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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): 20.0-65.0, Head Pain Neck Pain Shoulder Pain Arm Pain Neural Sensory Hearing Loss ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss coagulopathy, pulmonary disease, neuropathy
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, Intraventricular Hemorrhage Age 18-75 Radiographic evidence of intraventricular hemorrhage with hydrocephalus Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2) Placement of an external ventricular drain with an opening pressure >20 mm Hg Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.) Age <18 or >75 Pregnancy (positive pregnancy test) Clotting disorders Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist Medical contraindications to surgery as determined by the attending neurosurgeon Contraindication to recombinant tissue plasminogen activator administration Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
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, Pain Patient ≥ 18 years-old, male or female, whatever his/her ethnic group Patient with untreatable cancer Patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week Pain unresponsive to conventional treatments Effectiveness of the injection test Signed informed consent Patients > 18 years-old Patients with pain other than cancer pain Patient's refusal Coagulation disorders Local infection Known hypersensitivity to local analgesics Inefficacy of the injection test Contraindication for analgesics
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, Aneurysmal Subarachnoid Hemorrhage Intraventricular Hemorrhage Adult patients (> 18 years old) with a proven ruptured cerebral aneurysm Aneurysm has been / will be treated with coil embolization EVD has been / will be placed as part of routine care Modified Fisher score is 4 (cisternal blood > 1 mm thick with concomitant IVH) CT scan after EVD placement shows "stability" with no increase in the amount of intracranial blood (Note: there is sometimes layering of blood, especially in the occipital horns of the lateral ventricles, that develops during the first 24-48 hours after a ruptured aneurysm due to circulation of blood in the CSF this does not necessarily constitute an criterion) Study drug can be administered within 72 hours of the time of SAH Concern expressed by endovascular neurosurgeon / interventional radiologist that aneurysm has only been incompletely treated / isolated by coil embolization Patient requires craniotomy and clipping of the culprit aneurysm CT scan performed post-EVD insertion OR post-coiling shows increase in amount of intracranial blood Uncorrected coagulation disturbance (INR > 1.5, PTT > 45); correction is permitted (if coagulation disturbance develops during the study, subsequent doses of TPA should simply be withheld until coagulation can be corrected) Uncorrected thrombocytopenia (platelets < 50,000); correction with platelet transfusions is permitted Involvement in another clinical trial Uncontrolled active internal hemorrhage Known allergy to study drug Patient is pregnant Any other condition the investigator believes would place the subject at risk if included in the study
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, Tumor Benign intraspinal process (tumor or vascular malformation AVM) Primary lesion caudal of the brainstem, affecting C1 Cognitive ability to give written informed consent Metastases, malign tumors Traumatic lesions Myelitis, polyneuropathy Disc prolaps
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): 1.0-999.0, Abnormality Greater than 1 year of age Diagnosis of vascular malformation Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so Patients less than 1 year of age Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
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, Idiopathic Restless Legs Syndrome It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro® The patient must have a diagnosis of moderate to severe idiopathic RLS The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator The decision to prescribe the drug has been made by the physician independently of his/her decision to the patient in the study Subject is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent Hypersensitivity to the active substance or to any of the excipients Magnetic resonance imaging or cardioversion (see SmPC)
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, Adverse Effects All adult (18 years or older) patients presenting to the ED All adult (18 years or older) patients transferred from the ward to ED for upgrading of care All patients who died on arrival in the ED Patients transferred from another acute care facility
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): 30.0-999.0, Cerebrovascular Disorders and outpatients of the Neurology Department of the CHL and their family members Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction No acute stroke/TIA/amaurosis fugax (at least 3 months ago) Temporal ultrasound window suitable for recording of the middle cerebral artery Ability to give informed consent No signed informed consent patient not able to give informed 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): 0.0-999.0, Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Intracranial Aneurysm Diagnosis of recent aneurysmal subarachnoid hemorrhage Definitive treatment of the aneurysm by surgical clipping or endovascular coiling has been completed Patients with unprotected (untreated) cerebral aneurysms Patients with a known history of lower limb vascular disease, lower limb vascular bypass surgery and/or peripheral neuropathy
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, Hereditary Hemorrhagic Telangiectasia Definite clinical HHT diagnosis (at least 3 Curacao criteria)or genetic diagnosis of HHT or Definite clinical HHT diagnosis (at least 3 Curacao criteria) or genetic diagnosis of HHT and Presence of Brain Arteriovenous Malformation Able to provide informed consent Curacao 1. spontaneous recurrent nosebleeds; 2. mucocutaneous telangiectasia at characteristic sites (lips, oral cavity or the nose); 3. visceral involvement such as pulmonary, hepatic or CNS BAVM; and (d) an affected first degree relative by same criteria. Willingness Willingness to participate in the study and ability to give informed consent Patients not complying with
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, Head Pain headache at the time of screening Patients must be able to give informed consent less than 18 years of age preceding (head) trauma
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 Age 18 years or older IV nicardipine can be initiated within 4.5 hours of symptom onset Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival International normalized ratio (INR) value < 1.5 CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND spontaneous SBP reduction to below 180 mmHg at the time of randomization OR For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND SBP reduction to below 140 mmHg at the time of randomization Informed consent obtained by subject, legally authorized representative, or next of kin Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP < 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the window closes ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms Intracerebral hematoma considered to be related to trauma ICH located in infratentorial regions such as pons or cerebellum Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles Patient to receive immediate surgical evacuation Current pregnancy, or parturition within previous 30 days, or active lactation Use of dabigatran within the last 48 hours** A platelet count less than 50,000 per microliter (µL or mm3) Known sensitivity to nicardipine Pre-morbid disability requiring assistance in ambulation or activities of daily living
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): 7.0-17.0, Pediatric Headache Anxiety To determine youth will complete an evaluation consisting of clinical interviews, self-, and parent-report measures To be included in the study, all children must: 1. have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache 2. obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., > 20) 3. be between 7 and 17 years old 4. have a parent/guardian who gives consent and agrees to participate 5. be English speaking 6. not currently participating in other psychosocial treatments specifically directed at reducing head pain or anxiety For youth receiving prophylactic medication, it is preferable that they remain on a stable dose and agree to avoid medication changes while enrolled in the study. Thus, all participants will be permitted to continue with their prescribed medical/neurological treatment, however the use of medications (both prophylactic and over-the-counter analgesics) will be closely monitored Youth will be excluded from the study if they have a medical or psychiatric condition contraindicating study treatment or warranting an alternative intervention (e.g., suicidality, depression)
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, Coronary Artery Disease Significant stenosis at CT angiography Normal ejection fraction on echocardiography Informed consented patient total occlusion and collateral flow to target vessel AV conduction abnormality Left ventricular hypertrophy significant valvular heart or primary myocardial disease
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 All cases must meet the following 1. Age 18 years or greater, fulfillment of the for intracerebral hemorrhage 2. Resident for at least 6 months within 50 miles of the recruiting center 3. No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage 4. Ability of the patient or legal representative to provide informed consent Malignancies leading to coagulopathy 2. Hemorrhagic transformation of ischemic infarct 3. Hemorrhage secondary to dural venous sinus thrombosis
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): 18.0-44.0, Congenital Malformations age between 18 and 44 years women who intend to become pregnant (not excluded women pregnant women women planning to move to an area where the study is not ongoing women who do not understand and speak Italian women who do not have a phone women affected by epilepsy, even not assuming anticonvulsivant drugs women affected by diabetes women who previously had a tumour or a disease relevant for the study (Crohn disease, rheumatoid arthritis, ulcerative colitis) women who recently assumed antifolates, like methotrexate women who currently abuse or previously abused alcohol obese women
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, Genomic Aberrations in Patients Diagnosed as Congenital Malformation With Unknown Etiology Subject is diagnosed as congenital malformation/syndromes. 2. Participants can be any ages, and both males and females are eligible. 3. Subjects agree and are capable of giving informed consent. If participants are under 18 years old or incapable of giving consent, an informed consent must be approved by their legal guardians. 4. Availability and willingness of the proband and first-degree biological family (parents, full sibling, or adult-age offspring) who also meets the same congenital malformation syndrome. 5. Availability and willingness of the proband's biological parents whatever with or without the same congenital malformation syndrome Subject or legal guardian is unable to understand or give informed consent. 2. The molecular cause for congenital malformation/syndromes of subjects or their affected first-degree biological family (parents, full sibling, or adult-age offspring) can be revealed by karyotype assay or FISH
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, External Causes of Morbidity and Mortality Independent ambulation pre-operatively Undergoing gynecologic procedure Expected to ambulate within 12 hours of their procedure Children under the age of 18 Inability to ambulate independently prior to their surgery Primary surgeon does not want patient to ambulate within 12 hours of procedure English is not the primary language spoken by the patient
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, Aneurysmal Subarachnoid Hemorrhage Age of 18 years or older First aneurysmal SAH Pre-morbid modified Rankin Scale score 0 or 1 Aneurysm treatment performed in the first 48 hours after the initial hemorrhage Informed consent by the patient or his/her legal representative. In case neither the patient is capable of giving informed consent nor a legal representative is available, informed consent can be given by an independent physician neither involved in the patient´s treatment nor the trial (for specification see below) Subarachnoid hemorrhage of other than aneurysmal origin No hemorrhage visible on initial CCT scan (Fisher Grade I) Pregnancy Concurrent participation in another interventional trial (participation in an observational trial is allowed) Life expectancy less than 1 year for other reasons than the actual SAH Other concomitant severe disease that would confound with treatment Other clear contraindication for treatment
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, Healthy Adults. No medical conditions Not taking any medication or supplements (or willing to stop taking supplements for duration of study) Not lactose intolerant Willing to give blood and urine samples Not partaking in frequent vigorous exercise Not suffering from or history of depression On blood pressure medication, taking Aspirin or other blood thinning medication BMI > 30 Cholesterol > 6 Diabetes or other serious medical condition Lactose intolerant Any learning difficulty e.g. dyslexia
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, Migraine Headache Age ≥18 years. 2. Subject has onset of migraine headache occurring before age 60. 3. Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS 1.1 and 1.2. 4. Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of adequate and appropriate previous migraine treatment. 5. Subject has carried the diagnosis of migraine for at least 6 months prior to enrollment. 6. Subject has had at least three migraine headache attacks per month. 7. Subject has had at least three headache days (migraine or non-migraine) per month and maintains this requirement during the baseline period on diary. 8. Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches). 9. Subject has the ability to read, comprehend and legibly and reliably record information as required by the protocol. 10. Subject is able to provide written informed consent prior to participation in the study. 11. Subject agrees to not participate in supplemental or alternative therapy during the baseline or treatment phases of the clinical study. This includes: acupuncture, spinal manipulation, TENS, and magnetic field treatments. 12. Subject agrees to maintain current preventative headache medication regimens (no change in type, frequency, or dose) from baseline screening visit to the end of the Phase 2 treatment phase Subject currently has Medication Overuse Headache (MOH) in the judgment of the investigator or by ICHD-II criteria. 2. Subject has a history of headaches days ≥ 15 per month. 3. Subject has a history of trigeminal autonomic cephalalgias. 4. Subject has any medical condition or disorder that: 1. Is considered to be clinically significant and may pose a safety concern 2. Could interfere with the accurate assessment of safety or efficacy 3. Could potentially affect a subject's safety or study outcome. 5. Subject has had a major infection or surgery in the past month. 6. Subject has undergone facial surgery in the area of sphenopalatine ganglia for cosmetic, corrective, therapeutic, or traumatic reasons. 7. Subject has been treated with radiation to the face. 8. Subject was diagnosed with any major infectious processes, primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months. 9. Subject currently meets as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active significant psychiatric disorders, including dementia, uncontrolled general anxiety disorder, psychotic disorders or uncontrolled bipolar disorder suicidality, active psychosis, untreated severe depression and/ or anxiety disorder, litigation, addiction, homicidal ideation, significant Axis II disorders and untreated sleep disorder. 10. Subject currently has clinically significant drug or alcohol abuse as defined by DSM-IV-TR or is unable to refrain from substance abuse throughout the study. 11. Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device. 12. Subject is felt to be at risk of non-compliance (e.g. for completing the diary or maintaining a stable headache medicine regimen) in the investigator's opinion. 13. Subject is woman of childbearing age who is pregnant, nursing, or not using contraception. 14. Subject has had previous radio-frequency ablation of the SPG. 15. Subject has had blocks of the SPG in last 3 months. 16. Subject has undergone botulinum toxin injections of the head and/or neck in the last 3 months. 17. Subject has an implantable stimulator or any implanted devices in the head and/or neck. 18. Subject has H/O bleeding disorders or coagulopathy, or is on anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication. 19. Subject has H/O malignancy or any other condition that requires MRI monitoring. 20. Subject has or requires pacemaker/defibrillator. 21. Subject is not suitable for the study, in the judgment of the Investigators, due to social, co-morbid psychological, and/or medical considerations. 22. Subject has H/O stroke, cardiovascular disease, and/or epilepsy. 23. Subject was on antipsychotic or antidepressant medications (except for migraine prevention) in the past 3 months prior to the study. 24. Subject is allergic or has shown hypersensitivity to materials of the Medtronic components which come in contact with the body
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): 18.0-65.0, Cluster Headache Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are 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, Postpartum Depression Women who are currently pregnant and who have a history of MDD. In order to minimize heterogeneity in the sample, all women must be currently taking a serotonin reuptake inhibitor (SSRI) antidepressant medication or not taking antidepressants. We will attempt to recruit approximately 50% in each category (SSRI versus no medications). If a woman becomes depressed during the study she will be referred to her treating psychiatrist or given appropriate clinical care. We will continue to follow women for the specified time course even if she placed on an (any) antidepressant medication during the course of the study Diagnosis of bipolar disorder Current active suicidal ideation or medical instability Active substance abuse or dependence during the last 90 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): 0.0-999.0, Headache Cephalgia Migraine chronic or recurrent headaches at least as often as one time per week recent head trauma brain disease or pathology seizure disorder using beta or alpha blocker medications allergy to sticky tape used to affix leads to skin
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, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker
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): 0.442-0.577, Apneas of Prematurity see above intraventricular hemorrhage posthaemorrhagic hydrocephalus cerebral infection cerebral malformation
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, Spinal Metastases Vertebral Metastases Benign Spinal Tumors Chordoma Meningioma Schwannoma Neurofibroma Paragangliomas Arteriovenous Malformations Patient age >= 18 years performance status of 0-3 Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs) Established histologic diagnosis of a benign or malignant tumor of the spine Arteriovenous malformation of the spine identified radiographically (no biopsy) Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal segment Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor should not be within 5 mm of the spinal cord If chemotherapy is planned, ideally it should not have been given within 30 days of starting radiation and should not resume until at least 2 weeks after completing radiation. In addition, it is not recommended to perform SBRT when targeted anti-angiogenesis therapy is planned within 2 months of the procedure Signed study-specific consent form Lesion involving > 3 adjacent vertebral levels Overt spinal instability Neurologic deficit due to bony fragments/bony compression of neural structures Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s) Rapidly progressive spinal cord compromise or neurological deficit Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression Patient unable to undergo an MRI Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females Patients with psychiatric or addictive disorder that would preclude obtaining informed 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, Response to Hepatitis A Vaccine Diagnosis of rheumatoid arthritis TNF-alfa blocker and / or methotraxate in use as a medication against RA A desire to get protected against hepatitis A Men and women age 18-65 years Written informed consent Women of childbearing potential must use effective contraception - Treatment with rituximab within 9 months before study start Known previous hepatitis A infection Previous vaccination against hepatitis A Allergy to eggs or formaldehyde Pregnancy or lactation Excessive use of alcohol Mental retardation Acute disease at the time of examination (fever > 38 degrees) Volunteer works as an employee of the researchers Previous vaccination against hepatitis A
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): 18.0-89.0, Peripheral Vascular Disease Clinical 1. Subject must be at least 18 and < 90 years of age. 2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form. 3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site. 4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4). 5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months. Angiographic 1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side). 2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion) 3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis 4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro) 5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm 6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro) 7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. 8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite). 9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite). Clinical Subject is unable to walk. 2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery. 3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver). 4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6. 5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s). 6. Subject has elevated serum creatinine > 2.0 mg/dl. 7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl). 8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days. 9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk. 10. Subject has unstable angina defined as rest angina with ECG changes. 11. Subject has a groin infection, or an acute systemic infection that is currently under treatment. 12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity. 13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure. 14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years). 15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints. 16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits. 17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®). 19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions. 20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy. 21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 22. Requirement of general anesthesia or spinal block for the procedure. 23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic. 24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion. 25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary. 26. Target lesion is in an iliac artery that has been previously stented. Angiographic Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion. 2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion 3. Target lesion is within or adjacent to an aneurysm. 4. Lesion is located within or beyond a vessel that contains a bypass graft. 5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery. 6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm. 7. Lesion extends beyond the inguinal ligament. 8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies. 9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure. 10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. 11. Requirement for > 1 stent to treat full length of lesion
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, Brain Injuries Craniocerebral Trauma Males and females ages 18 to 80 (the entire age range), who are admitted to the Emergency Department (ED), who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head with a Glasgow Coma Scale of >8. The acute, suspected traumatically induced structural brain injury and/or clinical manifestations of functional brain injury will have occurred within the past 24 hours upon admission to the ED The 'head injured' control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED and are suspected or who have sustained a head injury but do not report or manifest symptoms, e.g. facial lacerations and/or whiplash The ED normal control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED for presenting complaints that do not involve the head or neck (no trauma above the clavicles) and no history of Road Traffic Accident requiring an ED visit or TBI within the last one (1) year and no primary complaint of syncope Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin. In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumours, history of brain surgery, psychiatric disorder for which there is a prescribed psychiatric medication taken on a daily basis, substance dependence, history of TIA or stroke within the last year, currently receiving dialysis or in end-stage renal disease, active fever defined as greater than 100 degrees F or 37.7 degrees C, current condition is listed as "critical", subject is suffering from an open head injury, subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications (e.g. benzodiazepine, anaesthetic, NMDA receptor antagonist, or opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners will not be eligible for study. ED normal control subjects will be excluded if there is a suspected neck injury or trauma above the clavicles, a primary complaint of generalized weakness, or a primary complaint of headache or migraine
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, Migraine Disorders Respondents age 18 or older at the time of survey completion Respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009) Based on the respondents answers to the 2004 survey, their symptoms meet the for EM which is characterized by headaches meeting International Classification of Headache Disorders (ICHD-2) for migraine 1-14 days a month Responses to questions suggest that the respondent's diagnosis is not migraine or CM
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): 18.0-49.0, Endometriosis Women 18 years of age or older Women of reproductive age (less than 50 years) undergoing diagnostic laparoscopy for suspected endometriosis Willingness to provide informed consent Pregnancy General health issues that the physician determines would make laparoscopy unsafe
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, Intracranial Aneurysms Peripheral Aneurysms Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of Intracranial aneurysms Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Arterial and venous embolizations in the peripheral vasculature Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable
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): 15.0-85.0, Acute Pancreatitis patients that newly diagnosed as acute pancreatitis other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic 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): 18.0-60.0, Headache Versus Non-headache Day Migraine without aura according to IHS criteria Other primary headaches Tension-type headache more than 5 days/month Use of anti-pain medication before the scanning on the examination day Pregnant or nursing women Contraindication for MR scan Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse Other clinical conditions assessed by the examining doctor
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, Intraventricular Hemorrhage Intracerebral Hemorrhage Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the neurosurgical intensive care unit Age greater than 18 years No evidence of ischemic cerebrovascular injury Concomitant traumatic brain injury Antibiotics on admission to the NICU Immunocompromised by chemotherapy or HIV positive or patient with neutropenia (ANC <1000) Women who are pregnant and/or of childbearing age where a pregnancy test has not already occurred
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, Pseudoxanthoma Elasticum Male or female subject at least 18 years of age If female, the subject is not pregnant or nursing If female of child bearing potential, the subject has a negative urine pregnancy test at the first visit, and agrees to use an approved method of contraception (hormonal contraceptives [birth control pills, implants [Norplant] or injections [DepoProvera]); intrauterine device (IUD); two forms of barrier methods [condoms and diaphragm]; or abstinence (no sexual activity) throughout the entire study Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification of elastic fibers) Subject has a clinical disease severity grade of at least "1" (Poorly defined, barely visible macules) at screening Normal kidney function tests Any subject who is pregnant or becomes pregnant during the study Subjects with a serum creatinine greater than 1.6 mg/dL Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on dialysis Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism Subjects with acute gout Subjects with malabsorption, or osteomalacia Subjects on diuretics, magnesium containing antacids, or anabolic steroids Subjects with Cushing's syndrome Subjects receiving lithium and those with significant psychiatric disorders that would likely interfere with participation in this 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): 18.0-55.0, Migraine Is between the ages of 18 and 55 years Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification (2nd), with or without aura Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months) Has age of onset of migraine less than 50 years old Is able to give written Informed Consent Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people Has had a previous bilateral or right cervical vagotomy Has a clinically significant irregular heart rate or rhythm Has uncontrolled high blood pressure Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant Has a history of carotid endarterectomy or vascular neck surgery on the right side Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site
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, Brain Injuries Craniocerebral Trauma Males and females ages 18 to 80 (the entire age range), who are admitted to the Emergency Department (ED), who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head with a Glasgow Coma Scale of > 8 The acute, suspected traumatically induced structural brain injury and/or clinical manifestations of functional brain injury will have occurred within the past 24 hours upon admission to the ED The ED normal control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED for presenting complaints that do not involve the head or neck (no trauma above the clavicles) and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumors, history of brain surgery, mentally retarded, psychiatric disorder for which there is a prescribed psychiatric medication taken on a daily basis, substance dependence, history of TIA or stroke within the last year, currently receiving dialysis or in end-stage renal disease, active fever defined as greater than 100oF or 37.7oC, current condition is listed as "critical" in the opinion of the investigator, subject is suffering from an open head injury, subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners will not be eligible for study ED normal control subjects will be excluded if there is a suspected neck injury or trauma above the clavicles, a primary complaint of generalized weakness, or a primary complaint of headache or migraine
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, Neurovascular Diseases Men and women over 18 years Any adult patient known or clinically suspect to present a neurovascular disease (arterial stenosis ou arteriovenous malformations), the assessment of which requires an MRA or patient having an arteriovenous malformation for which treatment by embolization or radiosurgery is indicated multidisciplinary meeting and followed in the ordinary course of this treatment Patient able of accepting protocol information Patient who received information about the protocol and had not expressed its opposition to participate A contraindication to MRI, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection Hemodynamically unstability, acute respiratory failure, a precarious condition or a need for continuous monitoring incompatible with the constraints of MR imaging Patient with severe kidney with Glomerular Filtration rate < 30 ml/min Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
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, Hemorrhagic Stroke Venous Thromboembolism Deep Venous Thrombosis Intracranial spontaneous hemorrhage on brain CT scan Intracranial hemorrhage during treatment with oral anticoagulants Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage) cerebral hemorrhage due to intracranial vascular malformation rebleeding on CT scan after 72 hours from stroke (before randomization)
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): 18.0-40.0, Femoroacetabular Impingement Cartilage, Articular Hip Joint MRI Group 1: Patient has been diagnosed by the surgeon as having femoro-acetabular impingement (FAI) of the hip) Group 1: Must meet all the following A) History and Physical Exam 1) Intermittent pain worse with activity 2) Positive impingement test (pain with flexion, adduction, and internal rotation of affected hip) B) X-ray 1) No signs of OA on plain radiological films (i.e. no osteophytes, no loss of joint space) 2) Non-spherical femoral head Group 2: Patient has not been diagnosed by the surgeon as having any hip problems Previous Hip Surgeries (Pelvic Osteotomies) Previous Hip Trauma History of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia Over the age of 40 years
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, Lung Cancer Patients eligible for in this study must meet all of the following SCLC pathologically confirmed at MSKCC Untreated ES SCLC, defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular lymphadenopathy, or contralateral hilar adenopathy Age 18 years or older Karnofsky Performance Status ≥ 70 Presence of at least one measurable site of disease as defined by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Adequate bone marrow, liver and renal function, as specified below Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Hemoglobin (Hgb) ≥ 9 g/dL Patients eligible for this study must not meet any of the following Patients who have had major surgery within 4 weeks of initiation of study medication Patients who are unable to take oral drugs Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225. Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy, or radiotherapy) concurrently or within 2 weeks of starting treatment Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) Patients who are on concomitant treatment with drugs that are contraindicated in this study and that cannot be discontinued within the time frames as listed Patients who are planning on embarking on a new strenuous exercise regimen that can result in significant increases in plasma CK levels Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or with drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers should be discontinued for at least 14 days prior to starting treatment with LDE225 Some of these medications are recognized to cause rhabdomyolysis.) Patients who are receiving treatment with statins that are known to cause rhabdomyolysis and that cannot be discontinued at least 2 days prior to starting LDE225 treatment
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): 0.0-1.0, Congenital Malformation All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy (at any gestational age) after prenatal diagnosis of malformation born from mothers living in Brittany at delivery with a congenital anomaly according to Eurocat diagnosed or suspected (and then confirmed) at birth or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) Non Spontaneous abortion before 22 weeks gestational age Mother with legal protection (guardianship) Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution
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, Traumatic Brain Injury Trauma all patients with traumatic brain injury patients without traumatic brain injury
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): 10.0-999.0, Minor Head Injury Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT
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): 18.0-70.0, Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB Symmetric hearing prior to onset of SSHL Enrollment has to be accomplished within 7 days after SSHL onset Bilateral SSHL Incomplete recovery after previous SSHL Previously existing, known retrocochlear hearing loss Any history of any ear operation or local inflammatory disease in the past one year History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops Treatment with steroids for any reason within the preceding 30 days Body weight > 140 kg
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, Binocular Vision Dysfunction Vertical Heterophoria Initially all patients presenting to Emergency Department with chief complaints of Headache, Head Pain, Face Pain and/or Migraine Greater than or equal to 18 years old Ability to speak and read English Chronic headache disorder as defined by physician diagnosis, or greater than three months of headaches requiring symptom relief with medication more than once every two weeks, or having headaches so severe that previous Emergency Department evaluation or treatment was necessary Symptoms directly caused by trauma within the last three months Known TMJ disorder and presenting with TMJ pain Suspected infectious sinusitis or meningitis Pain originating from ear Pain originating from dental source Patient not willing or able to travel to study optometrist for follow-up Known history of cerebral aneurysm Known history of brain tumor Without previous CT, MRI, or other imaging to assess patient's headache disorder Patient a prisoner
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, The Sequelae Caused by Severe Brain Injury Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation) Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage Subject's modified Rankin scale (mRS) grades IV~V Ages between 20~40 years Estimated life expectancy must be greater than 2 months Signed informed consent from the subject Pregnancy test positive Subject infected with hepatitis C, HIV or syphilis Subject not suitable for liposuction surgery Subject not eligible for PET or MRI Subject enrolled in any other cell therapy studies within the past 30 days Subject deemed to be not suitable for the study by 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): 18.0-999.0, Renal Artery Stenosis Hypertension, Renovascular General 1. Age ≥ 18 at the time of informed consent. 2. Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF). 3. Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥ 155mmHg. 4. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period). a. A documented history for a minimum of 3 months showing reasonable and aggressive efforts to manage hypertension prior to consent. This must the use of a broad variety of medications that have been used and failed or not tolerated. 5. Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence. 6. New York Heart Association (NYHA) class I, II, or III the time of trial enrollment. Note: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it is recommended to treat both kidneys with an iCAST™ RX Stent System during the index procedure. In the event that a subject needs a renal stenting procedure staged for renal protection, it is important that the Investigator treats the second renal artery with an iCAST™ RX Stent System after 30 days of the index procedure. If subjects with bilateral stenosis have only one lesion that meets protocol that lesion should be treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion, however if the operator feels strongly it is indicated, then they should treat per standard of care after 30-days post index procedure in order to comply with #10. Subjects with flash pulmonary edema are allowed into the trial should they meet all other and Angiographic Anatomic 1. Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral renal arteries. a. The degree of percent diameter stenosis for all lesions intended to be treated, must be confirmed via one of the following methods: i. Manual or automated measurement with calipers ii. Measured Flow Fraction Reserve (FFR) < 0.8 using a pressure wire iii. Measured translesional peak pressure gradient of > 21 mmHg after induced hyperemia via dopamine or papaverine using a 4 Fr or less catheter or pressure wire. b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be enrolled. 2. Renal pole-to-pole length > 8cm (per visual estimate). 3. Target lesion length ≤ 16mm per vessel (per visual estimate). 4. Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate). 5. Lesion originating ≤ 15mm of the renal ostium. General Subject's estimated life expectancy is < 12 months. 2. Subject has a history of transplanted kidney(s), has had another recent organ transplant or polycystic kidney disease. 3. Subject with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 4. Subject has a history of bleeding diathesis or coagulopathy or refuses blood transfusions. 5. Subject has a known contraindication to heparin, aspirin, thienopyridine, other anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or polytetrafluoroethylene (PTFE). 6. Subject has had a previous renal bypass operation, a bypass is planned, or the target lesion is located within or beyond a bypass graft. 7. Subject has received a thrombolytic agent within the past 30 days. 8. Subject has documented acute pulmonary edema or systolic heart failure with ejection fraction < 30% and/or hospitalization requiring intubation and ventilation support for this diagnosis within the previous 90 days or hypertensive emergencies defined as resulting in organ damage. 9. Concurrent enrollment in any investigational trial wherein subject's participation has not been completed. 10. Subject has had a planned or anticipated cardiovascular surgical or interventional procedure outside of the affected renal artery (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to the index procedure and prior to completion of the 30 day follow-up. 11. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months. 12. Subject is pregnant, lactating, or is of child-bearing potential and plans to become pregnant during the follow-up trial period. 13. Subject with significant valvular disease. 14. Subject with known significant proteinuria > 2+ or > 2.0gm/d. 15. Subject with known bilateral upper-extremity arterial stenosis that result in spuriously low arm pressures or without the ability to gain reliable blood pressure measurements in at least one upper extremity. 16. Subject with active sepsis. 17. Subject with serum creatinine ≥ 3.0mg/dL. 18. Subject with NYHA Class IV at the time of enrollment. 19. Subject is on hemodialysis. 20. Subject has a history of renal aneurysm. 21. Subject with cardiogenic shock. 22. Subject with cardiomyopathy. 23. Subject has an uncontrolled concurrent illness, including but not limited to ongoing or active infection or active autoimmune disease requiring immunosuppressive therapy. 24. Any subject with clinically significant cardiovascular, respiratory, neurologic, hepatic, endocrine, major systematic disease, making implementation or interpretation of the protocol or protocol results difficult or who in the opinion of the investigator would not be a good candidate for enrollment. Angiographic Anatomic The planned site of intervention is totally occluded or has an anatomic configuration likely to prohibit adequate dilatation, and/or passage or implantation of the investigational device. 2. Subject has multiple ipsilateral lesions of the target renal artery that cannot be covered by a single stent. 3. There is a previously implanted stent in the target vessel or there is a previously implanted stent in the contralateral vessel < one year. 4. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed. 5. The target lesion site is associated with a thrombus. 6. Target lesion treated with laser atherectomy, directional atherectomy or other adjuncts to percutaneous balloon angioplasty (PTA). 7. Subject has a critical stenotic (> 70%) small accessory renal artery. 8. Subject has an abdominal aortic aneurysm > 4.0cm in diameter or a severe atherosclerotic aorta. 9. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal stent. 10. Any lesion that would blocking of renal artery side branch. 11. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic
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): 20.0-75.0, Hypervascular Tumor and Arteriovenous Malformation Subjects who are subject to any of the following vascular embolization therapies 1. Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumor confirmed by dynamic computerized tomography (CT) after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor, and are not amenable to resection and local therapy, and meet any of the following (a) to (c). 1. 1 lesion of >50 mm in diameter 2. 2 or 3 lesions of >30 mm in at least one diameter 3. 4 or more lesions 2. Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deep stained early stage tumor confirmed by dynamic CT after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor but not amenable to resection, and whose primary lesion and extrahepatic lesion are controlled. 3. Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stained early stage tumor confirmed by dynamic CT after bolus injection of contrast media and who have a typical finding of hypervascular tumor other than the liver (e.g., renal cell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b). 1. Subjects applicable to pre-operative arterial embolization therapy to reduce tumor size or volume of bleeding for safer conduct of surgical resection or local therapy (e.g., radiofrequency ablation (RFA)) 2. Subjects in stable general condition and are applicable to pain control treatment 4. Arteriovenous malformation: Subjects with arteriovenous malformation (except for central nervous system, heart, and lung) confirmed by dynamic CT but at a low risk of undesirable reflux into systemic circulation and with vessel malformation suitable for particle embolization in size 2. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (PS 0-1 for metastatic hepatic cancer) 3. No carry-over effect of prior therapy or adverse drug reactions which may influence the embolic effect of E7040, if having a history of prior therapy time elapsed from the end of prior therapy to the start of E7040 embolization therapy should be: Surgery: greater than or equal to 6 weeks Local therapy: greater than or equal to 4 weeks Embolization for non-target vessel: greater than or equal to 4 weeks 4. With a survival of greater than or equal to 12 months after the prior arterial embolization therapy using E7040 Subjects with clinical symptom or brain metastasis or cerebral encephalopathy requiring medical treatment 2. Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in patients with any disease other than HCC 3. Previously treated with arterial embolization therapy in target vessel 4. Previously treated with arterial embolization therapy in non-target vessel, resection in target organ, or local therapy (e.g., RFA) (except for HCC patient) 5. Subjects expected to have artery-pulmonary vein shunt or right-to-left shunt, or those with a possible risk of influx of embolized particles into the central nervous system
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): 16.0-50.0, Cesarean Section Pregnancy cesarean section via transverse skin incision informed consent vertical skin incision
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, Cerebral Hemorrhage Intracranial Arteriovenous Malformations Intracranial Hemorrhage, Hypertensive Brain Neoplasms CT demonstrated ICH Cardiopulmonary stable Informed consent from patient or proxy No General contraindication of MRI Age above 18 Lack of informed consent lack of cooperability
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): 18.0-70.0, Chronic Cluster Headache Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3. Subjects diagnosed with chronic cluster headache for at least 1 year, without remission periods or with remission periods lasting <1 month, in accordance with the ICHD-II classification (2ndEd): a. At least 5 attacks fulfilling the following i. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated ii. Headache is accompanied by at least 1 of the following: 1. Ipsilateral conjunctival injection and/or lacrimation 2. Ipsilateral nasal congestion and/or rhinorrhea 3. Ipsilateral eyelid oedema 4. Ipsilateral forehead and facial sweating 5. Ipsilateral miosis and/or ptosis 6. A sense of restlessness or agitation iii. Attacks have a frequency from 1 every other day to 8 per day and are not attributed to another disorder iv. Attacks recur over > 1 year without remission periods or with remission periods lasting < 1 month. 4. Has minimum mean attack frequency of 4 CH attacks per week. 5. Is able to distinguish CH from other headaches (i.e. tension-type headaches). 6. Is capable of completing headache pain self-assessments. 7. Agrees to use the GammaCore® device as intended and follow all of the requirements of the study, including follow-up visit requirements. 8. Is willing to keep all concomitant medication stable during the entire study period. 9. Women of child-bearing potential must use 2 methods of contraceptive i.e. hormones and condom Is currently taking CH prophylactic medication for indications other than CH which in the opinion of the clinician may interfere with the study 2. Has had a change in type or dosage of prophylactic headache medications < 1 month prior to enrollment 3. Has a history of intracranial or carotid aneurysm, intracranial hemorrhage, brain tumors or significant head trauma. 4. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site. 5. Has other significant pain problem that might confound the study assessments in the opinion of the investigator. 6. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5years). 7. Has had a previous unilateral or bilateral vagotomy. 8. Has uncontrolled high blood pressure. 9. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. 10. Has a history of carotid endarterectomy or vascular neck surgery on the right side. 11. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore® stimulation site. 12. Has a history, the last 12 month, of syncope. 13. Has a history, the last 12 month of seizures. 14. Has a known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH. 15. Has psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the investigator may interfere with the study 16. In the opinion of the investigator the subject is incapable of operating the GammaCore® device as intended and performing the data collection procedures. 17. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. 18. Woman who are pregnant or lactating
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 Haemorrhage Stroke Patients presenting with an acute ICH Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA according to three all of which must be present: 1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel; 2. The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and 3. No hyperdensity at the corresponding location on non-contrast CT Age ≥18 years Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well) Informed consent has been received in accordance to local ethics committee requirements Glasgow coma scale (GCS) total score of <8 Brainstem ICH ICH volume >70 ml as measured by the ABC/2 method ICH known or suspected by study investigator to be secondary to trauma, aneurysm, vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumor, or infection Contrast already administered within 24 hours prior to initial CT or contraindication to imaging with CT contrast agents (e.g. known or suspected iodine allergy or significant renal failure) Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 14 days, irrespective of laboratory values Pregnancy (women of childbearing potential must be tested) Planned surgery for ICH within 24 hours
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, Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service ≥18 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines Estimated Injury Severity Score (ISS) ≤9 Likely to be discharged before hospital day 7 Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2 Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr ≥1.3) Delayed transfer to this facility (>24 hrs) Prisoners
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): 12.0-60.0, Intracranial Arteriovenous Malformations Diagnosis of intracranial AVM by DSA/CT/MRI 2. Age from 12-60 years 3. Be suitable for microsurgery treatment 4. All patients are able to cooperate with the fMRI examination 5. All patients gave written informed consent Patients with age < 12 years or > 60 years 2. Various conditions unable to meet the indications for microsurgery treatment 3. Intracranial hemorrhage need emergency surgery 4. Patients can not cooperate with fMRI examination
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): 10.0-999.0, Cutaneous Arteriovenous Malformations Male or feminine Subject Subject of 10 and more years old Subject weighing more than 55 kg. patients Subject presenting a cutaneous artério-venous deformation there outside of any other deformation or known vascular tumor Subject presenting no other susceptible pathology to influence endothéliaux markers (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular, diabetes, evolutionary tumoral pathology). volunteers Unhurt Subject of deformation or vascular tumor Subject presenting no other susceptible pathology to influence endothéliaux markers(scorers) (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular) Subject of less than 10 years old Subject weighing less than 55 kg Subject presenting another type(chap) of vascular vascular deformation or tumor
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): 18.0-55.0, Cervicogenic Headache unilateral pain starting in the neck and radiating to the frontal-temporal region pain aggravated by neck movement restricted cervical range of motion joint tenderness in at least one of the joints of the upper cervical spine (C1-C3) headache frequency of at least one per week over a period greater than 3 months active TrPs in the sternocleidomastoid muscle other primary headaches (i.e., migraine, tension type-headache) bilateral headaches had received treatment for neck or head pain in the previous year presented any contraindications to manual therapy had pending legal action regarding their neck and head pain
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): 18.0-75.0, Cluster Headache Is between the ages of 18 and 75 years. 2. Has been diagnosed with cluster headache, in accordance with the ICHD-2 Classification (2ndEd): o At least 5 attacks fulfilling the following Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated Headache is accompanied by at least 1 of the following Ipsilateral conjunctival injection and/or lacrimation Ipsilateral nasal congestion and/or rhinorrhea Ipsilateral eyelid edema Ipsilateral forehead and facial sweating Ipsilateral miosis and/or ptosis A sense of restlessness or agitation 3. currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks. 4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches). 5. capable of completing headache pain self-assessments. 6. [Intentionally left blank]. 7. Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements. 8. Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects. 9. able to provide written Informed Consent had surgery to treat cluster headache. 2. currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study. 3. [Intentionally left blank]. 4. undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month. 5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma. 6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site. 7. structural intracranial, or cervical vascular lesions that may potentially cause headache attacks. 8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments. 9. known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction. 10. history of prolonged QT interval or a history of clinically significant arrhythmia. 11. abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction). 12. previous bilateral or right cervical vagotomy. 13. uncontrolled high blood pressure. 14. currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. 15. history of carotid endarterectomy or vascular neck surgery on the right side. 16. implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site. 17. recent or repeated history of syncope. 18. recent or repeated history of seizure. 19. known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH. 20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study. 21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of childbearing years and is unwilling to use an accepted form of birth control. 22. participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. 23. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised
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, Epilepsy Temporal Lobe For healthy volunteers Age 18 or older Able to give written informed consent No prior diagnosis of drug or alcohol abuse or dependence. For patients Age 18 or older Able to give written informed consent Having clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, which may be refractory or responsive to standard antiepileptic treatment. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies Negative toxicology testing at the time of screening No prior diagnosis of drug or alcohol abuse or dependence For healthy volunteers Any current Axis I diagnosis Clinically significant laboratory abnormalities Positive test for HIV Unable to have a MRI scan History of neurologic illness or injury with the potential to affect study data interpretation History of seizures, other than in childhood and related to fever Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits Inability to lie flat on camera bed for at least two hours Pregnancy or breast feeding
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): 18.0-64.0, Traumatic Brain Injury Has sustained a documented TBI that required an inpatient rehabilitation program is at least one year post TBI is at least 18 and no more than 64 years of age at the time of enrollment is English or Spanish speaking is at least three months beyond completion of formal PT, including acute inpatient rehabilitation, outpatient and home-based therapy provides written medical clearance for participation in an in-home balance exercise program ambulates independently within the home (with assistive devices and/or orthotics as needed) has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the VR system completes a 15 minute trial using a VR system in the absence of a negative physical or behavioral reaction self-reports ongoing balance deficits and demonstrate such deficits by scoring at or below one standard deviation above the mean (75 or below) on the CB&M; and has a history of another medical illness or neurological disorder which may affect balance has experienced a seizure within the last year has a history of psychiatric disorder requiring hospitalization is currently participating in another RCT is currently using VR technology to address specific balance goals is unable to travel to Craig for assessments throughout the study period is unable to communicate effectively to complete standardized assessments has cognitive impairment that precludes completion of baseline testing is unavailable to participate in 12 continuous weeks of therapy has no access to television able to connect to VR-gaming system; and
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): 18.0-89.0, Subarachnoid Hemorrhage Cerebral Vasospasm Hydrocephalus Non traumatic SAH documented by CT scan Patient with SAH who would need external ventricular drain (EVD) for the management of hydrocephalus Patients with normal pressure Hydrocephalus that require an external drain Control (non hemorrhagic) group CSF collected from patients with posterior fossa tumor or stroke with EVD in place for the management of hydrocephalus Recent infection within last 1 month of presentation can increase inflammatory markers Recent surgery or acute myocardial infarction within last 1 month of presentation Age > 89 years or < 18 years
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, Intracranial Arteriovenous Malformations All the patients that diagnosed of intracranial AVM by DSA/CT/MRI All patients gave written informed consent patients refuse to attend the survey
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, Migraine Without Aura Migraine With Aura Chronic Migraine Age 18 or more Diagnosis of migraine, chronic or episodic, at the first visit. We expect the majority of patients to suffer form frequent or chronic migraine Consent to participate in the CHUM Migraine Clinic project For future post-hoc analysis, groups will be stratified according to baseline headache frequency (all severity included), assessed retrospectively at the first visit <6 headache days per month to 14 headache days per month or more headache days per month Patients whom first headache diagnosis is not migraine (for example post-traumatic headache, cluster headache, trigeminal neuralgia, facial pain) Women with ongoing or planned pregnancy Patient with an active psychiatric condition (needing hospitalisation or psychosis) Patient with mental retardation impairing assessment or follow-up Patient with an active medical condition which may lead to frequent hospitalisations (eg active cancer, organ graft, hemodialysis etc). This will be determined and detailed by the evaluating physician Active drug addiction or alcoholism Active follow-up at a pain clinic Patient speaking a language other than french and incapable to communicate in a reliable way
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, Cerebral Vasospasm Male or female 18 years of age and older Subarachnoid hemorrhage documented on head CT Fisher Grade 3 or 4 Hunt Hess Grade 1-5 Cerebral aneurysm as definitive source of subarachnoid hemorrhage Cerebral aneurysm must be treated via open or endovascular techniques Presence of external ventricular drain Written informed consent obtained from subject or subject's legally authorized representative Absence or inability to have an external ventricular drain (coagulopathy) Non-aneurysmal subarachnoid hemorrhage (perimesencephalic) Untreated cerebral aneurysm Inability to be randomized prior to post-hemorrhage day 4 Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain) Inability to obtain angiography (coagulopathy, renal failure) Pregnant Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
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, Traumatic Brain Injury Participants with traumatic head injury and requiring intracranial pressure (ICP) monitoring Post menopausal females, (or when known not to have menstruated for at least 12 months), or previously documented sterilization Body Mass Index (BMI=weight per square height): 18 to 35 kilogram per square meter inclusive Legally acceptable representatives (relatives or guardians) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are allowing the participant to participate in the study To participate in the optional pharmacogenomic component of this study, legally acceptable representatives (relatives or guardians) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not a participant from participation in the clinical study Major injury (multi-trauma) or disease outside the central nervous system causing significant vital organ or blood counts dysfunction (for example, disseminated intravascular coagulation, serious hepatic or kidney failure, acute respiratory distress syndrome, etc) Participants who already received specific ICP lowering therapy, other than ventricular drainage, before being dosed with JNJ-17299425 Rapid increase of ICP expected to result in death of the participant Relevant abnormal values for hematology, clinical chemistry or urinalysis at admission Any known significant history or family history of anemia, hemolytic or autoimmune disease or thrombocytopenia
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, Intracerebral Hemorrhage Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6 Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth < 5 mL as measured by ABC/2 method) Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary) Ability to randomize between 12 and 72 hours after dCT Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to the time of randomization Historical Rankin score of 0 or 1 Age ≥ 18 and older Infratentorial hemorrhage Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat intracranial pressure (ICP) is allowed Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4 Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage diagnosed with radiographic imaging Patients with unstable mass or evolving intracranial compartment syndrome Platelet count < 100,000; international normalized ratio (INR) > 1.4 Any irreversible coagulopathy or known clotting disorder Inability to sustain INR ≤ 1.4 using short and long-active procoagulants (such as but not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K)
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, Stroke Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain). 2. You cannot take part in this study if you are not able to safely have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition
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, Intra Cerebral Hemorrhage Age between 18-80 years patient is able to sign the informed consent form Spontaneous brain hemorrhage ICH in the last12 hours ( pre admission,or sub dural bleeding (whether acute or chronic ) The patient meets a contraindication to undergo MRI The patient is too unstable to undergo MRI The patient is a candidate for surgery within 24 hours
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, Pain Participants in good general health, and with diagnosis of ETTH with following conditions: 1. number of days with the condition is historically greater than or equal to two per month; 2. severity of headaches is historically at least moderate; 3. duration of headaches is historically more than or equal to 4 hours, if untreated Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments
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, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness
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, Venous Vascular Malformation Patient over 18 years Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI Recurrence of symptoms after initial treatment Symptomatic deformation :pain, tangible mass,functional discomfort Recurrence after treatment by surgery or sclerosis Cryotherapy considered technically feasible after discussion in multidisciplinary committee Localization at distance from the skin and major neurovascular structures Absence of contra-indication of anaesthesia Signed informed consent Coverage by French social security Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve) TP <50% TCA> 1.5 x control, anticoagulation Platelets <90000/mm3 Progressive infection Patient included in another clinical study Unable to undergo medical tests for geographical, social or psychological Adult under a legal guardianship or unable to consent Pregnancy and breastfeeding
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, Type 1 Diabetes Mellitus Male or female of age 18 years or older with a history of T1DM for at least 12 months 2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results 3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL) 4. Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant 5. Current treatment at the time of screening with insulin <300 units per day (U/day) 6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average CGM use 5 or more days per week over the preceding 3 months) and those who do not routinely used CGM are both eligible for in the study. Intermittent use of CGM is also acceptable but will not be a criterion use for stratified randomization. 7. Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol Type 2 diabetes 2. Known or suspected allergy to any component of any of the study drugs in this study 3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator 4. History of transmural myocardial infarction, congestive heart failure and uncontrolled hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury [mmHg]) are exclusionary 5. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures 6. History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant 7. As judged by the Investigator, clinically significant findings in routine laboratory data at screening 8. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis. 9. Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator. 10. Current addiction to alcohol or substance abuse as determined by the Investigator. 11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study. 12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
0
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): 0.0-85.0, Diabetes Adult patients at 22 Providence Medical Group primary care clinics Diagnosis of type 2 diabetes mellitus Currently using greater than 80 units/day of insulin glargine or greater than 1 unit/kg/day of insulin glargine Current A1C > 8.5% (within 3 months of randomization) Diagnosis of type 1 diabetes mellitus Age > 85 years Self-reported history of severe hypoglycemia or hypoglycemia unawareness Hospice/limited life expectancy Current enrollment in Providence Medical Group Medication Assistance Program Current use of a GLP1 agonist (i.e., liraglutide, exenatide, exenatide extended-release) End stage renal disease (i.e., dialysis or estimated glomerular filtration rate <15 ml/min/1.73m2) Cirrhosis Unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or hospitalization within 6 months pre-randomization) Psychiatric condition that prevents adequate follow-up (i.e., > 3 missed follow-up visits within a 3 month period or persistent non-adherence to dosing or monitoring recommendations)
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): 8.0-65.0, Migraine Adult ≥ 18 and ≤ 65 years of age females or males; 2. Willing to participate in the study and to complete all study-related procedures, evaluations, and headache diaries; 3. Able to understand, agree to, and sign the study's IRB-approved informed consent form; 4. Has a physician-made diagnosis of Chronic Migraine as defined by the following (a, b, and c): 1. Headache (tension-type and/or migraine) lasting a minimum of 4 hours on ≥15 days per month for at least 3 months and on ≥XX (redacted by sponsor to preserve integrity of study) days in the 30 days prior to the Screening Visit; 2. Headaches on ≥8 days per month for at least 3 months that have fulfilled the following: i. Headaches with at least two of the following unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs); ii. AND at least one of the following nausea and/or vomiting photophobia and phonophobia; iii. OR headaches that have been treated and relieved by triptan(s) or ergot before the expected development of the symptoms listed in 4.b.i and 4.b.ii above; c. Headaches are not attributed to a substance or substance withdrawal, infection, cranial neuralgias, cluster headaches, autonomic cephalalgias, or cranial, cervical vascular, non-vascular, intracranial homeostasis and psychiatric disorders; 5. If taking medication (prescribed or over-the-counter) for migraine prophylaxis, the medication must have been taken for at least 2 months and the dosage(s) must have been stable for at least 1 month prior to the Screening Visit. There must be no plan to add to, discontinue, or change the dose of these medications throughout the subject's participation in the study; 6. To be eligible for the inpatient Treatment Period: the subject must have recorded in the Headache Diary ≥XX (redacted by sponsor to preserve integrity of study) headaches days (at least 4 hours of continuous head pain per headache day) in the 30 days immediately prior to the Inpatient Treatment Visit (Visit 2); 7. To be eligible for the inpatient Treatment Period: mean head pain severity of ≥XX (redacted by sponsor to preserve integrity of study) and ≤XX (redacted by sponsor to preserve integrity of study) based on the 11-point Numerical Rating Scale (NRS) in the 30 days immediately prior to the Inpatient Treatment Visit (Visit 2) [only data from headache days will be used to calculate the mean head pain severity; missing data on a headache day will be considered to be zero (0) for this calculation]; and 8. To be eligible for the inpatient Treatment Period: The subject must be experiencing head pain on the day of the inpatient Treatment Visit (Visit 2). Subjects may continue the Screening Period for another week if head pain is not present at Visit 2 Any head pain, including coexisting head pain, not attributable to Chronic Migraine as defined in this study's Criterion #4; 2. Any condition that could affect the subject's ability to assess the effect of neurostimulation or in which neurostimulation may be a safety concern, including but not limited to: 1. Known history of epilepsy or recurrent seizures; 2. Known neurogenic and neuromuscular disorders (i.e. myasthenia gravis, multiple sclerosis, autonomic disorders); 3. Uncontrolled diabetes mellitus; 4. Known peripheral neuropathy; 3. History of taking the following medications in the 30 days prior to the Screening Visit: 1. Opioid and opioid-containing medications; 2. Butalbital, butalbital-containing, and barbiturate medications; 3. Systemic corticosteroids (exceptions: acute corticosteroid medication including inhaled therapy (pulmonary), ocular therapy, or non-spinal intra-articular therapy); 4. Urine drug screen that is positive for any of the tested drugs (i.e., cannabis, opiates, barbiturates, amphetamines , benzodiazepines and cocaine) at the Screening Visit (Visit 1) and the Inpatient Treatment Visit (Visit 2); 5. Positive pregnancy test at the Screening Visit (Visit 1) or at the Inpatient Treatment Visit (Visit 2); 6. Known history of cardiac conduction or heart rate abnormalities associated with symptoms; 7. Uncontrolled hypertension; 8. Any tattoos or extensive tissue scarring in the cervical/occipital area; 9. Any active skin lesions, skin damage, broken skin, history of easy bruising or bleeding disorders, or history of surgery and/or trauma in the cervical/occipital area at the time of the Screening Visit; 10. History of occipital nerve (ON) block, peripheral ON stimulation, or botulinum toxin (e.g., Botox) for treatment of headaches within the 90 days prior to the Screening Visit; 11. Radiofrequency rhizolysis involving the occipital nerve or cervical nerves; 12. Surgery involving the occipital nerve or cervical nerves (e.g. neurectomy or rhizotomy), or cervical ganglionectomy; 13. History of craniotomy or intracranial surgery; 14. Presence of metallic implant (e.g., metal pin, staple, clip) in the skull or neck area; 15. Presence of any implanted neuromodulation or cardiac device; 16. Severe or uncontrolled psychiatric disorders (i.e. schizophrenia, depression, anxiety, or at investigator discretion); 17. Any other medical condition, concomitant medication or finding for which, at the discretion of the investigator, the subject should be excluded for reasons of safety or capacity for study compliance; or 18. Participation in any other clinical study (not to registries or survey-only studies) within 30 days or 5 half lives of an investigational drug, whichever is longer, of Visit 1 (Screening Visit) and for the duration of the 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): 55.0-999.0, Intracerebral Hemorrhage Cerebral Amyloid Angiopathy Ischemic Stroke (study group) Fulfillment of the modified Boston for CAA-related hemorrhage with evidence of supratentorial superficial siderosis on MRI MR-/CT-/digital subtraction (DS) -angiography without evidence of cerebral aneurysm, arterio-venous malformation (AVM) , AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction) A maximum of two lobar or cerebellar intracranial hemorrhages (ICH) (old or acute) Written informed consent by patient or guardian prior to study participation Willingness to participate in follow-up (control group) Fulfillment of the classic Boston for CAA-related hemorrhage Absence of superficial siderosis on MRI A maximum of two lobar or cerebellar ICHs (old or acute) MR-/CT-/DS -angiography without evidence of cerebral aneurysm, AVM, AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction) (both groups) Severe medical condition with expected life expectancy <3 years More than two lobar or cerebellar ICH (old or acute) any intracerebral hemorrhage in the deep grey matter (basal ganglia or thalami) or in the brain stem History of head trauma resulting in loss of consciousness or radiologically visible traumatic brain injury (contusions, diffuse axonal damage) in the last 5 years prior to Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage Infratentorial siderosis Infratentorial subarachnoid hemorrhage
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): 16.0-44.0, Vaginismus cases with resistant vaginismus cases with congenital anomalies in the lower female genital tract
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 Cerebral Vasospasm Cerebral Aneurysm Hydrocephalus Age greater than 18 years old SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus Ventriculostomy placement must occur prior to randomization Informed consent obtained from the patient or patient's decision maker Determination by treating physician(s) that no ventriculostomy is needed Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study Presence of significant anemia, defined as hemoglobin < 8 gm/dL Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy Residual aneurysm sac filling (Raymond class III occlusion) Aneurysm or vessel perforation during the endovascular procedure Presence of craniectomy Significant neurologic disability prior to the onset of SAH Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram
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, Brain Injuries Craniocerebral Trauma Age 18 years within 6 hours post injury Closed head injury Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation The intracranial pressure is more than 25 mmHg Cerebral contusion on computed tomographic scan GCS of 3 with bilateral fixed and dilated pupils A life-threatening injury to an organ other than the brain No spontaneous breathing or cardiac arrest at the scene of the injury No consent 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, Subarachnoid Hemorrhage. Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage In need for CSF drainage based on clinical judgment intraventricular clots intraparenchymal clots causing midline shift 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): 30.0-85.0, Cardiovascular Risk Factors Coronary Artery Disease Cerebrovascular Disease Peripheral Artery Disease Patients (male and female) aged 30 to 85 years with at least one traditional cardiovascular risk factor (hypertension, smoking, diabetes, dyslipidemia, family history) or established coronary artery disease, cerebrovascular disease, or peripheral artery disease diagnosed by objective testing lack of informed consent the impossibility of follow-up testing once per year for the following four years
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, Treatment of Submassive Pulmonary Embolism Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9 age > 80 Recent thrombolytic therapy (with in 4 days) Active bleeding or know bleeding diathesis Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 Thrombocytopenia (PLT cound < 100,000) History of any intracranial or intraspinal surgery, trauma or bleed Intracranial neoplasms, AVM, or aneurysm Recent (< 1 month) GI bleed Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy Recent (< 7 days) major surgery, trauma, or obstetrical delivery
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): 20.0-65.0, NSAID-associated Gastroduodenal Injury Need to take NSAID pills for longer than four weeks should be normal diagnosed by the endoscopy test The patients have gastric ulcer or duodenal ulcer within 30 days The patients have a gastro-intestinal surgery within a year The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen 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): 18.0-65.0, Major Depressive Disorder Healthy Controls for MDD Subjects: 1. Male or female, age 18-65 2. Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder. 3. Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16. 4. Ability to visually read and understand English language 5. Not currently taking an antidepressant. 6. Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study. for Healthy Control Subjects: 1. Male or female, age 18-65 2. No current DSM-IV TR diagnosis of a mental illness. 3. No lifetime history of Major Depressive Disorder or Dysthymia. 4. Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7. 5. Ability to visually read and understand English language 6. Not currently taking any psychoactive medication for all subjects: 1. Has met at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia. 2. Meet for substance abuse or dependence within three months of the screening visit. 3. Presents with a clinically significant suicide risk, as assessed by a study physician. 4. Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation. 5. Women who are currently pregnant or lactating, or plan to become pregnant during the 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, Cough Irritation in Throat Irritation in Skin Lacrimation All participants with a history of exposure to pepper gas grenade explosion Combatant role while exposure
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): 25.0-95.0, Ischemic Cerebrovascular Disease symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis stenosis ≥ 50% (MRI or CT angiography) Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research diffuse intracranial arterial stenosis cranial magnetic resonance imaging shows lesions as the branch artery blockage caused non-atherosclerotic lesions occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage potential cardiac thrombus source has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50% known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications hemoglobin less than 10g/dL, platelet count <100000/dL responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3)
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, Migraine Disorders Headache Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months Eight (8) headache days per month for at least 1 of the preceding 15 months Not currently diagnosed with chronic migraine, headache or migraine History of receiving botulinum toxin injections for the treatment of chronic migraine
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): 18.0-50.0, Hand Washing Behavior Hand Cleansing Behavior Chlorhexidine Neonatal Period Pregnant women older than 18 years that are at 32-36 weeks gestation and intend to reside in the location which they are residing at the time of recruitment into the study through the remainder of the antenatal period and the first 4 weeks after birth Plans to move out of study area between enrollment and 1 month after birth
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, Coagulation; Intravascular Craniocerebral Trauma Haemorrhage Admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of atrial fibrillation (AF) Initial ED Glasgow Coma Scale (GCS) score of ≥13 Achievable follow up Informed consent form signed by the patient or if he/she isn't able an emergency can be realised Delay between the minor head trauma and the possible preventive PCC's administration > 6h Subject receiving anticoagulant treatment other than anti vitamin K (heparin, fondaparinux, dabigatran, rivaroxaban, apixaban...) Subject receiving anticoagulant treatment for other reason than a AF Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100 mg/day) Delocalised biology INR in capillary blood < 1.5 if it's available (only in departement where this analyse is a usual practice) Haemorrhage or suspected haemorrhage other than intracranial which could led to a reversion of the anticoagulation Head trauma associated with one or further potential haemorrhagic traumatic lesions Subject who reject the use of products derived from human blood Women who are pregnant Subject with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
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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): 18.0-85.0, Primary Headache 85 years old Benign headache Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic Unable to provide informed consent Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection Known renal impairment Known hepatic impairment A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease Perforated ear drum Pregnant
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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): 18.0-45.0, Postdural Puncture Headache Post-Lumbar Puncture Headache Cerebrospinal Fluid Leaks Postpartum patients following vaginal delivery Unintentional dural puncture Functioning intrathecal catheter Patients must be 18 years of age or older English speaking History of previous PDPH Body mass index BMI > 40 kg/m2 History of obstructive sleep apnea (OSA) Morphine allergy Patients who receive Cesarean delivery
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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): 7.0-999.0, Type 1 Diabetes Type 2 Diabetes for A subject is eligible for the user evaluation study if all of the following are met: 1. Subject is 7 years or older at time of screening 2. Subject is current insulin pump user for at least 3 months 3. Subject has the following CGM experience as determined by the Investigator Has experience and is able to insert/change sensor by herself/himself and Has experience and can recharge the transmitter and Has experience and can read sensor data in real-time on her/his pump screen 4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures; 5. Subject is willing to complete study questionnaires throughout the study 6. Must have the following clinical diagnosis: 1. Type 1 diabetes, for a minimum of 6 months prior to enrollment for A subject is excluded from the user evaluation if any of the following are met: 1. Female subject has a positive urine pregnancy screening test. 2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn 3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures. 4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff 5. Subject is unable to tolerate tape adhesive in the area of sensor placement 6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection) 7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled 8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this
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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): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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): 0.0-14.0, Occlusion or Malformation of a Cerebral Vessel malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology opposition ot the parent(s) to the participation of their child in the trial and/or no social security
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