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Spinal Dysraphism clinical trials

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NCT ID: NCT01392989 Completed - Anemia Clinical Trials

Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders

Start date: March 2011
Phase: Phase 2
Study type: Interventional

Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

NCT ID: NCT01302314 Completed - Clinical trials for Executive Dysfunction

Cognitive Rehabilitation in Patients With Spina Bifida

Start date: January 2011
Phase: N/A
Study type: Interventional

This study will examine the effects of a theoretically grounded and manualized cognitive rehabilitation program on patients with Spina Bifida (SB). SB is often associated with deficit in higher order control over cognition, emotion and behaviour; which is typically referred to as executive functions. The present study will examine the efficacy of Goal Management Training (GMT) in patients with SB that experience executive difficulties. It is expected that GMT will have a favourable effect on cognitive executive functioning, psychological and health related factors.

NCT ID: NCT01263392 Completed - Neurogenic Bladder Clinical Trials

Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization

Start date: April 2007
Phase: N/A
Study type: Interventional

The primary aim of this study was to determine if using the SpeediCath hydrophilic catheter would reduce the incidence of symptomatic urinary tract infections (UTI)in children with spina bifida who perform clean intermittent catheterization for bladder management. The hypothesis was that the incidence of symptomatic urinary tract infections would be significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared to users of a reused polyvinyl chloride (PVC) catheter. Subjects were randomly assigned to either starting the study with PVC catheter for 6 months followed by the hydrophilic catheter for 6 months or visa versa. Each subject kept a weekly diary recording urinary tract infections symptoms, hematuria determined by urine dipstick, physician visits, days of missed school and other activities. At the end of each 6 months subjects completed a questionnaire recording their comfort and satisfaction in using the PVC or hydrophilic coated catheter. 70 subjects were randomized and 46 had complete data. There were no differences in febrile UTI, antibiotic use, healthcare visits or school days missed. The incidence of self reported UTI was lower in the PVC group than the hydrophilic group. 40% of subjects indicated that the hydrophilic coated catheter was slippery and difficult to handle compared to 10% for the PVC catheter. However overall satisfaction was no different between products. The study results are consistent with the current Cochrane Review that there is a lack of evidence to state that the incidence of UTI is affected by multiuse or hydrophilic catheter use.

NCT ID: NCT01244399 Completed - Neural Tube Defects Clinical Trials

Influence of "Espresso" on Adsorption of Myo-inositol

Start date: November 2010
Phase:
Study type: Observational

Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise from failure of embryonic neural tube closure. Several studies have demonstrated that periconceptional administration of folic acid can prevent approximately 70% of all NTDs cases. The finding of several NTDs cases in a single family, despite prophylactic therapy with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no preventive therapy for folate-resistant NTDs is available. Studies performed on folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs occurrence. Preliminary results in patients with at least two previous pregnancies affected by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with 500 mg/day of inositol (three months before conception and two months after) is able to prevent NTDs recurrence in humans. Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of NTDs, especially for subgroups of people that carry genetic variants for enzymes involved in caffeine metabolism. The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest to pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether pre-conception caffeine intake interferes with prophylactic therapy for NTDs. In the proposed study, we aim to evaluate the effect of "espresso" consumption (corresponding to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (MI), in order to highlight any possible negative effects of caffeine on MI adsorption and excretion before conception. The study will consist of two phases and will be carried on twelve healthy volunteers. During phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this period, 20 g of MI will be administrated in a single dose. Basal levels of serum and urinary concentration will be evaluated before MI administration (t0); subsequently, sampling will be performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist of 15 additional days of inositol-poor diet: basal levels of MI will be again measured before MI administration. In phase 2, MI administration will be concomitant to caffeine exposure through single"espresso" consumption. Samples will be collected at the same time points as in phase 1.

NCT ID: NCT01100697 Completed - Pregnancy Clinical Trials

Outcome of Fetal Spina Bifida

Start date: December 2009
Phase:
Study type: Observational

Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to long-time survival. Concerning psychomotor development as well as urinary bladder and intestinal morbidity the prognosis ranges from normal functional outcome to severe disability. The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound screening allows patients to prepare for the birth of an impaired child or to consider termination of the pregnancy. In current practice, prenatal counseling and obstetric management depend not only on the detection of a spinal dysraphism but also on an appropriate assessment of the severity of the defect and its possible impact on the postnatal development of the affected child. Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on the postnatal outcome. Previous studies reported that postnatally determined lesion levels correlated well with functional status and survival. On the contrary, it is still not clear whether similar data obtained antenatally are of value. In this study, the investigators will review their database of all cases of prenatally diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the prenatal and postnatal characteristics of fetuses with spina bifida in relation to the anatomic level of the lesion, the investigators aim to contribute further information regarding the natural course of affected pregnancies and the correlation of prenatal ultrasound findings with their functional outcome.

NCT ID: NCT00975338 Completed - Cerebral Palsy Clinical Trials

The LETS Study: A Longitudinal Evaluation of Transition Services

LETS
Start date: September 2009
Phase:
Study type: Observational

This project will describe and evaluate the impact of a unique partnership model designed to coordinate transfer of care by formally linking pediatric and adult heath care services. The experiences of young people receiving this model of care will be compared and contrasted against the experiences of young people receiving the current standard of care. Young people with a diagnosis of Cerebral Palsy (CP), Acquired Brain Injury in childhood (ABIc), and Spina Bifida (SB) will be followed during the transition period. Preparation for transition, health care, and transfer of care service delivery will be detailed in a process evaluation. An outcome evaluation will measure the ability of the two models of service to enable youth to maintain continuity within the health care system after transitioning from pediatric to adult care. Secondary outcomes, including how health, well-being, social participation, transition readiness, and health care utilization are affected will also be explored.

NCT ID: NCT00951509 Completed - Spinal Cord Injury Clinical Trials

Virtual Reality Based Testing of Power Wheelchair Driving Skills

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this research study is to examine whether computer based or virtual reality based driving assessments are as useful as real-world power wheelchair driving tests in measuring driving performance and whether they may be useful in helping to identify the problems that some individuals may have with driving power wheelchairs. The specific aims are as follows: Specific Aim 1: To develop computer-based and VR-based wheelchair driving assessments for both drivers and non-drivers that correspond to an accepted real-world driving assessment (Power Mobility Road Test) and compare them to the real-world assessment and to each other. Specific Aim 2: To develop additional features of the computer-based and VR-based assessments that present dynamic tasks and determine whether skills on these tasks can be delineated within the virtual environment.

NCT ID: NCT00866112 Completed - Stroke Clinical Trials

A Randomized Exercise Trial for Wheelchair Users

Start date: May 2008
Phase: N/A
Study type: Interventional

People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.

NCT ID: NCT00720161 Completed - Clinical trials for Neuromuscular Diseases

Metformin in Children With Motor Deficit

Start date: November 2006
Phase: N/A
Study type: Interventional

Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.

NCT ID: NCT00655681 Completed - Cerebral Palsy Clinical Trials

Prevention of Post Operative Bone Loss in Children

Start date: September 2007
Phase: N/A
Study type: Interventional

Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.