[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arteriovenous-malformations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arteriovenous-malformations":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,88,136,162,190,216,239,256,286,319,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100212425","phase-2-prospective-evaluation-of-the-efficacy-of-sirolimus-rapamune-in-the-treatment-of-severe-arteriovenous-malformations-100212425",false,"NCT02042326","Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations","MAV-RAPA","Inclusion Criteria:\n\n* Patients (adults, adolescents and children older than 2 years), with arteriovenous malformation stage II + III or IV (according to Schöbinger's classification) : active or quiescent, marked or not by hemorrhagic phenomena.\n* Patients (parents for minors) must sign a consent form established after clear information risks and expected benefits of the study.\n* Patients (major and minor of childbearing age) must have effective contraception during the study period and continuing until 12 weeks after the end of treatment\n* Negative pregnancy blood test for women of childbearing age.\n\nExclusion Criteria:\n\n* Chronic or acquired immunosuppression :\n\n  * patients with transplanted organ or who received a hematopoietic stem cell\n  * patient with congenital immunodeficiency\n* Patients implanted with chronic active infection associated with hepatitis B , hepatitis C or HIV\n* Pregnant or nursing woman.\n* Allergy to macrolides\n* Allergy to peanut or soya\n* Hypersensitivity to \" Sirolimus \" or any of the excipients of the investigational product\n* Contraindications to performing an MRI\n* Leukopenia below 1 000 \u002Fmm3\n* Thrombocytopenia lower to 80,000 \u002Fmm3\n* Anemia with Hb \\\u003C 9 g\u002Fdl\n* Elevated transaminase \\> 2.5 N\n* History of cancer less than two years before the inclusion\n* Surgery older than 2 months before inclusion\n* Active infection (viral and bacterial ) on the date of inclusion\n* Hypercholesterolemia \\> 7 mmol \u002F l despite appropriate medical treatment\n* Hyperlipidemia \\> 2 mmol \u002F l despite appropriate medical treatment\n* Uncontrolled diabetes\n* Patients unable to follow a clinical study\n* Major under guardianship, persons deprived of their liberty","ALL","2 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).\n\nSirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.",[26],"Arteriovenous Malformations",[26,28,29],"Sirolimus","Maxillofacial Surgery","RECRUITING","2026-05-12",{"date":33,"type":34},"2026-05-13","ACTUAL",{"date":36,"type":34},"2014-09-12",{"date":38,"type":20},"2027-09",{"name":40,"class":41},"Centre Hospitalier Universitaire, Amiens","OTHER",13,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":72,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100514796","phase-2-a-trial-of-targeted-therapies-for-patients-with-slow-flow-or-fast-flow-vascular-malformations-100514796","NCT05983159","A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations","A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)","TARGET-VM","MODULE 1\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over\n2. Patient has a clinical diagnosis of a slow-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with alpelisib\n4. A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Patient is able to swallow and retain oral medication\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 3 x ULN; Total bilirubin \\\u003C 2x ULN except for participants with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits, or corrected with supplements\n   * Fasting blood glucose ≤ 7.0 mmol\u002FL and Glycosylated Haemoglobin (HbA1c) ≤ 6.4% (both criteria must be met)\n9. Patient agrees to abstinence or highly effective contraceptive measures for males and women of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking alpelisib and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 4 weeks after stopping alpelisib\n   * Females who are of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 1 week after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child bearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of PI3K inhibitors or any of the excipients of alpelisib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of an alpha-specific PI3K inhibitor\n5. History of pneumonitis or interstitial lung disease\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for women of child-bearing potential in the screening period\n7. Established diagnosis of type I diabetes mellitus, type II diabetes mellitus requiring anti-hyperglycaemic medication or any participant with HbA1c \\> 6.4%\n8. Patient who is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes\n9. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment:\n\n   * Strong inducers of CYP3A4\n   * Strong inhibitors of CYP3A4\n   * Inhibitors of BCRP\n10. History of acute pancreatitis within 1 year of screening or past history of chronic pancreatitis\n11. Patient with Child Pugh score B or C\n12. Unresolved osteonecrosis of the jaw\n13. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n14. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n15. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n16. Known history of clinically significant, uncontrolled heart disease and\u002For recent cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of impaired Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% (an assessment of LVEF is not mandatory in screening)\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n17. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of alpelisib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n18. Patient is unable to understand and comply with treatment instructions and requirements\n\nMODULE 2\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over where Body Surface Area (BSA) is greater than or equal to 0.4m2.\n2. Patient has a clinical diagnosis of a fast-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with mirdametinib\n4. A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Participant has the ability to swallow capsules whole if the capsule dosage form is being utilized. This criterion does not apply if participant is utilizing the dispersible tablet form of study treatment\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 2 x upper limit of normal (ULN); Total bilirubin \\\u003C 1.5x ULN (isolated bilirubin \\> 1.5x ULN is acceptable if bilirubin is fractioned and direct bilirubin \\\u003C 35%), except where impaired hepatic function is a consequence of the fast-flow malformation and hence is an indication for treatment, in which case impaired hepatic function is acceptable.\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits or corrected with supplements; Phosphate ≤ 1x ULN.\n9. Patient agrees to abstinence or highly effective contraceptive measures if of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking mirdametinib and for at least 90 days after stopping mirdametinib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 90 days after stopping mirdametinib\n   * Females who are of child-bearing potential, defined as all individuals physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 180 days after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of childbearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of MEK inhibitors or any of the excipients of mirdametinib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of a MEK inhibitor\n5. Patient has abnormal QT interval corrected by Fridericia's formula (\\> 450 msec for male participants, \\> 470 msec for female participants, or \\> 480 msec for participants with bundle branch block) (triplicate ECG readings taken approximately 2 to 3 minutes apart and averaged) at Screening;\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for persons of child-bearing potential in the screening period\n7. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n8. Any clinically significant active or known history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n9. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years;\n10. Breast cancer within the past 5 years;\n11. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n12. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n13. Patient has a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration. Patients will be excluded from study participation if they have any of the following risk factors for RVO at Screening:\n\n    * Intraocular pressure \\> 21 mmHg;\n    * Serum cholesterol \\> 7.8 mmol\u002FL;\n    * Serum triglycerides \\> 3.4 mmol\u002FL;\n    * Hyperglycaemia (fasting blood glucose \\> 7.0 mol\u002FL );\n    * Age specific hypertension\n\n      * Patients ≥ 13 years of age with a blood pressure ≥ 140\u002F90 mmHg\n      * Patients ≤ 12 years of age with a blood pressure ≥ 95th percentile for age + 12 mmHg\n14. Known history of glaucoma\n15. Known history of clinically significant, uncontrolled heart disease and\u002For recent (within 6 months \\[24 weeks\\] of signing informed consent\u002Fassent) cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 140 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 90 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n16. Patient has recorded a left ventricular ejection fraction (LVEF) \\\u003C 55% at Screening\n17. Patient has experienced a cerebrovascular accident, transient ischaemic attach, or symptomatic pulmonary embolism within 6 months (24 weeks) of signing informed consent\u002Fassent.\n18. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of mirdametinib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n19. Patient is unable to understand and comply with treatment instructions and requirements",{"count":19,"type":20},[23],"Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).",[55,56,57,58,59,60,61,26,62,63,64,65,66,67,68,69,70,71],"Slow-Flow Vascular Malformation","Fast-Flow Vascular Malformation","Vascular Malformations","Venous Malformation","Lymphatic Malformation, Low Flow","Lymphatic Malformation","Lymphangioma","Venous Malformation, Low Flow","Cystic Hygroma","Vascular Anomaly","Vascular Anomalies","PI3K Gene Mutation","MAP2K1 Gene Mutation","PIK3CA-related Overgrowth Spectrum","Arteriovenous Malformation (AVM)","KRAS G12C","KRAS G12D",[73,74,75,76,77],"Targeted therapy","vascular malformations","skin diseases, vascular","Phosphatidylinositol 3-Kinases","MEK inhibitor 1","2026-04-29",{"date":80,"type":34},"2026-05-05",{"date":82,"type":34},"2024-09-13",{"date":84,"type":20},"2027-05",{"name":86,"class":41},"Murdoch Childrens Research Institute",2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":124,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100571728","neurosurgical-outcome-network-100571728","NCT06724029","Neurosurgical Outcome Network","Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia","NEON","Inclusion Criteria:\n\n* Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)\n* Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial\u002Fparasellar development.\n* Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, dural fistulas, nontraumatic hematomas)\n* Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage, diffuse damage with edema, diffuse damage with shift) and focal damage (acute\u002Fsubacute\u002Fchronic subdural hematoma, extradural hematoma, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.\n* Spinal pathology: degenerative cervical (anterior\u002Fposterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.\n* Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain\u002Falgia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.\n* Peripheral nervous system pathology: peripheral nerve compression syndromes, peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)\n* Malformative pathology: Chiari malformation type 1 and craniostenoses including both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.\n* For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology\n\nExclusion Criteria:\n\n* For cognitive and psychological assessment: patients with psychiatric diseases in history and\u002For taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.","18 Years",{"count":98,"type":20},4500,"OBSERVATIONAL","The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a \"common language\" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.",[102,26,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123],"Aneurysms","Cavernomas","Skull Base Tumors","Moyamoya Disease","Dural Fistulas","Subdural Hematoma","Extradural Hematoma","Subarachnoid Hemorrhage","Hydrocephalus","Parkinson&Amp;#39;s Disease","Spasticity","Trigeminal Neuralgia","Craniofacial Pain","Neuropathic Pain","Tremor","Dystonias","Obsessive-compulsive Disorder","Drug-resistant Epilepsy","Depression","Normal Pressure Hydrocephalus","Tumors of Peripheral Nerves","Chiari Malformation Type 1",[125],"Neurosurgery Outcome Artificial Intelligence predictors","2026-03-25",{"date":128,"type":34},"2026-03-30",{"date":130,"type":34},"2022-12-05",{"date":132,"type":20},"2027-06",{"name":134,"class":41},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",27,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100629659","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-everolimus-in-patients-with-teratment-refractory-vascular-anomalies-100629659","NCT07477548","A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies","Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Everolimus in Relapsed or Refractory Hemangioendothelioma and Other ISSVA Group I or II Vascular Malformation and Neoplasms","Inclusion Criteria:\n\n① Diagnosis per the 2014 ISSVA classification: Group 1 (hemangioendothelioma, tufted angioma): histologically confirmed tumor, OR Kasabach-Merritt Syndrome (histologically confirmed or histologic diagnosis not feasible) Group 2 (vascular tumors not in Group 1, or vascular malformations): histologically confirmed, OR radiologically diagnosed when biopsy is not feasible\n\n* Age ≥1 year ③ Failure of at least one prior therapy (e.g., vincristine, corticosteroids, interferon), stratified as: Cohort 1: sirolimus-naïve Cohort 2: prior sirolimus failure\n\n  * At least one measurable target lesion ≥1 cm in longest diameter per RECIST 1.1 on CT or MRI\n\n    * ECOG Performance Score 0, 1, or 2 ⑥ WOCBP must have a negative pregnancy test prior to enrollment; adequate contraception required during the study and for 8 weeks after completion ⑦ Written informed consent obtained\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding (WOCBP must use adequate contraception)\n\n  * Documented allergy or hypersensitivity to everolimus\n\n    ③ Inadequate organ function: Bone marrow: ANC \\\u003C1,000\u002FµL or platelets \\\u003C75,000\u002FµL Renal: serum creatinine \\>1.5×ULN; if \\>1.5×ULN, 24-hour creatinine clearance \\\u003C60 mL\u002Fmin Hepatic: total bilirubin \\>1.5×ULN or ALT \\>3.0×ULN\n    * KMP associated with vascular tumors or malformations is not an exclusion criterion, including: thrombocytopenia (\\\u003C100,000\u002FµL), hypofibrinogenemia, anemia (Hb \\\u003C8 g\u002FdL), consumptive coagulopathy, or overlying skin changes (edema, warmth, erythema, purplish\u002Fdark discoloration)\n\n      * Uncontrolled hyperlipidemia (fasting cholesterol \\>300 mg\u002FdL or triglycerides \\>2.5×ULN)\n\n        * Uncontrolled diabetes (fasting glucose \\>1.5×ULN)\n\n          * Active uncontrolled infection\n\n            * Hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive) ⑨ Known HIV infection (positive serology)\n\n              * Clinically significant symptomatic pulmonary dysfunction; PFTs and room air SpO₂ performed if clinically indicated; exclusion if FEV₁ ≤70% or DLCO ≤70% of predicted (assessed in patients ≥8 years)\n\n                ⑪ Prior solid organ or hematopoietic stem cell transplantation (bone marrow, liver, kidney, lung, or heart)\n\n                ⑫ Concomitant investigational agents (e.g., mTOR inhibitors: sirolimus, temsirolimus)\n\n                ⑬ Concurrent chemotherapy (e.g., mTOR inhibitors: sirolimus, temsirolimus)\n\n                ⑭ Concurrent other malignancy not meeting eligibility criteria","1 Year",{"count":145,"type":20},67,[23],"Background and Objectives Vascular anomalies are a heterogeneous group of disorders classified into vascular tumors and vascular malformations according to the ISSVA classification. Although most follow a benign course, a subset causes serious complications including organ dysfunction, chronic pain, thrombocytopenia, and hemorrhage. Kaposiform hemangioendothelioma (KHE) complicated by Kasabach-Merritt Phenomenon (KMP) carries a mortality rate of 14-24%. Surgical resection is the primary treatment when organ damage is not anticipated; however, when surgery is not feasible, pharmacologic therapy is considered. Agents such as interferon, corticosteroids, vincristine, cyclophosphamide, and propranolol have been used with variable efficacy, and no established therapy exists for patients refractory to these treatments.\n\nThe PI3K-Akt-mTOR and RAS-MEK-ERK pathways have been identified as key molecular mechanisms underlying vascular anomalies. Targeted therapies against these pathways are emerging, including anti-VEGF antibodies, PI3K\u002FAkt inhibitors (e.g., alpelisib, miransertib), and mTOR inhibitors. Sirolimus has demonstrated clinical benefit in 50-80% of patients with vascular anomalies, with a 96% symptom response rate in KMP-associated vascular tumors. Everolimus, another mTOR inhibitor, is already approved and established for tuberous sclerosis-associated angiomyolipoma and SEGA in pediatric patients, with a well-characterized safety profile. Given its shared mechanism with sirolimus and emerging case reports supporting efficacy in KHE with KMP, this phase 2 study aims to evaluate the efficacy and safety of everolimus in patients with treatment-refractory vascular anomalies.\n\nStudy Design This is a single-center, open-label, uncontrolled phase 2 clinical trial enrolling 67 patients over 60 months from IRB approval, stratified into two cohorts: Cohort 1 (sirolimus-naïve, n=39) and Cohort 2 (prior sirolimus failure, n=28). Everolimus is administered orally at age- and CYP3A4\u002FP-gp inducer-adjusted doses, with maintenance dosing titrated to a target trough level of 5-15 ng\u002FmL. The primary endpoint is overall response rate (ORR) at 6 months. Secondary endpoints include toxicity per NCI CTCAE v4.0, ORR at 12 months, platelet recovery rate at 4 weeks (KMP patients), 1-year overall survival, and 3-year progression-free survival.",[57,26,58,61,149,150,151],"Nevus, Port-Wine","Hemangioendothelioma","Hemangioma","NOT_YET_RECRUITING","2026-03-12",{"date":155,"type":34},"2026-03-17",{"date":157,"type":20},"2026-04-01",{"date":159,"type":20},"2030-11-30",{"name":161,"class":41},"Yonsei University",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":170,"minAge":96,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100377445","pregnancy-in-women-with-rare-multisystemic-vascular-diseases-cograre5-study-100377445","NCT04194619","Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study","A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study","COGRare5","Inclusion Criteria:\n\n* Women aged ≥ 18 years and ≤45 years at the time of inclusion\n* Pregnant and\u002For having given birth less than 1 month (≤ 30 days)\n* Clinically and\u002For radiological and\u002For molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery.\n* Having been informed of all pertinent aspects of the study and provided oral non-opposition.\n\nExclusion Criteria:\n\n* Any person not fulfilling the inclusion criteria or refusing to take part in the study.\n* Major under legal protection","FEMALE","45 Years",{"count":173,"type":20},400,"There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome or related, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.\n\nThe purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.\n\nIn this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.",[64,176,177,178,26,179],"Osler Rendu Disease","Marfan Syndrome or Related","Lymphedema Primary","Cerebrospinal; Disorder","2026-03-09",{"date":182,"type":34},"2026-03-11",{"date":184,"type":34},"2020-02-06",{"date":186,"type":20},"2028-11",{"name":188,"class":41},"Hospices Civils de Lyon",36,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100624056","microwave-ablation-for-treatment-of-vascular-malformations-efficacy-and-safety-100624056","NCT07404670","Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety","A Multicenter, Prospective Study to Analyze the Efficacy and Safety of Microwave Ablation for the Treatment of Vascular Malformations","Inclusion Criteria:\n\n1. Patients with clinically diagnosed vascular malformations (venous malformations (VM) or arteriovenous malformations (AVM)) confirmed by MRI or ultrasound.\n2. Presence of symptomatic lesions (pain, swelling, functional impairment, or ulceration) that require treatment.\n3. Lesions that are amenable to microwave ablation based on preoperative clinical and imaging assessment.\n4. Ability to provide informed consent or parental consent for minors (if applicable).\n\nExclusion Criteria:\n\n1. Capillary malformations or congenital arteriovenous fistula.\n2. Lesions that are too close to critical structures (e.g., major blood vessels or nerves) and cannot be safely treated.\n3. Pregnancy or breastfeeding.\n4. Severe coagulopathy or significant bleeding disorders.\n5. Active infection at the treatment site.\n6. Patients with severe uncontrolled systemic disease that could interfere with treatment or recovery.\n7. Recent treatments (e.g., surgery, sclerotherapy, embolization) for the same lesion within the last 6 months.",{"count":198,"type":20},150,[200],"NA","This clinical trial aims to assess the safety and efficacy of microwave ablation in treating vascular malformations, including both venous malformations (VM) and arteriovenous malformations (AVM). Vascular malformations are abnormal clusters of blood vessels that can cause pain, swelling, and functional impairment, significantly affecting a patient's quality of life. Microwave ablation is a minimally invasive treatment that uses heat to shrink abnormal vessels, but its effectiveness and safety for these conditions need further investigation.\n\nThe trial will enroll 150 patients (100 with venous malformations and 50 with arteriovenous malformations), all of whom will undergo a single session of microwave ablation. Ultrasound guidance will be used during the procedure to precisely target the lesions, while MRI will be used for both preoperative and postoperative evaluations to assess lesion size and track changes over time.\n\nThe primary goals of the study are to determine whether microwave ablation can reduce lesion size and improve symptoms such as pain and swelling. Additionally, the study will monitor adverse events to evaluate the safety of the procedure, including any potential complications like infection, bleeding, or nerve injury.\n\nPatients will be followed for 12 months, with MRI scans taken at 1 month, 3 months, 6 months, and 12 months after the procedure to evaluate lesion shrinkage and monitor for any recurrence. Clinical symptoms will also be assessed at these time points to track improvement.\n\nThis study could provide important data on the safety and efficacy of microwave ablation, potentially offering a less invasive treatment option for patients with vascular malformations.",[203,26,204,57],"Venous Malformations","Microwave Ablation",[204,57,203,26,206],"Minimally Invasive Treatment","2026-02-05",{"date":209,"type":34},"2026-02-11",{"date":211,"type":20},"2026-03-01",{"date":213,"type":20},"2028-03-01",{"name":215,"class":41},"Chengdu University of Traditional Chinese Medicine",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":238},"100421835","genetics-of-central-nervous-system-arteriovenous-malformations-gene-mav-100421835","NCT04772963","Genetics of Central Nervous System Arteriovenous Malformations (GENE-MAV)","Genetics of Central Nervous System Arteriovenous Malformations (AVM): Genotype-Phenotype Correlation and Prognostic Impact on Patients With AVM","GENE-MAV","Inclusion Criteria:\n\n* Patient with a vascular malformation of the cerebral or medullary identified on diagnostic imaging (angio-CT, angio-MRI or diagnostic angiography) for which clinical monitoring alone or intervention (endovascular treatment, surgery or radiosurgery) is planned in the centres participating in the research.\n\nExclusion Criteria:\n\n* Pregnant, parturient or breastfeeding woman",{"count":225,"type":20},300,"Cerebral and medullary arteriovenous malformations (AVMs) lead to arterial and venous networks to communicate pathologically, creating an arteriovenous shunt. The occurrence of intracranial haemorrhage is the most important prognostic factor of AVMs because it is associated with a significant morbidity and mortality. The genetic, molecular and cellular mechanisms that cause vascular malformations of the central nervous system are partially known and the influence of genetic damage on the prognosis of AVMs is poorly known.",[26],"2026-01-21",{"date":230,"type":34},"2026-01-22",{"date":232,"type":34},"2022-02-17",{"date":234,"type":20},"2027-03",{"name":236,"class":237},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",1,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":238},"100276497","long-term-follow-up-after-embolization-of-brain-arteriovenous-malformations-100276497","NCT02879071","Long Term Follow-up After Embolization of Brain Arteriovenous Malformations","MAV-endovasc","Inclusion Criteria:\n\n* arteriovenous malformation\n* age \\> 18 years old\n\nExclusion Criteria:\n\n* none",{"count":247,"type":20},1000,"The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients.",[26],{"date":230,"type":34},{"date":252,"type":34},"2015-11-26",{"date":254,"type":20},"2037-11-25",{"name":236,"class":237},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":264,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":265,"targetDuration":267,"studyType":99,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100536012","comprehensive-hht-outcomes-registry-of-the-united-states-chorus-100536012","NCT06259292","Comprehensive HHT Outcomes Registry of the United States (CHORUS)","CHORUS: Comprehensive HHT (Hereditary Hemorrhagic Telangiectasia) Outcomes Registry of the United States","CHORUS","Inclusion Criteria:\n\n* Diagnosed with HHT based on the Curacao diagnostic criteria or genetic testing.\n* Able to provide informed consent or informed consent via a parent or legally authorized representative due to their age or medical condition.\n\nExclusion Criteria:\n\n* Unable to provide informed consent or informed consent via a parent or legally authorized representative.",true,{"count":266,"type":20},10000,"10 Years","The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The purpose of this study is to better understand HHT, the symptoms and complications it causes, and the impact the disease has on people's lives. The investigators will collect long-term information about the participant, allowing us to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease.\n\nAnother important goal of the study is to provide a way to contact people to participate in future clinical trials and other research. The registry will be a centralized resource for recruitment for clinical trials. People in the registry will not be obligated to join any of these additional studies, but if interested, can agree to be contacted if they may be eligible for a study.\n\nParticipants will:\n\n* Be asked to provide permission to collect information from their medical records, including things like demographic information, diagnosis information, family history, test results, treatment information, symptoms, complications, lifestyle and other relevant medical information.\n* Be asked study-related questions by phone or at a clinic visit.\n* Be asked study-related questions every year after enrollment for up to 10 years or until the study ends. A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous year\u002Fs including new test results, treatment information, symptoms, and complications from HHT.",[270,26,271,272,273,274,275],"Hereditary Hemorrhagic Telangiectasia","Telangiectasia","Epistaxis","GastroIntestinal Bleeding","Cerebral Arteriovenous Malformations","Vascular Malformation","2025-06-10",{"date":278,"type":34},"2025-06-13",{"date":280,"type":34},"2023-11-13",{"date":282,"type":20},"2033-11",{"name":284,"class":41},"Cure HHT",16,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":303,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":238},"100475957","intraoperative-brain-shift-calculation-study-100475957","NCT05477680","Intraoperative Brain Shift Calculation Study","Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial","BRASH","Inclusion Criteria:\n\n* all intracranial tumors\n* cavernomas\n* arteriovenous malformations\n* spontaneous (non-traumatic) intracerebral hemorrhages\n* traumatic intracerebral hemorrhages\n* supratentorial localization\n* newly diagnosed\n* age 18-100 years\n* stable hemodynamics\n* error of patient registration in neuronavigation no more than 2 mm\n\nExclusion Criteria:\n\n* rapid cerebral dislocation","100 Years",{"count":296,"type":20},100,[200],"The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.",[300,301,26,302],"Tumor, Brain","Cavernoma","Intracerebral Hematoma",[304,305,306,307,308],"brain shift","tumor","cavernoma","arteriovenous malformation","intracerebral hematoma","2025-05-13",{"date":311,"type":34},"2025-05-16",{"date":313,"type":34},"2022-09-01",{"date":315,"type":20},"2027-08-31",{"name":317,"class":318},"Sklifosovsky Institute of Emergency Care","OTHER_GOV",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":294,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":338,"locationsCount":238},"100476462","sonography-guided-resection-of-brain-mass-lesions-100476462","NCT05484245","Sonography-guided Resection of Brain Mass Lesions","Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial","SOMALI","Inclusion Criteria:\n\n* all intracranial tumors\n* cavernomas\n* arteriovenous malformations\n* spontaneous (non-traumatic) intracerebral hemorrhages\n* traumatic intracerebral hemorrhages\n* supratentorial localization\n* newly diagnosed\n* age 18-100 years\n* stable hemodynamics\n\nExclusion Criteria:\n\n* rapid cerebral dislocation\n* previously performed brain radiotherapy",{"count":296,"type":20},[200],"Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.",[300,26,301,302],[332,333,334,306,307,308],"intraoperative sonography","intraoperative ultrasound","brain tumor",{"date":311,"type":34},{"date":313,"type":34},{"date":315,"type":20},{"name":317,"class":318},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":356,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100216702","treatment-of-brain-avms-tobas-study-100216702","NCT02098252","Treatment of Brain AVMs (TOBAS) Study","Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry","TOBAS","Inclusion Criteria:\n\n* Any patient with a brain AVM\n\nExclusion Criteria:\n\n* Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS.","5 Years",{"count":247,"type":20},[200],"The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.\n\nThe trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).\n\nAs for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.",[352,353,26,354,355],"Unruptured Brain Arteriovenous Malformation","Ruptured Brain Arteriovenous Malformation","AVM","BAVM",[357,26,354,355,358,359,360,361,57,362,363,364],"brain arteriovenous malformation","Stroke","Intracranial Hemorrhage","Congenital Abnormalities","Aneurysm","Cardiovascular Abnormalities","Cardiovascular Diseases","Vascular Diseases","2024-08-13",{"date":367,"type":34},"2024-08-15",{"date":369,"type":4},"2014-05",{"date":371,"type":20},"2036-01",{"name":373,"class":41},"Centre hospitalier de l'Université de Montréal (CHUM)",30]