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Cerebral Aneurysm

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5241. First in Human Dose Escalation Study of TEW-7197 in Subjects With Advanced Stage Solid Tumors

of the liver, Child-Pugh Stage B or C, or history of liver transplant, Severe diabetes that is not currently controlled, Current or history of interstitial pneumonitis, Presence of aneurisms of the ascending aorta or aortic stress. Uncontrolled metastatic disease to the brain or central nervous system (CNS). Known history of difficulty swallowing, malabsorption or other conditions that may reduce absorption of the product. Received prior treatment targeting the signaling pathway of TGF-β. Major (...) : Elevated Troponin 1 levels at screening or known to have persistently elevated brain natriuretic peptide (BNP). Serious pre-existing medical conditions as follows: Myocardial infarction within 6 months prior to screening, or pericardial effusion, History of cardiac or aortic surgery, Serious arrhythmia, Unstable angina pectoris, Congestive heart failure of New York Heart Association class III/IV, Hypertension that is not controlled by standard medication (to 150/90 mmHg or below), Cirrhosis

2014 Clinical Trials

5242. Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic Endovascular System

to treatment to evaluate the status of the IVC. Active bleeding, recent (< 3 mo) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, bleeding diathesis. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR), obstetrical delivery, or other invasive procedure. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm. Active cancer (metastatic

2014 Clinical Trials

5243. Study of the Efficacy, Safety and Tolerability of Low Molecular Weight Heparin vs. Unfractionated Heparin in Stroke

to confirm the absence of intracranial hemorrhage and to assess the size of cerebral ischemia. First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued until the target INR level (2.5) is reached then clexane will be discontinued. The second group will receive continuous UFH infusion 1000 unit per hour and then the dose will be adjusted to maintain a therapeutic aPTT (two times (...) is ruptured or leaks that causes neurological symptoms. It can result from nontraumatic causes as occurs in hemorrhagic stroke such as a ruptured aneurysm. Anticoagulant therapy can heighten the risk that an intracranial hemorrhage will occur. Non-CNS hemorrhage [ Time Frame: up to the 3 months of follow-up ] any bleeding of other sites of body except CNS. asymptomatic CNS_hemorrhage [ Time Frame: up to the 3 months of follow-up ] Intracranial bleeding occurs when a blood vessel within the skull

2014 Clinical Trials

5244. Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, severe coronary artery disease, severe peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness >30 minutes Current use of the following medications: antidepressants, benzodiazepines (...) , antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide) Caffeine intake >10 cups/day or recent significant changes in consumption MRI exclusions, including claustrophobia, cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro

2014 Clinical Trials

5245. MRSI to Predict Response to RT/TMZ ± Vorinostat in GBM

spectroscopic imaging (MRSI) can predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the early determination of response to this new therapy. Condition or disease Intervention/treatment Phase Glioblastoma Multiforme of Brain Radiation: Standard Radiation Therapy Drug (...) by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (QLQ-C30/BN20) and the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), validated instruments for assessing QOL in brain tumor patients. Neurocognitive function changes [ Time Frame: up to 2 years ] The investigators will determine whether changes in MRSI metabolite maps correlate with changes in subjects' neurocognitive function as measured by the Hopkins Verbal Learning

2014 Clinical Trials

5246. The ISLAND Study: InSuLa Assessed Needs for Depression

: National Institute of Mental Health (NIMH) Information provided by (Responsible Party): Boadie W. Dunlop, Emory University Study Details Study Description Go to Brief Summary: While there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. The goal of this study is to test how brain function changes in depress patients treated (...) by the investigator. Received electroconvulsive therapy in the past 6 months or during the current depressive episode. Currently responding to medication treatment, without clinical reasons to change. Current treatment with weekly individual or group psychotherapy of any type targeted at depressive symptoms. QTc >500 milliseconds on EKG at screening. Contraindications for MRI, including, but not limited to pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, intra-uterine

2014 Clinical Trials

5247. Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment

after treatment ] For the endovascular treatment group successful recanalization will be defined as Thrombolysis in Cerebral Infarction scale (TICI) 2b or 3. Other Outcome Measures: Safety endpoints [ Time Frame: within 90 (+/- 14) days after treatment ] Number of patients with any of the following: Death or dependency (mRS 5-6) Symptomatic intracranial haemorrhage (sICH) at 30 (-/+ 6) hours (CT or MRI) as defined in Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST (...) Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible. A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA). Prior to new focal neurological deficit, mRS score was ≤1. Exclusion Criteria

2014 Clinical Trials

5248. A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure

of Oxygen [SaO2] <88%). Exclusion Criteria for Healthy Volunteer Group and Heart Failure Groups Current smoker, defined as having smoked in the preceding 6 months. Contraindication for MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to: Intracranial aneurysm clips or other metallic objects; Intra-orbital metal fragments that have not been removed ; Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves; Inner ear (...) the use of oxygen) Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: Intracranial aneurysm clips (except Sugita) or other metallic objects OR intra-orbital metal fragments that have not been removed OR pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves OR inner ear implants OR history of claustrophobia Estimated creatinine clearance (Cockcroft-Gault) <40mL/minute Contraindication

2014 Clinical Trials

5249. Decompressive Craniectomy After Removing Hematoma to Treat Intracerebral Hemorrhage

table for MeSH terms Hemorrhage Hematoma Intracranial Hemorrhages Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases (...) intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability. Condition or disease Intervention/treatment Phase Intracranial Hemorrhages Procedure: Decompressive Craniectomy Procedure: non-Decompressive Craniectomy Not Applicable Detailed Description: Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset

2014 Clinical Trials

5250. A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects

major abdominal, chest or brain surgery in the three months prior to Visit 0; Have a known cerebral, aortic or abdominal aneurysm; Be breast feeding or pregnant, or plan to become pregnant while in the trial; Be using an unreliable form of contraception (female subjects at risk of pregnancy only); Be participating in another investigative drug trial, parallel to, or within 4 weeks of screening (Visit 0); Have a known allergy to mannitol; Be using non-selective oral beta blockers; Have uncontrolled (...) adopted; Be considered "terminally ill" or eligible for lung transplantation; Have had a lung transplant; Be using maintenance nebulized hypertonic saline in the 2 weeks prior to visit 1; Have had a significant episode of hemoptysis (> 60 mL) in the three months prior to Visit 0; Have had a myocardial infarction in the three months prior to Visit 0; Have had a cerebral vascular accident in the three months prior to Visit 0; Have had major ocular surgery in the three months prior to Visit 0; Have had

2014 Clinical Trials

5251. Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing

affiliation Being under guardianship Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI. Patient with movement disorder Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided (...) : May 9, 2014 Last Update Posted: May 9, 2014 Last Verified: February 2013 Additional relevant MeSH terms: Layout table for MeSH terms Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders

2014 Clinical Trials

5252. Absorb IV Randomized Controlled Trial

), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI (...) such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI Number of Participants Experienced Death/All MI [ Time Frame: 90 days ] All

2014 Clinical Trials

5253. A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia

myocardial ischemia. CHD risk equivalents include atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease [transient ischemic attacks or stroke of carotid origin or >50% obstruction of a carotid artery]), diabetes and 2+ risk factors with 10 year risk of over 20% Subject must be able to understand the trial procedures and be willing to cooperate and complete the trial. Exclusion Criteria: Severe hypertension patients with mean siSBP ≥ 180mmHg (...) cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months) Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue disease. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months) Subjects

2014 Clinical Trials

5254. The Role of IntraNasal Insulin in Regulating HepaTic Lipid COntent in HUMANS

towards claustrophobia Chronic sinusitis, diagnosed nasal polyposis, diagnosed severe septum deviation metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation [heart pacemaker, brain (aneurysm) clip, nerve stimulators, electrodes, ear implants, post coronary by-pass graft (epicardial pace wires), penile implants, colored contact lenses, patch to deliver medications through the skin, coiled spring intrauterine device, vascular filter for blood (...) of insulin, which further promote lipid accumulation. Secretion of very-low-density-lipoproteins (VLDL), the main carriers of triglycerides (TG) in the plasma, is the principal pathway for the liver to mobilize and dispose of lipids. Thus, hepatic TG export must not be too low in order to prevent steatosis. Our preliminary data from animal experiments suggest that enhanced brain insulin signaling promotes hepatic VLDL secretion, and reduces lipid accumulation in the liver. It remains to be tested whether

2014 Clinical Trials

5255. Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants

of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or premature stroke (cerebrovascular accident less than 65 years of age) Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening or history of major surgery within 3 months of screening Have planned surgery within 14 days after the last day of dosing Have (...) vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study Have consumed grapefruit, cranberries, or grapefruit- or cranberry-containing products within 7 days prior to the first dose of warfarin Have a history or presence of significant bleeding disorders that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, clinically overt hematuria or intracranial hemorrhage, gastrointestinal ulcers with hemorrhage Have a personal or family history

2014 Clinical Trials

5256. Positioning of Surgical Patients With Sleep Apnea

Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery Currently undergoing treatment for sleep apnea including CPAP Requiring prolonged postoperative ventilation NYHA functional class III and IV Valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina Myocardial infarction or cardiac surgery within 3 months Chronic obstructive pulmonary disease, or asthma Presence of tracheostomy, facial, neck, or chest wall abnormalities Abdominal (...) aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months Visiting preoperative clinic less than 3 days before surgery Requiring postoperative nasogastric tube Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123238

2014 Clinical Trials

5257. An MRI Study of Post-op Cognitive Deficit in Patients Undergoing Major Surgery

bears fruit. At the least, further elucidation into POD for major surgery is expected with this study. Study Design Go to Layout table for study information Study Type : Observational Estimated Enrollment : 20 participants Observational Model: Case-Only Time Perspective: Prospective Official Title: "Blue" Cerebrovascular Reactivity (CVR) Maps as a Marker for Post-operative Delirium (POD) in Patients Undergoing Abdominal Aortic Aneurysm (AAA) Surgery: A Pilot Study: Addition of Other Patients Being (...) Outcome Measures Go to Primary Outcome Measures : Blue voxel count/whole brain voxel count [ Time Frame: Baseline ] the number and distribution of 'blue' voxels - those with reversed CO2 responsiveness to a controlled CO2 change with blood oxygen level dependent (BOLD) MRI. Incidence of post-op delirium [ Time Frame: Post-op out to discharge or maximum of 2 weeks post-surgery ] the incidence and severity of post-op delirium using the cognitive assessment method - intensive care unit (CAM-ICU) scoring

2014 Clinical Trials

5258. Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps. Individuals with a significant neurological disorder or insult including, but not limited to: Any condition likely to be associated with increased intracranial pressure Space occupying brain lesion History of cerebrovascular accident Transient ischemic attack within two years Cerebral aneurysm Dementia Mini Mental State Exam score of less than or equal to 24 Parkinson's disease (...) of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions. Other Name: Brainsway Deep TMS Treatment Sham Comparator: Sham Treatment Brainsway Sham Treatment Device: Sham Treatment In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric

2014 Clinical Trials

5259. Investigation of the Impact of Concomitant Use of Multiple Doses of Clopidogrel With Multiple Doses of Dabigatran Etexilate on the Pharmacokinetic and Pharmacodynamic Parameters in Healthy Male Subjects

History of arteriovenous malformation or aneurysm History of gastroduodenal ulcer disease, gastrointestinal haemorrhage and haemorrhoids History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding Use of drugs that may interfere with haemostasis during trial conduct (e.g.acetyl salicylic acid or other non-steroidal anti-inflammatory drugs) Relevant surgery of gastrointestinal tract Diseases of the central nervous system (such as epilepsy) or psychiatric

2014 Clinical Trials

5260. Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, central nervous system (CNS) trauma, retinopathy, nephrolithiasis) Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye (...) of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, CNS trauma, retinopathy, nephrolithiasis) considered by the investigator or one of the coinvestigators to be clinically relevant Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days

2014 Clinical Trials

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