View clinical trials related to Brain Diseases.
Filter by:Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a frequent complication of cirrhosis that is associated with significant morbidity and poor quality of life. Large-volume ascites has been associated with impaired pulmonary function. In a previous study, the presence and severity of ascites were determined to be significant determinants of fatigue. In this study, we will determine whether large-volume ascites contributes to fatigue by assessing the response to drainage of ascites by means of a procedure called large-volume paracentesis. We hypothesize that treatment of ascites with a single large-volume paracentesis leads to decreased fatigue and improved quality of life and that this improvement is associated with improved sleep pattern. 20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites fluid by large-volume paracenteses will be recruited for the study. All patients will undergo a complete clinical and physical examination for liver function, including blood tests. Hepatic encephalopathy, a change in mental status associated with liver dysfunction, will be assessed by obtaining historical data and by means of simple bedside neuropsychological examinations. Study visits will take place on two consecutive days, with each visit lasting approximately 2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be performed 1 day after the procedure. Statistical analysis will then be performed to determine the effect of the paracentesis on the various clinical assessments.
The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations. Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants. Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger. The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.
The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction) scoring method adapted for the developing world (BIND II, developed by our team for use by health care workers), with additional modifications for community use (the community BIND, C-BIND), will improve the ability to identify infants with ABE and to distinguish ABE from other common causes of neonatal morbidity and mortality compared to currently available survey tools.
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.
The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.
Hepatic encephalopathy (HE) is a potentially reversible functional disorder of the brain with neurological and psychiatric symptoms. HE occurs in up to 70% of patients with cirrhosis at some time during the course of disease. The chief neurotoxin implicated in the development of HE is ammonia. An important aim of treatment of HE is the reduction of the ammonia in the body by lowering the amount of ammonia produced and increasing its detoxification. Enteric production of ammonia can be decreased by non-absorbable disaccharides such as lactulose and antibiotics such as rifaximin. L-ornithine- L-aspartate (LOLA), the salt of the natural amino acids ornithine and aspartate acts through the mechanism of substrate activation to detoxify ammonia. In clinical trials, LOLA has shown a statistically significant effect with respect to reduction in HE grade, reduction of blood ammonia concentration and positive effects on psychomotor function in patients of cirrhosis with minimal HE and overt chronic Grade I HE, as compared to placebo. However, there is lack of data on the efficacy of LOLA in patients with overt acute hepatic encephalopathy which is one of the major causes of hospital admissions and resource utilization in decompensated cirrhotics. Each admission for HE causes a major financial loss to the family and financial burden on the society. Any drug which decreases the hospital stay by rapidly improving HE, will clearly lead to decreased hospital costs to the individual and the society as a whole. Hence, such a trial is a national priority. The investigators hypothesize that LOLA, if added to the standard treatment of overt acute HE (i.e lactulose), may lead to a faster recovery and decrease in hospital stay of these patients. In this prospective, randomized, placebo controlled trial, the investigators aim to evaluate the efficacy of intravenous L-ornithine, L-aspartate in reversal of overt acute hepatic encephalopathy in patients with liver cirrhosis.
The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.
The purpose of the study is to determine the long-term safety and exploratory efficacy of NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I. Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects with comparable demographics and disease characteristics as the treatment group will be enrolled into a control group, followed-up for 3 months, and compared for various disease progression indicators with the treatment group. The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of the Alzheimer's type.