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A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Pulmonary Arteriovenous Malformation Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM) PAVM unable to be embolized | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-90.0, Cervicogenic Headache Headache Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region) Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation A positive result in the flexion-rotation test A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test Be at least 18 years old Have signed the informed consent Contraindications for manual therapy or exercise Participation in exercise or manual therapy programs in the last three months Inability to maintain supine position The use of pacemakers (the magnets in the CROM device could alter their signal) Inability to perform the flexion-rotation test Language difficulties Pending litigation or lawsuits | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Hereditary Hemorrhagic Telangiectasia All laboratory test for study may be obtained at any point in the 30-day screening period A clinical diagnosis of "possible/suspected" or "definite" hereditary hemorrhagic telangiectasia, as defined by presence of 2 or more of the Curacao (spontaneous and recurrent epistaxis, telangiectasias at characteristic sites, visceral arteriovenous malformations (AVMs), first degree relative with HHT) Age ≥18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab for HHT in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials Red blood cell transfusion and/or iron infusion dependence, as defined by a hematologic support score (HSS) of ≥3 in the 3 months prior to consent. HSS is calculated by dividing the total milligrams of elemental iron infused by 250 and adding to this the number of red cell units transfused ECOG performance status ≤2 (see Appendix B) Participants must have adequate organ and marrow function as defined below leukocytes ≥2,500/mcL absolute neutrophil count ≥1,500/mcL platelets ≥75,000/mcL AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN* Participants who have received intranasal or systemic bevacizumab, systemic ramucirumab, or systemic ziv-aflibercept in the 6 weeks prior to consent Participants who have received oral anti-angiogenic agents, including pazopanib, axitinib, sorafenib, thalidomide, lenalidomide, or pomalidomide in the 6 weeks prior to consent Participants receiving oral tranexamic acid, epsilon-aminocaproic acid, or doxycycline unless they are on a stable dose for at least 2 weeks prior to consent to be continued at that same dose over the entire duration of the study Participants receiving erythropoiesis-stimulating agents unless they are on a stable dose for at least 4 weeks prior to consent to be continued at that same dose over the entire duration of the study Participants receiving oral iron preparations must discontinue these preparations within 2 weeks prior to the initiation of the study. Multivitamins or other pharmaceuticals containing iron are allowed if the daily dose of elemental iron does not exceed 25 mg per day Participants receiving systemic estrogen or testosterone preparations unless they are on a stable dose for at least 4 weeks prior to consent to be continued over the entire duration of the study. Use of non-prescription testosterone preparations (e.g. illicit anabolic steroids) in the 4 weeks prior to consent is exclusionary Participants who are receiving any other investigational agents History of allergic reactions to bevacizumab Participants with uncontrolled intercurrent illness, in the opinion of the investigator Participants with psychiatric illness/social situations that would limit compliance with study requirements, in the opinion of the investigator | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-70.0, Covid-19 Sars-CoV2 Diabete Mellitus Cardiopathy Pulmonary Disease Renal Disease Liver Diseases Population over 18 years of age up to 70, sample size 30 Subjects with mild to moderate* symptoms of respiratory illness caused by 2019 coronavirus infection as defined below: Mild disease (uncomplicated) Diagnosed with COVID-19 by a standardized RT-PCR assay and Mild symptoms, such as fever, runny nose, mild cough, sore throat, malaise, headache, muscle pain, or discomfort, but no shortness of breath and No signs of more serious lower airway disease RR <20, HR <90, oxygen saturation (pulse oximetry)> 93% in ambient air. *Moderate illness Diagnosed with COVID-19 by a standardized RT-PCR assay and In addition to the above symptoms, more significant lower respiratory symptoms, including difficulty breathing (at rest or with exertion) or Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry)> 93% in ambient air, and If available, X-ray or computed tomography-based lung infiltrates <50% present 3. 12-lead ECG at rest clinically normal at the screening visit or, if abnormal, not considered clinically significant by the lead investigator. 4. The subject (or legally authorized representative) provides her informed written consent before starting any study procedure. 5. Understand and agree to comply with planned study procedures. 6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combined oral contraceptives, transdermal patches or rings) ] or intrauterine devices) for the duration of the study None | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 17.0-999.0, Dysphagia, Esophageal Dysphagia, Oral Phase Dysphagia Comes and Goes Thyroiditis Thyroid Cancer Thyroid Neoplasms Thyroid Goiter Thyroid Nodule (Benign) Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma) Patients with total thyroidectomy (TT) indication Patients over 17 year-old Patients without thyroid disease Patients with thyroid disorder, but prepared for surgery other than TT Healthy volunteers Patients below 17 y/o | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 16.0-100.0, Subarachnoid Hemorrhage, Aneurysmal Adult patients aneurysmal subarachnoid hemorrhage admitted to Neurointensive care unit at Sahlgrenska University Hospital, Gothenburg, Sweden cardiac arrythmias use of pacemaker | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, ICU Patient Patient ≥ 18 years old in intensive care unit (ICU) or surgical intensive care unit (SICU) Intubated and under mechanical invasive ventilation for at least 24 hours or under non-invasive ventilation for more than 12 hours a day or under continuous high-flow nasal oxygen therapy for more than 24 hours or alternating NIV/HFNO Patient or next of kin who has expressed consent to participate in the study Tracheotomized patient Patient with a contraindication to sitting in a chair Deep vein thrombosis not effectively anticoagulated Fracture or orthopaedic disorder contra indicating mobilization Lung Embolism Hemodynamic instability with Average Arterial Pressure < 65 mmHg or a vasopressor amine dose greater than 0.5 ug/kg/min Pregnant or breastfeeding woman Therapeutic limitation with decision of non-reintubation in case of extubation failure Non-affiliated or non-beneficiary patient of a social security scheme Person deprived of liberty by judicial or administrative decision | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Cervicogenic Headache History of occipital nerve injection, occipital nerve stimulation or history of surgical procedures in the occipital region History of allergic reaction to the substance to be applied as local anesthetic Pregnancy or lactation Uncontrolled hypertension Uncontrolled diabetes mellitus Uncompensated congestive heart failure Chronic renal failure Chronic liver disease Tumor and/or vascular disease Inflammatory and/or infectious diseases Anticoagulant or antiplatelet medication use that may interfere with the injection process were also excluded | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Prader-Willi Syndrome PWS-like Syndrome Silver Russel Syndrome Congenital Hypopituitarism Klinefelter (XXY-)Syndrome Congenital Adrenal Hyperplasia XXXXY Syndrome XXYY Syndrome XXXX Syndrome (Tetra-X Syndrome) Disorders of Sex Development Turner Syndrome 46, XY DSD Tuberous Sclerosis Neurofibromatosis Albright Hereditaire Osteodystrofie Cornelia de Lange Syndrome Saethre-Chotzen Syndrome 17p- Deletiesyndrome VCF Syndrome POLR3A Mutatie Ohdo Syndrome Jacobsen Syndrome / 11 q Syndrome Myrhe Syndrome CHARGE Syndrome 1q25-32 Deletie Bardet Biedl Syndrome Rett Syndrome 22q11 Deletion Syndrome Allan-Herndon-Dudley Syndrome Kallmann Syndrome Rare Bone Disorders Noonan Syndrome Williams-Beuren Syndrome Patients with rare syndromes or rare congenital diseases visiting the multidisciplinary outpatient clinic for patients with rare diseases at the department of endocrinology, internal medicine, Erasmus Medical Center None | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-90.0, Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Vasospasm, Cerebral Aneurysmal Subarachnoid Hemorrhage Age: >18, <90 SAH HH 3 Cerebral saccular Aneurysm Digital subtraction angiography prior to aneurysm repair Aneurysm repair within 72h Modified Fisher Grade 3+4 Presence of aneurysm needing treatment (clipping or coiling) Treatment within 24 hours of symptom onset External ventricular drain (clinical need) Non-aneurysmal SAH SAH HH<3 Extensive intraventricular haemorrhage (unable to obtain CSF without massive aspiration of clotted blood) Contraindication for digital subtraction angiography Aneurysm repair >72h after rupture Signs of radiographic vasospasm upon diagnosis Presence of systemic or CSF infection Contraindication for oral Nimodipin Pregnancy | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Supratentorial Hemorrhage Subject Age is > 18 Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume > 20 mL, assessed via standard of care techniques Subject Surgery can be initiated within 12 hours of the last known well time or, in patients with wake-up onset, within 12 hours of the time the patient awoke with symptoms Subject has a NIHSS score > 5 Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2 Subject with a CT Angiography demonstrating no vascular malformation Subject has an underlying vascular lesion defined as causative source of ICH Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing Subject has an Infratentorial or brainstem ICH Subject has a known life expectancy < 6 months Subject has an uncorrectable coagulopathy Subject has a mechanical heart valve Subject is pregnant Subject participates in another concurrent interventional clinical trial Subject who is unable to meet study follow-up requirements | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Head Trauma Craniocerebral Injuries Crushing Skull Injury Head Injuries Head Injuries, Multiple Head Injuries, Closed Head Trauma,Closed Head Trauma Injury Head Trauma, Penetrating Head Injury, Minor Head Injury Major Head Injury, Open Injuries, Craniocerebral Injuries, Head Multiple Head Injury Trauma, Head Any patient who presents to MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study None | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-75.0, Neurosensory Disorder Aged from 18 to 75 years old(including 18 and 75 years old), males or females; 2. First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients； 3. Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6； 4. Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)； 5. The patient/family knows and signs the informed consent form voluntarily Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination; 2. Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml); 3. Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction; 4. Patients who use anticoagulant drugs for a long time; 5. Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function; 6. The measured value of homocysteine at admission is higher than 15μmol/L; 7. Patients who need surgical treatment (including ventricular drainage); 8. Patients with severe primary diseases such as cardiovascular, liver (ALT or AST>1.5 times the upper limit of normal), kidneys (BUN>1.5 times the upper limit of normal and Cr>upper limit of normal), endocrine system and hematopoietic system; 9. Those who are allergic to protein and test drugs; 10. People who are dependent on drugs or alcohol; 11. Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women; 12. Participated in other clinical trials within the past 3 months; 13. Patients considered by the investigator to be inappropriate to participate in clinical trials | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 12.0-999.0, Compassion for clusters: Residential care homes (RCH) in the Centre region of Portugal, receiving adolescents (both genders) aged between 12 and 25 YO RCH mostly receiving children or specialized in mental and behavioural disorders/substance abuse problems will be excluded (to control for mental health treatments delivered in these RCH). for participants: for caregivers: Professionals working in RCH and directly interacting with the adolescents on a regular basis. for adolescents: have entered in the RCH at least 1-month before the study's onset (adjustment time); aged between 12 and 25 YO for adolescents: cognitive impairment; remaining in residential care for less than 9 months | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 20.0-40.0, Cervicogenic Headache Headache frequency of at least 1 per week for a minimum of 3 months Secondary Headache (cervical spine dysfunction) International Classification of headache Disorder: 1. Pain localized in the neck and occiput, which can spread to other areas in the head, such as forehead, orbital region, temples, vertex, or ears, usually unilateral. 2. Pain is precipitated or aggravated by specific neck movements or sustained postures. 3. At least one of the following: 1. Resistance to or limitation of passive neck movements 2. Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction 3. Abnormal tenderness of neck musculature Other types of headache Trigger points of upper cervical muscles Congenital conditions of cervical spine Cervical Disc herniation Fracture Cervical Artery disease Red flags of Thrust Joint Manipulation | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-90.0, Stroke Cluster Secondary or tertiary hospitals with an emergency department and neurologic wards that receive patients with AIS Hospitals with available brain MRI scans (1.5T or 3.0T) Patient Patients of 18 years or older Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle) Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI) Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated) Cluster Grade-one hospitals and rural hospitals The specialized hospitals, such as women and children specialist hospital and tumor hospital Hospitals with less than 20 patients with suspected AIS per month Patient Diagnosed DWI negative stroke Diagnosed other types of cerebrovascular diseases, such as transient ischaemic attack, hemorrhagic stroke, cerebral venous sinus thrombosis, and so on Diagnosed non cerebral vascular disease, such as stroke mimic, seizures, central nervous system infections, metabolic encephalopathy, and so on Received carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS) Involving in other investigational drug or device clinical trials | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-60.0, Headache Pituitary Tumor Acromegaly Patients with GH tumor who have undergone transnasal pituitary tumor resection or craniotomy for pituitary tumor resection in the past (3 months or more), aged between 18 and 60 years old, regardless of gender Preoperative glucose tolerance test (OGTT) simultaneously determines that the trough value of GH is greater than 1ng/ml, and the level of IGF-1 is greater than the upper limit of the age-sex-matched normal value; ③. Biochemical remission is achieved after surgery, that is, the random GH value is less than 1ng/ml, and the IGF-1 level is within the normal range of age and gender matching; ④. The patient still has headaches after the operation, the duration of each attack is more than 4 hours, and the attack is more than 3 times per month; ⑤. The patient is in a headache attack period; ⑥. A clear consciousness, able to understand and sign an informed consent form Patients who are being treated with somatostatin and bromocriptine Patients with other intracranial organic diseases Pregnant women and children who cannot express Patients with other malignant tumors Participate in other clinical research in the same period; ⑥. Patients with severe medical complications, such as heart, lung, kidney, liver and other diseases, severe hypertension or poor blood pressure control, hyperglycemia, blood diseases Those with mental illness who cannot cooperate well with the experiment Patients with acute infection or open wounds; ⑨. Acetaminophen is contraindicated (hemolytic anemia, severe liver and kidney dysfunction) or allergic to its components; ⑩. Patients with contraindications to transcranial magnetic stimulation: patients or users who have implanted cardiac pacemakers, implantable defibrillators and neurostimulators together; those who have a history of epilepsy; wear electronic products (such as insulin Pumps, Holter, etc.) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Subarachnoid Hemorrhage Spontaneous subarachnoid hemorrhage Trauma-induced subarachnoid hemorrhage Ongoing chemotherapy Taking immunosuppressive medications for other medical illnesses Presence of a pacemaker Prolonged bradycardia at time of admission | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-0.058, Maternal Depressive Disorder Complicating Childbirth Preterm Birth Maternal Anxiety Disorder Complicating Childbirth Mother Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby Older than 18 years of age Infant • Gestational age between 26 0/7 and 30 6/7 weeks Mother • Younger than 18 years Infant • Major congenital or chromosomal anomalies | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 6.0-9.0, Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries Children with good health and without any systematic diseases history which may interfere with their oral hygiene. 2. Children ranging in age from 6 to 9 years. 3. Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II). 4. Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale. 5. Informed consent to the child's participation in the study signed by one of his/her parents/guardian. 6. No children will be excluded on the basis of gender, race, social or economic status Children with systemic diseases. 2. Children with oral habits affecting occlusion. 3. Children with any physical or mental disorders. 4. Children with cavitated, defected, missed or restored contralateral tooth. 5. Children with history of allergy to resin or latex. 6. Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects. 7. Not approving to sign the consent | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Thoracic Spine Neoplasm Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.) All diagnoses are eligible Vertebral body site to be treated located from T2 to T12 Signed informed consent Requires open spinal procedure or a percutaneous procedure without the use of image guidance Unable to tolerate general anesthesia and prone position Unable to undergo MRI scan of the spine | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Dementia Alzheimer Disease Anomia Person with mild/moderate dementia Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language Able to tolerate MRI brain scan Able to give informed consent Able to use the DNI (app) No diagnosis of developmental language disorders No diagnosis of severe dementia or primary progressive aphasia No major co-existing neurological or psychiatric diagnosis No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 1.0-80.0, Cerebral Arteriovenous Malformation The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI). 2. Patients with complete clinical and imaging data. 3. Patient or patient's legal representative agreed to collection of information for this study and signed informed consent Received other treatment (surgery, embolization or SRS)before and could not provide the treatment data such as imaging data before or after treatment; 2. Expected survival time is less than 6 months | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Stroke (CVA) or TIA Headache, Migraine Botulinum Toxins, Type A Cerebral Venous Sinus Thrombosis Carotid Dissection Artery Vertebral Dissection Artery Hemorrhagic Stroke Reversible Cerebral Vasoconstriction Syndrome Adult patients (>18 y) fulfilling ICHD-3 criteria* of persistent post stroke/hemorrhagic stroke headache; persistent headache post dissection* and post RCVS persistent headache will be enrolled at 3 months or greater of persistence of symptoms. For the purposes of this study, as suggested elsewhere in the literature, the initial onset of headache will be considered for study if occurring within 72 hours prior to and 7 days post sentinel vascular event ("Stroke"). The 72 hours prior allowing for of patients of intracerebral hemorrhage who are known to have anticipatory headache as well as alternate ischemic syndromes in which new onset headache may anticipate stroke symptoms such as dissection and reversible cerebro-vasoconstriction syndrome. 2. The syndrome of post CVST headache patients will only be enrolled after symptoms have persisted for a minimum of 6 months and after relevant imaging demonstrates a resolution of potentially structural contribution from the sentinel event (i.e. recanalization or chronic thrombo sis with a normal opening pressure on lumbar puncture) Note the patients of post dissection persistent headaches may be enrolled despite the absence of an identified ischemic lesion, i.e. in the setting of TIA or new onset headache without embolic symptoms but with a history of the (stabilized) vascular injury associated with the syndrome Note the co-existence of medication overuse headache will not be a contraindication to randomization Tension type Post Stroke Persisting Headache, Post stroke pain syndrome such as the Thalamic syndrome of Dejerine-Roussy, or any headache semiology that does not fulfill diagnostic for chronic migraine, will be excluded. 2. Contraindications to Botox, neuromuscular illness or documented hyper sensitivity will preclude randomization of patients. 3. Concurrent active systemic illness, such as sepsis, chronic infective processes, neoplastic syndromes, or autoimmune syndromes. (Headache secondary to medical illness, even if occurring post-stroke). 4. Subjects must be screened for coexistent (including psychiatric) conditions to illnesses that may influence the conduct or results of the trial. Subjects with coexisting conditions, such as depression, may be included if they are defined a priori, stable on current treatment regimens (with no anticipated changes in management that may interfere with study results), and recorded throughout the study. One of the secondary outcome measures in the study investigates the potential impact on concurrent symptoms of depression. However, the stability of symptoms treatment and concomitant medications should be assessed prior to in the study. If factors are identified which might interfere with patient compliance, follow up or confound results, such patients should be excluded. Other common reasons for severe depression and overuse of alcohol or illicit drugs, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. 5. CGRP inhibitors will be contraindicated during the period of study | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Stroke, Ischemic Age ≥18 ; 2. The time from onset to treatment was less than 4.5 hours; 3. Ischemic stroke confirmed by head CT or MRI; 4. There are measurable neurological deficits; 5. First onset or previous onset without obvious sequelae (Mrs ≤1 score) ; 6. signed informed consent Severe neurologic deficits before onset (mRS ≥2) ; 2. Significant head trauma or stroke in the last 3 months; 3. Subarachnoid hemorrhage; 4. A history of intracranial hemorrhage or head injury or acute stroke within 3 months; 5. Intracranial tumors, arteriovenous malformations or aneurysms; 6. Intracranial or spinal cord surgery within 3 months; 7. Non-compressible arterial puncture within 7 days; 8. Gastrointestinal or urinary tract hemorrhage within last 21 days; 9. Major surgery within 1 month; 10. Thrombocytopenia (platelet count <10×109/L); 11. Use of heparin or oral anticoagulation therapy within 48 hours; 12. Use of warfarin with an international normalised ratio >1.7 or PT >15 s; 13. Uncontrolled hypertension (SYSTOLIC >180 mmHg OR mmHg) ; 14. The Blood Glucose concentration <50 mg/dl (2.7 mmol/L); 15. Severe systemic disease with poor life expectancy (<3 months); ; 16. Allergic to research drug; 17. Within 3 months or participating in other clinical trials; 18. Other conditions due to which investigators consider study participation inappropriate | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 1.0-80.0, Cerebral Arteriovenous Malformation The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI) Patients had underwent interventions in our institution AVMs were located in eloquent area Patients with multiple AVMs Patients with hereditary hemorrhagic telangiectasia (HHT) Patients with missing clinical and imaging data | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-60.0, Embolic Stroke of Undetermined Source Transient Ischemic Attack Right-To-Left Atrial Shunt Patent Foramen Ovale Subject 18 to 60 years of age. 2. Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, embolic stroke or transient ischemic attack (TIA) in the differential diagnosis. 3. Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent. 4. Subject is able to successfully perform a Valsalva Maneuver (VM). 5. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure. 2. Female who is pregnant or lactating at time of admission 3. Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months. 4. Subjects who have a physical limitation preventing TCD headset placement | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-65.0, Tension-Type Headache Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below: 2.2 Frequent Episodic Tension-type Headaches: Frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting minutes to days. The pain does not worsen with routine physical activity and is not associated with nausea, but photophobia or phonophobia may be present. 1. At least 10 episodes of headache occurring on 1 days per month on average for >3 months (12 and <180 days per year) 2. Headache lasting from 30 minutes to 7 days 3. Patient has headaches that have at least two of the following four characteristics: 1. Bilateral location 2. Pressing or tightening (non-pulsating) quality 3. Mild or moderate intensity 4. Not aggravated by routine physical activity such as walking or climbing stairs 4. Both of the following are true: 1. No nausea or vomiting 2. No more than one of photophobia or phonophobia 2.2.1 Frequent Episodic Tension-type Headache associated with pericranial tenderness 1. Episodes fulfilling for Frequent episodic tension-type headache (See 2.2 above) 2. Increased pericranial tenderness on manual palpation. 2.3 Chronic Tension-type Headaches: A disorder evolving from frequent episodic tension-type headache, with daily or very frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting hours to days, or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia or phonophobia. 1. Headache occurring on 15 days per month on average for >3 months (180 days per year) 2. Headache lasting hours to days, or unremitting 3. At least two of the following four characteristics 1. Bilateral location 2. Pressing or tightening (non-pulsating) quality 3. Mild or moderate intensity 4. Not aggravated by routine physical activity such as walking of climbing stairs 4. Both of the following: 1. No more than one of the photophobia, phonophonbia, or mild nausea 2. Neither moderate or severe nausea nor vomiting 2.3.1 Chronic Tension-type Headache associated with pericranial tenderness 1. Headache fulfilling for 2.3 Chronic tension type headache 2. Increased pericranial tenderness on manual palpation Must all be NO to be eligible 1. Patient presents with other primary and/or secondary headache 2. Patient presents with Medication Overuse Headache defined as: 1. Headache occurring on 15 days per month in a patient with a pre-existing headache disorder 2. Regular overuse for >3 months of one of more drug that can be taken for acute and/or symptomatic treatment of headache 3. Not better accounted for by another headache diagnosis 3. History of head/neck trauma (to whiplash) 4. History of Cervical Stenosis 5. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia 6. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc. 7. Bilateral upper extremity symptoms 8. Evidence of CNS involvement, to hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes). 9. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following: 1. Muscle weakness involving a major muscle group of the upper extremity. 2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors 3. Diminished or absent sensation to pinprick in any UE dermatome. 10. Prior surgery to neck of thoracic spine 11. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches 12. Diagnosis of fibromyalgia syndrome 13. Received anesthetic blocks or botulinum toxin within the previous 6 months 14. Received physical treatment in the neck and head the previous 6 months 15. Any condition that might contraindicate spinal manipulative therapy 16. Pregnancy | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Headache Emergencies Telephone call from center 15 for the headache pattern Age ≥ 18 Non-opposition expressed by the patient Or non-opposition delayed (adults with cognitive disorders, protected adults, clinical situations judged to be serious by the Medical Regulation Assistant, physician regulator, incoming call flow, call by close or trusted person) Head trauma < 48 hours Moribund patient Non-affiliation to a social security scheme Opposition to the continuation of the study expressed orally by the patient or by return mail within 30 days | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 5.0-18.0, Children, Only Headache, Migraine Headache, Tension Diagnosis of migraine or TTH headache according to the ICHD-3 criteria Can describe the current headache status * Secondary headaches | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-45.0, Anorexia Nervosa Bulimia Nervosa Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa The onset of their illness must have been at least 4 years prior to participating in this study Must have recovered for 12 months or more prior to entering the study Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study Organic brain syndromes, dementia, psychotic disorders or mental retardation Neurological or medical disorders Use of psychoactive medication in the 3 months prior to the study Pregnancy or lactation, lack of effective birth control during 15 days before the scans | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 3.0-10.0, Child, Only children between the ages of 3 and 10 with white, green and yellow triage code Red triage code inadequate knowledge of the Italian language yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-60.0, Head Trauma,Closed Age from 18-60 (inclusive). 2. Clinical diagnosis of TBI, cerebral contusion of moderate severity without compression. 3. The written consent of the legal representative or the decision of the council to the patient in the study. 4. Possibility of a full assessment of eye opening, speech and motor response by GCS. 5. GCS at the time of 9 (inclusive). 6. Time of initiation of study drug therapy within 24 hours after the estimated or determined time of injury. 7. The presence of post-traumatic amnesia, confusion and disorientation. 8. Absence of indications for neurosurgery or other surgical intervention under general anesthesia. 9. Normal brain CT scan, or the presence of subarachnoid hemorrhage and / or contusion foci of I-III types according to Kornienko and / or limited or diffuse cerebral edema. 10. The expected duration of hospital stay >= 10 days. 11. Absence of a disabling neurological or mental illness, information about the patient's disability prior to injury. 12. Possibility to perform all procedures stipulated by the study protocol The need to use the therapy prohibited by the study protocol. 2. Concomitant injury, except for cases of damage to the skeleton, soft tissues, internal organs, which do not require (1) surgical intervention under general anesthesia, and (2) are not an independent indication for hospital treatment. 3. Past / planned surgical intervention for the current episode of trauma under general anesthesia. 4. Penetrating open TBI. 5. Presence of the following lesions on the results of computed tomography (CT) of the brain performed prior to the patient's randomization: 1. epidural hematoma or subdural hematoma; 2. evidence of a previous head injury based on CT results; 3. type IV contusion foci according to Kornienko's classification. 6. Presence of any of the following risk factors for secondary brain injury at any time after TBI: hypoxia (SpO2 <90% based on pulse oximetry results); hypotension (systolic blood pressure <90 mm Hg) or shock;hypothermia (body temperature <35 ° C); clinical signs of respiratory failure, the need for mechanical ventilation. 7. Drug addiction. 8. Alcohol in saliva >=2 ‰ or a previous diagnosis of alcohol dependence. 9. Depression of consciousness, presumably resulting from other reasons (for example, alcohol, drugs, drugs, poisonous substances). 10. The presence of aphasia due to focal brain damage, which prevents communication with the researcher. 11. Status epilepticus at the time of admission to the hospital or condition after an epileptic seizure. 12. Pregnant and lactating women. 13. Availability of information about concomitant chronic disease in the stage of decompensation. 14. Intolerance to the components of anamnestic data on drug allergy to succinic acid, riboflavin, inosine, or nicotinamide. 15. Severe renal or heart failure requiring restriction of the volume of injected fluid. 16. The presence of a condition or disease that, in the opinion of the investigator, jeopardizes the patient's safety if the patient participates in the study, or may interfere with the performance of examination procedures, an objective assessment of the patient's condition, or distort the assessment of the outcome of TBI. 17. Participation in any clinical study less than 3 months before the start of the study. 18. Patients who are employees of the research center and their families. 19. Language barrier. 20. Availability of information that the patient is a stateless person or a citizen of another state | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 22.0-999.0, Intracranial Hemorrhages Traumatic Brain Injury Male or female patients age 22 years and older Diagnostic head CT scan within 24 hours of primary spontaneous ICH (parenchymal ICH without secondary causes, such as arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation of ischemic stroke, venous sinus thrombosis) symptom onset or traumatic intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage and/or traumatic contusions/ intraparenchymal hemorrhage) Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian Willingness and ability to comply with schedule for study procedures • Female patients who are pregnant or lactating Known history of seizure or clinical seizure prior to initiating SENSE monitoring Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT In stroke patients, secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis) Planned withdrawal of care within 24 hours of enrollment Planned surgical evacuation within 24 hours of enrollment Current participation in a medical or surgical interventional clinical trial Planned or current use of continuous EEG monitoring | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-85.0, Endothelial Dysfunction We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital History of Coronary artery disease History of Peripheral Arterial Disease History of Heart failure History of Stroke hepatic failure renal failure active neoplasia poorly controlled DM, defined as Hba1C>7% | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 22.0-65.0, Correction of Moderate to Severe Nasolabial Folds (NLFs) Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator Is ≥ 22 and ≤ 65 years of age Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration Has an acute inflammatory process or active infection at the injection site Has received mid and/or lower-facial region treatments with any dermal fillers Has received facial dermal therapies Had prior surgery in the mid and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid and/or lowerfacial area that could interfere with effectiveness assessments | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Peripheral Arterial Hemorrhage Age ≥18 years Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study Subject is willing and able to comply with the specified follow-up evaluation schedule Life expectancy >30 days No prior embolization in the target territory Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure Coexisting signs of peritonitis or other active infection Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening Uncorrectable coagulopathies such as thrombocytopenia <40,000/ μL, international normalization ratio (INR) >2.0 Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO) More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-60.0, Migraine Episodic migraineurs age between 18-60 years diagnosis of episodic migraine without aura developed before the age of 50 no current prophylactic treatment for migraine prevention chronic migraineurs with medication overuse according to the chronic or medication-overuse headache or cluster headache diagnosis any chronic pain condition or disorders other than migraine an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia a diagnosis of tension type headache with a frequency of more than 5 days per month any cardiovascular diseases in which the NTG use could be contraindicated blood pressure hypotension, closed angle glaucoma, anaemia women in child bearing, breast feeding; continuous use of benzodiazepines any neuroradiological pathological findings at a previous MRI scan of the head. Chronic migraineurs age between 18-60 years diagnosis of migraine without aura developed before the age of 50 according to the ICHD III criteria | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-41.0, Habitual Abortion Recurrent Pregnancy Loss Fertility Disorders Miscarriage Women with ≥ 2 consecutive pregnancy losses (miscarriages or biochemical pregnancies) ≤ completed gestational week 10 after ART with the present partner or with an egg/semen donor BMI ≥35 2. Age ≥41 3. Significant uterine malformation(s) 4. Known parental balanced chromosomal translocations 5. ≥2 previous pregnancies with fetuses with known abnormal karyotype 6. Patients with IgA deficiency, IgA-autoantibodies or hyperprolinaemia 7. Treatment with medication interacting with prednisolone CYP3A4-inhibitors (fx erythromycin, itraconazole, ritonavir, lopinavir), CYP3A4-inductors (fx phenobarbital, phenytoin og rifampicin), loop diuretics, thiazides, amphotericin B, beta2-agonists, antidiabetics, interleukin-2, somatotropins, anticholinergics and regular treatment with NSAIDs. 8. Patients with moderate/severe hypertension, diabetes mellitus, heart insufficiency, severe mental disorders, Cushing syndrome, myasthenia gravis, ocular herpes simplex, pheochromocytoma, systemic sclerosis, and moderate/severe renal dysfunction. 9. Patients with a clinical or biochemical profile indicating need for heparin or levothyroxine treatment during pregnancy 10. Previous treatment with IVIg 11. Allergy to prednisolone and/or IVIg 12. AMH <4 pmol/L. If transfer of donor egg is planned for her IVF cycle, the AMH value will not be an criterion | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Cancer, Lung Perfusion Computed Tomography Target Lesion Cancer Liver Metastatic Lung Cancer Metastatic Liver Cancer Patients suffering from primary malignant thoracic tumoral pathology or second line patients having had a therapy pause of at least 6 weeks; at least one tumoral lesion/component should have ≥15mm in diameter All patients willing to participate and to sign the informed consent All patients younger than 18-years-old Documented allergy for iodine Neutropenia (absolute White Blood Cell count ≤ 1.5 × 109/l) Thrombopenia (absolute platelet count ≤ 100 × 109/l) Renal insufficiency: serum creatinine ≥ 1.5× the upper limit of normal (ULN); 24-hours creatinine clearance ≤ 50ml/min) Serum bilirubine ≥ 1,5 x ULN, AST ≥ 2,5 x ULN, ALT ≥ 2,5x ULN Brain metastases | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-80.0, Covid19 ages 18-80 performed audiometry testing in the last two years known inner ear dysfunction Sudden sensorineural hearing loss; autoimmune disease (Cogan's syndrom, SLE, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure. knowm conductive hearing loss (Air-bone gap>10dB) prior ear surgery chronic tympanic membrane perforation | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-69.0, Trauma Having experienced at least one criterion A trauma according to the DSM-5 Having at least two intrusive memories over the previous week Reporting being bothered by intrusive memories over the past month (scoring at least a moderate or higher score on PCL-5 item 1) Being able and willing to complete 3-9 sessions with researcher Being willing to monitor intrusive memories in daily life Having access to a smartphone Being able to speak Icelandic and read study materials in Icelandic Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI)) Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI)) Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI)) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-18.0, Tonsillectomy Tonsillitis Chronic Hemorrhage Postoperative Pain Postoperative Hemorrhage Surgery--Complications Otorhinolaryngologic Diseases Tonsil hypertrophy with sleep disordered breathing Recurrent tonsillitis or pharyngitis Tonsil asymmetry or neoplasm Tonsil stones Must be able to take ibuprofen Bleeding disorders such as von Willebrand's disease or hemophilia Down's Syndrome or other craniofacial syndromes Revision tonsillectomy cases | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 20.0-80.0, Inguinal Hernia all patients with confirmed groin hernia of both sexes none | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Arteriovenous Malformations Patient with a vascular malformation of the cerebral or medullary identified on diagnostic imaging (angio-CT, angio-MRI or diagnostic angiography) for which clinical monitoring alone or intervention (endovascular treatment, surgery or radiosurgery) is planned in the centres participating in the research Pregnant, parturient or breastfeeding woman | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Stroke Cerebrovascular Diseases Cerebral Infarction Cerebral Hemorrhage Transient Ischemic Attack Subarachnoid Hemorrhage Patients were included in the registry if they were hospitalized with a primary diagnose of： cerebral infarction (I63) nontraumatic intracerebral hemorrhage (I61) nontraumatic subarachnoid hemorrhage (I60) transient cerebral ischemic attack and related syndromes (G45) intracranial and intraspinal phlebitis and thrombophlebitis (G08) vascular dementia (F01) other aneurysms (I72) Patients diagnosed with other diseases | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Intracerebral Hemorrhage Stroke Hematoma Age > 18 years Patients willing to participate via signing a consent form' Patients diagnosed with CT-Confirmed spontaneous intracerebral hemorrhage (ICH) Patients willing to participate in the follow up assessment Not willing to participate Secondary ICH to hemorrhagic infarction or tumor bleeding etc. Traumatic ICH | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Post-Traumatic Headache Included patients will be adults who meet International Classification of Headache Disorders for acute post-traumatic headache. These are as follows Traumatic injury to the head has occurred Headache has developed within 7 days of injury to the head Headache is not better accounted for by another diagnosis (eg, migraine or tension-type headache) The headache must be rated as moderate or severe in intensity at the time of initial evaluation Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-85.0, Intracerebral Hemorrhage (ICH) No relevant disability prior to ICH (mRS 0-1 prior to ICH) Primary supratentorial deep or superficial intraparenchymal ICH of volume ≥ 20 mL < 100 mL (measured using formula) demonstrated on CT or MRI, with or without a 2 component of intraventricular haemorrhage CT/MRI demonstrates ICH stability (< 5 mL growth) at 6 hours after the admission scan if surgery is performed >6 hours after admission CT NIHSS ≥ 10 Presenting GCS 5 Endoscopic haematoma evacuation can be initiated within 24 hours of symptom onset Systolic blood pressure can be controlled at <160 mmHg Imaging "Spot sign" identified on CT angiography (CTA) Structural vascular or brain lesion as suspected cause of ICH, such as a vascular malformation (cavernous malformation, arteriovenous malformation (AVM) etc), aneurysm, neoplasm Haemorrhagic conversion of an underlying ischemic stroke Infratentorial haemorrhage Large associated intra-ventricular haemorrhage requiring treatment for related mass effect or shift due to trapped ventricle (extraventricular drainage (EVD) for intracranial pressure (ICP) management is allowed) Midbrain extension/involvement Coagulation Issues Oral or parenteral therapeutic anticoagulation at time of ICH onset Absolute requirement for long-term anti-coagulation (e.g., Mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation) | 1 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Coronary Artery Disease Age ≥ 18 years Informed written consent At least one major or two minor bleeding risk of Academic Research Consortium (ARC) Major Long-term oral anticoagulation Severe or end stage chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <30 ml/min) Hemoglobin <110 g/l Spontaneous bleeding requiring hospitalization and transfusion in the past 6 months Moderate to severe baseline thrombocytopenia (platelet count <100 x 10e9/L) Chronic bleeding diathesis Inability to give written consent STEMI Reference diameter of the vessel is <2.0mm or >5.0 mm Bifurcation lesion requiring the stenting of either of the branches after predilatation (TIMI<3 or significant recoil >30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation) Dissection affecting the flow (TIMI<3) or significant recoil (>30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation in-stent restenosis Chronic total occlusion Life expectancy < 12 months Cardiogenic shock at the arrival to the coronary angiography Uncertainty about neurological recovery e.g. after resuscitation | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Vascular Malformations Vascular Anomaly Hemangioma Arteriovenous Malformations Venous Malformation Klippel Trenaunay Syndrome Lymphatic Malformation Patients with a clinical and imaging diagnosis of a vascular anomaly No prior treatment for the vascular anomaly Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation Male or female with age greater than or equal to 18 years Capacity and willingness to provide a written informed consent Subjects with prior treatment for their vascular anomaly Uncorrectable coagulopathy Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the 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): 13.0-999.0, Meningitis, Cryptococcal HIV Infections Concurrent Medication: Allowed Aerosolized pentamidine or systemic chemoprophylaxis for PCP Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin). Patients must have Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.) Acute cryptococcal meningitis with cerebrospinal fluid opening pressure >= 250 mm H2O prior to receipt of antifungal therapy for this episode Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection Ability to begin therapy within 8 hours after the pre-entry lumbar puncture Consent of parent or guardian if less than 18 years of age. NOTE Comatose patients eligible provided informed consent can be provided by guardian or next of kin Co-existing Condition: Patients with the following symptoms or conditions are excluded Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response Prison incarceration. Concurrent Medication: Excluded Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study Treatment or prophylaxis with other systemic antifungal agents at any time Antiretroviral therapy during the first 72 hours of the study. Prior Medication: Excluded within 7 days prior to study entry Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin | 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, Lymphoma, Non-Hodgkin Patients with a histologic diagnosis of small noncleaved cell (undifferentiated) (SNCL), lymphoblastic (LL), and large cell lymphoma (LCL) who were treated according to National Cancer Institute Pediatric Branch non-Hodgkin's lymphoma protocols 74-0, 75-6, 76-5, 77-04, 85-C-67, and 89-C-41A, and who have been in continuous remission for one year or longer following completion of treatment. Patients who have relapsed and been successfully re-treated are not excluded, except for patients with lymphoblastic lymphoma who have been re-treated according to acute lymphoblastic leukemia protocols | 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): 13.0-999.0, Lyme Disease Screening FOR PTLDS: Age greater than or equal to 13 years old, suspect of suffering from Lyme disease Post-Treatment Lyme Disease Syndrome (PTLDS): For the purposes of this study, PTLDS is defined as occurring in male or female patients age 13 and above who have been diagnosed with confirmed or probable Lyme disease per CDC definition (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/). Studyphysician will review history to confirm probable cases. They have received recommended antibiotic therapy and have persistent or relapsing symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms. Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joint, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria. Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic. Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme disease. OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix [R]). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot. Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5. Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with Lyme disease and negative serological testing to B.burgdorferi by the CDC criteria. All study participants must agree to allow their samples to be used for future research General Age less than 18 (less than 13 for patients with PTLDS). Weight less than 70 Lb (35 kg). Pregnancy or lactation. Women with childbearing potential who are sexually active with a male partner and unwilling to use effective contraception during the evaluation and treatment phases of the protocol. Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV. Chronic medication use will be evaluated in a case-by-case basis. Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation FOR PTLDS AND LYME In addition to the general these individuals will be excluded for: 1. Use of immunosuppressive drugs such as systemic (but not topical or inhalant) steroids and cytotoxic agents. 2. History of any recognized autoimmune disease such as rheumatoid arthritis, vasculitis, systemic erythematous lupus, etc. 3. Serious pre-existing or concurrent chronic medical or psychiatric illnesses other than Lyme disease. 4. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness that might produce neurologic deficit (such as cerebrovascular disease). 5. Use of systemic antibiotics in the previous month. 6. Use of immunomodulators such as interferons. 7. Chronic medication use will be evaluated in a case-by-case basis. 8. Patients will be excluded from this protocol if they are judged by the principal investigator as having a significant impairment in their capacity for judgment and reasoning that compromise their ability to make decisions in their best interest FOR OSPA AND In addition to the above applicable (general and for PTLDS patients and Lyme arthritis controls), these individuals will be excluded for: 1. Pre-existing or concurrent serious chronic medical or psychiatric illness FOR In addition to the above general these individuals will be excluded for: 1. Pre-existing or concurrent serious psychiatric or chronic medical illness besides Multiple Sclerosis. 2. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness, besides Multiple Sclerosis, that might produce neurologic deficit (such as cerebrovascular disease). 3. Previously received total lymphoid irradiation (TLI) or cladribine. 4. Has used of immunoactive medications (excluding beta-interferon) in the three months preceding the study. 5. In the three months prior to the study initiation, was given such investigational treatments as plasmapheresis, hyperbaric oxygen, gangliosides, Copolymer 1, etc. OF Children: Children 13 years and older are eligible to participate in the PTLDS cohort because the condition under study can affect children. T, and this age was selected as appropriate for the children to provide assent to and comply with the study procedures. Children younger than 13 will be excluded from the PTLDS cohort, and no children will be enrolled in the other study cohorts. Pregnant and lactating women: Pregnant and lactating women are excluded from study participation. An enrolled participant who becomes pregnant during the study will be withdrawn Adults who lack capacity to consent: Adults who lack decision-making capacity to provide informed consent are excluded at screening, and enrolled adult participants who permanently lose the ability to consent during study participation will be withdrawn. NIH staff members: NIH staff may be enrolled if they meet criteria. Neither participation nor refusal to participate as a subject in the research will have an effect, either beneficial or adverse, on the participant s employment or position at NIH. Every effort will be made to protect participant information, but such information may be available in medical records and may be available to authorized users outside of the study team in both an identifiable and unidentifiable manner | 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, HIV Infections Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent Co-existing Condition: Patients with unstable disease characterized by the following are excluded Hospitalization within the past 14 days Major opportunistic infection, current or past An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as Temperature = or > 100.5 degrees F Night sweats Weight loss = or > 10 percent of body weight Diarrhea (3 or more bowel movements/day) Persistent cough, shortness of breath, or dyspnea on exercise Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a) gradient | 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, Leukemia Lymphoma Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1 of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement (lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan) Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR Prior therapy allowed for non-Hodgkin's lymphoma No prior therapy for all other diseases | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-999.0, EBV-induced Lymphomas EBV-associated Malignancies Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy OR Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500 copies/ml DNA, and are therefore at high risk for developing an EBV LPD It is expected that five types of patients afflicted with EBV-associated lymphomas or lymphoproliferative diseases will be referred and will consent to participate in this trial. These are: 1. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant. 2. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant. 3. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV. 4. Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy. 5. Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma The following patients will be excluded from this study Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of the EBV-specific T cells to be used for therapy and the subsequent 3 weeks required to achieve an initial assessment of the effects of infusions of EBV-specific T cells Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells | 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, Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Histologically confirmed malignancy (solid tumor or lymphoma) No history of brain metastases Age: 18 and over Life expectancy: At least 12 weeks Performance status: ECOG 0-2 WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin less than 1.5 mg/dL Creatinine normal | 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): 16.0-999.0, Lymphoma Histologically confirmed B-cell non-Hodgkin's lymphoma (low, intermediate, or high grade categories) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: BUN no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN Other: No known allergies to mouse proteins No second primary malignancy within past 5 years other than adequately treated in situ carcinoma of the cervix or uterus, or basal or squamous cell carcinoma of the skin Not pregnant or nursing Effective contraception required of all fertile patients PRIOR Biologic therapy: No prior exposure to mouse antibodies other than technetium Tc 99m LL2 monoclonal antibody Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 1 month since any other prior investigational therapy No concurrent participation in another protocol involving medical devices or investigational agents | 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): 16.0-999.0, Lymphoma Histologically confirmed B-cell non-Hodgkin's lymphoma (low, intermediate, or high grade categories) Must have been treated with chemotherapy and/or radiotherapy with evidence of minimal residual disease by conventional diagnostic modalities A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: BUN no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN Other: No known allergies to mouse proteins No second primary malignancy within past 5 years other than adequately treated in situ carcinoma of the cervix or uterus, or basal or squamous cell carcinoma of the skin Not pregnant or nursing Effective contraception required of all fertile patients PRIOR Biologic therapy: No prior exposure to mouse antibodies other than LymphoScan Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 1 month since any other prior investigational therapy No concurrent participation in another protocol involving medical devices or investigational agents | 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, Lymphoma Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including Diffuse large B cell lymphoma Intermediate grade diffuse large cell lymphoma High grade large cell immunoblastic lymphoma Burkitt's lymphoma High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma) No primary CNS lymphoma (parenchymal brain or spinal cord tumor) Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology Age: Over 18 | 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, Lymphoma Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103) Diffuse small cleaved cell lymphoma Diffuse mixed small and large cell lymphoma Diffuse large cell lymphoma Diffuse large cell immunoblastic lymphoma Small noncleaved cell lymphoma Mantle cell lymphoma OR Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available Age years and older | 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): 10.0-65.0, Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols HLA-identical or one antigen-mismatched related donor Age to 65 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No known sensitivity to E. coli derivatives PRIOR See Disease Characteristics | 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, Lymphoma Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma No relapsed intermediate or high grade disease eligible for bone marrow or stem cell transplant Intermediate or high grade disease must have received a prior anthracycline containing regimen Low grade disease (with or without prior therapy) felt to be incurable with standard therapy allowed No CNS involvement by lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST/ALT less than 3 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No history of angina Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No uncontrolled infection No autoimmune related phenomena No peptic ulcer disease PRIOR Biologic therapy: At least 12 months since prior rituximab No prior interleukin-12 No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior fludarabine or 2-chlorodeoxyadenosine unless CD4 count normal Recovered from prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified | 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, Brain Tumors Central Nervous System Tumors Leptomeningeal Metastases Documented leptomeningeal metastases Carcinomatous meningitis that is previously untreated or failed prior therapy OR Lymphomatous meningitis Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious Age 18 and over Karnofsky Performance Status 60-100% Life expectancy of at least 6 weeks Absolute neutrophil count greater than 1,500/μL Platelet count greater than 100,000/μL Creatinine no greater than 2.0 mg/dL | 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, Angioimmunoblastic T-cell Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia Patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma Indolent B-cell lymphoma will Waldenström's macroglobulinemia, lymphoplasmacytoid lymphoma small lymphocytic lymphoma, marginal zone lymphoma, and follicular small cleaved-cell or mixed cell lymphoma; patients with prior or concurrent evidence of transformation to large cell lymphoma or with follicular large cell lymphoma are ineligible Peripheral T-cell lymphoma will all entities described in the REAL classification; patients with B-cell ALCL are ineligible; patients with cutaneous T-cell lymphoma and all its variants and/or histologic transformation of cutaneous T-cell lymphoma are not eligible for this protocol, because they will be instead eligible for a separate protocol Relapsed peripheral T-cell lymphomas all those achieving and maintaining a complete or partial response during initial therapy; refractory includes those achieving all other responses during initial therapy; since the response rate of indolent B-cell lymphomas to up-front therapy exceeds 90% this distinction is not meaningful there No more than 2 prior chemotherapy and one prior immunotherapy regimens; if chemoimmunotherapy was used, the limit will be 3 prior regimens Performance status =< 2 Zubrod Staging work-up within 3 weeks and bidimensionally measurable disease No anti-cancer treatment within the past three weeks ANC >= 1,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma Platelets >= 100,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-70.0, Lymphoma One of the following histologically confirmed diagnoses High grade non-Hodgkin's lymphoma Immunoblastic or small noncleaved cell lymphoma (Burkitt's or non-Burkitt's) in complete or partial remission after initial therapy Localized (stage I or Zeigler stage A) small noncleaved (Burkitt's or non-Burkitt's) after relapse or incomplete response to initial therapy Lymphoblastic lymphoma in second or greater complete or partial response High risk lymphoblastic lymphoma in first complete remission or after initial therapy (high risk factors stage IV disease, LDH greater than 2 times normal, and 2 or more extranodal sites) Intermediate grade non-Hodgkin's lymphoma Diffuse large cell lymphoma Diffuse mixed cell lymphoma Diffuse small cleaved cell lymphoma | 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, HIV Kaposi's Sarcoma Lymphomas Multicentric Castleman's Disease Primary Effusion Lymphoma Age 18 years or older ECOG performance status less than or equal to 3. At least one of the following Exposure risk to HIV, KSHV, or HPV HIV seropositive KSHV seropositive EBV seropositiv HTLV-1 seropositive NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if patients have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma [PEL], or KSHV-multicentric Castleman s disease), this is sufficient to meet this criterion for eligibility Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma Cervical or anal intraepithelial lesion Inability to provide informed consent | 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, Lymphoma Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's lymphoma Failed to achieve initial complete response (CR) after at least 2 courses of standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow transplant Measurable disease defined as one of the following: Bidimensionally measurable disease at least 2 cm in diameter by radiograph or CT scan Enlarged spleen extending at least 2 cm below the costal due to lymphomatous involvement Enlarged liver with focal lesions on CT scan or biopsy proven lesions Lymphomatous hepatic involvement must be biopsy proven for the liver to be sole area of measurable disease No evidence of CNS involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count at least 100,000/mm3* *unless there is bone marrow involvement with lymphoma Hepatic: Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR See Disease Characteristics No prior rituximab | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-65.0, Adult Langerhans Cell Histiocytosis Childhood Langerhans Cell Histiocytosis Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Diagnosis of one of the following Chronic myelogenous leukemia Philadelphia chromosome-positive OR Molecular evidence of bcr/abl gene rearrangement Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities Multiple myeloma Hereditary immunodeficiency disorders Confirmed by immunologic determination Sickle cell anemia or beta-thalassemia | 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): 1.0-80.0, Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Clinically and/or histologically confirmed hematologic malignancy or genetic disorder Chronic myelogenous leukemia Typical blood and marrow morphology Presence of Philadelphia chromosome OR Molecular evidence of bcr/abl rearrangement if Philadelphia chromosome-negative Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma High risk of relapse or progressive disease Typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities Multiple myeloma Typical marrow morphology, radiographic findings, and paraprotein | 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): 18.0-69.0, Lymphoma Histologically confirmed mantle cell lymphoma Presenting with at least one of the following Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by immunophenotyping Positive for cyclin D1 by immunostaining Presence of t(11,14) by cytogenetic analysis Molecular evidence of bcl-1/IgH rearrangement Stage I-IV disease Stage III or IV if nodular histology mantle cell lymphoma present Any stage for other mantle cell histologies No mantle zone histology | 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, Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Small Lymphocytic Lymphoma Histologically documented non-Hodgkin's lymphoma; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable for follicular lymphomas; patients with NHL must have one of the following World Health Organization (WHO) histologic subtypes Follicular, grade 1 Follicular, grade 2 Follicular, grade 3 B-cell small lymphocytic lymphoma Note: Patients diagnosed more than one year prior to entry on protocol must have a repeat lymph node biopsy; in the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required; patients are ineligible for this study if a separate lymph node biopsy shows a lymphoma with a higher grade; failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible No known lymphomatous involvement of the CNS including either parenchymal or leptomeningeal involvement (lumbar puncture prior to study is not required in the absence of neurologic symptoms) or any seizure disorders or prior brain injury which could precipitate seizures Measurable disease must be present either on physical examination or imaging studies; evaluable disease alone is not acceptable; any tumor mass reproducibly measurable in two perpendicular diameters and > 1x1 cm by physical examination, X-ray, computerized tomography (CT), or magnetic resonance imaging (MRI) is acceptable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure; the following lesions are not considered measurable Barium studies Ascites or pleural effusion | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-56.0, Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma Eligible for autologous stem cell transplantation No pleural effusion, pericardial effusion, or ascites No T-cell lymphoma Age Under 57 Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease) SGOT or SGPT no greater than 2 times upper limit of normal | 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, Leukemia Lymphoma Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or Burkitt's or Burkitt-like lymphoma L3 morphology surface IgG expression Cytogenetic evidence for t(8;14), t(8;22), or t(2;8) Previously untreated disease except hydroxyurea for leukocytosis CNS involvement allowed Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement must also be enrolled on CALGB-8461 Patients with Burkitt's leukemia must also be enrolled on CALGB-9665 Age and over Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal Creatinine no greater than 1.5 times ULN Other | 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, Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm Patients will be eligible for the study if they Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study) Have an ECOG performance status of Zero or One Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain Have signed an informed consent form Patients will not be eligible for this study if they Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed Are taking or have taken part in any investigational study within 30 days of start of study Have received an indium agent within 30 days of start of study Are not able to remain immobile during scanning time Have taken drugs that may damage the kidneys within 2 weeks of start of study Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration Have undergone a PET scan within 7 days prior to 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): 16.0-999.0, Leukemia Lymphoma Diagnosis of diffuse B-cell lymphoma in a nodal or an extranodal site CD20 and CD79 positive expression of Ki67 (MIB1) in all of the tumor cells OR Diagnosis of bone marrow replacement/leukemia comprising mature B-cell lymphoma sIg and CD19 positive CD34 and Tdt negative Patients in the low-risk group must meet at least 3 of the following Normal lactate dehydrogenase (LDH) level WHO performance status 0-1 Ann Arbor stage I or II | 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, Lymphoma, Non-Hodgkin Diagnosis and disease status Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting < 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates) HIV positive Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms If cardiac ejection fraction has been measured, it must be greater than 50% | 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, AIDS-related Diffuse Large Cell Lymphoma AIDS-related Immunoblastic Large Cell Lymphoma AIDS-related Peripheral/Systemic Lymphoma AIDS-related Small Noncleaved Cell Lymphoma Previously untreated histologically or cytologically documented B-cell non-Hodgkin's lymphoma; the following histologies are eligible: diffuse large B-cell lymphoma, high-grade large cell immunoblastic lymphoma, anaplastic large cell lymphoma, Burkitt's lymphoma, high-grade B-cell lymphoma, Burkitt-like (small non-cleaved lymphoma) Tumors must be CD20 positive Documented HIV infection: documentation may be serologic (ELISA, western blot), culture, or quantitative PCR or bDNA assays Evaluable or measurable disease Stage I and IE or Stage II-IV disease patients ANC >= 1000 cells/mm^3 Platelet count >= 75,000/mm^3 unless cytopenias are secondary to lymphoma All patients must be off colony stimulating factor therapy at least 24 hours prior to chemotherapy Transaminase =< 5 times the upper limit of normal unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir or other antiretrovirals Total Bilirubin < 2.0 unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir or other antiretrovirals; for bilirubin > 3.0 due to hepatic involvement the initial dose of doxorubicin will be decreased by 50% and the initial dose of vincristine will be omitted Previous chemotherapy or radiotherapy for this lymphoma Primary Central Nervous System Lymphoma (parenchymal brain or spinal cord tumor) Acute active HIV-associated opportunistic infection requiring antibiotic treatment; patients with mycobacterium avium are not excluded; chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic are met Concurrent malignancy (excluding in situ cervical cancer, or non-metastatic non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy) Previous therapy with rituximab within 12 months; patients treated with rituximab more than 12 months earlier are eligible only if it was given for indications other than the treatment of intermediate or high-grade lymphoma (eg, low-grade lymphoma or ITP) | 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): 1.0-29.0, Childhood Burkitt Lymphoma Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Stage I Childhood Large Cell Lymphoma Stage I Childhood Small Noncleaved Cell Lymphoma Stage II Childhood Large Cell Lymphoma Stage II Childhood Small Noncleaved Cell Lymphoma Stage III Childhood Large Cell Lymphoma Stage III Childhood Small Noncleaved Cell Lymphoma Stage IV Childhood Large Cell Lymphoma Stage IV Childhood Small Noncleaved Cell Lymphoma Untreated Childhood Acute Lymphoblastic Leukemia Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes Diffuse large cell lymphoma Burkitt's lymphoma High-grade B-cell lymphoma (Burkitt-like) No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas One of the following FAB prognostic groups Group B (intermediate risk) Group C (high risk) Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following Any L3 blasts in cerebrospinal fluid | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-21.0, B-cell Childhood Acute Lymphoblastic Leukemia Childhood Burkitt Lymphoma Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma L3 Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining) The following histologies are generally CD20+ and are eligible Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma, or follicular lymphoma, grade III (rare), documented by flow cytometry or appropriate immunohistochemistry, any stage Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or demonstration of surface immunoglobin by flow cytometry Atypical precursor B-cell lymphoblastic lymphoma or other unusual histologies that are CD20+ Measurable disease by clinical, radiographic, or histologic Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy No isolated CNS disease | 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 Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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) Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Myelodysplastic Syndromes Chronic Myelogenous Leukemia, BCR-ABL1 Positive Disseminated Neuroblastoma Malignant Neoplasm Ovarian Choriocarcinoma Ovarian Embryonal Carcinoma Ovarian Immature Teratoma Ovarian Mature Teratoma Ovarian Mixed Germ Cell Tumor Ovarian Monodermal and Highly Specialized Teratoma Ovarian Polyembryoma Ovarian Yolk Sac Tumor Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Mantle Cell Lymphoma Recurrent Neuroblastoma Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Stage I Multiple Myeloma Stage II Multiple Myeloma Stage II Ovarian Epithelial Cancer Stage III Malignant Testicular Germ Cell Tumor Stage III Multiple Myeloma Stage III Ovarian Epithelial Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Ovarian Epithelial Cancer Testicular Choriocarcinoma Testicular Choriocarcinoma and Embryonal Carcinoma Testicular Choriocarcinoma and Seminoma Testicular Choriocarcinoma and Teratoma Testicular Choriocarcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma Testicular Embryonal Carcinoma and Seminoma Testicular Embryonal Carcinoma and Teratoma Testicular Embryonal Carcinoma and Teratoma With Seminoma Testicular Embryonal Carcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma and Yolk Sac Tumor With Seminoma Testicular Teratoma Testicular Yolk Sac Tumor Testicular Yolk Sac Tumor and Teratoma Testicular Yolk Sac Tumor and Teratoma With Seminoma Diagnosis of persistent or progressive hematologic malignancy or solid tumor after allogeneic hematopoietic stem cell transplantation (AHSCT) Patients are eligible for study entry at any time between post-transplantation day 90 and 3 years after withdrawal of immunosuppressive therapy Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that meets any of the following hematologic relapse by standard hematologic persistence evidenced by bone marrow blasts > 10% after day 30 post-AHSCT Cytogenetic progression as evidenced by an increase in the percentage of Philadelphia chromosome (Ph)1-positive metaphases (or Ph1-positive cells by fluorescent in situ hybridization) from complete cytogenetic response (0% Ph1-positive cells) to partial response (1-34% Ph1-positive cells); PR to minor response (35-94% Ph1-positive cells); or MR to no response (95-100% Ph1-positive cells) Resistance to imatinib mesylate, defined as disease progression (hematologic, cytogenetic, or molecular) during OR failure to respond to (i.e., lack of complete hematologic response after 3 months, lack of partial cytogenetic response after 6 months, or lack of complete cytogenetic response after 12 months) prior imatinib mesylate therapy Myelodysplastic syndromes that meet any of the following Hematologic relapse by standard cytogenetic relapse evidenced by recurrence of clonal abnormality in patients who achieved CCR after AHSCT, hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT OR; Hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT, or cytogenetic persistence evidenced by persistence of clonal abnormality more than 90 days after AHSCT Chronic lymphocytic leukemia that meets any of the following greater than 25% increase in absolute lymphocytosis of > 5,000/mm3, greater than 25% increase in measurable lymphadenopathy, persistence of absolute lymphocytosis of > 5,000/mm3 at day 90 or later after AHSCT, persistence of lymphadenopathy of ≥ 3 cm in diameter at day 90 or later after AHSCT Aggressive non-Hodgkin's lymphoma (e.g., diffuse large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, or peripheral T cell lymphoma), Hodgkin's lymphoma, OR solid tumor that meets any of the following greater than 50% increase in measurable or evaluable disease, persistence of measurable lesions > 3.0 cm in diameter at day 90 or later after AHSCT OR Persistence of malignancy by biopsy or positron emission tomography scan unless there is clear evidence of progression | 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): 3.0-999.0, Malignant Meningeal Neoplasms Over 3 years of age with meningeal malignancies that are progressive or refractory to conventional therapy. Patients with meningeal malignancies secondary to an underlying solid tumor are eligible at initial diagnosis if there is no conventional therapy Patients with leukemia, lymphoma, or other solid tumor who also have overt meningeal involvement by their tumor Must have a life expectancy of at least 8 weeks and an ECOG performance status of 2 or better Must sign an informed consent indicating that they are aware of the investigational nature of this study Patients must have recovered from the acute toxic effects of all prior intrathecal chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection). Patients must not have received any CNS therapy within 1 week prior to starting treatment on this study or craniospinal irradiation within 8 weeks prior to starting treatment on this study. Patients must not have received intrathecal chemotherapy within 1 week (2 weeks if prior DTC101) Must not have clinically significant abnormalities with regard to liver function, renal function or metabolic parameters (electrolytes, calcium and phosphorus) Durable Power of Attorney (DPA): A DPA must be offered to all patients ≥ 18 years of age Receiving other therapy (either intrathecal or systemic) designed specifically to treat their meningeal malignancy are not eligible for this study. However, patients receiving concomitant chemotherapy to control systemic or bulk CNS disease will be eligible, provided the systemic chemotherapy is not a phase I agent, an agent which significantly penetrates the CNS (e.g., high dose methotrexate, (> 1 gm/m2), thiotepa, high dose cytarabine, (> 2 gm/m2 per day), 5-fluorouracil, intravenous 6-mercaptopurine or topotecan), or an agent known to have serious unpredictable CNS side effects Clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by a radioisotope Indium111 or Technitium99-DTPA flow study are not eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of block to restore flow and a repeat CSF flow study showing clearing of the blockage is required for the patient to be eligible for the study Patients who have leukemia or lymphoma and a concomitant bone marrow relapse Women of childbearing age must not be pregnant or lactating Patients must not have received any other systemic investigational agent within 14 days prior to, or during, study treatment. The 14 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 14 days. Patients must not have received any other intrathecal investigational within 7 days prior to, or during, study treatment. The 7 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 7 days or a prolonged half-life | 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 Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types Diffuse large cell Mantle cell Burkitt's Relapsed or refractory disease No more than 2 prior regimen for patients with refractory disease Any number of prior therapies (including peripheral blood stem cell or bone marrow transplantation) allowed for patients with relapsed disease provided there was an objective response to the most recent therapy Measurable disease At least 1 lesion ≥ 1.5 cm in diameter No transformed lymphoma | 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): 12.0-999.0, Lymphoma, Large-Cell, Ki-1 Lymphoma, T-Cell Relapsed or refractory systemic Anaplastic Large Cell Lymphoma (ALCL). Relapsed or refractory mature T-cell lymphoma to peripheral T-cell lymphoma unspecified and the following "specified" mature T-cell lymphomas: Adult T-cell lymphoma; Extranodal natural killer (NK)/T-cell lymphoma, nasal type; Enteropathy-type T-cell lymphoma; Hepatosplenic T-cell lymphoma; Subcutaneous panniculitis-like T-cell lymphoma; Angioimmunoblastic T-cell lymphoma. All patients should have evaluable or measurable disease on entry to study. Histology confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Performance Status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2. Age 7 years or older. Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 50 ml/min for patients at least 18 years. Pediatric patients should have maximum serum creatinine by age as follows Less than age 7 and less than or equal to age 10 may have a Maximum Serum Creatinine of 1.0 mg/dl Less than age10 and less than or equal to age 15 may have a Maximum Serum Creatinine of 1.2 mg/dl Age 15 years or older may have a Maximum Serum Creatinine of 1.5 mg/dl Alternatively, pediatric patients should have a creatinine clearance of greater than 50 m1/min/1.73m^2. Total bilirubin less than 1.5 x upper limit of normal (ULN) (patients with elevation of total bilirubin consistent with Gilbert's disease are eligible providing they have a normal direct bilirubin); aspartate aminotransferase (AST) less than or equal to 2.5 x ULN; absolute neutrophil count (ANC) greater than 500/mm^3; and platelet greater than or equal to 50,000/mm^3; unless hematological impairment due to organ involvement by lymphoma. Provides signed informed consent. Not pregnant or nursing. This drug has unknown effects in pregnancy and on young infants/children. Human immunodeficiency virus (HIV) negative. Willing to use contraception and continue for at least 8 weeks following the last treatment. No active central nervous system (CNS) lymphoma. Patients should not have received systemic cytotoxic chemotherapy within 3 weeks of study entry. Have recovered from the toxic effects of prior therapy to a grade less than or equal to 1. No history of diabetes mellitus requiring insulin treatment. No symptomatic pulmonary disease. No evidence of symptomatic cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, exertional angina pectoris, cardiac arrhythmia). Patients may not be concurrently receiving any other investigational agents. Not a candidate for potentially curative (i.e. transplant) treatment at the time of study entry or the patient has a window of opportunity to receive UCN-01 before a transplant. Patients are required to have considered a transplant. If, having done this, they refuse it, decide against it or decide to wait, they would be eligible 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): 25.0-80.0, Stiff Person Syndrome Stiff Person Syndrome with elevated anti-GAD antibody titers. Between 25 to 80 years of age. Willingness to stop IVIg therapy 6 weeks prior to Rituximab/Placebo treatment and for the remainder of the study. [If receiving IVIg, patients will be allowed to receive the ongoing non-immunosuppressive drugs used to treat SPS including Diazepam, Neurontin or Baclofen. The dose of these drugs will remain stable throughout the study and unchanged for 6 weeks prior to enrollment.] Willingness and legal ability to give and sign informed study consent. Willingness to travel to NIH for scheduled protocol studies and treatment. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. Adequate bone marrow, renal, and liver function: ANC greater than 1000/mm(3), BUN/Cr in normal range for age. Patients with Diabetes (Type II) will be allowed to participate because up to 40% of SPS patients have Diabetes. Patients with a history of controlled epilepsy will be allowed to participate because up to 5% of SPS patients have mild epilepsy which is easily controlled Immunosuppressive drug therapy for SPS at the time of or 6 weeks prior to enrollment and for the remainder of the study. Specifically, candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive. Any medical or social condition that precludes follow-up visits. Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are treated prior to enrollment. History of a coagulopathy or patients requiring anticoagulation. Any history of cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Patients with cardiomyopathy grade III or IV by the New York Heart Classification will be excluded from this study. Systemic edema or pulmonary edema. Chronic and severe symptomatic hypotension (SBP less than 100 mmHg). Chronic liver disease or alcoholism. Any condition, including active infections, that would likely increase the risk of protocol participation or confuse the understanding of the data. Pregnancy. Serum pregnancy test will be performed and must be negative in all women of childbearing potential enrolled in the study. History of active psychiatric disorder that may interfere with participation in the study (AT Hemoglobin: less than 7.0 gm/dL. Platelets: less than 100,000/mm. AST or ALT greater than 2.5 x Upper Limit of Normal unless related to primary disease. Positive Hepatitis B or C serology (Hep Surface antigen and Hep C hepatitis C antibody). Positive HIV | 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): 16.0-999.0, Anaplastic Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Mantle Cell Lymphoma Negative pregnancy test Fertile patients must use effective contraception prior to and during study treatment Must have normal organ and marrow function Not a candidate for stem cell transplantation ECOG 0-2 OR Karnofsky 60-100% Bilirubin normal Creatinine normal Histologically or cytologically confirmed relapsed or refractory mantle cell lymphoma, anaplastic large cell lymphoma (CD30-positive disease), or classical Hodgkin's lymphoma Recovered from prior biologic therapy or autologous stem cell transplantation Prior antibody therapy within the past 3 months allowed No cardiac arrhythmia or uncontrolled dysrhythmia No history of myocardial infarction within the past year No New York Heart Association class III or IV heart failure No other significant cardiac disease No paroxysmal nocturnal dyspnea No oxygen requirement No AIDS No history cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine) No pulmonary lymphoma No known CNS lymphoma | 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, Mantle Cell Lymphoma Histologically confirmed mantle cell lymphoma in 1st or 2nd relapse, or with persistent disease following induction therapy Measurable disease (lymph node > 1.5 cm) No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy An IRB-approved signed informed consent Age >/= 18 years Expected survival >/= 3 months ECOG performance status 0, 1, or 2 Acceptable hematologic status within two weeks prior to registration, including: * Absolute neutrophil count ([segmented neutrophils + bands] x total WBC) ≥ 1,500/mm3; * Platelet counts ≥ 100,000/mm3 Female patients who are not pregnant or lactating Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method) Patients with impaired bone marrow reserve, as indicated by one or more of the following: * Prior myeloablative therapies with allogeneic or autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue; * Platelet count < 100,000 cells/mm3; * Prior external beam radiation to >25% of active bone marrow; * History of failed stem cell collection Prior radioimmunotherapy Known cardiac ejection fraction < 40%. In patients with prior adriamycin exposure >= 300 mg/m2, echocardiogram must be obtained within three months prior to registration Known CNS lymphoma (lumbar puncture only required if symptomatic) Chronic lymphocytic leukemia (CLL) HIV or AIDS-related lymphoma Pleural effusion or ascites Abnormal liver function: total bilirubin > 2.0 mg/dL (if total bilirubin is >75% indirect, then may use direct bilirubin > 0.8 mg/dL) Abnormal renal function: serum creatinine > 2.0 mg/dL G-CSF or GM-CSF therapy within two weeks prior to treatment, or neulasta within four weeks | 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, Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria Pathology must be reviewed at the Brigham and Women's Hospital (BWH) Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease Age > 18 Laboratory data (within 2 weeks of study registration) ANC > 1500/ul platelet > 100,000/ul creatinine < 1.5 X normal creatinine clearance > 60 ml/min Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed Uncontrolled bacterial, fungal, or viral infection Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be > 50% Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study Major surgery within the previous 2 weeks | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-75.0, AIDS Related Lymphoma HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin's lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: *Burkitt's lymphoma, *diffuse large B-cell with standard histological diagnosis, *Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive Good and intermediate prognostic group (no more than one of the following prognostic factors: *CD4 below 100/µl, *history of opportunistic infection, *Karnofsky index below 60 percent or ECOG over 2) Written inform consent to participate Active viral hepatitis Pregnancy | 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, Lung Adenocarcinoma Lung Adenosquamous Carcinoma Malignant Pericardial Effusion Malignant Pleural Effusion Minimally Invasive Lung Adenocarcinoma Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Non-Small Cell Cancer AJCC v7 Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.) No uncontrolled central nervous system metastases (i.e., any known central nervous system [CNS] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be >= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy >= 3 weeks since prior radiation therapy >= 3 weeks since prior major surgery No treatment with an investigational agent currently or within the last 28 days Non-smoker or former light smoker; non-smoker is defined as a person who smoked =< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between > 100 cigarettes AND =< 10 pack years AND quit >= 1 year ago; this must be documented on the On-study Form (C-1405) | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.0-75.0, Malignant Pericardial Effusion Pathologically documented lung cancer Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology) Expected to live 6 weeks or longer Sufficient organ function Signed informed consent Myocardial infarction or unstable angina within 3 months Constrictive pericarditis Active pneumonitis Severe infection or disseminated intravascular coagulation (DIC) Other severe co-morbidity which could not be relieved with pericardial drainage Chemotherapy-naive small cell lung cancer | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 30.0-120.0, Leukemia Lymphoma Histologically confirmed diagnosis of 1 of the following Classic, sporadic Burkitt's lymphoma Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia) Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following Characteristic morphologic features High proliferative index AND Ki-67 ≥ 85% Any stage allowed Newly diagnosed or untreated disease Steroids allowed Age and over Performance status | 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): 20.0-40.0, Preeclampsia Preeclampsia | 0 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 18.0-59.0, CD20-Positive Large B-Cell Lymphoma Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification) Aged from 18 to 59 years, eligible for transplant Patient not previously treated Age adjusted International Prognostic Index equal to 2 or 3 Having previously signed a written informed consent Women of childbearing potential currently practicing an adequate method of contraception Any other histological type of lymphoma Any history of treated or non-treated indolent lymphoma Central nervous system or meningeal involvement by lymphoma Contra-indication to any drug contained in the chemotherapy regimens Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Any serious active disease (according to the investigator's decision) HIV, HTLV1 or HBV related disease Any organ transplantation before inclusion | 1 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 12.0-50.0, Polycystic Ovary Syndrome Insulin Resistance Obesity for the definition of PCOS: (2 out of 3 in the following) Oligomenorrhea / chronic anovulation, defined as less than eight cycles of spontaneous menstrual period in one year. Clinical and /or biochemical signs of hyperandrogenism Polycystic ovaries of other aetiologies, such as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome ever received hormone therapy in the past 6 months, having pregnancy in the past 6 months, having acute illness found in the past 3 months, or having systemic diseases including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents | 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, Burkitt Lymphoma Age : 18 years or older Histologically or cytologically proven Burkitt lymphoma according to the WHO classification WHO performance < 3 Informed consent Known HIV positive infection Positive serology for HCV and HBV (except after vaccination) Patients previously treated for lymphoma cardiac disease that contradict anthracycline chemotherapy Psychological or psychiatric condition who contradict steroids therapy Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L) Cirrhosis or severe hepatic failure unrelated to the lymphoma Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Primary organ transplant or other immunosuppressive conditions Pregnancy | 2 |
This is a 44 year old female with PMH of PCOS, Obesity, HTN who presented with symptoms of cholecystitis and was found incidentally to have a large pericardial effusion. A pericardiocentesis was performed and the fluid analysis was consistent with Burkitt's lymphoma. Pericardial fluid was kappa light chain restricted CD10 positive monotypic B cells expressing FMC-7, CD19, CD20, and myc rearrangement consistent with Burkitt's Lymphoma. A subsequent lumbar puncture and bone marrow biopsy were negative for any involvement which made this a primary cardiac lymphoma. A cardiac MRI showed a mass that was 3cm x 1cm on the lateral wall of the right atrium adjacent to the AV junction. Past Medical History: 1. Rare migraines 2. HTN 3. Obesity 4. PCOS/infertility 5. Viral encephalitis/meningitis-->ICH-->seizure/stroke ([**2137**]) =- from severe sinus infxn, caused mild non-focal residual deficits 6. CSF leak w/ meningitis s/p lumbar drain placement 7. R LE DVT s/p IVC filter placement 8. Knee surgery | eligible ages (years): 0.5-20.0, Burkitt Lymphoma Histologically or cytologically proven B-cell malignancies, either Burkitt NHL or L3 ALL or large B-cell lymphoma or aggressive B-cell NHL, with the exception of diffuse large B-cell lymphoma arising in the mediastinum Immunohistochemistry showing CD20 positivity Measurable (at least one bi-dimensionally measurable lesion) or evaluable (bone marrow, bone involvement) disease in progression since the last evaluation First relapsed or refractory disease after LMB or BFM protocol, except the isolated CNS relapses Life expectancy > 4 weeks Performance status (Karnofsky) > 30 Adequate hepatic, renal and cardiac functions Wash out of 3 weeks in case of recent chemotherapy Complete initial work-up within 8 days prior to treatment Able to comply with scheduled follow-up and with management of toxicity Active viral infection, especially chronic hepatitis B previous salvage therapy for relapse Prior or current history of severe allergy Primary large B-cell lymphoma of the mediastinum Isolated CNS 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): 15.0-65.0, Burkitt's Lymphoma Burkitt's Leukemia Mediastinal Neoplasms Lymphoblastic Lymphoma Large Cell Anaplastic Lymphoma Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma Age > 15 years Written informed consent Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected HIV infection Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy Known severe allergy to foreign proteins Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy Pregnancy or nursing Participation in other studies that interfere with study therapy | 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, Adult Acute Lymphocytic Leukemia proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan indicating the presence of meningeal involvement in combined relapse in CNS and other locations: systemic therapy with CNS active drugs can be postponed for at least 2 weeks Karnofsky Performance Score is > or = 60% years of age or older free of uncontrolled infection recovered from any grade III / IV toxicities attributable to prior treatment with the exception of hematotoxicity patient not pregnant or breast feeding and effective methods to prevent pregnancy free from severe heart, lung, liver or kidney dysfunction written informed consent failed to respond (as defined by no clearance of the CSF) to > 1 dose of prior i.th. MTX or ARAC or triple therapy history of neurotoxicity (grade III IV) attributed to i.th. or systemic HD therapy with MTX or ARAC prior CNS relapse < 1 month before | 1 |
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