but will not be examined Multiple pregnancies and recurrent pregnancies will not be included 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): 18.0-999.0, Non-Hodgkin Lymphoma Clinical diagnosis of non-Hodgkin lymphoma Diagnosed in one of the participating hospitals Able to read and understand Dutch | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Adult B Acute Lymphoblastic Leukemia Adult T Acute Lymphoblastic Leukemia Anaplastic Large Cell Lymphoma Angioimmunoblastic T-Cell Lymphoma Chronic Lymphocytic Leukemia Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Hepatosplenic T-Cell Lymphoma Intraocular Lymphoma Lymphomatous Involvement of Non-Cutaneous Extranodal Site Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Nodal Marginal Zone Lymphoma Primary Cutaneous B-Cell Non-Hodgkin Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-Cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides and Sezary Syndrome Recurrent Non-Hodgkin Lymphoma Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Small Intestinal Lymphoma Splenic Marginal Zone Lymphoma T-Cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Waldenstrom Macroglobulinemia Patients must have a histologically or cytologically confirmed lymphoid malignancy (like Hodgkin lymphoma or one of the mature B or T-cell non-Hodgkin lymphomas as classified by World Health Organization [WHO]) for which standard curative or palliative measures do not exist or are no longer effective Patients must have measurable disease in two dimensions and >= 2 cm is acceptable (or 1.5 cm if 0.5 slices are used, as in spiral computed tomography [CT] scans); lesions that are considered intrinsically non-measurable the following Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines Treatment with valproic acid within 14 days prior to initiation of study and during the study Prior use of valproic acid or any other histone deacetylase (HDAC) inhibitor for lymphoma treatment Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237 Human Immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237 | 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): 18.0-50.0, Alcohol-Related Disorders Substance-Related Disorders Substance Abuse Men and women older than 18 years and 50 years Achieving a moderate risk score in the screening questionnaire Without any similar intervention in the last 3 months. (ie. AUDIT test) Pregnant women Users with cognitive disabilities Users with language and communication disabilities | 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): 19.0-39.0, Polycystic Ovarian Syndrome Age > 18 years but < 40 years old Was diagnosed PCOS Normal husband's seminal fluid analysis (SFA) Not having medical problems eg renal disease, tyhroid disorder, hyperprolactinemia, liver disease Other causes of anovulatory infertility | 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): 0.0-4.0, Pneumococcal Infections Infants Child has birth weight ≥ 2500g Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant Mother has resided in Burkina Faso for at least 2 years Mother has African nationality Child will reside in Bobo-Dioulasso urban area for the duration of the study Parent or guardian has given informed consent for child's participation Infants Child was born with a congenital abnormality Child has chronic or acute severe illness requiring specialized medical care Child has a blood coagulation disorder Mother has known HIV infection Child is enrolled in another clinical trial Child has known allergy to a component of the vaccine Child received a pneumococcal vaccine outside the context of the trial Child is 53 days of age or older at 6 week visit Child weighs <3500g at the 6 week visit Blood draw at 6 week visit was unsuccessful after 3 attempts Toddlers | 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, Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Promyelocytic Leukemia (M3) Adult Nasal Type Extranodal NK/T-cell Lymphoma Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma Anaplastic Large Cell Lymphoma B-cell Adult Acute Lymphoblastic Leukemia Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Phase Chronic Myelogenous Leukemia Contiguous Stage II Adult Burkitt Lymphoma Contiguous Stage II Adult Diffuse Large Cell Lymphoma Contiguous Stage II Adult Lymphoblastic Lymphoma Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Grade 3 Follicular Lymphoma Contiguous Stage II Mantle Cell Lymphoma Contiguous Stage II Small Lymphocytic Lymphoma Cytomegalovirus Infection de Novo Myelodysplastic Syndromes Essential Thrombocythemia Extramedullary Plasmacytoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Isolated Plasmacytoma of Bone Monoclonal Gammopathy of Undetermined Significance Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Peripheral T-cell Lymphoma Polycythemia Vera Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Primary Central Nervous System Hodgkin Lymphoma Primary Central Nervous System Non-Hodgkin Lymphoma Primary Myelofibrosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Stage I Adult Burkitt Lymphoma Stage I Adult Diffuse Large Cell Lymphoma Stage I Adult Hodgkin Lymphoma Stage I Adult Lymphoblastic Lymphoma Stage I Adult T-cell Leukemia/Lymphoma Stage I Chronic Lymphocytic Leukemia Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Grade 1 Follicular Lymphoma Stage I Grade 2 Follicular Lymphoma Stage I Grade 3 Follicular Lymphoma Stage I Mantle Cell Lymphoma Stage I Multiple Myeloma Stage I Small Lymphocytic Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Adult Hodgkin Lymphoma Stage II Adult T-cell Leukemia/Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Multiple Myeloma Stage IIA Mycosis Fungoides/Sezary Syndrome Stage IIB Mycosis Fungoides/Sezary Syndrome Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Adult T-cell Leukemia/Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Multiple Myeloma Stage III Small Lymphocytic Lymphoma Stage IIIA Mycosis Fungoides/Sezary Syndrome Stage IIIB Mycosis Fungoides/Sezary Syndrome Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Small Lymphocytic Lymphoma Stage IVA Mycosis Fungoides/Sezary Syndrome Stage IVB Mycosis Fungoides/Sezary Syndrome T-cell Adult Acute Lymphoblastic Leukemia T-cell Large Granular Lymphocyte Leukemia Untreated Adult Acute Myeloid Leukemia Untreated Hairy Cell Leukemia Waldenström Macroglobulinemia HLA A*0201 subtype CMV seropositive Able and willing to sign the informed consent form (ICF) Willingness to be followed for the planned duration of the trial (6 months post-HCT) Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA donor allele matching HCT for the treatment of hematologic cancers including, but not limited to Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed) Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase Hodgkin and non-Hodgkin lymphoma A poor-risk patient, as defined by any of the following Chronic myelogenous leukemia in blast crisis Acute myeloid leukemia beyond second remission Multiple myeloma Aplastic anemia Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent In vitro T cell depleted graft Planned prophylactic therapy with CMV immunoglobulin Planned CMV prophylactic therapy Experimental anti-CMV chemotherapy in the last 6 months | 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): 2.0-17.0, Stroke To be eligible for TIPS, a patient must meet the following 1. Age 2 to 17 years inclusive. 2. Clinical presentation consisting of clearly defined acute onset of neurological deficit in a pattern consistent with arterial territory ischemia. 3. Clinically significant deficit as defined by a PedNIHSS score of ≥ 6 and ≤ 24 felt to be due to acute stroke that is not improving at the time of initiation of tPA administration 4. Time of symptom onset within 4.5 hours of initiation of treatment for IV tPA. Time of symptom onset is defined as time the patient was last seen awake and at neurological baseline. 5. Radiological confirmation of an acute arterial ischemic stroke in one of two ways MRI confirmation, consisting of acute infarction with restricted diffusion in an arterial territory consistent with the clinical syndrome plus MRA showing partial or complete occlusion in an intracranial artery corresponding to the infarct location, OR CT and CT angiogram confirmation, consisting of normal head CT or early hypodensity in an arterial territory consistent with the clinical syndrome plus CT angiogram showing partial or complete occlusion in an intracranial artery corresponding to the infarct location. 6. Baseline neuroimaging (CT or MRI) with no evidence of intracranial hemorrhage (including HI-1, HI-2, PH-1 or PH-2). If no head CT scan is done, the pre-tPA MRI must Gradient-recalled ECHO (GRE) imaging or Susceptibility Weighted Imaging (SWI) sequences. 7. Children with seizures at or following onset of stroke may be included, as long as the clinical picture is consistent with the documented arterial occlusion. 3.4.1.2.2. Patients with the following will not be eligible for TIPS: Safety Related Patients in whom time of symptom onset is unknown. 2. Pregnancy 3. Clinical presentation suggestive of subarachnoid hemorrhage (SAH), even if head CT or head MRI scan is negative for blood. 4. Patient who would decline blood transfusion if indicated 5. History of prior intracranial hemorrhage 6. Known cerebral arterial venous malformation, aneurysm, or neoplasm 7. Persistent Systolic Blood Pressure > 15% above the 95th percentile for age while sitting or supine 8. Glucose < 50 mg/dl (2.78 mmol/l) or > 400 mg/dl (22.22 mmol/l) 9. Bleeding diathesis including platelets < 100,000, PT > 15 sec (INR > 1.4) or elevated PTT > upper limits of the normal range. 10. Clinical presentation consistent with acute myocardial infarction (MI) or post-MI pericarditis that requires evaluation by cardiology prior to treatment 11. Stroke, major head trauma, or intracranial surgery within the past 3 months 12. Major surgery or parenchymal biopsy within 10 days (relative contraindication) 13. Gastrointestinal or urinary bleeding within 21 days (relative contraindication) 14. Arterial puncture at noncompressible site or lumbar puncture within 7 days (relative contraindication). Patients who have had a cardiac catheterization via a compressible artery are not excluded. 15. Patient with malignancy or within 1 month of completion of treatment for cancer 16. Patients with an underlying significant bleeding disorder. Patients with a mild platelet dysfunction, mild von Willebrand Disease or other mild bleeding disorders are not excluded. Stroke related exclusions: 1. Mild deficit (PedNIHSS < 6) at start of tPA infusion 2. Severe deficit suggesting very large territory stroke, with pre-tPA PedNIHSS > 25, regardless of the infarct volume seen on neuroimaging 3. Stroke suspected to be due to subacute bacterial endocarditis, moyamoya, sickle cell disease, meningitis, bone marrow, air or fat embolism 4. Previously diagnosed primary angiitis of the central nervous system (PACNS) or secondary CNS vasculitis. Focal cerebral arteriopathy (FCA) of childhood is not a contraindication. Neuro-imaging related exclusions: 1. Intracranial hemorrhage (HI-1, HI-2, PH-1 or PH-2) on pretreatment head MRI or head CT 2. Intracranial dissection (defined as at or distal to the opthalmic artery) 3. Large infarct volume, defined by the finding of acute infarct on MRI involving 1/3 or or more of the complete MCA territory involvement, regardless of the pre-tPA PedNIHSS score due to increased risk of ICH.78, 79 Drug Related exclusions: 1. Known allergy to recombinant tissue plasminogen activator 2. Patient on anticoagulation therapy must have INR ≤ 1.4 3. Patient who received heparin within 4 hours must have aPTT in normal range 4. LMWH within past 24 hours (aPTT and INR will not reflect LMWH effect) | 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): 18.0-99.0, Non-Hodgkin's Lymphoma Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as defined by a B-cell neoplasm in the World Health Organization classification scheme except as noted in Subject (non-diffuse large B-cell lymphoma) must have relapsed or refractory non-Hodgkin's lymphoma, and require treatment in the opinion of the investigator Subject with diffuse large B-cell lymphoma must have relapsed diffuse large B-cell lymphoma or must have progressed after salvage therapy (with or without standard chemotherapy) for diffuse large B-cell lymphoma. The subject must have received first line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) [or a similar standard rituximab-containing front-line chemoimmunotherapy regimen including, but not limited to Etoposide, Prednisone, Vincristine (Oncovin), Cyclophosphamide, Doxorubicin (Hydrochloride) + Rituximab (EPOCH + R); Rituximab, Cyclophosphamide, Etoposide, Procarbazine, Prednisone (RCEPP); Rituximab, Cyclophosphamide, Mitoxantrone (Novantrone), Vincristine (Oncovin), Prednisone (RCNOP); Dose-adjusted-Etoposide, Prednisone, Vincristine(Oncovin), Cyclophosphamide, Doxorubicin (Hydrocloride) (DA-EPOCH); and Rituximab, Cyclophosphamide, Etoposide, Vincristine (Oncovin), Prednisone (RCEOP)] Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia, small lymphocytic lymphoma or mantle cell lymphoma (MCL) Subject has refractory diffuse large B-cell lymphoma, defined as meeting any of the following Subject progressed during or within 3 months of completion of a planned course of first-line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen Subject had no response (i.e., stable disease only) to first-line therapy with R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen Subject progressed during or within 2 months of completion of their last planned course of salvage therapy with chemotherapy (with or without rituximab, may autologous stem cell transplant) Subject has tested positive for human immunodeficiency virus (HIV) Subject has a cardiovascular disability status of New York Heart Association Class greater or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity, results in fatigue, palpitations, dyspnea or anginal pain | 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, Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Burkitt's Lymphoma Follicular Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Non-Hodgkin Lymphoma Patients 18 to 70 years old Patients must have available both: a)One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). At least low resolution DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential haploidentical sibling donors is required. b)At least two potential umbilical cord blood units identified. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Confirmatory typing is not required for randomization Acute Lymphoblastic Leukemia (ALL) in first complete remission (CR1) that is NOT considered favorable-risk as defined by the presence of at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), other Mixed Lineage Leukemia (MLL) rearrangements; White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL)at diagnosis; Recipient age older than 30 years at diagnosis; Time to CR greater than 4 weeks Acute Myelogeneous Leukemia (AML) in CR1 that is NOT considered as favorable-risk. Favorable risk is defined as having one of the following: t(8.21) without CKIT mutation, inv(16) without CKIT mutation or t(16;16), normal karyotype with mutated NPM1 and not FLT-ITD, normal karyotype with double mutated CEBPA, Acute promyelocytic leukemia (APL) in first molecular remission at end of consolidation Acute Leukemias in 2nd or subsequent CR Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR Burkitt's lymphoma: second or subsequent CR Lymphoma fulfilling the following Chemotherapy-sensitive (at least stable disease lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are for an autologous transplant. Patients with chronic lymphocytic leukemia (CLL) are not eligible regardless of disease status Performance status: Karnofsky score greater than or equal to 70%. Additional Patient for Conditioning Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%; b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit of normal; c. Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR)greater than 40 mL/min/1.73m^; d. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) greater than 50% predicted Patients with suitably matched related or unrelated donor, as defined per institutional practice Recipients of prior autologous hematopoietic stem cell transplantation are ineligible if disease recurrence occurred less than 6 months from their autologous stem cell transplant Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings) Prior allogeneic HCT Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis Planned use of prophylactic donor lymphocyte infusion (DLI) therapy Anti-donor HLA antibodies. Additional Pregnancy or breast-feeding Evidence of HIV infection or known HIV positive serology | 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): 18.0-35.0, Polycystic Ovary Syndrome patients with PCOS aged 18-35 years chronic or acute inflammatory disease cancer autoimmune disease treatment with clomiphene citrate antiandrogens drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes) | 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, B-Cell Lymphomas Subjects who have given their informed consent before any study-specific procedures 2. Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes: 3. High risk CD +20 Lymphoma having at least one of the following characteristics Less than a partial remission after two courses of treatment Relapse after autologous peripheral blood stem cell (PBSCT) Evidence of measurable disease (With CT and PET or PET / CT) three months after PBSCT Hematopoietic precursors improper count in patients with relapsed or partial remission after two treatment lines that prevent the realization of a PBSCT Patients after first relapse in RP after two lines of treatment in whom the probability of freedom from progression per year is very low due to risk factors such as: first CR less than 12 months after PBSCT low SLP, etc.. 4. Age between 18 and 65 years 5. ECOG between 0 to 1 (Appendix III). 6. Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be in the study but must undergo HBV DNA monitoring 7. Adequate lung Function 8. Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography. 9. Adequate renal and hepatic function defined by the following biochemical parameters 10. The disease status prior to transplantation had to be in place in accordance with the of Revised Response for Malignant Lymphoma, Cheson 2007. CT and PET or PET / CT. 11. Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated 12. Adults with ability to procreate must commit to use an effective method of birth control during the study treatment and at least 6 months Refractory disease at the time of transplantation 2. Progressive disease at the time of transplantation. 3. ECOG≤2 4. Lymphoma associated with infection with human immunodeficiency virus (HIV). 5. Test positive for HIV. 6. Presence of anti-murine antibodies (HAMA) or (HACA). 7. Treatment with any marketed or experimental drug administered not in a period between 5 terminal half-lives of clearance of therapy or 4 weeks before enrollment 8. Participation in another interventional clinical trial. 9. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy. This is generally required and may be excluded as applicable. 10. Hepatitis B positive serology 11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. 12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb. 13. Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis, metastases). 14. Other past or current malignancy. 15. Chronic infectious disease that requires ongoing treatment with systemic antibiotics, antifungal or antiviral drugs 16. History of cerebrovascular disease active in the last 6 months or event with significant symptoms or sequelae. 17. Clinically significant heart disease, such as unstable angina, acute myocardial infarction in the six months prior to congestive heart failure (grades III-IV NYHA) and arrhythmia unless it is controlled by treatment, except for premature or disorders Mild driving. 18. Concurrent medical disorder, uncontrolled and important, such as kidney disease, liver, digestive, endocrine, pulmonary, neurological, brain, psychiatric, or which in the opinion of the investigator may represent a risk to the patient 19. Pregnancy or breastfeeding 20. Women of childbearing potential, including those whose last menstrual period was one year prior to screening. 21. Men unable or unwilling to use contraception 22. Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus, sirolimus and / or any excipients | 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, Osteoarthritis of the Knee Group 1, Non-traumatic primary OA: 1. Subject scheduled to undergo primary unilateral total knee arthroplasty for primary osteoarthritis as determined by an orthopedic surgeon 2. Subject is male or female over 45-75 years of age 3. Subject is able to read and understand informed consent form and must subsequently sign and date consent form Group 2, Secondary post-traumatic/overuse OA: 1. Subject scheduled to undergo unilateral total knee arthroplasty secondary osteoarthritis as determined by an orthopedic surgeon, which MUST either previous injury or surgery to the operative knee. 2. Subject is male or female 45-75 years of age 3. Subject is able to read and understand informed consent form and must subsequently sign and date consent form Group 1, Non-traumatic primary OA: 1. History of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) 2. Indication for surgery other than osteoarthritis 3. Revision total knee arthroplasty 4. Age >75, age <44 5. Unable to read, understand, or sign informed consent form 6. Previous knee infection 7. Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition disease Group 2, Secondary post-traumatic/overuse OA: 1. History of inflammatory arthritis (e.g. rheumatoid arthritis, ankyolosing spondylitis) 2. Indication for surgery other than osteoarthritis 3. Age >75, age <44 4. Unable to read, understand, or sign informed consent form 5. Previous knee infection 6. Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition 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): 14.0-40.0, Polycystic Ovary Syndrome (PCOS) PCOS as defined by NIH/NICHD 1) oligo or amenorrhea (≤8 menstrual periods annually, persisting 2 years post menarche); 2) biochemical hyperandrogenism(HA), i.e.,elevated total or free testosterone concentration and/or clinical evidence of HA (defined as the presence of hirsutism); and 3) of secondary causes of ovulatory dysfunction and HA (including hyperprolactinemia, thyroid dysfunction, non-classical congenital adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency, Cushing syndrome, androgen secreting neoplasms, and androgenic/anabolic drug use) for adolescent and adult control subjects will 1) normal menstrual periods (defined as regular cycles between 22-36 days in length); 2) normal serum androgens (total/free testosterone and dehydroepiandrosterone-sulfate [DHEA-S]); and 3) absence of clinical evidence of hyperandrogenism. Additionally, adolescent controls must be 2 years post menarche Diabetes mellitus Underlying endocrine, neurologic, and/or genetic syndromes leading to obesity Congenital heart disease or abnormal resting ECG Renal or hepatic disease History of rheumatologic disorders or malignancy Use of medications or dietary supplements known to affect insulin sensitivity (i.e. metformin, corticosteroids, and oral contraceptive pills), blood pressure, or cholesterol within 3 months of study participation Investigation drug use within 3 months of study participation Pregnancy Current tobacco use | 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): 40.0-75.0, Osteoarthritis Written informed consent (IRB/IEC specific) has been obtained prior to initiation of any protocol required procedures. 2. Male or female between 40 and 75 years of age. Females of childbearing potential must have a negative urine pregnancy test at screening. 3. Body weight >40 kg and <150 kg with a body mass index (BMI) between 19-40 kg/m2 inclusive. 4. Idiopathic osteoarthritic knee pain diagnosed in accordance with the American College of Rheumatology modified clinical classification (Altman et al, 1986) and verified radiologically as Kellgren-Lawrence grade I, II or III (Kellgren and Lawrence, 1957) at the index knee. The clinical diagnosis of OA will be confirmed by the ACR clinical and radiographic for classification of idiopathic OA based upon the following (index knee): 1. Knee pain for at least 14 days per month for the 3 months before study entry. 2. Osteophytes (with radiographic evidence). 3. And at least 1 of the following 3 conditions: Age >50, or morning stiffness <30 minutes, or crepitus. 4. X-ray images of the knee joints are available confirming OA. X-ray images older than12 months cannot be used. New photos are needed to confirm the diagnostic for OA. 5. For the index knee, the average of the worst daily pain score over the last 14 days prior to day 0 must be 4.0 to 9.0. The 14-day average score will be derived from worst daily pain scores recorded in a diary for the index knee. 6. Discontinued use of all analgesic medications (including over-the-counter analgesics/ Non-Steroidal Anti-Inflammatory Drug at least 3 days prior to visit 2 (subjects are allowed limited use of analgesic medications). 7. Have agreed to maintain the same activity level throughout the course of the study Have a history of recurrent seizures other than febrile seizures. 2. Have a history of frequent and/or severe allergic reactions with multiple medications. 3. Have a current or recent history, as determined by the investigator or his delegates, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric or cerebral disease which could interfere with the subject's participation in the study. 4. At screening, have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study. In addition, subjects with following findings will be excluded: 1. Confirmed Bazett's corrected QT (QTcB) interval > 450 msec for men and > 470 msec for women at screening. If QTcB is prolonged a second ECG will be taken to confirm the finding; (additional ECGs may be performed if required), 2. Bundle branch blocks and other conduction abnormalities other than mild first degree atrio-ventricular block, left anterior hemi block due to left axis deviation and right bundle branch block of benign origin i.e. not caused by other cardiac disease, 3. Irregular rhythms other than sinus arrhythmia or occasional supraventricular or ventricular ectopic beats, 4. History of unexplained syncope, 5. Family history of unexplained sudden death or sudden death due to long QT syndrome, 6. T-wave configurations are not of sufficient quality for assessing QT interval determination, as assessed by the investigator. 5. Have an alanine aminotransaminase > 2.5 times Upper Limit of Normal (ULN) at screening, based on reference ranges of the local laboratory. Moderate or greater hepatic impairment. 6. Have prior renal transplant, current renal dialysis or severe renal insufficiency (determined by a derived glomerular filtration rate using Cockcroft Gault formula of ≤30 ml/min/1,73m² calculated by the local lab), or serum creatinine laboratory value >1.5 times ULN, based on the reference ranges of the local laboratory. 7. Have active peptic ulcer or gastrointestinal bleeding. 8. Have known inflammatory intestinal disease. 9. Subject with ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 10. Subject with congestive heart failure (NYHA II-IV). 11. Subject with uncontrolled arterial hypertension (>160/90). 12. Subject with diabetes mellitus and documented atherosclerosis. 13. History of bronchospasms, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other type of allergic reaction after having used acetylic acid or NSAID, inclusive COX-2 inhibitors. 14. Is allergic to the active ingredient of etoricoxib or one or more of the excipients. 15. Pregnant female, breast feeding or planning a pregnancy during the study period. Females of child-bearing potential, not using a reliable means of contraception. 16. Subject with an active malignancy of any type or a history of malignancy within the last 5 years (except basal cell carcinoma of the skin that has been excised prior to study start). 17. Are taking any excluded medications (analgesic medications) that cannot be discontinued during the screening period (3 days prior to visit 2). 18. Subject in treatment with anticoagulants (with the exception of acetylsalicylic acid), methotrexate or rifampicin or antihypertensives (with the exception of Ca+-antagonists). 19. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at Visit 1. 20. Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine. 21. Subject at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and subjects who are permanently bed ridden or wheelchair bound). 22. Subject with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis). 23. Have an autoimmune disorder (not including psoriasis). 24. Subject that do not fully understand the EPM procedures according to investigator experience. 25. Investigator site personnel directly affiliated with this study and/or their immediate family cannot participate. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 26. Subject diagnosed with any condition suggestive of a secondary cause of knee OA including but not limited to knee trauma, septic arthritis, inflammatory joint disease, articular fracture, major dysplasia or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, or primary osteochondromatosis. 27. History of surgery (including arthroscopy) in the index knee within 3 months prior to visit 1 or already planned surgery of the index knee at any time. 28. History of significant prior injury to the index knee within 12 months prior to visit 1. 29. Subject diagnosed with Kellgren and Lawrence grade IV at the index knee. 30. Use of lower extremity assistive devices other than a knee brace or 'shoe lift'. Use of a cane in the hand opposite to the index knee is acceptable. 31. History of prior synovial fluid analysis showing a White Blood Cell count ≥ 2000 mm3 that is indicative of a diagnosis other than OA at the index knee. 32. Have a confounding painful condition that may interfere with assessment of the index knee joint. (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for instance). 33. History of any other musculoskeletal or arthritic condition that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (i.e., currently symptomatic fractures or any concurrent rheumatic disease such as but not limited to fibromyalgia, rheumatoid arthritis, gout, pseudo-gout or Paget's disease and Reiter's syndrome are excluded). 34. Have used corticosteroids prior to baseline: 1. Intra-articular injection of steroids into the index knee or into any other site than the index knee within the previous 3 months, 2. Intra-muscular corticosteroid injections within the previous 3 months, 3. Oral corticosteroids within the previous 1 month. 35. Have initiated or changed their established physiotherapy program within the last 14 day prior to visit 3. 36. Have not recorded a minimum of 10 days of diary data of the last 14 days immediately preceding visit 3 | 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): 30.0-999.0, Cardiovascular Risk Reduction of Having a Coronary Event years of age a patient of the primary care practices involved in the study able to provide informed consent under the age of 30 not a patient of the primary care practices unable 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, Migraine Disorders Headache, Migraine Migraine Migraine Headache Migraine With Aura Migraine Without Aura Headache Disorders, Primary Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) Active prescription for an oral triptan medication to abort acute migraines Tetracycline group or other anti-inflammatory medication use in the preceding three months 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): 18.0-90.0, Pericardial Effusion adult patients pericardial effusion requiring pericardiocentesis non-malignant etiology known neoplastic etiology known bacterial etiology | 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): 7.0-999.0, Infection Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug Patients who are contraindicated based on the product label | 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, Pleural Effusion, Malignant malignant pleural effusion Recurrent pleural effusion Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography Karnofsky index > 40 Agreed to participate in the study and sign an Informed Consent Thrombocytopenia or coagulation disorders Patients with impaired renal function Pleural or active systemic infection Massive neoplastic infiltration of the skin Inability to understand the quality of life questionnaire Previous pleural procedures Allergy to iodine Thyroid disorders | 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, Healthy SIRS healthy volunteers (treatment arm I) on contraceptive agent and/or contraceptive device visual peripheral veins signed informed consent planned for elective larger interabdominal surgery (treatment arm II) patients with a acute pancreatitis or cholecystitis (treatment arm III) pregnant women and/or lactating allergy towards excipients in 123 I HSA or 125 I HSA participates in another study involving radiation or stabile isotopes within a period of 60 days to study start it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good | 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): 7.0-999.0, Infection The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax The patients treated with this drug without dilution due to strict restriction of fluid intake In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects Patients who are contraindicated based on the product label | 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): 1.0-21.0, Neuroblastoma Patients must be <= 21 years of age Patients must be diagnosed with neuroblastoma according to the INSS criteria Disease must be considered refractory to conventional therapy including patients over 1 year of age and presenting as stage 4 disease which have been refractory to first line chemotherapy over 1 year with recurrent disease after multi-agent chemotherapy (including any stage and biological pattern) If the patient history meets the above any disease states except overt progressing disease at the time of antibody treatment renders the patients eligible for this study Patients may not have developed human anti-chimeric antibody due to pre-treatment with ch14.18/SP2/0 Patients must have a performance status greater or equal 70% (Lansky Score) Patients must have an estimated life expectancy of at least 12 weeks Patients must consent to the placement of a central venous line (Broviac or Hickman catheter), if one has not already been placed, or a stable IV anticipated to last for the 5 days required to administer the 5 infusions each month Patients who have received chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapy within three weeks prior to study Females of childbearing potential will be excluded if they are pregnant, nursing, or not using effective contraception during the treatment period, as the potential effects of ch14.18 on the fetus have not been determined Patients with significant intercurrent illnesses Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance Patients with significant psychiatric disabilities or uncontrolled seizure disorders Patients with active infections or active peptic ulcer, unless these conditions are corrected or controlled Patients with a clinically significant neurologic deficit or objective peripheral neuropathy (Grade >= 2) are ineligible Patients with clinically significant, symptomatic, pleural effusions Patients who require, or are likely to require, corticosteroid or other immunosuppressive drugs for intercurrent disease Patients who have had major surgery, i.e. laparotomy or thoracotomy) within the past two 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): 18.0-999.0, Meningeal Carcinomatosis Patients who are treated for advanced EpCam positive solid tumors (such as breast cancer, lung cancer, gastrointestinal cancer) Age >= 18 years Able and willing to give written informed consent WHO performance status (0, 1, 2, 3 or 4) Able and willing to undergo lumbar puncture and veni-puncture Lumbar puncture not clinically / diagnostically indicated | 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 Burkitt Lymphoma Central Nervous System Lymphoma Intraocular Lymphoma Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System Recurrent Adult Diffuse Large Cell Lymphoma Retinal Lymphoma Relapsed or refractory primary central nervous system (CNS) diffuse large B cell lymphoma (PCNSDLBCL) with a CNS lesion, with cerebrospinal fluid (CSF) relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy is not absolutely necessary for CNS tumor unless clinical and radiologic findings strongly suggest other etiologies as per treating physician; initial diagnosis must be made by tissue biopsy; NOTE: patients with B-cell lymphoma with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma are also eligible for the protocol as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a CNS lesion, with CSF relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy requirement of the CNS lesion is as outlined in bullet above Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 Absolute neutrophil count (ANC) >= 1000/uL Platelets (PLT) >= 100,000/uL Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be =< 1.5 x ULN (=< 0.45 mg/dL) Aspartate aminotransferase (AST) =< 3 x ULN Creatinine =< 2.5 x ULN Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the REMS (TM) program Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or heparin) Any of the following Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Uncontrolled infection Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration; NOTE: patients who have recovered from cytopenia related to previous treatment and meet of this protocol will be eligible Persistent toxicities >= grade 3 from prior chemotherapy or biological therapy regardless of interval since last treatment History of thromboembolic episodes =< 3 months prior to registration Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-999.0, Pleurisy With Effusion Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination Significant hypoxemia on room air Hemodynamic instability Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina) Refractory cough Lack of pleural space due to adhesions Uncorrected coagulopathy | 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, CD20 Positive Recurrent B-Cell Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Previously treated, histologically confirmed cluster of differentiation (CD)20+ B cell lymphoma; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra nodal biopsies; fine needle aspirates are not acceptable All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines Able to adhere to the study visit schedule and other protocol requirements Karnofsky >= 70% Life expectancy expected to be greater than 3 months Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,000/mcL Platelets >= 50,000/mcL Total bilirubin =< 2.0 x institutional upper limit of normal Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients with a history of prior treatment with ipilimumab Patients with a history of prior treatment with an anti-programmed cell death (PD) 1 antibody, CD137 agonist or other immune activating therapy such as anti-CD 40 antibody are excluded unless 5 half-lives of the agent (minimum of 8 weeks) have intervened since the therapy; patients who have received prior vaccine therapy are eligible Patients who are receiving any other investigational agents Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis) Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody Patients with known uncontrolled brain metastases are excluded; however, patients with stable brain disease (off corticosteroids) at least 2 weeks after completion of appropriate therapy for their brain metastases are eligible History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab Patients on systemic corticosteroids (except for patients on stable doses of hormone replacement therapy such as hydrocortisone), or other immunosuppressants (e.g., infliximab, mycophenolate mofetil) are excluded Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Lymphoma, Non-Hodgkin Hodgkin Disease Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section 3.2.1 for excluded subtypes) At least 3 sites of disease 1. One for diagnosis (lymph node or bone marrow biopsy) 2. One palpable for treatment 3. One measurable radiographically > 60 days after RIC allogeneic transplant for lymphoma years of age or older Mixed (5-95%) or complete (>95%) chimerism Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2 ANC >1000/mm3, platelets >50,000/mm3 Total bilirubin ≤ 2.5 mg/dL, AST and ALT < 3 times upper limit of normal Serum creatinine ≤ 3 mg/dL No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment HIV associated lymphoma Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted) Active infection within 14 days prior to scheduled treatment Active Cytomegalovirus (CMV) disease at the time of enrollment Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia) 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): 18.0-65.0, Systemic Hypertension Obesity Adults aged between 18 and 65 years old hypertension diagnosis defined as in use of at least 2 high blood pressure medication at full doses body mass index between 30,0 and 39,9 kg/m2 hypertension ≥ 180/120 mmHg cerebrovascular diseases in the last 6 months Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min Patients with secondary hypertension except due to the sleep apnea Advanced peripheral arterial disease atrophic gastritis Diabetes mellitus type 1 and type 2 with HbA1 c >7,0% alcoholism or use of illicit drugs | 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, B-cell Lymphoma Refractory Patient Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy Patients younger than 65 years old A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered Patient must be competent to give consent. Patient Patients treated with an autologous transplant as salvage therapy Patients with progressive lymphomas despite conventional therapies Patients with progressive lymphomas despite conventional therapies Uncontrolled CNS involvement with disease Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Females who are pregnant or breastfeeding Organ dysfunction defined as follows Cardiac function: ejection fraction <30% or uncontrolled cardiac failure Pulmonary: DLCO <40% predicted Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-999.0, Burkitt Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Precursor B-cell Lymphoblastic Leukemia-Lymphoma Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy Eastern Cooperative Oncology Group status of 0 or 1 Measurable disease Allogeneic stem cell transplant (SCT) | 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): 18.0-85.0, Pruritus Patients w/ histologically confirmed mycosis fungoides stage IB to IVA eligible to receive oral vorinostat Patients w/ stage IB to IV reporting pruritus Patients age 18-85 years, of any race, sex, and ethnicity Life expectancy > 24 weeks Patient must have performance status of ≤2 on the ECOG Performance Scale Patients w/ a min. of 3 weeks since their last systemic treatment Women who are not pregnant, lactating, or of childbearing potential Female patients w/ reproductive potential must use an adequate contraceptive method during treatment and for three months after completing treatment Male patient w/ reproductive potential, agrees to use an adequate method of contraception for the duration of the study and for 30 days beyond the duration of study Patients, or legal representative must to be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study Patients w/ a recent cardiac history, such as a myocardial infarct within the last year, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities Patients w/ a history of liver damage (2.5 x normal ALT, AST), leukopenia, or thrombocytopenia Women who are pregnant or nursing a child Patients w/ severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen Patients who have received and histone deacetylase inhibitor within the last 6 months Patients receiving valproic acid will be excluded unless there has been a wash-out period of 30 or more days Patients who will have received systemic therapy, radiation therapy or phototherapy within 3 weeks prior to initial dosing with study drugs or who has not recovered from adverse events due to agents administered more than 3 weeks earlier QTc prolongation greater than 500ms Patient w/ a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse | 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, Cholelithiasis Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also 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): 18.0-60.0, Neuromediated Cardioinhibitory Syncope Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study age between 18 and 60 years syncopal episodes at least of likely CNS in the previous 2 years marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration [7]. Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%) documented tachyarrhythmias as possible causes of symptoms channelopathies (Brugada syndrome, LQT or SQT syndrome) ventricular preexcitation symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement pregnancy in women previous cardiac pacemaker implantation | 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, Type 1 Diabetes Mellitus Male or female of age 18 years or older with a history of T1DM for at least 12 months 2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results 3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL) 4. Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant 5. Current treatment at the time of screening with insulin <300 units per day (U/day) 6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average CGM use 5 or more days per week over the preceding 3 months) and those who do not routinely used CGM are both eligible for in the study. Intermittent use of CGM is also acceptable but will not be a criterion use for stratified randomization. 7. Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol Type 2 diabetes 2. Known or suspected allergy to any component of any of the study drugs in this study 3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator 4. History of transmural myocardial infarction, congestive heart failure and uncontrolled hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury [mmHg]) are exclusionary 5. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures 6. History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant 7. As judged by the Investigator, clinically significant findings in routine laboratory data at screening 8. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis. 9. Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator. 10. Current addiction to alcohol or substance abuse as determined by the Investigator. 11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study. 12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study | 0 |
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, Newly Diagnosed Diffuse Large B-Cell Lymphoma Intermediate (Burkitt-Like) Lymphoma Diffuse large B-cell lymphoma or intermediate ("Burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for MYC-R. 2. Positivity for MYC-R by Fluorescent in-situ Hybridization (FISH) or by classical cytogenetics. 3. No prior lymphoma treatment, with one exception: One cycle of R-CHOP regimen is permitted (consisting of one single dose each of Rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of Prednisone when part of chemotherapy). 4. No prior radiation therapy is permitted 5. Age ≥ 18 years to 70 years of age 6. CT imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. Any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration 7. Bidimensionally measurable disease by imaging within 28 days prior to registration 8. Adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment 9. Indication for primary treatment with systemic multiagent chemotherapy 10. Creatinine ≤ 2.0 mg/dL and estimated (Cockroft-Gault) creatinine clearance> 50 ml/min within 7 days prior to registration 11. Cardiac ejection fraction of ≥ 50% by MUGA scan or by 2-D echocardiogram , as well as EKG without significant abnormality within 28 days prior to registration 12. Performance status of 0, of 1, or of 2 (ECOG scale) 13. Patient willing to have, and to maintain, a central venous line throughout the treatment phase (either PICC line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system) 14. Willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase. 15. Signed informed consent to accept transfusion of blood products as medically indicated 16. Signed informed consent to participate in this trial Age > 70 years 2. Leukemic presentation, or no evidence of disease by imaging 3. Unwilling to be screened for HIV. HIV positive patients must receive combined antiretroviral treatment while on study. They are excluded from participation unless they show a CD4 count >250/uL and a viral load < 50 within 28 days of registration. 4. Hepatic involvement and total serum bilirubin ≥ 5 mg/dL within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dL without hepatic involvement within 7 days prior to registration 5. Patients with bone marrow involvement and either ANC < 1000/uLor Platelets < 50,000/uL, within 7 days before registration 6. Patients without bone marrow involvement by lymphoma, and either ANC < 1500/uL or Platelets < 100,000/uL within 7 days before registration 7. Patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis oflymphoma. 8. Known hypersensitivity to E. coli derived proteins 9. Patients at risk of reactivation of hepatitis B who are unwilling to be treated with appropriate antivirals as medically indicated. 10. Pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence. 11. Additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ~ 5 years 12. Unwilling to receive transfusions of blood products as medically indicated | 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, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma Ann Arbor Stage III Diffuse Large B-Cell Lymphoma Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma PRE-REGISTRATION (STEP 0) Histologically confirmed DLBCL expressing CD20 antigen; patients with transformed lymphoma are excluded; in this regard, patients with composite lymphoma in the diagnostic tissue (concomitant DLBCL and follicular or other low-grade lymphoma component) are excluded; however, patients with DLBCL in primary diagnostic tissue but a bone marrow that shows low grade or indeterminate lymphoma are eligible; patients with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded; similarly, patients with known c-myc translocation (by fluorescence in situ hybridization) positive DLBCL are encouraged to participate in trials specifically designed for these patients; however patients with known c-myc DLBC positive are NOT excluded from this study; c-myc testing prior to study enrollment is NOT required Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study A paraffin-embedded tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the Mayo Clinic Lymphoma Laboratory following pre-registration; Note: excisional tumor biopsy is preferred; core needle biopsies will be considered adequate if there is enough tissue for the mandatory central pathology review immunohistochemistry and Genomics Education Partnership (GEP); submission of a tumor block is preferred, but if unavailable submit alternative materials Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma; for subjects with severe systemic symptoms, compressive disease, or rapidly progressing symptomatic adenopathy, are allowed for lymphoma associated symptom treatment with up to 1 mg/kg/day prednisone, or equivalent, for a maximum of 7 days is permitted prior to beginning the treatment, at the discretion of the investigator; a washout period does not apply No known central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells; these patients are usually treated with CNS directed therapy; screening for cerebrospinal fluid (CSF)/CNS involvement is NOT required but can be performed per treating medical doctor (MD) discretion; intrathecal (IT) methotrexate or IT cytarabine prophylaxis in patients with negative CSF who are felt to be at high risk of CNS relapse is allowed per local MD discretion; this should be noted on the treatment form Absence of history of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia; patients with a history of deep vein thrombosis(DVT)/pulmonary embolism (PE) or thrombophilia may participate if they are willing to be on full anticoagulation during the treatment if randomized to rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R2CHOP) arm A; full anticoagulation is defined as warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible | 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): 3.0-31.0, Diffuse Large Cell Lymphoma Burkitt's Lymphoma High Grade B-cell Lymphoma Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2. Burkitt's Lymphoma High Grade B-cell Lymphoma---Burkitt's like. B-Cell Anaplastic Large cell Ki 1 positive lymphomas, Primary Mediastinal B-Cell Lymphoma (PMBL), and B-Lymphoblastic lymphomas are ineligible. No previous chemotherapy. Patients who have received emergency irradiation and/or steroid therapy will be eligible ONLY if started on protocol therapy not more than 72 hours from the start of radiotherapy or steroids. Bone marrow and cerebrospinal fluid MUST be obtained before steroids are given for patient to be eligible for the study Patients with newly diagnosed Group A (low risk) lymphoma. Patients with Group B (intermediate risk) if classified as Murphy Stage III/IV and diagnostic LDH > 2 XULN and patients with primary mediastinal B-cell lymphoma (PMBL) Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy No prior solid organ transplantation Patients with previous malignancies that have been treated with systemic chemotherapy with alkylator or anthracycline therapy. The latter group of patients are excluded due to an expected increase in late effects (eg. late cardiac toxicity, secondary malignancies, sterility, etc.) Patients with known G6PD deficiency are NOT for Rasburicase therapy. Patients with G6PD deficiency should be treated with alkalinization, IV hydration and po and/or IV allopurinol during the reduction phase (COP). 4.2.6 Patients with serious (sepsis, pneumonia, etc..) proven or suspected infections at diagnosis will be excluded. 4.2.7 Pregnancy or Breast-Feeding: No information is available regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method | 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): 18.0-70.0, Hepatocellular Carcinoma With CSPH 18 Years < ge ≤ 70 Y,KPS ≥ 70 2. A solitary HCC ≤ 5cm in diameter,or multiple HCC(≤3) ,each ≤3cm in diameter without evidence of radiologically definable vascular invasion or extrahepatic metastasis. allowing to both SR and PLAT 3. Child-Pugh class A or B,without history of encephalopathy,ascites refractory to diuretics,or variceal bleeding 4. NO previous treatment of HCC 5. Platelet count>40,000/mm3；prothrombin time prolongation of no more than 3 seconds 6. Patients who can understand this trial and have signed information consent metastatic liver cancer 2. Patients with apparent cardiac,pulmonary,cerebral and renal dysfunction,which may affect the treatment of HCC 3) Patients with other diseases which may affect the treatment mentioned 4） Patients participating in other clinical trials 5） Patients with a medical history of other malignant tumors 6) Pregnant and breast-feeding 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, Cholelithiasis Gallbladder Polyps Man or woman > 18 years old Symptomatic gallbladder lithiasis or gallbladder polyps Clinical, biological ou medical imaging history leading to suspicion of gallstones migration Absence of contra-indication to anesthesia and cholecystectomy procedure Ability to understand the study related information and to provide written informed consent Registered with the French social security regime Non Inability to give informed consent Acute Cholecystitis Contraindications to MRI exam (claustrophobia, implantable devices) Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds | 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 Calculous Cholecystitis Acute Acalculous Cholecystitis Clinical diagnosis of acute cholecystitis Underwent the ultrasound-guided percutaneous cholecystostomy Transferred patients from other institute after cholecystostomy 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): 18.0-65.0, Healthy Healthy males and females, non-vegetarians, non-smokers, age 18-65 with BMI 18-35 kg m-2, taking no medication Diabetes Severe gastrointestinal disorders Kidney disease Thromboembolic or coagulation disease Hepatic disease Alcohol or any other substance abuse Gout Eating disorders Allergy Unregulated thyroid disease Asthma Eczema Hay fever Gluten/wheat intolerance Psychiatric disorder resulting in a perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioral disorders) Medication (Confirmed with GP) Orlistat (Xenical) Oral antidiabetics, insulin Digoxin, anti-arrhythmics Anti-inflammatories/anti-pyretics Tricyclic antidepressants, neuroleptics Antihistamines | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-70.0, Diffuse Large B-cell Lymphoma Previously untreated MYC positive diffuse large B-cell lymphoma Age range 18-70 years old Eastern Cooperative Oncology Group performance status 0-2 Life expectancy of more than 3 months Adequate organ function Primary or secondary central nervous system involvement Previous serious cardiac disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Serious uncontrolled diseases and intercurrent 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): 18.0-999.0, Prosthetic Valve Endocarditis (PVE) unexplained persistent or recurrent fever >38°C and/or unexplained increased serum C-reactive protein (CRP) level >10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography pregnancy an inability to lie flat a need for urgent cardiac surgery hemodynamic instability cardiac surgery <1 month ago and a blood glucose level >1.8 g/L. Patients with a poor PET/CT image quality | 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 Leukemias of Ambiguous Lineage B-cell Adult Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Burkitt Lymphoma Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt's leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded Patients must have evidence of acute leukemia in their peripheral blood or bone marrow; patients must have >= 5% blasts in the peripheral blood or bone marrow within 14 days prior to registration; at least >= 20% of those blasts must be CD22-positive (surface) based on local immunophenotyping and histopathology Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following Patient is in second salvage or more; OR Patient was treated on the standard of care arm of B1931022 and failed therapy Patients may have received prior allogeneic transplant or autologous transplant; however, patients with prior allogeneic bone marrow transplant will be eligible only if both of the following conditions are met The transplant must have been performed >= 90 days prior to registration The patient must not have >= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD within 14 days prior to registration Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least two second or third generation tyrosine kinase inhibitors | 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, Indolent B-cell Non-Hodgkin's Lymphoma Patient with CD20 positive low tumor burden indolent B-cell non Hodgkin's lymphoma Patient with at least one measurable lesion Patient with ECOG performance status 0 or 1 Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy Patient who has mAb therapy other than rituximab as prior line of therapy Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal) Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer. Other protocol-defined inclusion/ | 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, Non-Hodgkin Lymphoma Age ≥ 18 years. 2. Diagnosis of relapsed or refractory to previous therapy biopsy-proven Diffuse Large B cell non-Hodgkin's Lymphoma (there is no limit on the number of prior therapies. Subjects who have relapsed following an autologous stem cell transplant are eligible.) 3. Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter. 4. ECOG (Eastern Cooperative Oncology Group) performance status score of 0, 1, or 2. 5. Life expectancy of >= 90 days (3 months). 6. Must be able to adhere to the study visit schedule and other protocol requirements. 7. Signed informed consent 8. Social security program affiliation 9. Females of childbearing potential (FCBP*) must have negative pregnancy test (sensitivity of at least 25 mIU/mL) prior to starting study drug in accordance with the Global Pregnancy Prevention Plan (PPP, annex 6) 10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously** or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study drug; and 3) for at least 12 months after discontinuation from the study drug. Male Subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. Agree not to donate blood, semen or sperm while taking study drug and for 28 days after stopping study drug. Do not share drug with other person. Do not break, chew, or open study drug capsules. Return unused study drug capsules to the study doctor Any of the following laboratory abnormalities Absolute neutrophil count (ANC) < 1.5 x 109/L Platelet count < 60 x 109/L Calculated creatinine clearance (Cockcroft-Gault formula) of < 50mL/min Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN) Serum total bilirubin > 2.0 mg/dL (34 μmol/L)/conjugated bilirubin >0.8mg/dL, except in case of hemolytic anemia. 2. Subjects who are candidates for and willing to undergo an autologous stem cell transplant. 3. Subjects who are post allogenic stem cell transplant. 4. All subjects with active central nervous system (CNS) lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery who have remained asymptomatic for 90 days (3 months) and demonstrate, no CNS lymphoma, as shown by lumbar puncture, CT scan or MRI, are eligible. (If required, lumbar puncture, CT or MRI should be performed during screening process.) Subjects should not be receiving corticosteroids. 5. Prior history of malignancies other than NHL (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for 5 years 6. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 7. Pregnant or lactating females. 8. Uncontrolled intercurrent illness including, but not limited to Ongoing, severe or active infection requiring antibiotics Uncontrolled diabetes mellitus as defined by the investigator Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease) Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 168 days (6 months) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, CD20 Positive Recurrent Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Stage I Diffuse Large B-Cell Lymphoma Stage II Diffuse Large B-Cell Lymphoma Stage III Diffuse Large B-Cell Lymphoma Stage IV Diffuse Large B-Cell Lymphoma Histological confirmation of relapsed/refractory CD20 positive diffuse large B-cell lymphoma Ann Arbor stage I to stage IV DLBCL at the time of relapsed/refractory disease to be eligible Measurable or assessable disease is required; measurable tumor size (at least one node measuring 2.25 cm^2 in bidimensional measurement) per computed tomography (CT) scan, other radiological study, and/or physical exam Patients must have received at least 1 prior rituximab-based immunochemotherapy (e.g., R-CHOP, R-EPOCH, etc.) >= 2 weeks since major surgery Patients must not have any significant toxicity associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy, per principal investigator (PI) discretion Life expectancy >= 3 months Karnofsky score (KS) >= 50 Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3.5 times the upper limit of normal within 14 days prior to starting therapy Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 14 days prior to starting therapy* Patients with non-Hodgkin lymphoma (NHL) other than DLBCL; including "transformed" DLBCL Known to be seropositive for human immunodeficiency virus (HIV); an HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk Positive serology for HBV defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HepB DNA test will be performed and if positive the subject will be excluded Patients with symptomatic brain involvement Peripheral neuropathy of grade 2 or greater severity as defined by the National Cancer Institute's (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0; patients with grade 2 or higher (NCI-Common Toxicity [CTC]) neuropathy Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemia Uncontrolled intercurrent illness including, but not limited to, active infection, poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study Pregnant or breastfeeding Patient has received other investigational drugs within 4 weeks before enrollment Chemotherapy within 3 weeks of the first scheduled study treatment | 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): 2.0-70.0, Parental Stress Parent and Child Stress Parental and Child Obesity Child Obesity Between ages 18-70 years; 2. Able to read and write (parent) 3. Family with a child between 2-5 years old 4. BMI of parent in obese category 5. High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index) Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation 2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child 3. Inability to give informed consent 4. Current serious medical disorder precluding participation in physical activity | 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, Pulmonary Embolism Deep Vein Thrombosis > 18 years of age 2. fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent 3. willing and able to comply with follow-up visit requirements 4. requirement of transient PE protection of < 60 days 5. documented or high risk of PE or DVT 6. inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy 7. IVC diameter compatible with filter diameter 8. IVC length adequate for filter placement intellectual impairment preventing understanding involvement in a clinical study 2. hypersensitivity to device components 3. impaired renal function defined as a serum creatinine level of > 2.0 mg/dL 4. active systemic infection 5. life expectancy < 12 months 6. malignancy extending PE risk > 60 days 7. pregnant or plans to become pregnant during study follow-up period 8. participating in another investigational trial that has not reached its primary endpoint 9. known hypercoaguable state 10. inherited or acquired hemostatic disorder 11. history or presence of a caval stent or filter 12. inability to gain femoral or jugular access 13. duplicated or left sided IVC 14. renal vein thrombosis or IVC thrombosis extending to the renal veins 15. jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery 16. spinal irregularity that may interfere with successful device delivery 17. occlusive or free-floating thrombus in the IVC 18. contrast allergy that cannot be adequately pre-medicated | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
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 Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 0 |
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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 0 |
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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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 Adult (age > 18) with blood pressure >140/90 or >130/80 if also diagnosed with diabetes Under a physicians care for hypertension for at least 6 months Prescribed 2-3 hypertension medications Independently ambulatory Approval of participation from primary care physician or cardiologist Prescribed more than 4, or only 1 hypertension medication Severe cognitive dysfunction precluding informed consent and understanding of hula Pregnancy at time or during the study period | 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, Primary Progressive Multiple Sclerosis years old or more Progressive neurological deficit after 12 months At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions) Asiatic persons recurrent forms of the disease Persons wearing contact lenses Ocular Infection Corticoid treatment at least 30 days before sampling immunosuppressive or immunomodulatory treatment 3 months before sampling | 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, Pleural Mesothelioma Malignant Advanced Peritoneal Mesothelioma Malignant Advanced Non-squamous Non-small Cell Lung Carcinoma Uveal Melanoma Hepatocellular Carcinoma Glioma Sarcomatoid Carcinoma Histologically proven advanced MPM, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous NSCLC (stage IIIB/IV) who have not been treated with prior chemotherapy or immunotherapy, except that NSCLC subjects with EGFR mutant or ALK positive must have had an EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such ALK inhibitor and EGFR targeted therapy are approved and available in the country in which patients are being enrolled OR Histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (MTD cohort only), OR Histologically proven HCC who have failed (PD and/or side effects-been intolerant of) treatment with sorafenib. Failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. Intolerance is defined as discontinuation due to an AE(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. Failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. Cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix E). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.", OR Histologically proven high-grade glioma who have failed (PD and/or side effects) treatment with radiotherapy ± temozolomide, OR Sarcomatoid cancer of any line. 2. ASS1 deficiency (defined as ≤50% ASS expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (IHC). For subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. A new tissue specimen obtained after most recent chemotherapy is not required. Thus ASS1 deficiency is required for entrance into the study. If tissue is not available to determine ASS1 deficiency, then tissue must be obtained by biopsy to determine ASS1 status. 3. Measurable disease as assessed by modified for MPM and by 1.1 for peritoneal mesothelioma, NSCLC, uveal melanoma, HCC, glioma and sarcomatoid carcinoma 4. ECOG performance status of 0 5. Predicted life expectancy of at least 12 weeks Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment. 2. Ongoing toxic manifestations of previous treatments. 3. Symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, NSCLC, uveal melanoma excludes subjects with HCC or glioma). 4. Major thoracic or abdominal surgery from which the patient has not yet recovered. 5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment | 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, Heart Disease Pleural Effusion Pericardial Effusion Age >18 years Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations Be able to understand the written and oral patient information and to give informed consent Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions Simultaneous participation in any other clinical intervention trial | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-999.0, Non-small Cell Lung Cancer Malignant Pleural Effusion Histological or cytological diagnosis of non-small cell lung cancer. 2. Cytological diagnosis of malignant pleural or pericardial effusion (MPE) 3. Symptomatic MPE evaluated by researchers 4. Unsuitable for or reject systemic therapy of tumor 5. Estimated survival of more than 3 months. 6.18 years or older Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants 2. Be allergic to bevacizumab 3. Pregnant or lactating woman 4. Pleural or pericardial infection | 0 |
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