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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): 4.0-999.0, Arteriovenous Fistula Arteriovenous Malformation Spinal Cord Disease Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent. Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent Unable to tolerate MRI and/or spinal arteriography. Child less than 4 years | 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): 0.0-999.0, Epilepsy, Temporal Lobe Patients will be drawn from among those referred to the NINDS Epilepsy Research Branch. No patients with evidence for a progressive neurological disorder. No subjects with metal hardware in the cranial cavity, cardiac pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or evidence of increased intracranial pressure. Women must not be 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): 1.0-999.0, Syringomyelia Type I Arnold Chiari Malformation To be eligible for entry into the study, a candidate must meet the following Patient with a confirmed diagnosis of Chiari I malformation who has a family member with syringomyelia or Chiari I malformation, or Family member of a patient with a confirmed diagnosis of Chiari I malformation, AND There are at least two family members diagnosed with Chiari I malformation. If an adult, able to give informed consent; if a minor, has an adult who is legally responsible for the subject and who is able to give consent A candidate will be excluded if he/she: Has a contraindication to MRI scanning. Is unable to comprehend the risks of the testing. Is less than one year of age. Cannot undergo MRI scanning without sedation | 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, Cerebral Hemorrhage Intraventricular hemorrhage (IVH) confirmed by CT scan More than 12 hours post bleed Hematoma size stable by CT scan Post-IVH catheter CT scan Able to begin study within 24 hours of bleed Infratentorial bleed Supratentorial bleed greater than 30 cc Unclipped aneurysm suspected Arteriovenous malformation suspected Any severe, complicating illness (e.g., AIDS or DNR) Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis) Active internal bleeding Requirement for heparin doses greater than 10,000 U/day Concurrent coumadin Known allergy to rt-PA | 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): 12.0-999.0, Epilepsy Epilepsy, Temporal Lobe Seizures Intractability: Two AEDs, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance Frequency and Duration: Persistence of disabling seizures at 6 per year or greater for less than two years after onset, or after recurrence if initial treatment resulted in seizure freedom for 6 or more months Age: 12 years or older at baseline visit History: Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier Absence of a history of serious cerebral insult after the age of 5; a progressive neurological disorder; mental retardation (I.Q. less than 70); psychogenic seizures; focal neurological deficits other than memory disturbances; unequivocal focal extratemporal EEG slowing or interictal spikes; or lesions on neuroimaging outside of the mesial temporal area Seizure semiology: Auras that occur in isolation and are not primary sensory other than olfactory or gustatory. Absence of initial focal motor movements other than automatisms or dystonic posturing. Presence of postictal confusion Neurological examination: No unexplained focal or lateralized neurological deficits other than memory dysfunction Baseline QOL and ancillary outcome data Adolescents QOLIE-48-AD, CHQ, CBCL, PANAS, Life Events Scale, FAC, FEICS-PC completed | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm Patients will be eligible for the study if they Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study) Have an ECOG performance status of Zero or One Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain Have signed an informed consent form Patients will not be eligible for this study if they Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed Are taking or have taken part in any investigational study within 30 days of start of study Have received an indium agent within 30 days of start of study Are not able to remain immobile during scanning time Have taken drugs that may damage the kidneys within 2 weeks of start of study Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration Have undergone a PET scan within 7 days prior to study drug administration | 0 |
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): 20.0-34.0, Fecundability Spermatazoa Disorders Menstruation Disorders Endocrine Dysfunction it must be the first marriage for both the woman and her husband and they must currently live in the study area the female's age must range from 20 to 34 years the couple has no plan to leave the study area in which they live for the next two years those who are currently pregnant those who have tried unsuccessfully to get pregnant for at least 1 year those who are current or former smokers those who plan to move in the coming 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): 18.0-65.0, Migraine Headache Subjects who meet all the following will be eligible to participate in the study Are men or women, between the ages of 18 and 65, inclusive Satisfy diagnostic for migraine headache, consistent with described in Headache Classification Criteria Have at least 4 migraine attacks per 28 days [each attack separated by at least 48 hours] prior to the Screening Visit and experience at least 4 migraine attacks during the Screen/Baseline Phase Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as an adequate barrier method, hormonal contraceptive, or surgical sterilization. All women of childbearing potential must have a negative pregnancy test before entering the study and during the study Are able to swallow the capsules whole Are willing and able to follow Investigator instructions and study procedures, complete the daily diary, and report adverse events. Subjects meeting any of the following will not be eligible to participate in this study Have required more than 3 different rescue medications for control of a single attack anytime within 3 months prior to the Screening Visit Have cluster headache or chronic tension type headache and are unable to distinguish between their different types of headache Have basilar or hemiplegic migraine | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Epilepsy Temporal Lobe Patient Group: Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan. Native English speaker. Age 18 years or older. Signed informed consent. Volunteer Group: Native English speaker. Age 18 years or older. Signed informed consent Patient Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc; History of mental retardation; Pregnancy; Claustrophobia; Inability to comply with the protocol. Volunteer Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.); History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation. Pregnancy. Claustrophobia. Inability to comply with the 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): 18.0-999.0, Sudden Deafness Men/women 18 years and older in good health Unilateral sensorineural hearing loss developing within 72 hours (SSNHL) Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies Symmetric hearing prior to onset of SSNHL Hearing loss must be idiopathic Hearing loss must have occurred within the past 14 days Must be able to read or write English or Spanish >21 days prior oral steroid treatment within preceding 30 days History of tuberculosis (TB) or positive PPD Insulin-dependent diabetes mellitus 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): 18.0-999.0, Migraine Migraine with or without aura; probable migraine without aura Secondary headache Allergy, contraindication or intolerance to study medication | 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): 0.5-12.0, Malaria Plasmodium Falciparum Malaria Patients aged >= 6 months to 12 years presenting to Ndirande Health Centre with signs or symptoms consistent with malaria including but not limited to one or more of the following fever at the time of evaluation (axillary temperature 37.5° C by digital thermometer) report of fever within the last two days profound anemia (conjunctival or palmar pallor) headache body aches abdominal pain decreased intake of food or fluids weakness 2. Positive malaria smear for P. falciparum mono-infection 3. Parasite density of 2,000-200,000/microliter or < 10% 4. Willingness to remain at the Health Centre under continuous observation until the resolution of the infection 5. Parental consent for each participant, and child assent for children older than 5 years Signs of severe malaria: One or more of the following hemoglobin < 5 g/dl parasitemia > 10% prostration * as indicated by inability to drink or breastfeed respiratory distress (deep Kussmaul respirations) bleeding recent seizures*, coma* or mental obtundation* (Blantyre coma score less than 5) persistent vomiting* 2. Presence of a severe disease 3. Presence of a febrile condition caused by diseases other than malaria 4. Known allergy or history of adverse reaction to sulfadoxine/pyrimethamine (SP), sulfa drugs or chloroquine 5. Chronic medication with an antifolate drug 6. Enrollment in this clinical study in the past 28 days *Each of these symptoms or signs is considered a "danger sign." | 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): 6.0-17.0, Brain Concussion Post-Concussion Symptoms Greater than or equal to 6 years of age Admitted for observation of closed head injury GCS greater than or equal to 13 Presence of headache CT scan showing no brain injury or only a small contusion (an area of low attenuation less than 10 mm or a punctuate area of high attenuation with surrounding edema less than 5mm). CT evidence of high or mixed attenuation would be consistent with a hemorrhagic lesion and therefore not qualify to participate in the study. Evidence of skull fractures and cephalohematomas on CT would not the patient from the study Age less than 6 GCS less than 13 Radiographic evidence of extra-axial blood or subarachnoid blood Possible or witnessed posttraumatic seizure Developmental delay/ mental retardation Underlying cardiac or renal pathology Suspected and/or documented use of alcohol and/or illicit substances Medication history which includes administration of acetaminophen within 4 hours prior to enrollment or chronic anticoagulant use (ie: Coumadin, Aspirin Associated injuries requiring the use of narcotics for analgesia (ie: long bone injuries, deep laceration repair) Intubation | 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, Pain, Postoperative Subjects 18-65 years of age Subjects who are English speaking Subjects undergoing surgery in the supine position Subjects who are undergoing a procedure where the surgical incision is expected to be at least 4 inches Subjects who are undergoing a surgical procedure below the level of their arms Female subjects who have a negative Sure-Vue pregnancy test Subjects who are undergoing surgery under general anesthesia If the scheduled surgery involves the head, neck or arms Subjects who have a history of chronic pain Subjects who have cognitive disabilities secondary to medical, chemical and genetic causes Subjects who have peripheral vascular disease of the arms Subjects who have carpal tunnel syndrome Subjects who have psychiatric, substance abuse and cognitive impairments Subjects who have had a stroke which has affected function of the upper extremities Subjects who have had a mastectomy or other type of surgery which may have affected the lymph nodes of the arms Subjects who do not have a telephone Subjects who are having surgery under nerve block or regional anesthesia | 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): 2.0-32.0, Brain Tumor, Recurrent Glioblastoma Multiforme All patients must be between 2 and 32 yrs. of age. Patients who are pregnant or lactating will not be included in this study Patients must have an estimated survival time of > 3 months, and a Karnofsky performance status of > 50% or and ECOG performance status of 0-2 Patient must have radiographic imaging evidence of tumor recurrence except for glioblastoma multiforme The recurrent tumor prior to irradiation with PRS must be < 4 cm All patients must be > 3 weeks from cytotoxic chemotherapy, except if patient received < 1 week of non-myelotoxic chemotherapy. In that case, patient may be enrolled with permission of the principal investigator All patients must be > 6 weeks from high dose chemotherapy with stem cell rescue All patients must be > 3 weeks from prior radiation therapy Patients with a history of prior irradiation will be included Informed consent must be obtained prior to registration on the study. Tumor Sites Brain | 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, Acquired Bleeding Disorder Trauma Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation | 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, Painful Bladder Syndrome Interstitial Cystitis Women ages 18 and older Diagnosis of interstitial cystitis Subject has severity/stage of disease: at least 12 voids/day with the presence of pelvic pain Ability to follow study instructions and likely to complete all required visits Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential; if applicable) Use of any medications that might interfere with neuromuscular function Any medical condition that may put the subject at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Known allergy or sensitivity to any of the components in the study medication Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment Stress incontinence Urinary tract infection at time of enrollment Overtly psychotic or suicidal Pain from another source in the genital tract such as kidney stones or neoplasm Having had radiation therapy | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 15.0-65.0, Craniocerebral Trauma Criteria:Patients who have sustained a traumatic brain injury who have completed their inpatient rehabilitation at either of the three Sydney Metropolitan Brain Injury Units (Liverpool, Ryde or Westmead) will be included in this study if they have sustained a very severe or extremely severe traumatic brain injury have had a hospital admission of > 1 month are able to walk independently at > 1 m/s on discharge are able to commit 3 hours per week to a fitness programme live within the area serviced by the 3 units have a concurrent medical condition for which moderate to high intensity exercise is contraindicated are still in Posttraumatic Amnesia (PTA) have cognitive or language problems that affect their ability to understand verbal instructions have behaviour problems not suitable for a fitness centre environment | 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): 18.0-40.0, Headache Migraine MR-Angiography Healthy Volunteers GTN Middle Cerebral Artery healthy volunteers history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to >2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia | 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): 75.0-999.0, Acute Myocardial Infarction Subjects of 75 or more years of age 2. Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations: 1. ST-elevation >=2 mm in 2 or more precordial leads 2. ST-elevation >=1 mm in 2 or more anterior leads 3. Complete de novo (or probably de novo) left bundle branch block (LBBB) 3. Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP >180 mmHg or diastolic AP >110 mmHg 1.7. Known thrombocytopenia < 100.000 platelets/mL 1.8. Prolonged (>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection 2. Cardiogenic shock 3. Estimated door-to-needle time >120 minutes 4. Administration of fibrinolysis in the 14 days prior to randomization 5. Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization 6. Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization 7. Actual oral anticoagulant treatment 8. Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents) 9. Dementia or acute confusional state at the time of randomization 10. Subject incapacity or unwillingness to give informed consent -at least, verbally 11. Known renal failure (basal creatinine> 2,5 mg/dl) 12. Reduced life expectancy (<12 months) due to advanced or terminal concomitant condition 13. Subject participation in another clinical trial (assessing a drug or a device) in the 30 days prior to randomization | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 2.0-999.0, Vascular Anomalies Patient with vascular malformation causing risk of one or more of the following based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team airway/respiratory/visual/auditory/neurologic compromise high output cardiac failure life-threatening or disabling hemorrhage(cutaneous/GI/intracranial/ parenchymal/cavitary) skeletal distortion/destruction/erosion life-threatening or disabling soft tissue distortion or destruction Patient must be felt to have failed, be unable to significantly benefit from, or be at risk for other available therapies, including surgeries, embolization, and sclerotherapy based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team Patient must be felt to have one or more physical, imaging, photographic, physiologic or other measurable features that can be measured on a regular basis for preliminary evaluation of efficacy. The feature(s) must be agreed on by the designated physicians in the multidisciplinary Vascular Anomalies Team) Signed Patient informed consent Pregnancy Patient nursing child Female patient of childbearing potential unwilling to receive contraceptive counseling and use reliable contraceptive method Patient enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) Parent or guardian or child unwilling to provide consent or assent | 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, Headache History of fasting headache Age 18-65 Intention to fast on Yom Kippur History of Fasting on Yom Kippur Pregnant or Nursing Women Known allergy to NSAID type medication History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding | 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): 50.0-85.0, Alzheimer's Disease Is male, or if female meets one or more of the following Post-menopausal females defined as menopause is defined as>6months without menstrual period with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges). Women who are on HRT treatment, and have not been confirmed as post-menopausal should be advised to use contraception.(See Appendix 4)Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy only when the reproductive status of the woman has been confirmed by follow up hormone level assessment Meets the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) for Alzheimer's disease, regardless of date of diagnosis relative to study entry date. (See Appendix 5) Has an Alzheimer's disease status of mild to moderate, as classified by a Mini Mental State Examination (MMSE) score of 16-26 inclusive at screening. Is aged >/= 50 to </= 85 years Prior and current use of medication corresponds with listed in Appendix 3 Has the ability to comply with requirements of cognitive and other testing Has a permanent caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status. (Subjects living alone or in a nursing home are not eligible) Has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, provision of informed consent by cognitively intact legally acceptable representative (Where this is in accordance with local laws, regulations and ethics committee policy.) Caregiver has provided full written informed consent prior to the performance of any protocol-specified procedure Is unsuitable for MRI scanning as assessed by local pre-MRI questionnaire (GSK to review.) Has a history of or suffers from claustrophobia Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for at least 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis) Has a history or presence of other neurological or other medical conditions that may influence the outcome or analysis of the PET scan results. Examples of such conditions but are not limited to stroke, traumatic brain injury, epilepsy or space occupying lesions History of Type I or Type II diabetes mellitus Fasting plasma glucose level>126mg/dL (>7.0mmol/L) or HbA1c>6.2% History or clinical/laboratory evidence of moderate congestive heart failure defined by the New York Heart Association (class I-IV)(See Appendix 6). Ejection fraction</=40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with the definitions below). Significant ECG abnormalities for the purposes of this study. Detection of any of the following abnormalities renders the subject ineligible for the study: 1. ECG heart rate <50 and >100 bpm 2. Any previously unrecognised sustained or paroxysmal arrhythmia requiring further intervention e.g. anticoagulation, cardioversion, anti-arrhythmic agent, further investigation etc. 3. PR interval >0.3 s, 2nd or 3rd degree heart block, symptomatic bifascicular block, trifascicular block. 4. Multifocal ventricular ectopy. 5. Ventricular bigemini or couplets, triplets etc. ECG abnormalities permitted at entry to this study. A subject will not be rendered ineligible by the presence of any of the following abnormalities: 1. AF with a heart rate <=90 in subjects receiving appropriate anti-platelet or anticoagulant therapy. 2. 1st degree heart block (PR<=0.3 s). 3. Subjects with a paced rhythm (further information required if subject has an implantable Cardiac Defibrillator). 4. Atrial ectopic beats. 5. Unifocal ventricular ectopic beats. 6. Left or right bundle branch block. 7. Asymptomatice bifascicular block. 8. Left ventricular hypertrophy. 9. Q waves present suggesting previous MI. 10. Repolarisation abnormalities History of new cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled History or clinical laboratory evidence of cerebrovascular disease (stroke, transient ischaemic attack, haemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with National Institute of Neurological Disorders and Stroke, and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) (See Appendix 8) History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease. Significant peripheral oedema at the time of screening as assessed by Clinical Evaluation of Oedema and/or Signs of Congestive Heart Failure (Appendix 14) History of major psychiatric illness such as schizophrenia or bipolar affective disorder, or current depression (score on Hospital Anxiety and Depression Scale (HADS) depression questions >7, See Appendix 9). Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHG whilst receiving optimal antihypertensive therapy according to local practice. Clinically significant anaemia (i.e.haemoglobin <11g/dL for males or <10 g/dL for females) or presence of haemoglobinopathies which would prevent accurate assessment of HbA1c. Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula, See Appendix 10). ALT, AST, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal laboratory range, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis (Childs-Pugh classes B/C)) without enzyme elevation | 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): 0.0-21.0, Congenital Disorders Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January June, 2004 Those who did not meet criteria | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-80.0, Hyperalgesia Neurodynia Pain Trauma Baseline average daily Pain Score of greater than or equal to 4 (averaged over the 7 days prior to Treatment Visit 1), as reported on the 11 point pain intensity numerical rating scale Subjects on medications for neuropathic pain or received nerve blocks for neuropathic pain Known history of hypersensitivity or intolerance to acetaminophen, paracetamol, aspirin, COX-2 inhibitors or NSAIDs Subject is unable to discontinue NSAIDs or COX-2 inhibitors (except aspirin as a cardioprotective; certain doses apply), topical lidocaine and topical capsaicin for the treatment of pain for the period prior to randomization and for the duration of the study Subject is unable to refrain from sedative use during the study (benzodiazepines prescribed as hypnotic sleep agents allowed) Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and during the study | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-40.0, Headache Migraine Healthy volunteers Primary headache headache on the day of investigation Hypertension hypotension pregnant/nursing Daily intake of medication (except oral contraceptives) Cardiovascular or CNS disease Drug/Alcohol abuse Psychiatric 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): 18.0-65.0, Headache (Migraine) Subjects must have a demonstrated history of migraine headaches according to the International Headache Society (IHS) 1.1 or 1.2 (2004), had their first migraine prior to age 50, and have had an average migraine headache frequency of 2-6 migraines per month, of moderate or severe pain intensity, in each of the last 6 months prior to screening Subjects are willing to come to the study site when he/she has onset of the headache of migraine to receive an intravenous dose of study medication and is willing to remain in the investigator's clinic for at least 2 hours after the intravenous dose for collection of study data (Subject is discharged to home after 2 hour post-dose evaluations are completed) Subjects who are pregnant Subjects has known allergic reactions or intolerance to NSAIDs; any subject in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the symptoms of asthma, rhinitis and nasal polyps Subject is receiving any medications known or suspected to have drug interactions with lornoxicam. These warfarin or other anticoagulants, digoxin, probenecid, methotrexate, lithium, aspirin, cimetidine, cyclosporine and/or furosemide Subjects with a non-migraine (i.e., tension-type, sinus, etc.) headache frequency of >15 days/month in each of the 3 months (90 days) prior to screening Subjects experiencing greater than an average of 6 migraine attacks per month and/or >15 migraine days per month in the 6 months prior to screening Subjects with a history of documented gastrointestinal ulceration in the past six months or hospitalization for gastrointestinal bleeding in the past year Subjects with history of impaired renal function and/or a history of kidney disease, interstitial nephritis, nephrotic syndrome, and/or peripheral edema Subjects with history of heart disease or certain related conditions Subjects with uncontrolled hypertension or hypertension that is difficult to control with 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): 0.0-999.0, Sepsis Pneumonia Trauma Burn Injury All burn,trauma, or acute surgery victims admitted to the surgical, burn or trauma units within 24 hours of injury will be considered for inclusion severe immunosuppression, DNR, severe trauma, terminal diseases. - | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 21.0-999.0, Headache Emergency Department patients who present primarily for headache Need to consent to and be available 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): 18.0-999.0, Pulmonary Embolism Patients >= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure <= 90 mmHg, a drop in systolic arterial pressure >= 40 mmHg for >= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension 2. Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography 3. Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional) 4. Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present Active bleeding History of intracranial bleeding Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days History of stroke Gastrointestinal bleeding within 10 days Significant trauma within 15 days Head injury requiring hospitalization within 1 year Active cancer with known hemorrhagic risk Neurosurgery or ophthalmologic surgery within the past year Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale 2. Free floating right heart thrombi, left heart thrombi 3. Life expectancy due to underlying disease less than one month | 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, Acquired Bleeding Disorder Trauma Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard 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): 18.0-999.0, Headache Sinusitis Rhinitis Facial Pain patients greater than 18 years of age literate in the English language referred by a physician for primary complaint of "sinusitis" major symptomatic complaint of headache or facial pain/pressure CT scan must have been performed prior and available for review at the time of visit evidence of chronic rhinosinusitis a modified Lund Mackay score greater than 2 on CT pregnancy history of prior facial trauma or tumor in the head and neck region, specifically the nasal area past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis) | 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, Headache Healthy volunteers Aged 18-40 100 kg Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen Tension type headache more than once/month Other primary headaches Daily medication except contraceptives Drug taken within 4 times the halflife for the specific drug except contraceptives Pregnant or lactating women Exposure to radiation within the last year Headache within the last 24 hours before start of trial Hypertension Hypotension Respiratory or cardiac disease | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Cerebral Hemorrhage A. Men and non-pregnant women, at least 18 years of age. B. Patients with an ICH or IVH admitted to Stanford University Medical center within 48 hours of symptom onset. C. Ability to undergo MRI A. Patients with a known (preexisting) source for ICH, for example a known untreated arterio-venous malformation. B. Patients receiving investigational drug therapies or procedures prior to MRI scanning. C. Glasgow coma scale (GCS) score < 6 in the absence of sedating medications. D. Informed consent cannot be obtained either directly from the patient or from a legally authorized representative. E. Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study | 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, Postpartum Hemorrhage Severe postpartum hemorrhage, i.e non responsive to sulprostone infusion < 18 years personal antecedent of arterial or venous thrombosis written informed consent not approved/signed by the patient or her husband | 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, Headache Migraine Healthy volunteers Primary Headache, headache on the day of the investigation, hypertension, hypotension, pregnant/nursing, daily intake of medication (except oral contraceptives), Cardiovascular or CNS disease, drug/alcohol abuse, psychiatric 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): 50.0-85.0, Coronary Artery Disease Cerebrovascular Disease Peripheral Vascular Disease Male or female patients between 50 and 85 years of age Patient has seropositive evidence of C. pneumoniae defined by IgG antibody titers ≥ 1:128 on microimmunofluorescence assay The patient meets at least one of the following 1. Diagnosis of PAD: i. Ankle-brachial index (ABI) of <0.90 at rest in either leg, or toe brachial index of < 0.7 if ankle pressure is calcified. ii. Known PAD on the basis of history or symptoms of intermittent claudication, prior endovascular or surgical revascularization. 2. Known large vessel (non-cardioembolic) cerebrovascular event (stroke or TIA) within the last three years or carotid stenosis of >40% and ≤ 80% by Doppler ultrasound or asymptomatic carotid artery disease defined by a total plaque area >100 mm2and carotid stenosis of ≤ 80%by Doppler ultrasound. 3. Known coronary artery disease on the basis of an exercise tolerance test positive for myocardial ischemia, or history of a prior myocardial infarction (greater than 6 months), or prior percutaneous coronary intervention and/or surgical revascularization (greater that 6 months) Patient has a maximal IMT measurement by ultrasound in either the left or right common carotid artery of ≥ 0.70 mm and at least one or more echogenic carotid plaques detectable in either the right or left side of the carotid artery Patient is able to undergo magnetic resonance (MR) examination and MR baseline images obtained are of suitable image quality for analysis If patient is taking cilostazol, pentoxifylline, or other approved drugs for the treatment of PAD and/or intermittent claudication or taking a statin, patient has to be on the medication for at least 6 months prior to Screening Patients who have recently discontinued medications for PAD and/or intermittent claudication or statin must "wash-out" for at least one month prior to screening Male and female patients must agree to use an effective form of birth control throughout the study period The patient lacks evidence of intermediate or advanced carotid atherosclerotic lesions or has heavily calcified plaque or poor image quality of their carotid arteries as determined by the MRI lab Patient has critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene Patient has new, previously unrecognized clinically significant electrocardiogram (ECG) abnormalities Patient has liver function tests > 3.0 times the upper limit of normal, serum creatinine > 1.8 mg/dL for females and >2.0 mg/dL for males and a eGFR value <30 mL/min/1.73 m2. Enrollment of patients with eGFR values of between 30 and 59 mL/min/1.73 m2 will be left to the discretion of the investigator. Patients with abnormal laboratory values which are deemed clinically significant by the investigator will not be enrolled Patient has had a recent (< 6 months) coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), carotid endarterectomy (CEA), carotid artery stent, or lower extremity revascularization/amputation Patient plans for surgical/endovascular intervention for carotid and/or coronary during the course of the study Patient has or being evaluated or treated for tuberculosis. Patients who were treated previously for tuberculosis but presently have inactive disease may be included Patient has a chest x-ray obtained within the last month that is consistent with possible tuberculosis Patient has a history of malignant neoplasm within the previous 5 years (except curable non-melanoma skin malignancies) Patient has a known immunodeficient state or is being treated with immunosuppressive drugs including high-dose steroids or cyclosporine | 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, Arteriovenous Malformation Hereditary Hemorrhagic Telangiectasia Hematochezia Melena Patients must be 18 years of age or older Patient must have had greater than 2 episodes of overt bleeding over last 2 years requiring > 4 units of PRBC for bleeding 20 AVM. AVM's should have been identified at optical/capsule endoscopy or angiography Patients must have adequate hematologic, renal and liver function (i.e. Platelets ≥ 100,000/mm3, Creatinine ≤ 1.7mg/dl, Total Bilirubin ≤ 2.5mg/dl, Transaminases ≤ 4 times above the upper limits of the institutional norm) Patients must be able to provide written informed consent. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods (described in detail under thalidomide drug information section) to avoid conception. Women of child-bearing potential must have a negative pregnancy test prior to treatment on this protocol. Men taking thalidomide must agree to use latex condoms every time they have sex with women since it has been shown that thalidomide is found in semen. All patients must agree to participate in the S.T.E.P.S.® program (System for Thalidomide Education and Prescribing Safety). All patients must be educated under the requirements of the S.T.E.P.S.® program. Patients are required to complete a S.T.E.P.S.® survey and sign and additional consent form indicating that they understand all information provided to them as part of the S.T.E.P.S.® educational counseling Estimated life expectancy must be greater than 2 months Pregnant and/ or lactating female Personal history of thromboembolic disease History of seizure activity History of neoplasm except basal cell carcinoma in-situ History of severe neuropathies Women of child bearing potential Inability to comply with the 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): 18.0-55.0, Cerebrovascular Accident Adult patients (18 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study MRI-scan evidence of associated corresponding brain infarction or hemorrhage, regardless of the duration of symptoms. Alternatively also patients with no signs of stroke in the MRI can be included if a stroke-experienced neurologist has done the initial diagnosis as ischemic stroke, transient ischemic attack or hemorrhage Detailed MRI documentation at admission to entry to the study Diagnostic procedures for CVE according to the EUSI recommendations Written informed consent from patient or legal representative according to local regulations Patients being younger than 18 years or older than 55 years of age Acute ischemic stroke or transient ischemic attack longer than 3 months before enrolment into the study Diagnosis of the CVE within the last 3 months has been done by a non-neurologist if there is no MRI-scan evidence of associated brain infarction or hemorrhage No detailed MRI documentation at admission to entry to 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): 18.0-85.0, Acute Ischemic Stroke Patients must meet all of the criteria. 1. Diagnosis of acute ischemic stroke with onset less than 4.5 hours prior to the planned start of intravenous alteplase. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 4.5 hours are not eligible if their first symptoms started more than 4.5 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline. 2. Disabling neurological deficit attributable to acute ischemic stroke in the middle cerebral artery territory. 3. NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others. 4. Evidence of MCA occlusion (stem or branch) prior to drug administration by TCD, CTA or MRA. 5. Age 18-85 years, inclusive. 6. Able to sign informed consent. For MRI Arm only: 7. Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing DWI are eligible. 8. Evidence on PWI MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of rt-TPA therapy Patients will be excluded from study participation for any of the following reasons: 1. Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial. 2. Absence of acoustic window to insonate the MCA on the involved side. 3. Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence. 4. Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage. 5. Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I. 6. Acute Pericarditis. 7. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. 8. Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2). 9. High clinical suspicion of septic embolus. 10. Minor stroke with non-disabling deficit or rapidly improving neurological symptoms. 11. Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 16 for others. 12. Evidence of acute or chronic ICH by head CT or MRI. 13. CT or MRI evidence of non-vascular cause for the neurological symptoms. 14. Signs of mass effect causing shift of midline structures on CT or MRI. 15. Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. 16. Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair. 17. Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months. 18. Stroke within the past 3 months. 19. History of ICH at any time in the past. 20. Major trauma at the time of stroke, e.g., hip fracture. 21. Blood glucose greater than 200 mg/dl. 22. Presence or history of intracranial neoplasm (except small meninigiomas) or arteriovenous malformation. 23. Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before. 24. Seizure at the onset of stroke. 25. Active internal bleeding. 26. Major hemorrhage (requiring transfusion, surgery or hospitalization) in the past 21 days. 27. Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplantation. For non-listed procedures, the operating surgeon should be consulted to assess the risk. 28. Presumed or documented history of vasculitis. 29. Known systemic bleeding or platelet disorder, e.g., von Willebrand's disease, hemophilia, ITP, TTP, others. 30. Platelet counts less than 100,000 cells/micro L. 31. Congenital or acquired coagulopathy (e.g., secondary to anticoagulants) causing either of the following: 1. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. 2. INR greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours. 32. Life expectancy less than 3 months. 33. Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment. 34. Severe renal failure: Serum creatinine greater than 4.0 mg/dL or dependency on renal dialysis. 35. AST or ALT greater than 3 times the upper limit of normal for the local laboratory. 36. Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or GPIIbIIIa inhibitor outside of this protocol. 37. Any administration of a thrombolytic drug in the prior 7 days. 38. Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation. 39. Treatment of the qualifying stroke with a low molecular weight heparin or heparinoid. 40. Known hypersensitivity to TPA. 41. Anticoagulation (evidenced by abnormal INR, aPTT, or platelet count) caused by herbal therapy. FOR non-MRI arm only (#42-43): 42. Ischemic changes on screening CT of greater than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 43. Patients who were excluded by screening MRI, except for exclusions #45 (contraindication to MRI) and #46 (PWI was not obtained or is uninterpretable) and #50 (MRI not obtainable because it would have put the patient out of the 3 hour time window for alteplase). FOR MRI arm only (#44-51): 44. Contraindication to MRI scan. 45. PWI not obtained or uninterpretable. 46. No MTT defect corresponding to acute stroke deficit. 47. DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 48. Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion greater than 3 hours in duration). 49. Evidence of multiple microbleeds on gradient echo MRI (GRE). 50. MRI not obtained because it would have put the patient out of the 3 hour time window for alteplase | 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 Subjects with cerebral ischemia at any location producing a serious measurable deficit by NIHSS scale and who received study medication within 5 hours after the onset of the symptom. A serious measurable deficit by NIHSS was defined as the NIHSS 9 and 20 (for brain stem stroke, patients with NIHSS > 20 were included) Subjects were 18 years old, of either sex Subjects or his/her legal guardians demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent Subjects with Modified Rankin Scale > 1 Onset of symptoms on awaking from sleep Intracranial bleeding detected on a pretreatment head computerized tomographic (CT) scan Clinical presentation suggested a subarachnoid hemorrhage even if the head CT scan was normal Head CT showed the evidence of early infarct sign > 1/3 of MCA territory Subjects had generalized seizure at the onset of the stroke Subjects with blood glucose < 50 mg/dl or > 400 mg/dl Subjects had another stroke, head trauma, cerebral hemorrhage or ischemic infarction within 3 months prior to the study entry Subjects with a significant surgery within 14 days prior to study entry Subjects with a history of gastrointestinal or urinary tract hemorrhage within 21 days prior to the study entry Subjects with lumbar puncture or arterial puncture of non-compressible site within 14 days prior to the study entry | 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): 16.0-75.0, Traumatic Brain Injury Cerebral Infarction Cerebral Hemorrhage One week following Traumatic Brain Injury Cerebro Vascular Accident Subsequent brain CT showed cerebral cortex injury A known ailment of the central nervous system Use of medications or illicit drugs that significantly affect the central nervous system tourist or temporary residents not available for follow-up For MRI examinations: heart pacemaker, metal implants, or metal shrapnel | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Type 1 Diabetes Type 2 Diabetes HbA1c > 7% More than 2 follow-up visits | 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 With Aura years Will comply with requirements of the protocol Have a consistent history of migraine with visual aura of at least one year •>30% of episodes have a visual aura preceding headaches Approximately 90% of the time have moderate or severe headaches following their aura Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II) criteria(for migraine headache with aura after administration of a clinical interview by study personnel Has a history of 1-8 migraine headache episodes with aura per month Can differentiate a migraine headache from other types of headaches Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is negative Women who are pregnant or breastfeeding Routinely experiences any other type of headache that would confound discrimination from migraine headache with aura Have migraine with prolonged aura > 60 minutes Have headaches due to other underlying pathology Have headaches related to head or neck trauma Overuse headache medications Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or other metallic implants Has cardiac pacemaker or any other implanted electronic device Has any known history of alcohol abuse, drug dependency, or significant psychiatric illness in the previous 12 months Having any medical condition, including but not limited to: clinically significant renal or hepatic disease; uncontrolled hypertension; clinically significant coronary vascular disease not stable for the past 6 months; personal or family history of seizures or taking medications for seizures or drugs that may lower seizure threshold, cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding cutaneous basal cell carcinoma; tuberculosis | 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 Tension-type Headache Primary Headache Disorder Treated in the emergency department for acute primary headache Allergy, intolerance, or contra-indication to one of the study medications | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-65.0, Cluster Headache cluster headache in crisis no serious illnesses in progress as cancer, autoimmune disease, liver disease patient without chronic psychiatric disease excluding moderate and reactional depression no demential disease no anxious or depressive disease no contraindication to PET scan (pregnancy and breast-feeding) social security cover written informed consent No effective contraception taken unable to realize a decubitus of 15 minutes long | 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): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 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, Epilepsy Referred to neurological institute at University Hospitals Case Medical Center for care of seizures/epilepsy Referred to neuropsychology laboratory for evaluation Participants must complete the routine check-in of all patients and sign consent and HIPAA forms Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable Be aged 18-64 years old Be able to provide documented informed consent Have a confirmed diagnosis of right or left temporal lobe epilepsy (TLE), which is made independent of their pre-surgical neuropsychological evaluation. Neurological disease must be confirmed by one (or more) of the following: (a) MRI study of the head, (b) CT study of the head, (c) EEG study, (d) Video-EEG study, (e) PET study of the head, (f) Neurological and Psychiatric exam by a physician Referred from an attorney or their evaluation is part of a personal injury claim Be intoxicated from alcohol or other illicit substance Received Electroconvulsive (ECT) treatment within the last 21 days Have an MMSE score of 25 or less Have undergone Deep Brain Stimulator (DBS) surgery | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-55.0, Post Traumatic Headache Males and females between the ages of 18-55. A female is eligible to enter and participate if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study; subjects utilizing this method must agree to use alternate method of contraception if they become sexually active and will be queried on whether they have been abstinent when they present to the clinic for the Final Visit or, Female sterilization; or, Sterilization of male partner; or, Implants of levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combined or progestogen only); or, Any intrauterine device (IUD) with published data showing highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm). Any other barrier methods (only if used in combination with any of the above acceptable methods) or, Any other methods with published data showing highest expected failure rate for that method is less than 1% per year Formally diagnosed ICHD 5.2.2 chronic post traumatic headache Have had traumatic brain injury (TBI) not more than 5 years prior to enrollment Medically stable as determined by Investigator On stabilized dosage of any headache preventive medications for 3 months prior to screening On stabilized dosage of concomitant medications at discretion of investigator Chronic headache history only after the TBI Able to understand and communicate intelligibly with study observer Able to take oral medication, adhere to the medication regimens and perform study procedures Able to read and comprehend written instructions and be willing to complete all procedures and assessments required by protocol History of hypersensitivity to triptan-like medication Pathology of salivary glands such as sialadenitis (e.g., Sjorgen's Syndrome, viral or bacterial sialadenitis, or obstructive sialadenitis) Any condition or symptom that would knowingly alter content of saliva History of, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes or other significant underlying cardiovascular disease. Ischemic cardiac syndromes but are not limited to, angina pectoris of any type (e.g. stable angina of effort and vasospastic forms of angina such as Prinzmetal variant, all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease Any medication overuse that in the opinion of the investigator has exacerbated or contributed to current headache pattern of subject Uncontrolled hypertension, severe renal impairment, severe hepatic impairment, hemiplegic or basilar headache History of hypersensitivity to naratriptan or any components Pregnant, trying to get pregnant, or lactating Recent history of abuse of alcohol or other drugs that would interfere with participation Participation in another investigative drug study within previous 30 days | 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): 0.0-999.0, Congenital Hypothyroidism Patients with congenital hypothyroidism due to thyroglobulin defective synthesis Patients with another disease | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Intracerebral Hemorrhage Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms 2. Supratentorial location of hemorrhage 3. Older than 17 yrs Planned surgical evacuation of hematoma within 24hrs 2. Secondary ICH due to trauma or aneurismal rupture or etc 3. Taking antithrombotics or other NSAIDs previously 4. Pregnancy 5. Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician) | 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, Subarachnoid Hemorrhage Cerebral Vasospasm Patients with subarachnoid hemorrhage Patients with external ventricular drains Patients in whom consent is not attainable | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-55.0, Allogeneic Stem Cell Transplant Leukemia Non-Hodgkins Lymphoblastic Lymphoma Myelodysplastic Syndrome Paroxysmal Nocturnal Hemoglobinuria (PNH) Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome HLA 6/6 or 5/6 antigen matched related or unrelated donor creatinine = normal or if not, CrCl > 60 ml/min/1.73ml total bilirubin < 2.5, AST < 2xnl, cardiac function > 50% pulmonary function asymptomatic or if not DLCO > %50% (corrected for Hgb) Karnofsky performance status > 70% negative pregnancy test (where applicable) signed informed consent of patient and donor Pregnancy or lactation unwillingness to comply with protocol treatment or follow-up uncontrolled infection HIV or HTLV positivity active CNS/skin 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): 18.0-70.0, Anemia Liver Disease Hypoxemia Definite diagnosis of HHT by clinical or genetic diagnosis. For the clinical diagnosis, 3 of the 4 following criteria1 must be present: 1. Epistaxis: spontaneous, recurrent 2. Telangiectases: multiple at characteristic sites 3. Visceral lesions including telangiectases and/or arteriovenous malformations (AVM) (pulmonary, hepatic, gastrointestinal, cerebral, spinal) 4. Family history of a first degree relative with HHT 2. Transfusion-dependent anemia from HHT-related bleeding (epistaxis from nasal mucosal telangiectases or gastrointestinal bleeding from gastrointestinal telangiectases) defined as a hemoglobin (Hb) < 9g/dL with transfusion of at least one unit of packed red blood cells within the past 6 months or Hb < 11g/dL in females or < 13g/dL in males with transfusion of at least 5 units of blood within the past 6 months. Patients must be on a stable dose of iron or intolerant of iron. Patients must have failed traditional treatment options. 3. Clinically stable outpatient 4. Able and willing to return for outpatient visits 5. Ability to perform subcutaneous injections 6. Adult (Age 18 years) 7. Presence of the following laboratory results at entry: 1. White blood cell count ≥ 2000/mm^3 2. Neutrophil count ≥ 1000/mm^3 3. Platelet count ≥ 80,000/mm^3 4. Thyroid stimulating hormone within normal limits (Minimal abnormalities of the sensitive thyroid stimulating hormone may be allowed provided that the free thyroxin is normal and the patient is clinically euthyroid) 8. Negative pregnancy test at enrollment, if applicable 9. If the participant is a sexually active woman of childbearing potential, evidence that she is practicing adequate contraception during the treatment period. Adequate contraception includes use of an intrauterine device, oral contraceptives, progesterone implanted rods, medroxyprogesterone acetate, surgical sterilization, barrier method (diaphragm + spermicide), a monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide or a birth control method acceptable to the study physicians. Participants and/or their partners must agree to continue the use of adequate contraception for at least 6 months following completion of treatment. 10. Written informed consent specific for this protocol obtained prior to entry 11. Patients agree to take study medication as directed and follow all study related procedures until the conclusion of their protocol participation 12. Hepatic involvement by HHT characterized by high output heart failure due to hepatic vascular malformations (symptoms of heart failure including edema, ascites, S3 gallop, orthopnea, or jugular venous pressure > 10 cm H_2O) plus cardiac index (CI) measured at right heart catheterization > 4.4 L/min/m^2. Patients must have failed traditional treatment options. 13. Computed tomography scanning (CT) of the liver documenting vascular abnormalities consistent with HHT 14. Child-Pugh category A 15. Diffuse pulmonary telangiectases or AVMs documented by pulmonary angiography not amenable to treatment with embolization techniques. Patients must have failed traditional treatment options. 16. Positive contrast echocardiography documenting right to left intrapulmonary shunt 17. Resting or exercise-induced hypoxemia defined as a partial pressure of oxygen (PaO_2) < 70 mmHg at rest or an oxygen saturation (SpO_2) < 85% with exercise Anemia from any other cause than that due to HHT-related bleeding 2. Hypersensitivity to PEG-Intron or any other component of the product 3. Decompensated liver disease 1. Chronic active Hepatitis B infection 2. Child-Pugh category B or C 4. History of severe psychiatric disease 1. Prior suicide attempt 2. Hospitalization for psychiatric disease 3. Period of disability due to a psychiatric disease 4. Current episode of moderate to severe depression not responsive to treatment 5. History of immunologically mediated disease 1. Inflammatory bowel disease 2. Idiopathic thrombocytopenic purpura 3. Systemic lupus erythematosus 4. Autoimmune hemolytic anemia 5. Scleroderma 6. Sarcoidosis 7. Multiple sclerosis 8. Severe psoriasis 9. Clinical evidence of rheumatoid arthritis 10. Autoimmune hepatitis 6. History of clinically significant cardiovascular disease 1. Positive stress test 2. Clinically significant arrhythmia 3. Congestive heart failure 4. Uncontrolled hypertension 5. Coronary artery bypass surgery within 24 weeks prior to entry 6. Angina pectoris or myocardial infarction within 1 year prior to entry 7. Seizure disorder uncontrolled by anticonvulsants (within the last 12 months) 8. History of thyroid disease poorly controlled on prescribed medications 9. History or evidence of retinopathy 10. Patients on chronic anticoagulation 11. History of chronic renal insufficiency (creatinine > 2.5 mg/dL) 12. Patients who have received an investigational drug within 24 weeks of treatment assignment 13. History or other evidence of severe illness or other comorbid condition which would make the patient unsuitable for participation in a research protocol 14. Liver dysfunction from any other cause than that due to HHT (chronic active hepatitis B infection, hepatitis C infection, alcoholic cirrhosis, etc.) 15. Cardiac index < 4.4 L/min/m^2 16. Pulmonary AVMs with feeding arteries > 3 mm in diameter amenable to embolization techniques 17. Other pulmonary diseases causing hypoxemia | 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): 0.5-999.0, Thrombocytopenia In the 72 hours prior to study entry, participant has been diagnosed with "isolated HIT," as defined by an unexplained platelet count drop of over 50% that occurs after exposure to UFH (UnFractionated Heparin)/LMWH (Low Molecular Weight Heparin) at any time in the 4 to 14 days before the positive heparin-PF4 antibody test was sent(even if the person is no longer on UFH/LMWH) Currently hospitalized Available for study follow-up for at least 28 days after study entry No contraindications to ultrasound examination of upper and lower extremities For participants less than 7 years old, no contraindications to ultrasound examination of abdomen Participants are eligible whether or not they are receiving any therapy for isolated HIT Documented new venous or arterial thrombosis while on heparin Pregnant Ongoing active bleeding (as determined by the site investigator) Currently using a extracorporeal membrane oxygenator, chronic veno-venous hemofiltration, left ventricular support device, intra-aortic balloon pump, or any other mechanical heart pump Coronary artery bypass surgery occured within 96 hours prior to the time when the positive HIT test was drawn | 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, Diabetes Mellitus Healthy male or female subject. 2. Age ≥ 18 and ≤ 45 years. 3. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive. 4. Non-smoker, defined as no nicotine consumption for at least one year. 5. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) Previous participation in this trial or other clinical trials within the last 3 months. 2. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant). 3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial. 4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator. 5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. 6. History of alcohol or drug abuse. 7. Any positive reaction of drugs of abuse. 8. Hepatitis B or C or HIV positive. 9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. 10. Use of any insulin product for therapeutic purposes in the past. 11. Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol is permitted. 12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 13. Blood donation of more than 500 ml within the last 12 weeks. 14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 15. Known or suspected allergy to trial product or related products | 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): 20.0-45.0, Endometriosis The patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at Leuven University, Belgium, specialising in the surgical treatment of severe endometriosis All the women were symptomatic and scheduled for surgical excision of a rectovaginal nodule, at least 1 cm in diameter, diagnosed on the basis of clinical examination at the time of menstruation All the women had a menstrual cycle occurring every 25 to 40 days If previously treated with hormonal medication for endometriosis, at least 3 months must have elapsed and they must have had at least two menstrual cycles since stopping treatment Unless the women had previously been sterilised, they had to agree to use a double-barrier method of contraception for the duration of the study and for up to 6 months after receiving the last infusion The study was approved by the Institutional Review Board of Leuven University Written, informed consent was obtained before any study related procedures were performed Evidence on chest x-ray in the previous 3 months of old or currently active TB, or other history/evidence of active TB, even if adequately treated Evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months Evidence of a documented HIV infection, active hepatitis-B or C, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) in the previous 6 months Previous transplant surgery, a lymphoproliferative disorder or other malignancy Positive cervical cytology in the previous 6 months Previous treatment with infliximab, any drug known to affect TNF-α levels, e.g. pentoxifylline, thalidomide and etanercept, or any human/murine recombinant products Known allergy to murine products Use of other investigational drugs within 1 month of recruitment or within 5 half-lives of the investigational agent, whichever was longer Any haematological or biochemical abnormalities on routine screening Subjects were also excluded if there was any pelvic pathology on transvaginal ultrasound scan (TVS) other than small uterine fibroids (< 4 cm in diameter) and an ovarian endometrioma or endometriotic nodule | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Cancer Pain Main The subject is a male or female, at least 18 years of age The subject has a malignancy, is receiving opioid therapy for his or her underlying persistent cancer pain, and is tolerant to the opioid therapy The subject typically has 2 to 6 episodes of target BTP per day that require treatment The subject has a life expectancy of >3 months The subject or his or her caregiver has easy, reliable access to a telephone. Main The subject is a female who is pregnant or lactating The subject has any respiratory or cardiac condition that, in the opinion of the investigator, may be clinically worsened by opioids The subject has any allergy to the AD 923 product or excipients, namely: fentanyl, dehydrated alcohol, menthol, saccharin, and citrate buffer; or to the MSIR product excipients, namely: morphine sulphate, lactose (anhydrous), pregelatinized maize starch, povidone, purified water, magnesium stearate, talc, and tablet coatings The subject has any neurological or psychiatric disease that, in the opinion of the investigator, would compromise data collection The subject has uncontrolled or rapidly escalating pain The subject has any significant laboratory test results that, in the opinion of the investigator, will compromise subject safety or the conduct of the study The subject has plans to undergo chemotherapy, radiotherapy, or surgery during the treatment period. The exception is that subjects may continue chemotherapy over the study period, provided it is not expected to alter the pain state or response to pain medication | 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, Tonsillitis Obstructive Sleep Apnea Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea Written informed consent form is given from patient or patient's parents (in case of pediatric patient) Pregnancy History of bleeding disorders Unilateral tonsillectomy Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study) Patient unable to understand evaluation method Patient unable to be contacted via telephone | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-75.0, Intraventricular Hemorrhage Age 18-75 2. IVC placed as standard of care using less than or equal to 2 complete passes. 3. Spontaneous ICH less than or equal to 30 cc. 4. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours). 5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method). 6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT). 7. SBP < 200 mmHg sustained for 6 hours. 8. Historical Rankin of 0 or 1 Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI). 2. Clotting disorders. 3. Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT. 4. Pregnancy (positive pregnancy test). 5. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded). 6. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study). 7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement). 8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts. 9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention. 10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis. 11. Prior enrollment in the study. 12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. 13. Participation in another simultaneous medical investigation or trial | 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, Dementia Alzheimer's Disease Parkinson Disease Huntington Disease Capable of providing informed consent and having a legal representative able to consent out of concern for future competency to consent (as defined by a Mini Mental State Exam score of <24) or capable of assent but incapable of giving competent informed consent, but with a legal representative able to provide informed consent Subject or family voices concern about their memory or possess knowledge that they have been diagnosed with a memory disorder such as Age Associated memory Impairment, Alzheimer's disease, Parkinson disease, Huntington disease, vascular dementia, mixed dementia, dementia with Lewy Bodies, or frontotemporal dementia Children (less than 18 years of age) | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 12.0-80.0, Migraine Headaches Eligible subjects will be 12 years of age and above, either gender, meeting the 2004 International Classification of Headache Disorders (ICHD) for migraine with or without aura, with a frequency of 5 to 14 per month and a headache history of more than two years. Patients must be under the care of one of the physicians participating in the study. Patients with chronic daily headache (more than 15 headache days per month) will be included only if they also have between 5 and 14 migraine headaches per month that can be clearly differentiated from chronic daily headache. Subjects or their caregivers must be willing and able to document headache characteristics and use of medications, as well as complete the assessment instruments. They must be able to come in for 8 weekly CST or LSSM interventions Patients with significant, symptomatic depression, anxiety or psychosis requiring more than two psychotropic medications daily and/or more than two visits a month to a mental health care provider; those undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder; pregnancy; those with clotting disorders; those with a history of head trauma or cranial or neck surgery within two years; a prior history of use of CST or magnet therapy for headache; cardiac pacemakers; other implanted or external electrical devices | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 7.0-55.0, Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy FOR 1. Age 7-55 2. Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging 3. Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs 4. Willingness to be considered for surgery 5. Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker. FOR 1. Age 7-55 2. Willingness to participate in and complete the study 3. Right-handedness assessed by the Edinburg handedness inventory 4. Fluency in English FOR 1. Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator) 2. Claustrophobia or anxiety disorders exacerbated by the MRI scanner 3. People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies 4. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning 5. Patients on phenobarbital or chronic benzodiazepines FOR 1. Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator) 2. Any medical condition or chronic medication that might affect fMRI or MEG language activation by affecting cerebral structure or function, such as diabetes, hypertension, antihypertensive medications, psychotropic agents. 3. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning | 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, Diabetes Healthy male or female subject 2. Age between 18 and 45 years (both inclusive) 3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. 4. Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 (both inclusive) 5. Non-smoker, defined as no nicotine consumption for at least one year. 6. Signed and dated informed consent obtained before any trial-related activities Previous participation in this trial or other clinical trials within the last 3 months. 2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures. 3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. 4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator. 5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. 6. History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening. 7. Positive test for hepatitis B or C or HIV positive at screening or in the past. 8. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. 9. Use of any insulin product in the past. 10. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen will be permitted. 11. Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks. 12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 13. Known or suspected allergy to trial products or related products. 14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 15.0-40.0, Migraine Headache Migraine attack according to international headache society 2. Migraine without aura; at least 5 attack with mean duration of 4 to 72 hours and 2 of following Unilateral Pulsatile Severe enough to impair daily activity Aggravate with walking and climbing, also 1 of following Nausea and or vomiting Photophobia and phonophobia, and not contributed to other headache. 3. Migraine with aura; at least 2 attacks with 3 of following One reversible aura Aura became apparent at least in 4 minutes Aura not lasting more than 60 minutes Hypertension 2. Ischemic heart disease 3. Basilar migraine with sign and symptoms such as Diplopia Ataxia Dysarthria Dysphagia Weakness Sensory disorder Drowsiness 4. Peripheral vascular disease 5. Sepsis 6. Age more than 40 and less than 15 year old 7. Pregnancy 8. Use of triptans and ergots derivatives in past 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): 0.0-999.0, Pulmonary Arteriovenous Malformations patients with pulmonary arteriovenous malformations (PAVMs) unable to provide 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, Post-Hemorrhagic Hydrocephalus Infants enrolled in this study will be identified at the time of neurosurgical evaluation for placement of a shunt or an Omaya reservoir for post-hemorrhagic hydrocephalus. Infants who have received vasoactive drugs (e.g. non-steroidal anti-inflammatory, dopamine, dobutamine, epinephrine, etc), will not be excluded from the study but the measurements will be postponed until 72 hrs after discontinuation of the 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): 0.0-999.0, Brain Trauma Patients of acute moderate brain trauma Patients who are medically unstable or have CT findings that may interfere with the study such as a large hemorrhage or edema encephalomalacia prior neurosurgeries hardware placed in the head or neck prior head trauma history of neurological conditions | 2 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Pelvic Inflammatory Disease women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000 | 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): 13.0-999.0, Arteriovenous Malformations Cavernous Angiomas Brain Aneurysms years or older Female patients of child bearing age using barrier-type birth control Creatinine no greater than 2.0 mg/di Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal WBC count at least 3,800/mm3 BMI within 50% of normal Allergy to tetracycline Unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days Female patients of child-bearing age not using effective birth control (barrier) History of vestibular disease (except benign positional vertigo) History of noncompliance with treatment or other experimental protocols Patients taking other antibiotics History of systemic lupus erythematosis Patients who are immunocompromised Patients with clinically significant hepatic dysfunction | 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, Intraventricular Hemorrhage Age 18-80 Symptom onset less than 24 hrs prior to diagnostic CT scan Spontaneous ICH less than or equal to 30 cc or primary IVH IVH obstructing 3rd and/or 4th ventricles ICH clot stability at 6 hours or more post IVC placement IVH clot stability at 6 hours or more post IVC placement Catheter tract bleeding stability 6 hours or more post IVC placement EVD placed per standard medical care SBP less than 200 mmHg sustained for 6 hours prior to drug administration Able to randomize within 72 hours of diagnostic CT scan Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor Presence of a choroid plexus vascular malformation or Moyamoya Clotting disorders Platelet count less than 100,000, INR greater than 1.4 Pregnancy Infratentorial hemorrhage SAH at clinical presentation ICH/IVH enlargement that cannot be stabilized in the treatment time window Ongoing internal bleeding Superficial or surface bleeding | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Traumatic Brain Injury Clinical diagnosis of blast-related TBI of any severity, as made by LRMC staff, based on clinical history, examination, and/or standard clinical imaging (CT, conventional MRI). 2. Acute injury or injuries, defined as first occurring 0-90 days prior to enrollment. 3. Ability to lie still in a supine position for the duration of the scan sessions, e.g. no severe claustrophobia or limiting pain from other injuries. 4. No known metallic implants or metallic foreign objects. 5. Ability to provide informed consent. 6. Not known to be HIV positive 7. Not known to be pregnant 8. No previous major traumatic brain injury 9. No contraindication to MRI for medical reasons such as arrhythmias | 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, Oligohydramnios Patients above 18 years, who are able to consent, with 2. Singleton pregnancy 3. with a normal structural examination as much as possible; 4. At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios 5. Follow up ultrasound examinations weekly in the treatment group 6. Acceptance of randomisation and to comply with the protocol Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful; 2. Preterm labour defined as contractions >6/hour associated with cervical changes, cervix shortened (<15 mm at randomization), 3. Cervical cerclage in place 4. Chorioamnionitis, defined as 2 or more of the following: maternal temperature>38 degrees, foul-smelling vaginal discharge, uterine tenderness, fetal tachycardia>170 bpm, white blood cell count >18,000 5. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes 6. Previous invasive procedure in this index pregnancy 7. Fetal condition mandating immediate delivery 8. Severe bleeding 9. Maternal HIV and HCV infection 10. Multiple gestation | 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, Snoring Obstructive Sleep Apnea Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea Written informed consent form is given from patient Pregnancy History of bleeding disorders Patient unable to understand evaluation method Patient unable to be contacted via telephone | 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, Carpal Tunnel Syndrome Primary, idiopathic CTS Age 18-70 years, either gender Symptom duration of at least 3 months and inadequate response to wrist splint Symptoms of classic or probable CTS according to the diagnostic in Katz hand diagram Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery) Previous steroid injection for CTS in the same wrist Inflammatory joint disease, diabetes mellitus· Vibration-induced neuropathy, polyneuropathy Pregnancy Trauma to the affected hand in the previous year Previous CTS surgery in the affected hand Inability to complete questionnaires due to language problem or cognitive disorder Severe medical illness Known abuse of drugs and/or alcohol | 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, Insemination The woman's in our IUI program were at least one patent tube, normal cavity, basal FSH < 10 mU/mL and age under 40 years IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%) In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4) Previous infertility treatments had been carried out | 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, Intracerebral Hemorrhage Acute, spontaneous ICH (including bleeding in cerebellum) diagnosed by non-enhanced CT scan within five hours of symptom onset. (Time of onset is defined as the last time the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep) Age >/= 18 years through 80 years (candidates must have had their 18th birthday, but not had their 81st birthday) For spot positive patients, dosing of study drug within 90 minutes of enrolling CT scan Time of symptom onset of ICH is unknown or more than five hours prior to baseline CT scan ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment of any condition (e.g., myocardial infarction, cerebral infarction, etc.), central nervous system (CNS) tumor or CNS infection Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled) Serum creatinine > 1.4 mg/dl (123 μmol/L). Sites that currently perform CTA as standard of care for ICH will follow their standard procedures regarding renal insufficiency Known allergy to iodinated contrast media Intravenous or intra-arterial administration of iodinated contrast media within the previous 24 hours of baseline CT scan Known hereditary (e.g., hemophilia) or acquired hemorrhagic diathesis, coagulation factor deficiency, or anticoagulant therapy with international normalized ration (INR) > 1.2 Known or suspected thrombocytopenia (unless current platelet count documented above 50,000 / μl) Unfractionated heparin use with abnormal partial thromboplastin time (PTT) Low-molecular weight heparin use within the previous 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, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-80.0, Intracerebral Hemorrhage age 18-80 years 2. clinical presentation of spontaneous ICH 3. CT scan compatible with spontaneous ICH 4. Time to PIO treatment ≤ 24 hours from symptom onset 5. GCS ≥ 6 on initial presentation OR improvement to a GCS ≥ 6 within the time frame for enrollment 6. Hematoma volume ≥ 5cc on initial head CT Participation in another investigational trial in the previous 30 days 2. Patient will undergo surgical evacuation of ICH (ventriculostomy does NOT patient) 3. Inability to undergo neuroimaging with MRI (e.g. pacer, recent stent, inability to lie flat) a. If patient has mild claustrophobia or agitation amenable to mild sedation (1-2mg lorazepam IV or 5-10mg diazepam PO), he or she may be considered for enrollment. If, however, the patient has severe claustrophobia or agitation, he or she should not be considered for enrollment. 4. GCS < 6 5. Baseline mRS ≥ 3 6. Primary intraventricular hemorrhage 7. ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma 8. History of intolerance or allergy to any TZD 9. Thrombocytopenia: platelet count < 100,000 10. Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs ≥ 2x normal, coagulopathy as described above) 11. Co-morbid conditions, which in the opinion of the investigator, are likely to complicate therapy including but not limited to: 1. A history of NYHA class II, III, or IV CHF 2. clinically significant arrhythmia 3. end stage AIDS 12. Pregnancy as determined by a urine pregnancy test 13. Severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30% 14. Malignancy (history of or active) 15. Patient unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-89.0, Peripheral Vascular Disease Clinical 1. Subject must be at least 18 and < 90 years of age. 2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form. 3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site. 4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4). 5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months. Angiographic 1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side). 2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion) 3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis 4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro) 5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm 6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro) 7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. 8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite). 9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite). Clinical Subject is unable to walk. 2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery. 3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver). 4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6. 5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s). 6. Subject has elevated serum creatinine > 2.0 mg/dl. 7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl). 8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days. 9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk. 10. Subject has unstable angina defined as rest angina with ECG changes. 11. Subject has a groin infection, or an acute systemic infection that is currently under treatment. 12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity. 13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure. 14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years). 15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints. 16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits. 17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®). 19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions. 20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy. 21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 22. Requirement of general anesthesia or spinal block for the procedure. 23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic. 24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion. 25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary. 26. Target lesion is in an iliac artery that has been previously stented. Angiographic Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion. 2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion 3. Target lesion is within or adjacent to an aneurysm. 4. Lesion is located within or beyond a vessel that contains a bypass graft. 5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery. 6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm. 7. Lesion extends beyond the inguinal ligament. 8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies. 9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure. 10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis. 11. Requirement for > 1 stent to treat full length of lesion | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, Stress Healthy first-time mothers with singleton baby delivered at term with no complications Mothers with chronic health problems Pregnancy complications, OR Infants with congenital problems or conditions requiring admission to the intensive care nursery | 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, Brain Arteriovenous Malformations The patient or patient's guardian understands and will sign the informed consent for the procedure The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging The brain AVM has a Spetzler-Martin grade of I, II, III, or IV. If the brain AVM has a Spetzler-Martin grade of I or II, the anticipated benefit of embolization for surgical resection is greater than the risk of the embolization procedure (e.g., patient stability) The patient is a candidate for surgical resection of the AVM post embolization The patient is clinically and neurologically stable, for a minimum of 24 hours prior to embolization The patient agrees to have, and is capable of completing, all study-related exams and procedures Patient of any age The patient is pregnant The patient has a brain AVM with high flow arteriovenous fistulae that the investigator has determined to be unsuitable for embolization The brain AVM has a Spetzler-Martin grade of V The patient is participating in another research study involving another investigational device, procedure or drug The brain AVM has been previously treated with another embolization agent | 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): 18.0-50.0, Headache Patient meets ICHD for chronic post-traumatic headaches (see below). 2. Patient is 18-50 years old. 3. Patient has experienced 6 or more days of headache per month for each of the last 2 months. 4. Patient has full capacity to provide informed consent. 5. Patient will be available for all study-related visits over the next 4 months. 6. Patient must be eligible to receive care at Madigan Army Medical Center International Classification of Headache Disorders (version 2) diagnostic for chronic post-traumatic headaches attributed to mild head injury: 1. Headaches beginning within 1 week of mild traumatic head injury. 2. Headaches persisting > 3 months after head trauma. 3. Head trauma with all of the following no loss of consciousness or loss of consciousness < 30 minutes Glasgow Coma Score (GCS) 13-15 symptoms or signs diagnostic of concussion Patient has another headache disorder not attributable to head trauma which accounts for at least half of the patient's headache episodes. 2. Patient is currently taking propranolol, amitriptyline, or topiramate for any reason. 3. Patient previously tried propranolol, amitriptyline, or topiramate for headache treatment. 4. Patient started a new treatment for headache prevention within the last 6 weeks. Prophylactic treatments initiated prior to 6 weeks ago are allowed as long as the dose or regimen is stable. Medications for aborting acute headaches are also allowed. 5. Patient previously tried more than two medications for headache prevention. 6. Patient is using narcotic analgesics on average more than 10 days a month. 7. Patient has a medical condition or is taking a medication that is considered a contraindication for propranolol, topiramate, or amitriptyline. Medical conditions liver disease, renal impairment, cardiac dysrhythmias, untreated thyroid disease, orthostatic hypotension, asthma requiring treatment with inhalers, glaucoma, kidney stones, insulin-requiring diabetes, or pregnancy. 8. Patient has known hepatic, renal, or cardiac disorders. 9. Patient drinks on average more than two servings of alcohol (2 oz hard liquor, 5 oz wine, 12 oz beer) per day or more than 3 servings at one time on a weekly basis. 10. Patient has abnormalities on baseline EKG. 11. Patient has major depression defined as a score >15 on the Patient Health Questionnaire-9. 12. Patient is pregnant, planning to become pregnant in the next year, or is a female of reproductive potential who is not using a reliable form of birth control. 13. Patient has cognitive impairment defined as mini-mental status exam score <27. 14. SBP < 90, HR < 50, or HR > 100 | 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, Chronic Daily Headache Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center Subjects under age 18 | 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, Congenital Diaphragmatic Hernia Patient is a pregnant woman between 18 and 45 years of age Singleton pregnancy Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus Severe CDH: -Fetal liver herniated into the hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is < 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome Normal fetal karyotype The mother must be healthy enough to have surgery Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure Patient willing to remain in Houston for the duration following the balloon placement until delivery Signed informed consent Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia Allergy to latex Allergy or previous adverse reaction to a study medication specified in this protocol Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI Maternal BMI >40 High risk for fetal hemophilia | 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): 6.0-999.0, Attention-Deficit/Hyperactivity Disorder Patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit) 2. Patients must meet DSM-IV for ADHD 3. Patients and parents/guardians must have a degree of understanding sufficient to be able to communicate suitably with the investigator and study coordinator 4. Patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms 5. Must have shown clinically significant superiority in improvement in ADHD symptoms on amphetamine relative to MPH Must not have a true allergy to methylphenidate or amphetamines 2. Must not have a history of serious adverse reactions to methylphenidate | 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): 30.0-60.0, General Paresis EEG MR Serological test | 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, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Keratosis Pilaris Subject is willing and able to give informed consent Subject is willing and able to participate in the study as an outpatient and is willing to comply with the study requirements Subject is 18 years of age or older Subject has KP on 2 out of the 4 extremities For each assessed extremity, subject has at least a moderate severity (≥ 3) on the Investigator Site Assessment of KP Severity For each assessed extremity, subject has an aggregate score of at least 6 on the Investigator Assessment of Erythema, Roughness and Scaling If subject is a female of childbearing potential, subject will have a negative urine pregnancy test at screening (week 0) If female, subject will be either post-menopausal for > 2 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects should continue to practice birth control for 1 month after the completion of study Subject has evidence of a clinically significant, unstable or poorly controlled medical condition as determined by the investigators/sub-investigators Subject has active skin infection, atopic dermatitis or any other skin disease that will interfere with the clinical assessment of KP Subject has known allergies to any ingredient of study medication Subject who has used any of the following topical therapies for KP lesions within the last two weeks: topical corticosteroid, tretinoin, tazarotene, adapalene, salicylic acid, alpha-hydroxy acid, urea and/or ammonium lactate lotion Subject who has been treated with UVB therapy in the last two weeks Subject who has received systemic antibiotics, steroid, tacrolimus, tretinoin, isotretinoin and/or PUVA within the last 4 weeks Female subjects who are pregnant (positive urine pregnancy test), breast-feeding or are considering become pregnant during the study period Subject who is currently participating in another clinical trial or has completed a clinical trial within the last 4 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): 0.0-1.0, Intraventricular Hemorrhage Premature Infants severe IVH receiving weekly head ultrasounds for monitoring no or minimal IVH | 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, Chronic Daily Headache Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension. 2. More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale. 3. Headaches typically last for at least 4 hours. 4. Subjects are on a stable headache treatment, if any, for at least 2 months Headache symptoms assessed to be predominately occipital. 2. Allergy to oxytocin. 3. History of addictive behavior (e.g. alcoholism, drug abuse). 4. History of significant psychiatric disorder. 5. History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease. 6. Upper-respiratory tract infection at the time of randomization. 7. Past or current history of any condition that may hinder study procedures or confuse interpretation of data. 8. Nasal obstruction of any cause as determined at screening. 9. Major surgery or trauma within 4 weeks of screening. 10. Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive. 11. Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization. 12. Use of an investigational medication or device within 30 days of randomization. 13. Unable or unwilling to adhere to the study-specific procedures and restrictions. 14. Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data. 15. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN). 16. Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening | 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, Acute Cardiac Dysfunction The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable The subject is male or female, age 18 years or older The subject is able to ambulate unassisted The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding The subject is willing and able to read, understand and sign the study specific informed consent form The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments The subject, pre-device implant, is qualified as a transplant candidate There is an absence of a trained companion There is an absence of a psycho-social support The subject has an inadequate home environment, such as poor access which may hinder movements The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures < 90 mmHg The subject requires respiratory assistance The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL) The subject requires tube feeding The subject has any other medical condition requiring hospitalization | 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, Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Measurable disease as defined by Response In Solid Tumors (RECIST) Baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks (28 days) prior to randomization Eastern Cooperative Oncology Group (ECOG) performance status between 0-1 No prior chemotherapy for lung cancer; prior chemotherapy for an unrelated condition is allowed if completed > 3 years prior to date of randomization Histological or cytologic evidence of non-small cell lung cancer Patients must not have any additional active, invasive malignancies requiring therapy Patients must have smoked less than or equal to 100 cigarettes in their lifetime Stage IV or IIIB (with pleural or pericardial effusion or multifocal pleural involvement) or recurrence after prior curative resection or definitive radiation Prior radiation therapy (RT) is allowed, provided RT has ended at least 2 weeks (14 days) prior to date of randomization; patients must have recovered from any adverse events related to the RT (except alopecia and grade 1 neuropathy); no previous irradiation to the only site of measurable disease, unless that site has had subsequent evidence of pathologic or radiologic progression Absolute neutrophil count (ANC) >= 1500/mm^3 | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 16.0-999.0, Head Injury Consecutive adult patients presenting to one of the study hospital EDs after sustaining acute minor head injury will be enrolled into the study. as an 'acute minor head injury' case will be determined by the patient having all of the following characteristics upon arrival in the ED. 1. Blunt trauma to the head resulting in witnessed loss of consciousness, definite amnesia, or witnessed disorientation, no matter how brief; this may be determined from the patient or from the report of a witness (the patient will be asked specific questions: 'do you remember the accident?', 'how did you get to the hospital?', 'have you talked to me before?'). 2. Initial ED GCS score of 13 or greater as ascertained by the attending physician (e.g. opens eyes spontaneously, obeys commands, but speech may only comprehensible but inappropriate words). 3. Injury within the past 24 hours less than 16 years, 2. 'minimal' head injury i.e. no loss of consciousness, amnesia, or disorientation, 3. no clear history of trauma as the primary event (for example primary seizure or syncope), 4. GCS score of less than 13, 5. head injury occurred more than 24 hours previously, 6. obvious penetrating skull injury or depressed fracture, 7. acute focal neurological deficit (motor or cranial nerve) that cannot be ascribed to an extracerebral cause, for example, traumatic mydriasis or peripheral neuropathy, 8. have suffered a seizure prior to assessment in the ED, 9. a bleeding disorder or current use of oral anticoagulants,125 or 10. returned for reassessment of the same head injury | 1 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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 Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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 Obstructive Hydrocephalus supratentorial intracerebral hemorrhage <60ml intraventricular hemorrhage with casting of the third and fourth ventricles obstructive hydrocephalus with need of external ventricular drainage GCS <9 on admission or within 48h of symptom onset admission within 48h of symptom onset preceding modified Rankin scale ≤3 age 18-85 years ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis infratentorial hemorrhage pregnancy admission 48h after symptom onset preceding modified Rankin scale >3 | 1 |