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Neurobehavioral Manifestations clinical trials

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NCT ID: NCT03246269 Completed - Dementia Clinical Trials

Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)

MoCA-Norm
Start date: December 2016
Phase:
Study type: Observational

This observational cohort study in healthy volunteers establishes normative data for the German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible impacts of demographics on the MoCA total score.

NCT ID: NCT03232697 Completed - Cognitive Symptom Clinical Trials

French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)

MoCATEL
Start date: July 12, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to validate a french version of the 5 minutes version of the Montreal Cognitive Assessment as compared to the french full version of this test.

NCT ID: NCT03227653 Completed - Clinical trials for Medication Adherence

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

Start date: June 19, 2017
Phase:
Study type: Observational

Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing evidence shows that central nervous system side-effects in adults are more common than previously thought. Still, reliable data in children are lacking. As HIV-infected children nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential long-term central nervous system side-effects, interfering with neurodevelopment and psychosocial maturation. Using validated tools, we assessed (1) competence (social/activities/school) and psychopathology (internalizing/externalizing problems), (2) cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian children on an efavirenz or non-efavirenz based regimen In this cross-sectional observational study the investigators will examine neuropsychiatric and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination antiretroviral therapy (cART) with or without efavirenz.

NCT ID: NCT03222375 Recruiting - Clinical trials for Autism Spectrum Disorder

SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism

SQUED™
Start date: September 26, 2017
Phase: N/A
Study type: Observational

Locomotor, transport and information functions in human body systems are carried out by active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the transitions of subsystems from one autowave regime to another Autowave interaction (of Complex Coherent Action). Autowave interaction is a process associated with the evolution and interaction of spatial and wave structures in the active media of the organism. Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media of physiological systems is more optimal for their vital functions than periodic one. Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and easier in case of change of environmental conditions, i.e. the so called adaptive control is more easily implemented in them. Secondly, "spreading" of oscillations strength along comparatively wide frequency band takes place in chaotic regime. When an organism is young and healthy, physiological systems show the elements of chaotic behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics of health. Decrease in changeability and appearance of stable periodicity of Autowave reverberator are often connected with Autism. The main purpose is to study brain plasticity (the changes that occur in the brain through Autowave reverberator) in children with autism. Research suggests that during development, the brains of children may change in response to their Autowave reverberator differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™ series 28.1 home-use for Treatment of Autowave reverberator of Autism. Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between physicians and researchers with expertise in biostatistics, physics, mathematics, engineering, and computer science.

NCT ID: NCT03065348 Terminated - Clinical trials for Frail Elderly Syndrome

Perioperative Multimodal Care for Cystectomy Frail Patient

Start date: April 6, 2017
Phase: N/A
Study type: Interventional

Major surgery in the elderly and frail patient is a challenge. Optimal perioperative management is essential for outcome and survival. There is a need for improved multidisciplinary approach to improve postoperative outcome in this patient population at high risk for postoperative morbidity and mortality. Here the investigators will evaluate the implementation of a multimodal prehabilitation program including optimization of nutrition (protein and carbohydrate loading), optimization of preoperative hydration and the use of regional anesthesia during cystectomy and urinary diversion in a series old frail patients and compared/matched them to a historical series of similar patients in terms of early return of quality of life using the Convalescence and Recovery Evaluation (CARE) instrument, cognition, and postoperative morbidity. The importance of patient-reported health status is well recognized and is a facet of healthcare quality. In addition it is a valuable means for quantitatively measuring the implication of technology adoption for the patient, who typically judges the efficacy of a surgical procedure by whether it improves quality of life. The objective of this study is to evaluate the implementation of a multimodal prehabilitation program in a series old frail patients and compared them to a historical series of similar frail patients in terms of early return of quality of life, cognition, and postoperative morbidity. The importance of patient-reported health status is well recognized and is a facet of healthcare quality. In addition it is a valuable means for quantitatively measuring the implication of technology adoption for the patient, who typically judges the efficacy of a surgical procedure by whether it improves quality of life.

NCT ID: NCT02907437 Recruiting - Schizophrenia Clinical Trials

Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

Start date: January 2015
Phase: Phase 3
Study type: Interventional

Current medications have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. In the past years, various findings from clinical studies showed its potential role for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating positive, negative and cognitive symptoms in schizophrenia patients.The current study is a single center, double-blind, randomized study that assess the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in adult patients suffering from schizophrenia. Patients will be recruited and randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent any gastrointestinal influences of antibiotics administration. Positive and negative symptoms , as well as cognitive functions will be assessed before and after treatment.

NCT ID: NCT02790372 Completed - Dementia Clinical Trials

The Effect of Case Conferencing in Nursing Homes

Start date: April 2015
Phase: N/A
Study type: Interventional

This study evaluates the effect of using comprehensive geriatric assessment in combination with case conferences on the prevalence of neuropsychiatric symptoms (also known as behavioral and psychological symptoms of dementia) in Norwegian nursing homes

NCT ID: NCT02680210 Completed - Cognition Disorders Clinical Trials

Self-defining Memories in Patients With a TBI

IDENTITY
Start date: February 4, 2016
Phase: N/A
Study type: Interventional

The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.

NCT ID: NCT02590848 Completed - Clinical trials for Neurobehavioral Manifestations

Walnuts, Long-Chain Polyunsaturated Fatty Acids and Adolescent Brain Development

WALNUTs
Start date: April 2016
Phase: N/A
Study type: Interventional

Background: Adolescence is an important period for brain development as a result of increased synaptic plasticity. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are essential nutrients for brain development and protection against oxidative stress. Walnuts have the highest n-3 PUFA concentrations of all edible plants. Objective: The investigators hypothesize that walnut intake will increase n-3 PUFA availability in the body to a level that enhances the development of the brain during adolescence. The technicians will conduct a long-term (6 months) population-based randomized controlled trial in teenagers (n=400 in each arm), and determine the effectiveness of the intervention (30 g of walnut kernels per day, ~1.5g of n-3 PUFA) in enhancing brain development. Methods: Fieldwork team will contact teenagers and families in collaboration with 20 high schools. Families will receive a basic guide on following a healthy diet in order to ensure implementation and adherence. Brain development outcomes will be measured at baseline and after the intervention. The use of computerized neuropsychological tests will provide the precision required to detect even subtle changes in brain development resulting from the nutritional intervention. Behavioral (socio-emotional) development will be assessed in order to cover a wider picture of brain development. Blood samples will be collected to measure n-3 PUFA levels before and after the intervention in a randomized subsample from both groups (control/ intervention). Linear regression models adjusted for baseline neuropsychological scores will be used to analyze the intervention effect. Implications: The outcomes of this Project are expected to be a greater understanding of the role of n-3 PUFA intake (walnut) in brain development. A major goal in public health research is to develop cost-effective health recommendations to teenagers.

NCT ID: NCT02557425 Completed - Clinical trials for Neurobehavioral Manifestations

Prophylaxis Against Malaria to Enhance Child Development (PROTECT Study)

PROTECT
Start date: October 2015
Phase:
Study type: Observational

Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often without clinical symptoms in the mother. The systemic and placental changes that occur with malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no published studies to date on the impact of malaria in pregnancy on childhood ND. This study, conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and define mechanisms by which malaria may lead to ND impairment including micronutrient deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24, 36, and 60 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II protocol for research purposes. Some of that blood will be used to test for micronutrient deficiencies as well as other immune responses to malaria.