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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, Traumatic Brain Injury Written informed consent from patient's legal guardian or legal representative years of age, inclusive Head trauma within the last 12 hours Traumatic brain injury with Glasgow Coma Score (GCS) ≥ 5 and that requires ICP monitoring Catheter placement for monitoring and management of increased ICP Microdialysis probe placement in penumbra zone or ipsilateral to contusion if focal Systolic blood pressure ≥ 100 mmHg Females of child-bearing potential must have a negative pregnancy test Penetrating head injury (e.g. missile, stab wound) Not expected to survive more than 24 hours after admission Concurrent, but not pre-existing, spinal cord injury Unilateral and bilateral fixed and dilated pupil (> 4 mm) Cardiopulmonary resuscitation performed post injury continuing bleeding likely to require multiple transfusions (> 4 units red blood cells) Coma due to a "pure" epidural hematoma (lucid interval and absence of structural brain damage on CT scan) Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose) Known or CT scan evidence of pre-existing major cerebral damage Decompressive craniectomy, planned prior to randomization | 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): 18.0-60.0, Full-frequency Sudden Hearing Loss Older than 18 years, less than 60 years old patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB Primary presentation within 2weeks; standard treatment for 2 weeks After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies >/=30 dB better than before Written informed consent before participation in the study History of tuberculosis or positive purified protein derivative (PPD) Insulin-dependent diabetes mellitus Hypertension, poor control of BP(SBP/DBP)>=140mmHg) History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc Serious psychiatric disease or psychiatric reaction to corticosteroids History of heart disease or transient ischemic attacks(TIAs) Prior treatment with chemotherapeutic or immunosuppressive drugs Pancreatitis Active peptic ulcer disease or history of gastrointestinal bleeding History of HIV, Hepatitis B or C | 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, Idiopathic Parkinson's Disease Idiopathic Parkinson's Disease Not MRI Compatible Diabetes Hypertension or Cardiac disease History of a Stroke Cardiac Pacemaker Have had Surgery for an Aneurysm Major Surgery within the last 8 weeks Claustrophobia Pregnant or Nursing | 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, Intracerebral Hemorrhage Spontaneous intracranial or intraparenchymal hemorrhage 85 years of age Hemorrhage occurred in a supratentorial location Inability to obtain consent within 3 days of hemorrhage onset Known pregnancy Therapeutic anticoagulation with Lovenox, Coumadin or Heparin Prior history of therapeutic radiation to any area Brain tumor Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation Central nervous system infection Subdural hematoma Subarachnoid hemorrhage Chronic immunosuppression, including steroids or chemotherapy agents | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-18.0, Head Injury Parents and their child, seeking care for a child who: 1. Is < 18 years of age; 2. Had blunt trauma above the eyebrows (not isolated to face or eyes); 3. Is positive for at least 1 of the clinical prediction rule predictors described below: Predictors for children < 2 years of age: Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture predictors for children 2-18 years of age: Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians attending physicians and fellows or midlevel providers caring for children with head trauma Parents of children with: 1. GCS scores < 15 2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination 3. Brain tumors 4. Ventricular shunts 5. Bleeding disorder 6. Pre-existing neurological disorders complicating assessment 7. Neuroimaging at an outside hospital before transfer 8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) 9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma 10. Known to be pregnant 11. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid. 12. Strong suspicion of abuse for this head injury | 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): 21.0-45.0, Post-Traumatic Stress Disorder for All Participants Able to give informed consent Physically and neurologically healthy [confirmed by a comprehensive medical history] Age between 21-45 years old Right-handed for Participants with PTSD Current PTSD diagnosis [related to civilian trauma] for Trauma-Exposed Participants without PTSD Experience with a civilian trauma without a PTSD diagnosis Free of a lifetime Axis I or Axis II diagnosis for Non-Trauma-Exposed Healthy Participants Free of a lifetime Axis I or Axis II diagnosis for All Participants Clinically significant medical or neurological condition Less than a high school education Lack of fluency in English Night shift work Currently pregnant; planning pregnancy; or lactating Unwilling/unable to sign informed consent document Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia) Left-handed Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles) | 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, Tinnitus years of age History of chronic subjective tinnitus that cannot be attributed to vascular, neurologic, neoplastic or traumatic causes Capable of self-applying the lidocaine patches History of heart disease History of irregular heartbeat Prior MI Previous exposure to lidocaine as a treatment for tinnitus An allergy to adhesives Allergy to lidocaine Taking medications, herbal remedies and supplements that may interact with lidocaine, including but not limited to antivirals, benzodiazepines, and St. John's Wart Known liver disease Known kidney disease Adults who do not speak English | 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, Transformed Migraine Chronic Daily Headache Male and female age 18-90 2. Subject have formal medical diagnosis of migraine headache 3. Subjects currently require treatment for headache 4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax) 5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin Less than 18 years of age 2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain 3. Untreated Heart Failure 4. Pregnancy 5. Individuals unwilling to comply with study procedures and follow-up | 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, Unruptured Brain Arteriovenous Malformation Ruptured Brain Arteriovenous Malformation Arteriovenous Malformations AVM BAVM Any patient with a brain AVM Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS | 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): 18.0-45.0, Healthy Volunteer between 18 and 45 years old 2. right-handed. 3. Fluent in English. 4. able to provide written informed consent. 1. Has a dermatological condition such as scars, burns, callouses, or tattoos that might influence cutaneous sensibility on the hands 2. Has had recent or permanent injury of upper limbs or amputation or use of prosthetic arm or leg 3. Used recreational drugs within the past month 4. Is pregnant or breastfeeding. 5. Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months). 6. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (including blindness or deafness) or a chronic systemic disease (e.g. diabetes). 7. Has a medical condition potentially affecting somatosensation (e.g. Raynaud s Disease, peripheral neuropathy, or circulatory disorder). 8. Participant has or had psychiatric disorders such as major depression, major anxiety-related problems, substance or alcohol dependence or abuse, post-traumatic stress syndrome, bipolar disorder, psychosis, or suicide attempts or persistent suicide ideation. 9. Has metal implants or fragments in the body as this would make having an MRI scan unsafe. This includes pacemakers, medication pumps, aneurysm clips, metallic prostheses (such as metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have. 10. Is uncomfortable in closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine, or a condition that prevents him/her from lying flat for up to 1 hour or rotating palm up for 15 minutes while lying flat. 11. Weight of 275 pounds or higher. 12. History of head trauma that was diagnosed as a concussion or was associated with loss of consciousness or was associated with loss of consciousness. 13. Personal history of a seizure or first degree relative with a seizure disorder 14. Participation in brain stimulation within one week of any TMS session in this study 15. Use of neuro-active drugs including opioids, antidepressants, anticonvulsants/antiepileptics, antipsychotics, dopamine agonists, sleep or anxiety medications, stimulants like methylphenidate (Ritalin), antihistamines, certain viral medications, or any other medication affecting the central nervous system 16. History of hearing loss 17. Obtained less than 6 hours of sleep the night before either TMS session (will be asked at each TMS session) 18. Consumed more than 16oz of coffee or an energy drink (anything with 500mg caffeine or more) on the day of the TMS session. (Caffeine > 500mg and sleep deprivation can increase seizure risk (Engel J, 2008). 19. Consumed alcohol on the day of the TMS session or shows signs of alcohol intoxication or alcohol withdrawal syndrome 20. Motor threshold over 82% of Magstim output | 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): 30.0-99.0, Intracranial Vascular Disorders Stroke defined as symptoms lasting >24 hours and associated with imaging evidence of acute ischemia in the distribution of the stenotic vessel on CT or MRI. 2. Eligible TIA defined as transient neurological symptoms lasting <24 hours, need to be: 1. accompanied by DWI abnormalities in the distribution of the stenotic artery; or 2. multiple (≥2), stereotyped events associated with unequivocal ischemic symptoms (weakness, aphasia), and attributed to the symptomatic artery. 3. IAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries. 4. Stenosis 50-99% quantified by digital subtraction angiography (DSA), CT angiography-CTA or MR angiography-MRA tests. DSA is not required but will be used if obtained as part of clinical care. The for 50-99% are: 1. CTA or DSA: measured 50-99% stenosis by WASID (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%. 2. MRA: measured 50-99% stenosis or presence of a flow gap. 5. Age >30; those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years). 6. Enrollment within 21 days of symptom onset and completion of study imaging tests within 21 days of index event (stroke or TIA). 7. Provide informed consent for participation in the study Other cause for stroke: atrial fibrillation, acute anterior wall ST-elevation myocardial infarction <30days, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or ejection fraction <30%, proximal extracranial carotid or vertebral stenosis >50%. 2. Contraindications to MRI, including MR-incompatible metallic implants, implanted electronic devices, other potentially mobile ferromagnetic material, pregnancy (women in fertile age should have a negative pregnancy test), lactation, morbid obesity, and severe claustrophobia. 3. Renal impairment defined as either a creatinine level >1.5 mg/dL or a glomerular filtration rate (GFR) <30 mL/min/1.73 m2. 4. Known allergy to gadolinium. 5. Unable to obtain informed consent by patient or legally authorized representative. 6. Severe behavioral or social problems that may interfere with the conduct of the study. 7. In the investigator's opinion, patient unlikely return for follow up visit and to complete the study. 8. Participation in a drug or device clinical trial within the last 30 days | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-45.0, Pregnancy Headache Patients older than 18 years were included Conversion to general anesthesia was the | 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): 0.0-55.0, Sickle Cell Disease Transfusion Dependent Alpha- or Beta- Thalassemia Diamond Blackfan Anemia Paroxysmal Nocturnal Hemoglobinuria Glanzmann Thrombasthenia Severe Congenital Neutropenia Shwachman-Diamond Syndrome Non-Malignant Hematologic Disorders Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated Acceptable stem cell source identified Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score) Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40% active, uncontrolled infection pregnant or breastfeeding HIV positive | 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 Ischemia Patients 18-99 undergoing total shoulder arthroplasty Planned general anesthesia + brachial plexus nerve block Planned arterial catheter Patients younger than 18 years older and older than 99 Patients not intending to receive general anesthesia and peripheral nerve block Indication for endotracheal tube BMI ≥ 30 Ejection Fraction (if known) < 50% Known significant restrictive or obstructive pulmonary disease Patients with a history of transient ischemic attack (TIA) or stroke Patients with recent signs or symptoms of myocardial ischemia Current stress test positive for ischemia Intolerance to study medications | 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 diagnosis of spontaneous SAH impaired cerebral autoregulation on day 2-4 post SAH traumatic SAH other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations pregnancy severe renal disease or anuria | 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, Immediate Postpartum Hemorrhage The trial will women aged 18 years or older who have just had a vaginal delivery between 35 and 42 weeks of gestation with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data Patient beneficiary or affiliated to a health insurance The trial will not women who have just had a cesarean delivery with a contraindication to Sulprostone with clinical chorioamnionitis or an in utero fetal death or a medically-indicated termination of pregnancy with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta with arterial bleeding requiring embolization with a purulent infection of the cervix, vagina or uterus with symptoms indicating a hysterectomy with cervical cancer | 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): 0.0-3.0, Fetofetal Transfusion Infants who suffered from TTTS in utero that either required fetal laser photocoagulation or had death of their cotwin Born after implementation of our TTTS protocol in September 2013 Complete postnatal MRI and follow-up at Cardinal Glennon Children's Medical Center, or at an outside hospital and release medical information to the study Infants who did not have TTTS, or not severe enough to warrant fetal intervention or demise of the cotwin Infants who do not complete their follow-up per protocol | 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): 0.083-999.0, Pulmonary Arterial Hypertension of Congenital Heart Disease The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for in the study must be signed by parents or legal guardians for minors, by the patient for adults The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its | 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): 16.0-999.0, Traumatic Intracranial Haemorrhage Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan Unexpected to survive or remain in hospital >72 hours Known malignancy under active care at time of admission Known DVT, PE or other condition requiring anticoagulation at time of admission Coagulopathy (defined as international normalized ratio (INR) values >1.5 times the upper limit of normal, or partial thromboplastin time (PTT) values >1.5 times the upper limit of normal) at 24 hours after admission Platelet count <75 x 10^9/L at 24 hours after admission Bilateral lower limb amputation History of allergy to heparin or suspected or proven HIT Limitation of life support or palliative care Prior enrollment in this trial or currently in a confounding randomized trial Pregnancy | 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): 18.0-60.0, Depression Epilepsy, Temporal Lobe With Major depressive disorder according to from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Diagnosed with TLE according to the of the International League Against Epilepsy Literates had sign an informed consent Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression Patients with high risk of suicide who required hospitalization Patients who abused or are dependent on drugs Those with a history of head trauma six months prior to the interview Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc Patients who have previously received CBT Patients who have started, an antidepressant drug the last 8 weeks | 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): 8.0-18.0, Concussion Headache diagnosed with a first time concussion english speaking presenting to Emergency with headache 24-48 hours post concussion normal Glascow Coma Scale 18 years of age postive findings on CT scan patient with cervical injury history of multiple concussions positive neurology | 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): 0.0-45.0, Infants of Diabetic Mothers (understood to only abstemious women) 1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies 2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies 3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies 4. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies) 2. . Mothers who had a positive drug screen at any point during their pregnancy (and their babies) 3. . Babies whose mothers suffered a placental abruption during their pregnancy. 4. . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic visits prior to admission for delivery) 5. . Non-English-speaking mothers 6. . Babies who pass meconium in utero. 7. . Babies born with multiple congenital anomalies or abdominal wall defects | 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, Brain Arteriovenous Malformation bAVM deemed unsuitable for invasive treatment OR patient has elected to defer invasive treatment OR failed conventional therapy Age greater than 18 years at time of first study drug administration Spetzler-Martin grade III Progressive or disabling signs and symptoms as determined by the study investigators. In the case of sporadic bAVM, these would be referable to the lesion, e.g., progressive neurological deficits, refractory headaches and seizures; for HHT patients, bAVM may be asymptomatic, but patient must have one progressively symptomatic manifestation of HHT that is referable to a vascular lesion, e.g., epistaxis, GI bleeding; or another solid organ AVM Patients must have adequate bone marrow function (WBC > 3,000/μl, ANC > 1,500/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 mg/dl), adequate liver function (SGOT and bilirubin < 1.5 times ULN), and adequate renal function (creatinine < 1.5 mg/dL) within 14 days before starting therapy Negative pregnancy test within 14 days of starting therapy Patients must not have proteinuria at screening as demonstrated by either 1) urine protein: creatinine (UPC) ratio > 1.0 at screening, OR 2) urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible) Patients must not have inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg) on antihypertensive medications Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy Patients must not have New York Heart Association Grade II or greater congestive heart failure Diffuse lesion that cannot be assessed in terms of volume by cross-sectional imaging on MRI Inability to undergo MRI scans Coagulation disorders, e.g., thrombocytopenia, coagulopathy or anticoagulant therapy (Plavix and ASA is not excluded) Low probability to adhere to study protocol or functional impairment that could compromise safety monitoring Unstable medical or psychiatric illness Ovarian dysfunction (criteria waived if potential future to have children (e.g. post menopausal or s/p tubal ligation) limited biologically Clinically significant thrombotic episode within the last 24 weeks Atrial fibrillation | 1 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 1.0-999.0, Ebola Virus Disease age >1 year and weighting ≥10kg EVD confirmed by a positive qualitative PCR test signed informed consent (signed by the parents/adults guardians in case of minor patient). Non inclusion-criteria pregnancy* inability to take the drug (encephalopathy, severe vomiting). * Emergency use of favipiravir in pregnant women outside of the trial is envisaged and under evaluation. In this protocol, the investigators will refer to the following groups according to age and duration of symptoms** Group A1: adults with time between first symptoms and first dose of favipiravir ≤72h Group A2: adults with time between first symptoms and first dose of favipiravir >72h Group C: all children >1 year and weighting ≥10kg. Time of first symptom refers to the time of the beginning of any symptom considered to be related to EVD. **Symptoms to be considered will be: acute onset of fever, severe headache, myalgia, extreme fatigue, vomiting, diarrhoea, abdominal pain, or unexplained hemorrhage. The division in groups is a matter of analysis, and will not be perceptible by the patients during the trial process. Patients in the three groups will receive the same treatment and will be followed under the same procedures, with only two exceptions: the number of additional blood sample collections will be lower in group A2 and C (n=2) than in group A1 (n=3) and daily dosages will be adapted to the body weight in group C | 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, Bleeding Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by at least one of the following Acute bleeding that is potentially life-threatening, OR Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available, OR Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial. 2. If bleeding is intracranial or intraspinal, the patient must have undergone a head CT or MRI scan demonstrating the bleeding. 3. Patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin. 4. For patients with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation. 1. The patient is scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures. 2. A patient with an intracerebral hemorrhage has any of the following Glasgow coma score < 7, OR Intracerebral hematoma > 60 cc as assessed by CT or MRI 3. Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed. 4. Expected survival of less than 1 month 5. Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization or severe peripheral vascular disease within 2 weeks prior to screening. 6. Severe sepsis or septic shock at the time of Screening. 7. Pregnant or a lactating female. 8. Patient has received any of the following drugs or blood products within 7 days of Screening Vitamin K antagonist (VKA) Dabigatran Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa (rfVIIa) | 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 18 years of age or older 2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA) 3. Have symptomatic headache 4. Able to swallow and verbalize pain score 5. No known allergy to gabapentin or fentanyl 6. Numeric pain score ≥ 5 7. Ability to provide written personal consent Gabapentin use prior to SAH admission 2. Renal failure with creatinine clearance less than 30 mL/min 3. Unable to receive standard of care pain medications 4. Pregnant or breastfeeding patients 5. History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV) | 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 spontaneous, non-traumatic SAH SAH confirmed on computed tomography (CT) or lumbar puncture negative initial and follow-up angiography age: no limit traumatic SAH aneurysmal SAH SAH in whom other bleeding sources were identified (AVM 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): 18.0-50.0, Very Low Birth Weight Infants Premature Infants Intraventricular Hemorrhage Pregnant women who are expected to deliver a very low birth weight infant Neonates born weighing >= 500g and <1500 grams Mother 18 years of age or older English speaking mother Placental abruption Vasa previa Fetal hydrops or other signs of fetal volume overload Other major fetal anomalies Placenta Accreta Mother < 18 years of age Non-English speaking mother Infants >= 1500g (3.3 lbs) or <500g | 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): 25.0-40.0, Infertility Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care Women who had a prior failed IVF cycle Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status Both the patient (potential subject) and her partner must sign the consent form Pregnancy Undiagnosed vaginal bleeding Fallopian tube 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): 18.0-85.0, Hemiplegic Patients - For hemiplegic patients Aged between 18-80 years of age, men and women Left or right hemispheric sustentoriel stroke : oIschemic or hemorragic oFirst symptomatic episode or TIA without consequences oBetween one month and one year since the stroke Balance standing > 30 sec without assistance in closed eyes condition FAC score included between 3 and 7 Triceps Spasticity strictly less than 3 on the Modified Ashworth Scale with heel on the ground and an adductor spasticity up to 3 on the same scale Free, informed and written consent signed by the investigator and by the patient or one of his/her relatives (in the case of a patient able to understand the information and to express his/her consent but with motor difficulties resulting in the inability to sign) For healthy volunteers Aged between 18-85 years of age, men or women, age-matched ( +/ years ) with stroke patients Without a balance disorder For hemiplegic patients History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...) before the stroke Pregnant women Patient with tiredness incompatible with the tests and instrumental assessments Patients under legal protection (according to French law) and detainees Patients physically or mentally unable of giving informed consent For healthy volunteers History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...) Receiving a psychotropic treatment (antidepressant, antipsychotic, anxiolytic) Pregnant women Within the period of in the French national register of persons suitable for biomedical research | 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, Cerebral Amyloid Angiopathy Intracerebral Hemorrhage ①diagnosed wiht spontaneous cerebral hemorrhage after the head CT. ② the patients and their family members agreed to participate in this study ①cerebral hemorrhage caused by traumatic, cerebral infarction, tumor and arteriovenous malformation. ②patients who can not provide reliable information or are considered unsuitable for 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): 18.0-75.0, Migraine Is between the ages of 18 and 75 years. 2. Has been previously diagnosed with migraine (with or without aura) in accordance with the International Classification of Headache Disorders (ICHD)-3 Beta Classification criteria. 3. Experience between 5 and 12 migraine days per month (over the last 4 months) with at least 2 of the migraines lasting more than 4 hours. 4. Has age of onset of migraine less than 50 years old. 5. Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms). 6. Agrees to refrain from initiating or changing the type, dosage or frequency of any prophylactic medications for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anti convulsant, beta blockers, etc.). 7. Agrees to use the gammaCore®-R device as intended, follow all of the requirements of the study including follow-up visit requirements, record required study data in the subject dairy, and other self-assessment questionnaires. 8. Is able to provide written Informed Consent Has a concomitant medical condition that will require oral or injectable steroids during the study. 2. Has a history of any intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma. 3. Has a structural abnormality at the gammaCore®-R treatment site (e.g lymphadenopathy previous surgery or abnormal anatomy). 4. Has pain at the gammaCore®-R treatment site (e.g.dysesthesia, neuralgia and/or cervicalgia). 5. Has other significant pain problem (e.g.cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the investigator may confound the study assessments 6. Has know or suspected severe cardiac disease(e.g. symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF)). 7. Has known or suspected severe cerebrovascular disease, (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery). 8. Has an abnormal baseline Electrocardiogram (ECG) e.g. second and third degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction). 9. Has had a cervical vagotomy. 10. Has uncontrolled high blood pressure (systolic >160 diastolic > 100 after 3 repeated measurements within 24 hours). 11. Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator). 12. Has been implanted with metal cervical spine hardware or has a metallic implant near the gammaCore®-R stimulation site. 13. Has a known history of suspicion of secondary headache. 14. Has a history of syncope (within the last five years). 15. Has a history of seizures (within the last five years). 16. Has a known or suspicion of substance abuse or addiction (within the last 5 years). 17. Is using marijuana (including medical marijuana) for any indications, more than twice a month. 18. Currently takes simple analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) greater than 15 days per month or triptans, ergots or combined analgesics greater than 10 days per month for headaches or other body pain. 19. Currently takes prescription opioids greater than 2 days per month for headaches or body pain. 20. Has taken medications for migraine prophylaxis in the previous 30 days. 21. Has previous diagnosis of medication overuse headache (MoH) , which has reverted to episodic migraine within the last 6 months. 22. Meets the ICHD-3 Beta Classification for chronic migraine (> 15 headache days per month). 23. Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for the prophylaxis of migraine . 24. Has had surgery for migraine prevention. 25. Has undergone nerve block (occipital or other) in the head or neck within the last 2 months. 26. Has received Botox injections within the last 6 months. 27. Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use and accepted form of birth control. 28. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. 29. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner). 30. Is a relative of or an employee of the investigator or the clinical study site. 31. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study. 32. Has previously used the gammaCore® device | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Arteriovenous Malformations The Subject or Subject's legally authorized representative has signed and dated an informed consent form The Subject has a confirmed diagnosis of a brain AVM The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization The Subject has a life expectancy of at least 1 year The Subject agrees to and is capable of completing all study-required procedures Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease The Subject has a bleeding disorder The Subject is not a candidate for the use of vasodilators | 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): 18.0-35.0, Sleep Pregnancy Stillbirth Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Fetal Hypoxia ≥18 years old low-risk singleton pregnancy entering the last trimester of pregnancy (in range 26-30 weeks of gestation) residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital fluent in either English, Twi, or Ga BMI ≥ 35 at booking (first antenatal appointment for current pregnancy) pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth]) sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder]) multiple pregnancy known fetal abnormality maternal age >35 | 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, Mesial Temporal Lobe Epilepsy Participants are between the ages of 18 -65 years of age Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with unilateral or bilateral MTLE Participants must have tried and failed two trials of antiepileptic drugs (AEDs) Participants may have lesional or non lesional hippocampi, as evidenced by brain MRI acquired within the previous two years Participants are prescribed and taking 1-4 AEDs at the time of study entry Study participants will have intractable (MTLE) with a seizure frequency of at least 1/month averaged over the preceding 6 months prior to enrollment, including maximum seizure-freedom periods of no more than 60 days Participants must have a platelet count greater than 125,000 per cubic millimeter and prothrombin time (PT) and activated partial thromboplastin time (aPTT) within normal limits at the visit prior to surgery Progressive neurological or medical diseases, such as brain tumors or neurodegenerative disease or cancer Non-compliance with antiepileptic medications as demonstrated by the medical record Any conditions interfering with electrode implantation Any non-epileptic seizures Inability or unwillingness to complete neuropsychological tests or complete seizure diaries Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Pregnant, or planning to become pregnant* Participation in another research trial where the participant was treated with another investigational drug or device within 30 days prior to enrollment of study Intelligence Quotient showing a general ability Quotient of less than 70. The score excludes the contribution of working memory and processing speed (which are areas of cognitive functioning that are vulnerable to numerous influences including seizures and fatigue and effects of AEDs) Inability or unwillingness of individual to give written 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, Cerebral Vasospasm Subarachnoid Hemorrhage Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed Receive either open vascular clipping or endovascular coiling Patients under 18 years of age Patients arriving at the hospital >24-hours post-hemorrhage Patients who are not candidates for further care | 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, Intraventricular Hemorrhage Age > 18 Coma at presentation (i.e. Glasgow Coma Score <9) At least 50% of lateral ventricles cast with blood Evidence of hydrocephalus or raised intracranial pressure and External Ventricular Drainage Indicated Surgery possible within 48 hours of ictus Fixed and dilated pupils at presentation Uncorrectable coagulopathy or thrombocytopenia Aneurysm or arteriovenous malformation proven or suspected as the source of haemorrhage Large, predominant intracerebral haematoma | 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): 0.0-7.0, Congenital Heart Defects Brain Ischemia Hypoxia Brain Child Hypothermia, Induced Every child entering the PCICU, age < 7 years 2. The child will enter arm 1 or 2 if he underwent the event described in section 3. 3. Hypoxic ischemic event that would render hypothermia treatment is defined as During the hospitalization in the PCICU before or after the surgery: Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1 During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event 4. Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3 Suspected hypoxic ischemic event as described in the in the 2 weeks prior to the PCICU admission Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1 Rejection A second resuscitation after the hypoxic ischemic event and before a brain MRI is done | 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, Sinonasal Pathologies man or woman older than 18 years old patient affected by sinonasal pathology : who show one or more of the following functional sign : anosmia, pain with sinusal origin (frontal headache, lower-orbital throbbing pain increased in anteflexion, chronic unexplained headache), nasal blockage, runny nose, epistaxis requiring the realisation of a sinus imagery overview Deprivation of liberty by administrative or legal decision patients under 18 years old Patients in emergency | 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 Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean 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): 18.0-999.0, Post-Dural Puncture Headache The patient was informed about the implementation of the study, its objectives, constraints and patient rights The patient has signed the informed consent The patient must be affiliated or beneficiary of a health insurance plan The patient is available for follow up concerning her hospital stay The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency The patient has an indication for a blood patch The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47) The patient is in an period determined by a previous study The patient is under guardianship, curatorship or under judicial protection The patient refuses to sign the consent It is not possible correctly inform the patient The patient is pregnant The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study The patient was delivered by cesarean section | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 20.0-80.0, Stroke Cerebral Vascular Accident Subjects who hemiplegic due to stroke Subjects who have more than 22 points of Fugl-Meyer Assessment score in upper extremity subjects who have diagnosed as stroke before 3weeks to 3 months(subacute) subjects who have diagnosed as stroke more than 6 months ago(chronic) Subjects who have spasticity and upper extremity dysfunction at unaffected side Subjects who have bilateral or multiple brain lesion Subjects who have non-controllable medial or surgical disease Subjects who is less than 20 years old Subjects who have pre-existing and active major neurological or psychiatric disease Subjects who have less than 10 degrees of active wrist range of motion Subjects who can not complete outcome measurement task Subjects who have limitation of communication due to aphasia Subjects who have less than 17 points of K-MMSE Subjects who is pregnant | 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, Cerebrovascular Accident Clinical and radiological diagnosis (Functional magnetic Resonance (FMR) and/or Computerized tomography (TC) ) of the stroke More than one month from the date of the stroke Clinical stability Signed and dated informed consent form Disturbs that forbid the adherence in treatment Subjects already undergoing in other researches Pregnant women Lesions that could affect the proposed therapy The occurence of lesion or muscle,joint pain that could forbid the therapy Destabilization of the clinical comorbidities | 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, Pulmonary Arteriovenous Malformations Hereditary Hemorrhagic Telangiectasia Ability to provide informed consent Healthy volunteers: no concurrent health reason to avoid exercise Pulmonary AVMs: pulmonary AVMs confirmed by CT scan Hereditary hemorrhagic telangiectasia without pulmonary AVMs: HHT according to current international consensus with no evidence of PAVMs on dedicated thoracic CT scan Inability to provide informed consent Any known cardiovascular abnormality including a history of syncope (faintness, dizziness, lightheadedness or loss of consciousness due to an abnormality of the cardiovascular system) Current respiratory tract infection (eg a cold) Pregnancy Claustrophobia or needle phobia | 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, Chronic Migraine Female and male patients, 18-65 years of age with confirmed chronic migraine (defined as migraine headache with or without aura, occurring on > 15 days of each month for at least 3 months Headaches must have at least two of the following characteristics: unilateral location, pulsating quality, moderate-severe pain intensity and/or aggravation by or causing avoidance of routine physical activity (eg. Walking or climbing stairs) Headaches must also have at least one of: nausea and/or vomiting or photophobia and/or phonophobia Patients must be cognitively able to understand questionnaires and be able to complete Headache Logs Patients must be physically able to undergo treatment administration, including the required positional changes needed for administration Headaches that could be attributed to other causes, as determined by clinician, including medication overuse headaches and chronic tension type headache Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding Previous treatment with botulinum toxin-A for chronic migraine Confirmed allergy to botulinum toxin-A or any of the product components Contraindications to fMRI procedure Patients unable to discontinue migraine prophylaxis medications, including tricyclic antidepressants, beta-blockers and various antiepileptic medications, either due to unwillingness or safety issues (eg. Antiepileptics being used to manage seizure disorder). This will be determined by clinician Participants exhibiting severe depression (BDI score >40) and/or suicidal ideation. These individuals will receive appropriate medical follow-up for psychological management Active skin infection at planned injection site(s) | 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, Craniocerebral Trauma Participation in boxing at a pre-specified tournament 2. Medically cleared to participate in the tournament, as determined by the attending medical staff Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy. 2. Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion. 3. Any unstable medical 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): 6.0-60.0, Arteriovenous Malformation Age between 6 and 60 years inclusive Diagnosis of AVM or nuclear family member of a patient with AVM Grants access to saliva, blood, and/or tissue Age less than 6 years or greater than 61 years Nuclear family members who do not share the same parents as the AVM patient | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Stroke Cerebral Ischemia Disabling Ischemic stroke symptoms with onset < 3 hours treated with IV rt-PA by local standards* or </= 4.5 hours according to local standard of care. Symptoms must be distinguished from another ischemic event such as syncope, seizure, migraine, subarachnoid hemorrhage and hypoglycemia. If the patient reports awakening with the event, the time of onset should be considered as the last time the patient (or a witness to the patient's condition) considered herself/himself normal Patients should meet local, institutional to undergo emergent Endovascular Therapy (Intra-Arterial) to 1. IAT must be able to begin before 6-hours of stroke onset or last seen well. 2. CT-Angiogram confirmation of intra-arterial occlusion in any of the following locations: terminal ICA, MCA (M1 or M2 territories), PCA, distal vertebral or basilar artery. 3. score on non-contrast head CT must be >/= 6. 4. IAT must be able to begin within 90 minutes of qualifying CT scan Age >/= 18 Females of childbearing potential must have a negative pregnancy test prior to the administration of trial medication Signed (written) informed consent by the patient or the patient's legal representative and/or guardian Evidence of intracranial hemorrhage (ICH) on baseline CT scan or diagnosis of a non-vascular cause of neurologic deficit NIHSS Level of Consciousness score (1a) >/= 2 Pre-existing disability with mRS > 2 Any evidence of clinically significant bleeding, or known coagulopathy INR >1.5 Patients with an elevated aPTT greater than the upper limit of normal (test can be repeated if investigator suspects a falsely elevated value such as when the collection tube is not completely filled) Patients currently, or within the previous 24 hours, on an oral direct thrombin inhibitor (i.e., dabigatran), a factor 10a inhibitor (i.e., rivaroxaban, apixaban), or any other long-acting anticoagulant Heparin flush required for an IV line. Line flushes with saline only Any history of intra-cranial hemorrhage, known ateriovenous-malformation or unsecured cerebral aneurysms Significant bleeding episode [e.g. gastrointestinal (GI) or urinary tract] within the 3 weeks before study enrollment | 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, Hypertensive Intracerebral Hemorrhage Age 18-80 GCS < 14 or a NIHSS > or equal to 6 Spontaneous supratentorial ICH ≥ 20 mL diagnosed using radiographic imaging (CT, CTA, etc.) Symptoms less than 24 hours prior to diagnostic CT(dCT) scan (an unknown time of symptom onset is exclusionary) Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method Intention to initiate surgery between 12 and 72 hours after after diagnostic CT. First dose can be given within 76 hours after dCT (delays for post surgical stabilization of catheter bleeding) SBP < 180 mmHg sustained for 6 hours recorded closest to time of randomization Historical Rankin score of 0 or 1 Negative pregnancy test Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy) Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4 Intraventricular hemorrhage requiring treatment with extraventricular drainage (obstruction of third and fourth ventricles) Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease diagnosed with radiographic imaging Any irreversible coagulopathy or known clotting disorder. or having the experience of the use of anticoagulant drug Platelet count < 100,000, INR > 1.7, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT) Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease Historical Rankin score greater than or equal to 2 | 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, Migraine Healthy healthy subjects of both sexes age 18-70 years weight 50-90 kg Females were requested to use effective contraception. Migraine patients Migraine patients who meet International headache society (IHS) for migraine with or without aura of both sexes 70 years 95 kg Healthy Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives). Migraine patients Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy, and intake of daily medication (except oral contraceptives) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-70.0, Migraine Healthy Healthy subjects of both sexes Age 18-70 years Weight 50-90 kg Females were requested to use effective contraception. Migraine patients Migraine patients who meet IHS for migraine with or without aura of both sexes 70 years 95 kg Healthy Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives). Migraine patients Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) | 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, Radionecrosis Brain Metastases Pre-Registration 1. Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas 2. Patients at institutions that elect to utilize central imaging review to confirm must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC) 3. Patients at institutions that elect to confirm locally may be pre-registered at the same time as they are randomized Registration/Randomization 1. A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation. 1.1 'Symptomatic' brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where 'symptomatic' is defined as: 1.1.1 New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits 1.1.2 Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg (or equivalent corticosteroid) daily for 1 week 1.2 Clinical supported by central imaging real-time review. The presence of at least the following conventional MR image characteristic: 1.2.1 Conventional MR Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the T2-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the T1-weighted post-gadolinium sequence on a comparable axial slice. If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet for this study. 1.2.2 DSC MR The cut-offs below will be based on GRE EPI DSC perfusion images, acquired without using a gadolinium pre-load: 1.2.2.1 Relative cerebral blood volume (rCBV) <1.5 in the enhancing lesion relative to normal-appearing white matter (NAWM) 1.2.2.2. Percentage of signal recovery (PSR) > 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve 1.2.3 Centers that standardly use PET or MRS to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the described for conventional MR and/or DSC should also be met for study eligibility. Both PET and MRS are not mandatory for study eligibility. 2. Prior to start of treatment 2.1 Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI. 2.2 No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration. The protocol provides a list of 'approved systemic' therapies that are allowed for concurrent use with bevacizumab. 2.3 No bevacizumab ≤ 3 months of study registration. 2.4 Central imaging real-time review (72 hour turn around) to confirm eligibility. 3. Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 14 days prior to registration and confirmation they are not nursing is required. 4. Age ≥ 18 years 5. Karnofsky Performance Status ≥ 60% 6. Required Initial Laboratory Values ≤14 days of registration: 6.1 Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3 6.2 Platelet Count ≥ 100,000/mm3 6.3 Hemoglobin ≥ 10 g/dL* 6.3.1 allowing transfusion or other intervention to achieve this minimum hemoglobin 6.4 BUN < 30 mg/dL 6.5 Creatinine < 1.7 mg/dL 6.6 Bilirubin ≤ 2.0 mg/dL 6.7 ALT ≤ 3.0 x upper limits of normal (ULN) 6.8 AST ≤ 3.0 x ULN 6.9 INR <1.5 x ULN** 6.9.1 unless patients are receiving anti-coagulation therapy. Patients receiving anti-coagulation therapy with an agent such warfarin or heparin are allowed to participate if INR ≤ 3.0.** 6.10 UPC Ratio <0.5 or if ≥ 0.5 6.10.1 24-hour urine protein must be <1000 mg 7. Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires. Assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult. 8. No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor. 9. No excess risk of bleeding (any of the following): 9.1 Bleeding diathesis or coagulopathy 9.2 Thrombocytopenia 9.3 Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study. 9.4 Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past 7 days. 10. No clinically significant cardiovascular disease. 10.1 No uncontrolled hypertension (systolic blood pressure ≤ 160 mm Hg or diastolic ≤ 100 mm Hg). Patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet. 10.2 No history of arterial thrombotic events within the past 6 months, including: 10.2.1 transient ischemic attack (TIA) 10.2.2 cerebrovascular accident (CVA) 10.2.3 peripheral arterial thrombus 10.2.4 unstable angina or angina requiring surgical or medial intervention 10.2.5 myocardial infarction (MI) 10.2.6 significant peripheral artery disease (i.e., claudication on less than one block) 10.2.7 significant vascular disease (i.e., aortic aneurysm, history of aortic dissection) 10.3 Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation. 10.4 No current New York Heart Association classification II, III, or IV congestive heart failure. 11. No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within past 12 months. 12. No central lung metastases with excessive active bleeding. 13. No uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements. 14. No history of serious non-healing wound, ulcer, or bone fractures | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-0.008, Qt Interval, Variation in Adverse Effect of Selective Serotonin Reuptake Inhibitors Neonates 37 weeks or more gestation at birth Age of parent/ person with parental responsibility being at least 16 years old Clinically well parent/ person with parental responsibility English Speaking parent/ person with parental responsibility Neonate at least 48 hours old for case group participants only Maternal SSRI use at any point in pregnancy for control group participants only Neonate highlighted as at risk of infection and:- antibiotic therapy at less than 12 hours old CRP x 2 <10mg/l negative blood culture at 36-47 hours of age (depending on when antibiotic therapy was . commenced) Neonates less than 37 weeks gestation at birth Age of parent/ person with parental responsibility under 16 years old Neonate who is clinically unwell with risk of infection on examination Neonate with CRP greater than 10 mg/l Neonate with positive blood culture Neonate less than 48 hours old Maternal cocaine misuse Maternal methadone use Maternal use of other antidepressants Known maternal or fetal structural cardiac abnormality | 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): 21.0-90.0, Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Congenital Dysplasia of the Hip Ankylosing Spondylitis Post-traumatic; Arthrosis Injury of Hip The for subject participation in the study are: (Patient must meet all of the following characteristics to be enrolled in the study) Males and females, 21 to 90 years of age, inclusive Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form The patient will be available for follow-up through at least two years postoperative The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement) The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement) The patient meets none of the with any of the following characteristics must be excluded from the study) Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities Patients with active localized or systemic infection Patients who have not reached full skeletal maturity Patient has had a total knee arthroplasty of either leg Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation Immunosuppressive disorders immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis) 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): 0.0-999.0, All Eligible ED Patients (Not Limited to a Particular Condition) All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference. Patients are only enrolled during randomly selected 1-hour blocks once per week for 26 weeks Previously enrolled in the study Patients who are placed in the "special care" unit of the Emergency Department, which generally cares for intoxicated patients | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 6.0-18.0, Vascular Malformation Patients aged from 6 years to 18 years With a slow-flow vascular malformation confirmed by MRI, included or not into a genetic disorder, among the following microcystic lymphatic malformation mixed micro and macrocystic malformation venous malformation combined lymphatic and venous malformation Malformation voluminous and complicated (pain, functional impairment, bleeding, seepage) Extended to the underlying subcutaneous tissue, to the fascias, the muscles and/or the underlying bone MRI of the VM performed within 8 months Slow-flow VMs which are only macrocystic lymphatic malformations Visceral life-threatening involvement Patients who received prior per os treatment with an mTOR inhibitor Immunosuppression (immunosuppressive disease or immunosuppressive treatment) Known chronic infectious disease History of cancer in the 2 previous years Brest feeding or pregnant women, or women on childbearing age without effective contraception, up to 12 weeks after treatment discontinuation Known allergy to mTOR inhibitor Concomitant treatment that inhibits or activates CYP3A4, and P-gp glycoprotein, cytotoxic drugs, antilymphocyte immunoglobulines and metoclopramide Intolerance to fructose, intolerance or malabsorption to glucose, galactose, metabolic insufficiency in sucraseisomaltase, metabolic defect in lactase | 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, Tobacco Smoking Pregnancy the woman presents for her first prenatal visit before 14-week gestation she is a smoker years or older (legal age for consent and for consuming tobacco in Romania) married or in a stable relationship phone service in the home or mobile phone willing to have the partner contacted for participation, upon brief explanation of the study partner declines participation upon phone recruitment attempt | 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, Intracerebral Hemorrhage Surgery primary basal ganglion region intracerebral hemorrhage older than 18 years admitted within 6 h after onset of ICH other type of ICH than acute primary intracerebral hemorrhage patients who need neurosurgery life expectancy less than 3 months due to comorbid disorders confirmed malignant disease (cancer) confirmed acute myocardial infarction hepatitis and/liver cirrhosis renal failure infectious disease (HIV, endocarditis etc.) current or previous hematologic disease women of childbearing age if pregnant | 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 Headache Migraine Headache At least one year history of Episodic or Chronic migraine headache symptoms At least 6 headache days per month Subject able to complete online daily headache log Inability to understand the study or history of non-compliance with medical advice Currently taking a P2Y12 inhibitor Known hypersensitivity to Brilinta/ticagrelor History of stroke/transient ischemic attack (TIA) in the previous 6 months Active bleeding from any site Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6) months Migraine onset after 50 years of age Renal impairment: Creatinine Clearance < 60 cc/min Severe hepatic impairment with total bilirubin > 3.0 mg/dL Thrombocytopenia with platelet count < 100,000 / ul | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-70.0, Post-dural Puncture Headache headache has developed after the dural puncture PDPH was defined according to the International Classification of Headache Disorders III (ICHD-3) criteria The VAS score of the headache was 5 or more than 5 age between 18 and 70 years old a previous history of headache that could interfere with PDPH diagnosis a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension a history of peptic ulcer women who were pregnant, nursing, or planning a 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): 0.0-0.077, Neonatal Encephalopathy Suspected Neonatal Encephalopathy Postnatal age < or = 28 days 2. Written informed consent of parent or guardian With one of the following items 3. Hypoxic ischemic encephalopathy (HIE) 4. Hydrocephalus 5. Hypotonia 6. Interventricular hemorrhages 7. Intracranial calcifications 8. Intracranial hemorrhages 9. Meningitis and other brain infections 10. Metabolic diseases 11. Microcephaly 12. Neonatal stroke 13. Spina bifid 14. Cerebral arteriovenous malformations (AVMs) 15. Congenital brain malformations Known other major congenital anomalies but not not neurologic disease. 2. Failed to get sample or the volume of collected biosamples is not enough. 3. Parents refuse 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, Pregnancy Pregnant women at ≥37 weeks gestation by reliable dating as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago) 2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing" 3. Singleton gestation 4. Cephalic presentation 5. Amniotic fluid index greater than or equal to 5 centimeters 6. Formal prenatal ultrasound documenting the absence of placenta previa 7. Bishop score <6 and cervical dilation <3cm 8. The woman is able to give appropriate consent and has undergone an informed consent process. 9. Maternal age ≥ 18 years old at the time of consent New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) 2. Vaginal bleeding 3. Active labor 4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault. 5. Uterine tachysystole (>5 contractions in 10 minutes) 6. Nonreassuring fetal heart tracing before or after Foley placement 7. Chorioamnionitis or maternal fever 8. Intrauterine fetal demise 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) 10. Abnormal placentation including a low lying placenta 11. Prior cesarean delivery 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound) 13. Known fetal anomaly 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor 16. Pregestational diabetes 17. Rh isoimmunization 18. Non-English speaking 19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation | 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): 10.0-19.0, Headache Disorders, Primary Adolescents between 10-19 ages Prognosed with tension type headache according to 'The International Classification of Headache Disorders-III' Suffering from tension type headache for at least 6 months Pain severity must be between 4-7 on visual analog scale Current pregnancy Any kind of cancer history History of head trauma Any kind of neurological disorder Receiving physiotherapy in last 6 months Unwillingness to participate in 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): 18.0-65.0, Arteriovenous Malformation patients undergoing venous malformation embolization operation through general anesthesia. 2. aged 18-65 years old. 3. operating time varies 1-4h,and extubation after the operation long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history. 2. known for dexmedetomidine or other drugs allergy in this study. 3. cannot communicate. 4. preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min | 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): 8.0-999.0, Cystic Fibrosis Patient diagnosed with cystic fibrosis Girl aged 8 years of age, adolescents and young adults, had period or not visit the Reference and Competence Center of Cystic Fibrosis Affiliated to a social security scheme Lack of consent of the legal representative or the relevant patient Patient majoring in legal disability or minor patient whose legal representative is legal disability | 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 Diagnosis of spontaneous intracerebral hemorrhage (ICH) met by clinical and imaging Age 18 and above Able to consent ICH due to trauma ICH due to vascular malformation or aneurysm ICH due to brain tumor ICH due to underlying infectious lesion (e.g., abscess) | 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, Intracranial Arteriovenous Malformations (AVM) All patients age 18 or older Inpatients and outpatients, referred for radiosurgical treatment of an arteriovenous malformation Patients with lesions greater than 10 cc, who are currently symptomatic from the AVM (hemorrhage, seizure, or ischemia from steal phenomenon) Patients without symptoms related to AVM | 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, Intracranial Aneurysm Age ≥ 18 2. Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given 3. Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws) Aneurysms of the posterior circulation 2. Imaging evidence of bifurcation aneurysms 3. Imaging evidence of dissections 4. Imaging evidence of fistulae 5. Imaging evidence of arteriovenous malformations 6. Patient is harbouring another aneurysm that has to be treated within six months after first procedure 7. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media 8. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication) 9. Current involvement in another study or trial 10. Parent vessel treated with other Flow Diverters than p64 during intervention and re-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): 18.0-80.0, Ischemic Stroke Hemorrhagic Stroke Patients aged 18 to 80 years. 2.Supratentorial hypertensive intracerebral hemorrhage diagnosed by head CT or MRI. 3.The intracerebral hematoma is more than 10ml. 4.Ischemic stroke diagnosed by head CT or MRI. 5.Unilateral middle cerebral artery occlusion or infarcted volume more than 1/2 of a hemicerebrum. 6.The head temperature collection within 4.5 hours following stroke attack. 7.Glasgow Coma Scale between 5-10 the time after stroke attack exceed 4.5 hours. 2.The intracerebral hematoma is less than 10ml. 3.The infarcted volume less than 1/3 of a hemicerebrum. 4.With terminal cerebral hernia. 5.Pregnant women. 6.Serious impaired liver function, coagulation disorders, AIDS, combine other tumor or special 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): 0.25-70.0, Vascular Malformations Patients with complex vascular anomalies that are refractory to standard care such as medical treatment, surgical resection and/or sclerotherapy/embolization (ineffective or accompanied by major complications) Patients must have adequate medullary function: Hemoglobine> 10,0 g/dl, neutrophils >1500/mm³ and platelets > 100.000/mm³ Patients must have the following laboratory values Total serum bilirubin ≤ 1.5 x ULN (or totally bilirubin ≤ 3 x ULN with direct bilirubin ≤ 1.5 x ULN in patients with well documented Gilbert Syndrome) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or < 5.0 x ULN if hepatic metastases are present) Serum creatinine 1.5 x ULN. If the serum creatinine is ≥ 1.5 x ULN, then a 24-hour Creatinine Clearance must be conducted and the result must be ≥ 60 mL/min Karnofsky > 50 Patients have to be able to sign the informed consent Women in age of procreation have to be informed that contraceptive methods are mandatory during the study time Any of the following concurrent severe and/or uncontrolled medical conditions, which could compromise participation in the study or interfere with the study results Impaired cardiac function or clinically significant cardiac diseases, including unstable angina pectoris, ventricular arrhythmia, valvular disease with documented compromise in cardiac function, myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, family history of congenital long or short QT, or known history of QT/QTc prolongation of Torsades de Pointes (TdP) Impairment of Gastro-Intestinal (GI) function or GI disease that may significantly alter the absorption of sirolimus (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea ≥ Grade 2, malabsorption syndrome, or small bowel resection) Known hypersensitivity to drugs or metabolites from similar classes as study treatment Patient has other concurrent severe and /or uncontrolled medical condition that would,in the investigator's judgment, contraindicated participation in the clinical study (e.g. acute or chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with a spirometry ≤ 50% of the normal predicted value and/or O2 saturation ≤ 88% at rest, etc.) Immunocompromised patients, including known seropositivity for HIV Pregnant or lactating women Prior treatment with PI3K and/or mTOR inhibitors | 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, Cervicalgia Patient whose age is > to 18 years and <40 yo Patient presenting a chronic neck pain (symptoms over 3 months) No neurological deficit Asymptomatic volunteers (for control group) Obtaining the enlightened consent of the patient Patient having refused to sign his consent Patients whose age is < to 18 years or >40 yo Patients with neurologic deficits Patients presenting history of allergy History of cervical spine surgery Patient presenting an anticoagulant or salicylated treatment which can not be interrupted Pregnant woman Patient with acute head and neck trauma Patient with a contra-indication to radiography Patient with a psychiatric pathology preventing a clinical evaluation | 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 18-80 years 2. Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head 3. IVH involving < 50% of the ipsilateral lateral ventricle will be allowed 4. Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal Baseline mRS ≥ 2 2. Infratentorial hemorrhage (brainstem/cerebellum) 3. Any supratentorial hemorrhage extending to the brainstem 4. ICH > 30 mL 5. Patients who undergo surgical evacuation 6. Presenting outside of the 3 hour window 7. Intraventricular extension > 1/2 of one lateral ventricle 8. Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving >50% of the ipsilateral lateral ventricle 9. ICH due to trauma 10. ICH due to aneurysm of arteriovenous malformation 11. ICH due to underlying neoplasm or infectious mass 12. ICH due to Warfarin or other oral or intravenous anticoagulants 13. International normalization ratio > 1.4 14. Life expectancy < 1 year (prior to ICH onset); due to any cause. 15. History of recent ischemic stroke (within the past 3 months) 16. History of deep vein thrombosis or pulmonary embolism 17. History of recent myocardial infarction (within the past 3 months) 18. Known history of hypercoagulable state 19. History of cancer 20. Glomerular filtration rate < 60 mL/min 21. Received any hemostatic therapy for any indication (last 14 days) 22. Received any investigational therapy in last 90 days 23. "Do Not Resuscitate" order in place or expected, advance directives that could limit aggressive treatment measures | 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, Cluster Headache Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) in active or inactive phase Other primary headaches Subjects without social insurance | 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, Stroke Transient Ischemic Attack > 18 years of age Admission to the Hospital of the University of Pennsylvania Vascular Neurology service Incident or recurrent Ischemic stroke: focal neurological deficit of likely ischemic vascular origin Intracerebral hemorrhage: blood seen on initial head CT Transient Ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved Pregnancy Comfort or hospice care Severe dementia prior to stroke Non-communicative and have no family/social support | 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, Venous Thrombosis Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava Intolerance to anticoagulant medication A life expectancy <1 year | 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, Brain Injury Head Injury Head injury Age under 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): 22.0-999.0, Intracranial Hemorrhage Patient age 022 years or older Supratentorial brain hemorrhage, which may be: 1. Intracerebral (ICH) 2. Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH) 3. Primarily intraventricular hemorrhage (IVH) with a component of ICH 4. Intraventricular hemorrhage (IVH) Patient does not qualify for the concurrent Feasibility study Imaging Expanding hemorrhage on stability CT/MR scan "Spot sign" identified on CTA (May perform a second CTA at 12 hours to demonstrate resolution) Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc), aneurysm, neoplasm Hemorrhagic conversion of an underlying ischemic stroke Infratentorial hemorrhage Midbrain extension/involvement Coagulation Issues Absolute and imminent (within 7 days of treatment) requirement for long-term, full-dose, anti-coagulation (e.g., Mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation) Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency | 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, Overactive Bladder women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI urinary tract infection pregnancy current treatment for OAB or UUI stage 3 and 4 pelvic organ prolapse undergone major pelvic reconstructive surgery or incontinence surgery in the last 6 months neurogenic bladder | 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, Varicose Veins Primary or recurrent varicose veins Diagnosis on duplex of truncal (GSV and/or SSV and/or AATV) insufficiency Must be able to provide informed consent Patients who require long term compression (active ulcers/ deep venous incompetence) Patients who have already had one leg enrolled in the study Patients with congenital venous malformations Patients who require avulsions only Patients who are unable to complete the questionnaires due to a lack of command over the language or who have vision/ hearing disabilities Patients who are unable to attend the hospital for follow-up | 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): 18.0-59.0, Headache The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has nontraumatic headache pain with a visual analog scale > 3 The patient is participating in another study The patient is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient has a contraindication for magnetic resonance imaging Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21 | 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 Admission to one of the study centers or their referring hospitals CT-confirmed SAH with most recent ictus less than 24 hours ago Definition: subarachnoid hemorrhage is a bleeding pattern on computed tomography with hyperdensity in the basal cisterns and/or Sylvian or interhemipheric fissures or a intraparenchymal hyperdensity consistent with a hematoma from an anterior, a pericallosal, a posterior or a middle cerebral artery aneurysm No proficiency of the Dutch or English language No loss of consciousness after the hemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage Definition: on CT examination presence of hyperdensities exclusively in the basal cisterns maximal extending to the proximal part of the Sylvian fissure or posterior part of the interhemispheric fissure, without evidence for intracerebral or intraventricular haemorrhage (except slight sedimentation) Bleeding pattern on CT compatible with a traumatic SAH Treatment for deep vein thrombosis or pulmonary embolism History of a blood coagulation disorder (a hypercoagulability disorder) Pregnancy checked with a pregnancy test in women in their childbearing period History of severe renal (serum creatinin >150 mmol/L) History of severe liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or γ-GT > 150 U/l) Imminent death 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, Vasospasm, Intracranial Subarachnoid Hemorrhage Adult men and women at least 18 years of age inclusive at the time of hospital admission for stabilization and treatment of the SAH Subjects receiving intensive care neurological monitoring per standard care following treatment of SAH Subject or legal authorized representative is able and willing to comply with the requirements of the protocol Subject or legal authorized representative is able to understand and sign written informed consent to participate in the study Subject is expected to undergo standard care neurological intensive monitoring for a maximum of 14 days Confirmed presence of a ruptured saccular aneurysm on angiography (catheter or CTA) and treated by neurosurgical clipping or endovascular coiling Patient must have a modified Fisher of II to IV The SAH should be between grades I-IV as defined by the World Federation of Neurological Surgery (WFNS) Subject with ear disease, ear trauma Subjects with dural defects, punctures Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea) Reported allergy or hypersensitivity to any of the test materials or contraindication to test materials Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s) Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) Patients who have a modified Fisher of 0 to I Patients who have a WFNS of V Presence of an intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH | 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, Liver Transplantation First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O) Ages of 18 or older Patients receive liver transplantation due to benign end stage liver disease Patients or legal agent must be able to give informed consent Second or combined organ transplant recipient Combined transplantations such as simultaneous liver/kidney transplants Malignant disease Uncontrol bacterial, fungal, viral or parasitic infection Withdraw or unable to finish the follow-up Unwilling to sign informed consent | 0 |
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 Aneurysm Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which the embolization of Intracranial aneurysms Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Life expectancy less than one year Smart, PC 400, or POD account for less than 75% of total number of coils implanted Participation in another clinical investigation that could confound the evaluation of the registry device | 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): 13.0-55.0, Headache Migraine Disorders Emergency Department patients that complain of headache or migraine Males and females age 13-55 English is primary language Abnormal blood pressure (>200/100) Sudden rapid onsent (normal to worst pain in minutes) Fever Trauma Any history of masses, strokes, head injury or other causes of abnormal anatomy QT greater than 450 ms on EKG Allergy to Haldon Any altered mental status (GCS <15) Pregnancy Any abnormalities on neurologic exam | 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, Secondary Headache Disorders Medication-overuse Headache Diagnosed with medication-overuse headache (MOH) by neurologist (The International Classification of headache Disorders) Completed withdrawal (hospitalized of 8 days or at home) Age 18-65 years Understand and speak Danish Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment Mental health disorders | 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, Desmoplastic Melanoma A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per 1.1 Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient's chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1) Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration Patients must not have received prior systemic treatment for this melanoma Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology for Adverse Events [CTCAE] 4.0) prior to registration Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to registration) Platelets >= 50,000/mcl (obtained within 28 days prior to registration) | 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, Cluster Headache Obesity Male or female aged between 18 and 65 years Ambulatory or hospitalized monitoring Fluent in French and able to understand the study procedures, including completing the auto-questionnaires Registered in the French social security scheme Signed informed consent of the patient will be collected before in the study Cluster Headache or Obesity patients Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG) Contraindication to Magnetic resonance imaging (MRI) All categories of protected persons | 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): 42.0-80.0, Pain Migraine To be eligible for enrollment in the Study, patients must meet all of the following Patient is a veteran of the 1990-91 Gulf War, aged at least 42 years old Patient fulfills Kansas for Gulf War Illness including endorsement of musculoskeletal pain at moderate or severe intensities. This means patient has endorsed symptoms in at least 3 of the following problem areas: Fatigue/sleep; musculoskeletal pain; cognitive and mood; Gastrointestinal; respiratory; skin Patient has widespread pain as evidenced by endorsement of pain in at least 3 bodily quadrants plus in the axial skeleton Patient has a median 24 hour widespread pain score of at least 5 on a 0 to 10 VAS with data taken on five days To be considered as having migraine, the patient must fulfill International Headache Society (IHS) and it should have been present for at least one year prior to entry into the study Patient agrees to use the study device as intended, follow all of the requirements of the study including completion of diary after each self-treatment, follow-up visit requirements, complete self assessment questionnaires as scheduled, and report any adverse device effects to the study center within 24 hours of such adverse device effect Patient is able to provide written Informed Consent Patients with any of the following will not be eligible for enrollment Patient has a history of intracranial aneurysm, intracranial hemorrhage, brain tumor or significant head trauma Patient has in the opinion of the investigator a clinically relevant structural abnormality at the gammaCore-R treatment site (e.g., neoplasm, lymphadenopathy, previous surgery, neoplasm or abnormal anatomy) Patient has pain at the gammaCore treatment site (eg, dysesthesia, neuralgia, cervicalgia) Patient has other significant pain problem (e.g., cancer pain or other head or facial pain disorder) that in the opinion of the investigator may confound the study assessments Patient has known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF), significant premature ventricular contraction) or a history of cardiac arrhythmia Patient has known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery) Patient's electrocardiogram shows evidence of heart disease or arrhythmia including an abnormal baseline ECG (e.g. second and third degree heart block, prolonged QT interval (corrected QT (QTcB) interval >470 msec for women and > 450 for men), atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction) or a history of cardiac arrhythmia Patient has had a previous cervical vagotomy Patient has uncontrolled high blood pressure (systolic bp >160, or diastolic bp > 100) after 3 measurements 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, Central Nervous System Tumour Arteriovenous Malformation The patient must be at least 18 years old World Health Organization (WHO)/ Eastern Cooperative OncologyGroup (ECOG) performance status 0-2, Karnofsky score ≥60 The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial Adequate follow-up study must be possible; this will a patient who is uncooperative Must have a life expectancy of at least 3 years based on age and co-morbidities as well as diagnosis. For patients considered for re-irradiation the life expectancy must be estimated to minimum 6 months Must have a pathology proven CNS tumour or if not possible, the radiology findings must be evaluated at a multi-disciplinary conference at a university hospital Women of reproductive potential must agree to use an effective method of contraception during therapy such as an intrauterine device or condom. Pregnancy IS not an if radiotherapy is indicated and can-not be postponed Prior CNS radiotherapy is not an but re-irradiated patients will be included in a subgroup evaluated separately. Patients discussed at multidisciplinary conferences at one of the seven university hospitals in Sweden and found candidates for radiotherapy and one of following diagnoses Anaplastic glioma grade III with Loss of Heterozygosity (LOH) 1p/19q and isocitrate dehydrogenase-1 (IDH-1) mutation Arteriovenous malformations (AVMs) Chordomas and chondrosarcomas Craniopharyngiomas Ependymomas Intracranial germ cell tumours Low grade gliomas | 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, Ischemic Stroke Brain Tumor Brain Surgery Intracranial Hemorrhage Headache Head Trauma Patients with ischemic stroke diagnosed by clinical examination and CT-scan Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan Patients that have undergone brain surgery Patients with a normal CT-scan of the brain after head trauma Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up none | 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): 18.0-80.0, Intracranial Hemorrhage, Hypertensive Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume >20mL Adult patients with GCS score ≥5 Admitted within 24h of ictus Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation Concurrent head injury or history of head injury Multiple intracerebral hemorrhage Known advanced demential or disability before With indications of terminal brain hernia Severe concomitant diseases that affect life expectancy Patients having taken anti-platelet or anticoagulant drugs for a long time With severe intraventricular hemorrhage Pregnant women | 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, Radiation Necrosis Patients must have radiation necrosis based on radiographic evidence defined as Increased T1 contrast enhancement in the radiated area with central hypointensity Increased surrounding vasogenic edema on FLAIR MRI images The underlying lesion prompting the radiation can Benign lesions such as AVM, Meningioma, schwannoma, trigeminal neuralgia: No biopsy is necessary Radiation necrosis must be symptomatic, including severe headache, seizures, and neurological deficits Radiation necrosis must be refractory to steroid treatment; defined as failing a 3-week steroid regiment or not tolerating steroids because of side effects. Beyond 3 weeks, the side effects of steroid therapy worsen rapidly. The patient may receive other therapies such as Vitamine E, Pentoxyfylline, and hyperbaric oxygen during the trial. Other Age >18 years Ability to understand and the willingness to sign a written informed consent document Both men and women and members of all races and ethnic groups are eligible for this trial Karnofsky Performance Status >70% Patients may not be started on any other investigational agents during the course of this trial. They may however continue previous medical regiments aimed for treatment of radiation necrosis. These steroids, vitamin E, pentoxiphylline, and hyperbaric oxygen. We feel that these treatments are generally ineffectual and would not confound the results Malignant brain tumor Concomitant use of anticoagulation agents including Coumadin, anticoagulation dose Lovenox or Arixtra. Aspirin is acceptable Active bleeding or pathological condition that carries high risk of bleeding Abdominal fistula, abscess, or gastrointestinal tract perforation 28 days of study entry Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Any major surgery in the prior 4 weeks. Also any major surgery expected to be performed in the ensuing 4 weeks after treatment Pregnant women are excluded from this study because Bevacizumab is expected to disrupt angiogenesis during pregnancy with the potential for teratogenic or abortive effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Bevacizumab, breastfeeding should be discontinued if the mother is treated with Bevacizumab HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Bevacizumab | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-70.0, Temporal Lobe Epilepsy History of drug-resistant mesial temporal lobe epilepsy (MTLE) If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month Seizure symptoms and/or auras compatible with MTLE Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE MRI has evidence consistent with mesial temporal lobe sclerosis Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure Willing and able to comply with protocol requirements Able to complete study assessments in English or Spanish language Unwilling or unable to sign the study informed consent form Pregnant or intends to become pregnant during the course of the study Currently implanted with a device contraindicating MRI Progressive brain lesions and/or tumors not associated with epileptic disease state History of previous intracranial surgery for treatment of epileptic seizures Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG Seizures with contralateral or extra-temporal ictal onset on EEG Aura and/or ictal behavior suggest an extra-temporal focus MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation | 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): 0.462-0.596, Premature Birth Infants born preterm at Stanford Children's Hospital between 27 0/7 6/7 weeks gestational age Congenital anomalies Recognizable malformation syndromes Active seizure disorders History of Central Nervous System infections Hydrocephalus Major sensori-neural hearing loss Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA Intraventricular Hemorrhage Grades III-IV Cystic periventricular leukomalacia (PVL) Surgical treatment for necrotizing enterocolitis | 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, HIV Pregnancy Adult patients (>18 years) Pregnant women with HIV presenting for antenatal care at a study site The ability to understand and the willingness to sign/mark a written informed consent document in English or Kiswahili during 1st or 2nd visit for antenatal care at a study site Indication that patient does not intend to receive further antenatal, postnatal, or PMTCT care at the site Patient is not physically and/or emotionally able to complete the informed consent process to initiate/participate in study (mentally ill, drug abuse, etc.) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Arterial Embolization Subject is aged 18 years or over 2. Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment 3. Subject has provided written consent for the procedure. 4. Subject agrees to all follow up visits required by the protocol 5. The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization. 2. The subject has had acute cerebral bleeding within the last 6 months. 3. The patient is participating in another research study involving another investigational device, procedure or drug. 4. The brain AVM or DAVF or tumor has been previously treated with another embolization agent. 5. The subject has a bleeding disorder. 6. The subject is female and has a positive pregnancy test. 7. The subject has a life expectancy of less than 1 year. 8. Subject has a known allergy to contrast media used for radiography. 9. Subject has a known allergy to Dimethyl Sulfoxide DMSO (solvent for the embolic product). 10. Subject has a condition that would prevent them attending follow up visits for up to 1 year. - | 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, Arteriovenous Malformations arteriovenous malformation age > 18 years old none | 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): 18.0-80.0, Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage Age 18-80 years Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH Manual ICH volume between 30 Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the actual time of onset is unclear, then the onset will be considered the time that the subject was last known to be well Glasgow Coma Score (GCS) 5 Historical Modified Rankin Score 0 or 1 Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging NIHSS < 5 Bilateral fixed dilated pupils Extensor motor posturing Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles Primary Thalamic ICH Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar Use of anticoagulants that cannot be rapidly reversed Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site Uncorrected coagulopathy or known clotting disorder | 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): 18.0-80.0, Cerebrovascular Accident Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin Right-handed Possible cooperation: understanding of French instructions Normal or corrected vision Normal or corrected hearing Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient Possible follow up of patient Hearing problems Vision problems Right hemiplegia or acute monoparesis of right upper limb Hemispatial neglect Apraxia Psychiatric or neurological history possibly interfering with neuropsychological evaluation Important defect of working memory or executive functions | 0 |
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