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Pseudotumor Cerebri clinical trials

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NCT ID: NCT04796935 Completed - Cancer Clinical Trials

A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control

Start date: April 4, 2021
Phase: N/A
Study type: Interventional

This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

NCT ID: NCT04603118 Completed - Pseudotumor Cerebri Clinical Trials

Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

Idiopathic intracranial hypertensionis a type of increased intracranial pressure. Diagnosis is made by lumbar puncture, which is an invasive technique. The relationship between ICP and optic nerve sheath diameters (ONSD) were examined in our study. Thus, it was investigated whether the optic nerve sheath diameter could be used in the diagnosis of IIH. In the present study, it was found that ONSD measurement by optic USG significantly reflects increased ICP and decreasing pressure via LP is rapidly reflects to ONSD measurement. And it is suggested that ONSD measurements by optic USG, a non-invasive method, can be used in the diagnosis and follow-up of IIH patients.

NCT ID: NCT04314128 Completed - Clinical trials for Idiopathic Intracranial Hypertension

Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight females of child-bearing age. Patients suffer from increased intracranial pressure (ICP), typically resulting in headaches, visual disturbances and bilateral papilledema, pulsatile tinnitus and cognitive deficits. The disease is difficult to diagnose, treat and monitor. The only current method of measuring the ICP in day-to-day clinical practice is by lumbar puncture. This procedure is invasive, and often painful for the patient. There is an unmet need of methods that can reliable measure or estimate ICP in a non-invasive manner. Ultrasound is one such potential method, and the aim of this study is to investigate the use of ocular ultrasound and transcranial doppler to measure or estimate ICP.

NCT ID: NCT04207229 Completed - Hydrocephalus Clinical Trials

CERTAS Programmable Valve Registry

CERTAS
Start date: November 21, 2019
Phase:
Study type: Observational [Patient Registry]

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

NCT ID: NCT03963336 Completed - Clinical trials for Idiopathic Intracranial Hypertension

Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension

Start date: July 22, 2017
Phase: Early Phase 1
Study type: Interventional

Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology. The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.

NCT ID: NCT03867461 Completed - Clinical trials for Idiopathic Intracranial Hypertension

The Effects of MAP and EtCO2 on Venous Sinus Pressures

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

NCT ID: NCT02017444 Completed - Clinical trials for Idiopathic Intracranial Hypertension

Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension.

IIH:DT
Start date: April 25, 2014
Phase: Phase 2
Study type: Interventional

Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH) IIH is a condition of young, overweight women with characteristic raised intracranial pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there is little evidence for the treatments used for IIH. Weight control appears the most effective method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our previous research suggests it may influence the production of brain fluid(cerebrospinal fluid or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased intracranial pressure. Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter the study if they are between 18-55 years old with acute (<6 months) IIH, signs of active disease (papilloedema and raised CSF pressure (>25 cmH20)), no other major illnesses and have no plans for pregnancy during the study period. This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial. It will be conducted at the University Hospital Birmingham and the University of Birmingham will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a potential improvement in their condition. We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and consequently treat patients with IIH, thus opening a new and entirely novel therapeutic avenue.

NCT ID: NCT01407809 Completed - Clinical trials for Idiopathic Intracranial Hypertension (IIH)

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

VSSIIH
Start date: January 2012
Phase: Phase 1
Study type: Interventional

Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.

NCT ID: NCT01003639 Completed - Clinical trials for Idiopathic Intracranial Hypertension

Idiopathic Intracranial Hypertension Treatment Trial

IIHTT
Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).

NCT ID: NCT00071903 Completed - Cystinosis Clinical Trials

The Role of Susceptibility to Thrombosis in the Pseudotumor Cerebri of Nephropathic Cystinosis: A Case-Control Study

Start date: October 30, 2003
Phase: N/A
Study type: Observational

This study will examine whether the tendency to have thrombosis, or the formation of blood clots inside blood vessels, has a role in the development of pseudotumor cerebri (PTC). PTC causes symptoms and signs of isolated elevated blood pressure in the cranium, or covering of the brain. The disorder can lead to significant, negative effects on the visual system. Increased pressure of the cerebrospinal fluid, that is, fluid around the brain, is a factor, but the cause of the disorder is not clear. There has been documentation of clustering of PTC within families. It suggests that potential genetic polymorphisms-abilities to take on different forms-may become evident after exposure to conditions known to trigger PTC. Thrombosis comes about by interactions between genetic and environmental or acquired factors, or both, resulting in a blood clot at a specific time and location. Because the disease occurs in episodes, the interaction of the genetic and nongenetic risk factors is important. Cystinosis is a recessive disorder caused by deposits of cystine within the lysosomes of cells-that is, sac-like cell parts that contain various enzymes. Involvement of the kidneys remains the primary characteristic, eventually leading to renal failure. Of all of the risk factors that make it easier for blood clotting, a high level of a substance called homocysteine is of particular interest. Too much homocysteine in blood plasma is a common finding in patients with kidney failure, and it has been recently identified as an independent risk factor for diseases of the blood vessels. Participants of all ages who meet the Dandy criteria for PTC may be eligible for this study. Pregnant women will be excluded. There will also be a control group of nephropathic cystinosis patients who do not have PTC. Participants will be asked to undergo the following tests and procedures: - Medical history. - Physical examination, to evaluate the eye and nervous systems. - Collection of blood for DNA and other tests. - Collection of cerebrospinal fluid, through a procedure called lumbar puncture or spinal tap. The evaluation of patients will generally last 3 to 4 days. For the collection of cerebrospinal fluid, the patient's skin on the back will be numbed with a local anesthetic. A special needle will be inserted into the back, and a small amount of the fluid will be drawn through the needle. There will be pain for a minute, although there can be a headache lasting 24 hours. Also, there may be bruising, local pain, bleeding, or infection where the needle enters. Patients may also have a magnetic resonance imaging scan of their head. During the MRI scan, patients will lie still on a table that slides in and out of a metal cylinder surrounded by a strong magnetic field. Patients will be able to communicate with the MRI staff at all times and may ask to be moved out of the machine at any time.