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Syndrome clinical trials

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NCT ID: NCT00206336 Completed - Tourette Syndrome Clinical Trials

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

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

Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.

NCT ID: NCT00206323 Completed - Tourette Syndrome Clinical Trials

A Randomized, Placebo-controlled, Tourette Syndrome Study.

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

Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.

NCT ID: NCT00205504 Completed - Obesity Clinical Trials

Oral Contraceptives in the Metabolic Syndrome

Start date: June 2005
Phase: Phase 4
Study type: Interventional

Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors (such as obesity and the metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible. The investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients.

NCT ID: NCT00203996 Terminated - Clinical trials for Obstructive Sleep Apnea

Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

Start date: September 2003
Phase: Phase 4
Study type: Interventional

Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated. The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.

NCT ID: NCT00201292 Recruiting - Diabetes Clinical Trials

Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD)

Start date: March 2005
Phase: N/A
Study type: Observational

Diabetes is prevalent in schizophrenics and may be induced by antipsychotic treatments. Several retrospective studies have suggested that psychiatric patients exposed to atypical antipsychotics may be at a higher risk for developing diabetes and ketoacidosis. The association between these atypical antipsychotics and the onset of diabetes is further strengthened by observations of: 1. the time sequence between the initiation of antipsychotic treatment and the onset of diabetes; 2. remission after the discontinuation of medications; and 3. re-emergence of diabetes following the re-introduction of atypical antipsychotics. The treatment emergent diabetes, along with other metabolic disturbances, represents a serious issue in the use of atypical antipsychotics. Major current debates and unresolved research issues which are also the focus of this proposal, are: 1. schizophrenia per se, versus the use of antipsychotics, in triggering diabetes; 2. whether there are differences between "typicals" and "atypicals" in such an effect; 3. whether there are differences among different "atypicals"; 4. whether, and to what extent, treatment emergent diabetes may be associated with, or independent of, weight gain, which also often is associated with the use of antipsychotics; and 5. genetic and environmental risks in association with treatment emergent diabetes. The policy of some hospitals in Taiwan that discourages the use of atypical antipsychotics for new onset schizophrenia directs the investigators to a study design looking at the associated diabetes of both types of antipsychotics. Such a design may provide some hints to the unresolved research issues mentioned above. Meanwhile, a broader defined term, X-syndrome, or metabolic syndrome, is being used to describe the diabetic condition associated with antipsychotics. X-syndrome is a risky condition leading to cardiovascular diseases and diabetes, with insulin resistance as the major outcome, associated with two of the following conditions: truncal obesity (deposited in the thorax and abdomen, instead of the hips and thighs), high triglycerides, high low-density lipoprotein (LDL) cholesterol or hypertension. The proposed study will combine the phenotypes of diabetes and X-syndrome to explore the abnormal metabolism caused by antipsychotics, bridge important information gaps, and provide data contributing towards a better understanding of the risk and management of diabetes and X-syndrome associated with the use of antipsychotics. Three assessment tools, namely the Clinical Global Severity (Clinical Global Impressions - Severity) or the Positive and Negative Symptom Scale (PANNS), the Diabetes Risk Assessment (ADA) and the Life Style Survey, together with physical measurements, collect additional information for this study. Diabetes related biochemistry, including glucose, insulin, leptin, lipids and glycohemoglobin, will be measured to form a composite phenotype for further pharmacogenetic studies. Candidate genes involved in pancreatic beta cell insulin secretion will be examined in priority to see if they play a role in the development of the antipsychotics-induced diabetes.

NCT ID: NCT00200941 Completed - Clinical trials for Restless Legs Syndrome

Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

Start date: August 2001
Phase: Phase 4
Study type: Interventional

This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.

NCT ID: NCT00199446 Completed - Sleep Disorder Clinical Trials

Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.

NCT ID: NCT00198536 Completed - Dry Eye Syndromes Clinical Trials

Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Start date: April 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

NCT ID: NCT00198068 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

PROMISSE
Start date: September 2003
Phase:
Study type: Observational

The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.

NCT ID: NCT00197080 Completed - Clinical trials for Restless Legs Syndrome

Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Start date: June 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).