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Brain Diseases clinical trials

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NCT ID: NCT00216502 Completed - Alzheimer Disease Clinical Trials

A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease

Start date: August 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.

NCT ID: NCT00147030 Completed - Hypoxia Clinical Trials

TOBY: a Study of Treatment for Perinatal Asphyxia

Start date: December 2002
Phase: N/A
Study type: Interventional

Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

NCT ID: NCT00097097 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Neonatal Resuscitation in Zambia

Start date: October 2004
Phase: Phase 3
Study type: Interventional

Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

NCT ID: NCT00088426 Completed - Clinical trials for Developmental Delay Disorders

Clinical and Genetic Studies on Holoprosencephaly

Start date: January 23, 2004
Phase:
Study type: Observational

This study will examine how holoprosencephaly (HPE) affects people, how they change over time, and what genes may be involved in the cause of the disorder. HPE is a defect of brain development in utero in which the forebrain fails to sufficiently divide into two hemispheres, resulting in a single-lobed brain and skull and facial malformations. In most cases, the defects are so severe that babies die before birth. There are three classifications of HPE. In alobar HPE the brain does not divide at all; this form is usually associated with severe facial deformities. In semilobar HPE the hemispheres divide somewhat, causing an intermediate form of the disorder. In lobar HPE, the mildest form, separation of hemispheres is nearly normal. Patients with HPE and their direct blood relatives may participate in this study. Patients are seen by a team of medical specialists at the NIH Clinical Center for the following procedures: - Physical and neurological examination - Eye examination - Imaging studies, such as echocardiogram, abdominal ultrasound, brain MRI - Electroencephalogram (EEG) - Hearing evaluation - Blood and urine samples for genetic and endocrine studies, routine blood chemistries, urinalysis, and urine electrolytes - Other consultations as needed - Possibly photographs, including front and side views of the face and other body parts that may be involved in HPE, such as the eyes, teeth, hands, and feet Parents will be asked questions about the child's prenatal, birth, newborn, and past medical history, growth, behavior and development, and therapy and medication. Because HPE is a genetic disorder and gene changes can be passed on in a family, parents will also be asked to undergo the following procedures: - Completion of a medical and family history form - Physical and neurological examination - Blood and urine samples (for mothers only) - Specialty consultations as indicated - Possibly photographs, including front and side views of the face and other body parts that may be involved in HPE, such as the eyes, teeth, hands, and feet - Psychosocial study. Some parents will be asked to participate in a telephone interview or complete a questionnaire, or both, about their attitudes, beliefs, and concerns about how they and their family cope with their child's condition. Some questionnaires may include questions about aspects of their marriage and personal feelings and experiences. Parents will meet with a doctor and a genetics nurse to discuss the results of the tests and answer questions. Parents may be asked to bring their child back to the NIH after 2 years for follow-up examination and possible additional or repeat testing. ...

NCT ID: NCT00024908 Completed - Healthy Clinical Trials

Test of A Model of Representational Knowledge Stored in the Human Prefrontal Cortex

Start date: October 1, 2001
Phase: N/A
Study type: Observational

This study will examine the underlying mental processes that determine how people understand social behavior, remember information, and think. Language, planning, problem solving, reasoning, social behavior, and memory are the critical parts of cognition that make up daily life. This study will explore the association between performance on various experimental tasks and day-to-day functioning. Healthy normal volunteers and patients with certain kinds of brain damage (primarily focal or degenerative lesions of the human prefrontal cortex) or psychiatric disorders may be eligible for this study. Candidates with central nervous system trauma, disease or dysfunction will be screened with a routine neurological examination and history. Participants may be asked to complete written tests, sit in front of a computer monitor and press a key to indicate a decision about what appears on the screen (for example, whether a statement is accurate) and answer questions from a test examiner. A skin conductance response (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of metal attached to wires) placed on the fingers to measure the subject's emotional reaction to a test. Participants may also do an evoked response test, in which the subject watches words or scenes on a TV screen while his or her responses are recorded from electrodes placed on the scalp (similar to an electroencephalogram). The tests will be scheduled for an average of one session a week, with each session lasting from 30 minutes to 3 hours. Generally, 15 sessions will be scheduled over a 1-year period. Special arrangements will be made to accommodate participants from out-of-town. Participants may have a magnetic resonance imaging (MRI) scan of the brain. This test uses radio waves and a strong magnetic field to picture structural and chemical changes in tissue. For the procedure, the subject lies on a table in a space enclosed by a metal cylinder (the scanner) for about 1 hour. In addition, some study subjects will be invited to participate in a training study designed to improve their planning or social behavior. Participation requires coming to NIH daily over a 1- to 2-month period for 1 to 2 hours each visit.

NCT ID: NCT00016510 Completed - Healthy Clinical Trials

Differences in Brain Processing of First and Second Languages (Korean and English)

Start date: May 2001
Phase: N/A
Study type: Observational

This study will examine differences in how the brain processes English and Korean in native Korean speakers who are fluent and non-fluent in English as a second language. It is thought that people who are non-fluent in a second language process the second language differently from their native language-using different areas of the brain and requiring additional working memory. The study will increase understanding of language acquisition, brain plasticity and bilingualism. Native Korean speakers between 18 and 50 years of age with English as a second language may be eligible for this study. Three groups of individuals will be enrolled: 1) less fluent bilinguals - those who have lived in the United States for at least 1, but less than 2 years and studied English after age 12 and who have a TOEFL (Test of English as a Foreign Language) score above 550; 2) fluent bilinguals with early acquisition - those who were exposed to English before age 7 and lived in the United States after that; and 3) fluent bilinguals with late acquisition - those who were exposed to English after age 12 and lived in the United States after age 10. People with a history of head injury or neurological or thought disorder, left-handed people, and people who cannot read the material used in the study will be excluded from the study. Participants will undergo magnetic resonance imaging (MRI) scanning while reading words in English or Korean; while translating from one language to the other; and while answering questions about the meaning of words in each language. MRI uses a strong magnetic field to image brain tissue. The patient lies on a table that slides into a narrow metal cylinder, which is the scanner. The head is restrained gently with foam padding to limit movement. The patient can see out of the scanner through a mirror and is in contact with the technician via an intercom at all times during the procedure. The scans measures blood flow to different parts of the brain, providing information about what brain regions are being used during the tasks performed. Another scan will be done to obtain a detailed picture of the brain's structure. This study will evaluate the usefulness of MRI in identifying brain areas involved in processing different languages and increase knowledge about how illness affects brain function. It may help plan treatment for bilingual patients who must undergo brain surgery for uncontrolled epilepsy or who have a neurological disorder affecting different languages with varying degrees.

NCT ID: NCT00004796 Completed - Cirrhosis Clinical Trials

Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

Start date: November 1994
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.

NCT ID: NCT00001927 Completed - Clinical trials for Cerebrovascular Accident

Study of Abnormal Blood Clotting in Children With Stroke

Start date: February 22, 1999
Phase: N/A
Study type: Observational

Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood. There is increasing evidence that inherited and acquired coagulation abnormalities alone or in combination with environmental factors, predispose to arterial and venous thrombosis. Inherited abnormalities of factor V Leiden, prothrombin, protein C, protein S, and antithrombin III may account for many of these thromboses. At present there is little information on the existing distribution of these coagulation anomalies in children with thrombosis. Recent reports also suggest that these clotting abnormalities may be responsible for some instances of intracranial hemorrhage, porencephaly, cerebral palsy and fetal death. This study will measure the frequency of several coagulation factor abnormalities (factor V Leiden, prothrombin 20210A, protein C, protein S, antithrombin III, and antiphospholipid antibodies) in children with a history of porencephaly and stroke, and will compare these to the prevalence of these mutations in population controls and family members. We will also describe the exogenous conditions which in concert with these coagulation factors, may have led to the development of thrombosis in these children....

NCT ID: NCT00001284 Completed - fMRI Clinical Trials

Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers

Start date: May 10, 1991
Phase:
Study type: Observational

The purpose of this study is to use brain imaging technology to compare differences in brain structure, chemistry, and functioning in individuals with brain and mental disorders compared to healthy volunteers. Schizophrenia is a brain disorder that results from subtle changes and abnormalities in neurons. These deficits likely occur in localized regions of the brain and may result in widespread, devastating consequences. The neuronal abnormalities are inherited through a complex combination of genetic and environmental factors. Brain imaging technologies can be used to better characterize brain changes in individuals with schizophrenia. This study will use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize schizophrenia and other neurological and neuropsychiatric disorders....

NCT ID: NCT00000982 Completed - HIV Infections Clinical Trials

A Study of Azidothymidine in HIV-Infected Children

Start date: n/a
Phase: Phase 2
Study type: Interventional

AMENDED 07/07/93: To evaluate whether continuous infusion AZT will impact neurodevelopmental deficits associated with HIV infection or alter rate of encephalopathy progression in children who have failed to improve or shown progression of these deficits despite optimal AZT therapy. AMENDED: To assess whether didanosine (ddI) will be better tolerated than AZT administered by either continuous intravenous delivery or oral administration (ddI arm removed per amended version).To determine whether ddI will achieve comparable clinical efficacy as the continuous intravenous route of delivery of AZT, and to assess whether either or both of these regimens are superior to that achieved with an intermittent AZT dosage schedule. To determine whether there are differences in patient or parent (guardian) compliance between the three treatment regimens. Original design: To determine whether the pharmacokinetic profile (bloodstream levels) of zidovudine (AZT) influences its effectiveness on HIV infection in children. That is, the study seeks to find out whether there is a difference in the effect of AZT when given as a continuous intravenous infusion (and, if available, an oral sustained release dose) compared to an intermittent (not continuous) dose given orally every 6 hours. The study also plans to determine (1) whether there are differences in the tolerance and side effects associated with AZT when given on an intermittent schedule as opposed to a steady-state schedule; (2) the extent of variation from patient to patient in AZT levels and whether the plasma and cerebrospinal fluid levels of AZT are related to the degree of therapeutic effectiveness; and (3) whether there are differences in the response of children who acquired HIV infection perinatally (just before, during, or just after the time of birth) versus those who acquired HIV infection by transfusion. One of the most serious effects of HIV disease in children is neuropsychological deterioration (relating to mental and nervous system functioning). This complication affects the vast majority of HIV infected children. A previous study of continuous intravenous administration of AZT in pediatric patients with HIV infection showed consistent and dramatic improvements of symptoms in all patients that had shown neurodevelopmental deficits or abnormalities. These improvements were seen within 3 to 4 weeks after AZT treatment was started. Neurodevelopmental improvements have been sustained on AZT, usually showing steady improvement which, in some patients, was associated with restoration of pre-HIV intellectual and neurological function. This study also showed an increase in the IQ scores of children receiving continuous infusion of AZT who did not have overt clinical evidence of encephalopathy (disease of the brain). Thus changes in cognitive function may be among the earliest signs of AIDS encephalopathy and underscores the need to start therapies that will treat the central nervous system in patients who appear to be clinically intact. A study comparing continuous infusion to intermittent dosing of AZT showed a significant increase in IQ scores for those children receiving the continuous dose compared to those treated with the intermittent schedule. Although a portable infusion pump allows patients to receive continuous infusion of AZT, a sustained release oral formulation that could provide a continuous release of AZT into the bloodstream would be highly desirable.