Pseudotumor cerebri, also known as idiopathic intracranial hypertension, involves increased pressure around the brain without a detectable cause. Clinical trials in this area often explore treatment evaluations aimed at managing intracranial pressure...

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Found 47 Actively Recruiting clinical trials

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Actively Recruiting

Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.

Age: 18Years - 80YearsAll GendersPhase 4
1 location
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Actively Recruiting

This research aims to evaluate the effectiveness and safety of treatment guided by intracranial pressure (ICP) monitoring to improve outcomes for patients with aneurysmal subarachnoid hemorrhage (aSAH). Aneurysmal SAH is a severe brain hemorrhage caused by ruptured intracranial aneurysms, which leads to increased ICP and serious neurological damage. Given the high rate of elevated ICP in these patients, the study addresses a critical need for evidence on using ICP monitoring in managing aSAH. Participants will be randomly assigned to one of two groups. In the experimental group, after surgical treatment of the aneurysm, a ventricular ICP monitoring probe is implanted to guide postoperative ICP management based on measurable ICP values. The control group receives standard aSAH treatment without ICP monitoring, relying instead on clinical signs and CT imaging to assess ICP. Both groups receive similar other treatments as appropriate. During the study, participants will be followed to assess neurological outcomes, including the rate of good neurological functional prognosis at 90 days as the primary measure. Additional outcomes include prognosis at 30 and 180 days, mortality, incidence of hydrocephalus requiring shunt, delayed cerebral ischemia, and epilepsy. Safety and effectiveness will be monitored over time, with assessments conducted through clinical evaluations and imaging. The study is planned to continue until late 2026.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the ability of the ShuntCheck test to detect flow or no flow in ventriculoperitoneal shunts among patients with asymptomatic normal pressure hydrocephalus. This observational study aims to determine the test's accuracy in identifying shunt function without symptoms, providing important information for routine care. Participants will undergo the ShuntCheck diagnostic test, which uses an FDA-cleared device that analyzes shunt flow through transcutaneous thermal convection. The study involves a single testing approach, with some assessments measuring the test performed twice to evaluate specificity and negative predictive value. During the study, participants will be monitored through the ShuntCheck test and routine clinical visits. Researchers will measure the specificity and negative predictive value of the test at 15 minutes and also assess these outcomes when the test is performed twice at 60 minutes. The study is sponsored by the University of South Florida and continues until November 2026.

Age: 40Years +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating a daily nutraceutical supplement containing bioactive B vitamins to reduce optic disc edema in astronauts during long-duration space missions. This study focuses on optimizing the one-carbon metabolic pathway to improve enzyme function, enhance blood vessel health, strengthen eye tissue elasticity, and reduce retinal thickness changes. The investigation aims to better understand causes of optic disc edema and the effects of this nutritional countermeasure compared to astronauts who did not use supplements. Participants will take a vitamin B-complex supplement before, during, and after a 6 to 12 month spaceflight on the International Space Station. This supplement includes 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin. Blood samples are collected multiple times before, during, and after flight to assess vitamin levels, biochemistry, and genetic markers. Eye scans using optical coherence tomography and blood flow measurements will monitor ocular and vascular health. Throughout the study, participants will undergo various tests including blood draws, skin scans for advanced glycation end products, and fingertip temperature assessments to evaluate vascular function. Dietary intake, exercise logs, and medication use will be reviewed. The main outcome is measuring optic disc edema over six months, along with secondary measures of endothelial function, vitamin statuses, oxidative stress markers, and other biochemical indicators. The study lasts throughout the flight and follow-up periods to monitor ongoing effects.

Age: 20Years - 100YearsAll GendersPhase 1
1 location
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Actively Recruiting

Researchers are studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamide/phenylephrine 8 mg/50 mg/mL. This study aims to identify which clinical determinants may increase the risk of these reactions and provide safety information for this commonly used ophthalmic drug combination. It also seeks to establish safety measures for patients undergoing eye examinations or surgery where these drugs are used. The study involves hospitalized patients scheduled for surgery who will receive two drops of tropicamide/phenylephrine 8 mg/50 mg/mL. Vital signs will be measured before administration and then at several time points afterward, including 5, 15, 30 minutes, and 1, 2, and 3 hours post-administration. Data will be collected using questionnaires and analyzed to find associations between clinical factors and adverse reactions. Participants will be monitored closely through vital sign checks and questionnaires during the study period. Researchers will evaluate adverse drug reactions and clinical determinants to understand their connection. The main outcome is to assess vital signs at set intervals following drug administration and identify any adverse reactions. The study is observational and aims to enhance the safety profile of this medication in hospitalized patients.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying idiopathic normal pressure hydrocephalus (iNPH) and related disorders to understand their clinical characteristics and natural progression. This prospective single-center study aims to identify digital, imaging, and molecular biomarkers that can help with diagnosis and therapy development. It also explores the causes and molecular mechanisms of these conditions to better understand their effects and outcomes. Participants are divided into groups including those diagnosed with hydrocephalus and a normal group. The study involves advanced diagnostic tests such as high throughput sequencing, whole genome and exome sequencing, transcriptomics, proteomics, metabolomics, and imaging techniques like DTIALPS. These tests are conducted to gather comprehensive data on the disease and its biomarkers. During study visits, patients undergo standardized clinical examinations and complete clinical rating scales. Biosamples such as blood, urine, cerebrospinal fluid, and muscle biopsies may be collected optionally. Additional assessments like neurophysiological exams, patient-reported outcomes, and imaging are also performed. Researchers measure changes from baseline in DTIALPS imaging and various clinical scales six months after ventriculoperitoneal shunt surgery. The study includes monitoring cognitive function, gait, and molecular patterns, with participation lasting through these assessments and follow-ups.

Age: 18Years - 80YearsAll Genders
1 location
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Actively Recruiting

Researchers are evaluating a new non-invasive method to estimate intracranial pressure (ICP) and assess cerebral autoregulation (CAR) using the CoMind One EFS device. This observational study aims to develop safer alternatives to the current invasive ICP monitoring, which requires surgery to drill into the skull and carries risks like infection and pain. The study collects extensive data to improve the accuracy of this new technology for patients with conditions such as traumatic brain injury and stroke. Participants who are already receiving invasive ICP and arterial blood pressure (ABP) monitoring as part of their standard care will have concurrent measurements taken using the CoMind One EFS device. This device records a cerebral blood-flow index non-invasively, and these signals will be analyzed to create and test models estimating ICP without surgery. The study does not involve additional treatments but compares the new device's readings with existing invasive monitors during the observation period. During the study, participants will have simultaneous invasive and non-invasive ICP and ABP measurements recorded until either three weeks after removal of the CoMind device or discharge from the intensive care unit, whichever comes first. Researchers will analyze the data to evaluate the accuracy of the non-invasive device across different skin tones and its ability to detect changes in ICP states and trends. The goal is to gather detailed information to help develop a reliable, non-invasive ICP monitoring system.

Age: 18Years +All Genders
14 locations
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Actively Recruiting

Glaucoma is a leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. Researchers are studying Ultrasound Cyclo Plasty (UCP), a minimally invasive technique targeting the ciliary body to regulate intraocular pressure (IOP). This study aims to analyze changes in cytokines in the eye's aqueous humor after UCP to better understand their role in surgery outcomes and improve predictability of the procedure's success in patients with primary glaucoma. The treatment involves the use of the EyeOP1 device to perform UCP. During the procedure, a coupling cone is placed on the eye, secured with vacuum suction, and filled with balanced salt solution for ultrasound transmission. Ultrasound transducers emit energy at 21 MHz with controlled power and timing to target the ciliary body precisely. The study observes matched eyes of glaucoma patients before and after treatment to compare cytokine profiles and other eye parameters. Participants will be monitored over an average of two years, during which researchers will measure cytokine levels in aqueous humor, intraocular pressure, and anterior segment parameters. Additional evaluations include visual acuity and recording any complications. The study collects tear samples for follow-up, and data on the eye's environment changes post-treatment to assess the surgery's effects and safety over time.

All Genders
1 location
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Actively Recruiting

Researchers are studying patients with traumatic brain injury, stroke, brain tumors, brain hemorrhages, and other neurotraumas to understand how blood vessel function relates to important brain pressures and blood flow. The study focuses on measuring blood vessel parameters like Vasodilation/Constriction Index, Vascular Resistance Index, and Volume Reactivity Index, and their connection to intracranial pressure and mean arterial pressure. This observational research aims to improve knowledge of cerebral blood flow and brain autoregulation in various neurological conditions. For the study, two FDA-approved noninvasive sensors will be placed on patients' foreheads over the temporal area to measure brain oxygen levels and blood volume. These sensors collect data on regional tissue oxygen saturation and blood volume index. Blood pressure and intracranial pressure readings will be gathered from existing monitors. The sensors may be replaced every 6 hours if monitoring continues longer. This process allows continuous real-time tracking of blood vessel behavior and brain pressures. Participants will be monitored using the sensors and hospital equipment while continuous blood pressure and intracranial pressure monitoring are maintained. Investigators will analyze the collected data on cerebral oxygenation, blood volume changes, vascular resistance, and brain pressure to assess cerebral hemodynamics and autoregulation. The primary outcome measures these parameters over one hour. The study involves adults aged 18 to 100 with neurological injuries and requires consent and continuous monitoring during participation.

Age: 18Years - 100YearsAll Genders
1 location
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Actively Recruiting

Researchers are evaluating the diagnostic accuracy of a device called ShuntCheck compared to radionuclide shunt patency testing in patients with Normal Pressure Hydrocephalus (NPH) who are suspected of having a shunt obstruction. The study aims to determine how well ShuntCheck detects cerebrospinal fluid (CSF) shunt flow issues in this patient group. Participants will undergo the ShuntCheck diagnostic test, which is an FDA-cleared device that uses transcutaneous thermal convection to analyze shunt flow. This test is non-invasive and designed to assess whether the shunt is functioning properly without the need for radionuclide imaging. During the study, researchers will measure the sensitivity and negative predictive value of ShuntCheck compared to the radionuclide shunt patency study, with assessments at 15 minutes and 60 minutes respectively. Participants must be adults aged 40 or older with a ventriculoperitoneal (VP) shunt for NPH and suspected obstruction. The study involves informed consent, and safety exclusions are in place to ensure that the test does not interfere with urgent medical care or existing wounds.

Age: 40Years +All Genders
1 location

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