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Neural Tube Defects 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: 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: 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: NCT00636233 Completed - Anencephaly Clinical Trials

Genetics of Spina Bifida and Anencephaly

Start date: May 1993
Phase:
Study type: Observational

The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.

NCT ID: NCT00468481 Completed - Contraception Clinical Trials

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Start date: April 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the study drug is safe and effective

NCT ID: NCT00452829 Completed - Clinical trials for Recurrent Neural Tube Defects

Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The aim of the study is to develop a randomised, double blind clinical trial to compare (i) folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent neural tube defects.

NCT ID: NCT00394862 Completed - Neural Tube Defects Clinical Trials

Efficacy of Weekly Versus Daily Folic Acid Supplementation

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

Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

NCT ID: NCT00207558 Completed - Clinical trials for Neural Tube Defects - Spina Bifida and Anencephaly

Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Start date: n/a
Phase: N/A
Study type: Interventional

The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.

NCT ID: NCT00060606 Completed - Spinal Dysraphism Clinical Trials

Management of Myelomeningocele Study (MOMS)

MOMS
Start date: February 2003
Phase: N/A
Study type: Interventional

Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal cord is not fully developed. The overlying bones and skin are incompletely formed and the underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida defects are closed soon after birth to prevent further damage to the spinal cord and nerves. The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the standard closure, surgery after birth (postnatal surgery).