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Syndrome clinical trials

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NCT ID: NCT00937638 Completed - Metabolic Syndrome Clinical Trials

Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome

BOLD-X
Start date: February 2009
Phase: N/A
Study type: Interventional

The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain their weight loss, as is currently recommended in clinical practice. Importantly, the investigators will compare a diet high in lean beef (5 oz/day) which is compositionally similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors, including MetSyn. In addition, the investigators also will evaluate a moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study was conducted to assess dietary compliance in a sub-sample of the population at 12-months; participants were not informed of this end-point and additional consent was obtained. Hypotheses: 1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will show similar or greater reductions in CVD risk, respectively when compared to a modified-DASH diet. 2. A healthful weight-loss diet, including lean beef as the primary source of protein in a high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more than a BOLD + ex and DASH + ex intervention. 3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet more effective than the BOLD diet in maintaining the CVD benefits attained during phases 1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the modified DASH diet.

NCT ID: NCT00936741 Completed - Cushing's Syndrome Clinical Trials

An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Start date: July 2009
Phase: Phase 3
Study type: Interventional

Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.

NCT ID: NCT00936325 Completed - Clinical trials for Systemic Capillary Leak Syndrome

Studies in the Pathogenesis of Systemic Capillary Leak Syndrome

Start date: August 24, 2009
Phase:
Study type: Observational

Background: - Systemic Capillary Leak Syndrome (SCLS) is a disorder of unknown cause characterized by episodes of life-threatening drop in blood pressure and leakage of fluids into tissues. The outcome from an episode of SCLS may be mild and resolve on its own, or may be severe and result in death. Although SCLS likely involves abnormalities in the cells lining blood vessels, the specific cause(s) of this disorder are not known. - The treatment of choice for an acute SCLS episode is intravenous fluids and drugs such as norepinephrine (adrenaline), which are given to keep blood pressure at a level that will maintain vital organ function. This may be followed by a course of intravenous steroids and IVIG. Currently, there is no cure, but IVIG has been effective in diminishing the frequency and/or intensity of SCLS episodes when given regularly, as long-term effective preventive therapy for many patients who experience recurrent episodes of SCLS. - This protocol is focused on understanding what causes SCLS with the hope that research findings will lead to the design of safe and more effective treatments. Objectives: - To investigate mechanisms that may cause Systemic Capillary Leak Syndrome. Eligibility: - Patients between 16 and older who have been diagnosed with SCLS. Patients who have been diagnosed with SCLS and are between the ages of 7 and 16 may participate off-site, by sending specimens to the NIH. Patients 16 and older who have been diagnosed with SCLS and cannot travel to the NIH may also participate off-site. - Patients must have a documented history of at least one episode of SCLS with all three of the following documented on at least one occasion: low blood volume, low blood pressure without cause, and evidence of protein leakage during the episode. A letter of a referral from a treating physician is also required. Design: - Patients seen on site will be evaluated at the National Institutes of Health (NIH) for approximately 4 to 5 days on an inpatient basis, and will undergo the following procedures: - Medical history and physical examination. - Blood samples for evaluation and research purposes, as well as possible genetic testing. - Apheresis procedure, if needed, to obtain a larger volume of blood cells for research. - Bone marrow biopsy, if medically indicated. - Other medically indicated tests, such as skin tests to check for possible allergic reactions. - Patients who have a capillary leak episode while at NIH will be treated with the standard of care for treating SCLS. - Patients will be discharged from the protocol 1 year after the NIH visit. - Patients participating off-site will be asked to collect and send specimens (such as blood) to the NIH for research purposes and evaluation. - Unaffected Biological relatives of SCLS patients and Unrelated Normal Volunteers may also enroll on the study. Relatives and Normal Volunteers may be asked to provide research samples for the study, such as skin biopsy and research blood specimens.

NCT ID: NCT00936286 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.

NCT ID: NCT00935090 Suspended - Lymphoma Clinical Trials

3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

Start date: September 2009
Phase: N/A
Study type: Interventional

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.

NCT ID: NCT00934973 Completed - Clinical trials for Irritable Bowel Syndrome

Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)

MIBS
Start date: April 2010
Phase: Phase 4
Study type: Interventional

Aims: 1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website. 2. To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).

NCT ID: NCT00933725 Completed - Menopausal Syndrome Clinical Trials

Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.

NCT ID: NCT00933400 Completed - Clinical trials for Coronary Artery Disease

Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)

Start date: July 2009
Phase: N/A
Study type: Interventional

This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.

NCT ID: NCT00933296 Completed - Schnitzler Syndrome Clinical Trials

Schnitzler Syndrome: Clinical Study, Physiopathological and Search for Genetic Factors

Start date: July 2009
Phase: N/A
Study type: Observational

The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In 2001, the investigators proposed criteria to diagnose this syndrome, which are currently admitted in the literature. The main complications of the Schnitzler syndrome are a difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative disorders. About 15% of patients with a Schnitzler will eventually develop a lymphoproliferative disorder; thus this syndrome allows studying the relationship between lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic auto-inflammatory syndromes. The investigators stipulate that this could also be the case in the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently individualized this particular eruption, significantly associated with systemic inflammatory disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3) the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor, within hours after the first injection, similar to what is reported in the PAPA (pyogenic arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a direct pathogenic effect of IL-1.

NCT ID: NCT00932932 Completed - Clinical trials for Prader-Willi Syndrome

Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls

Start date: February 2009
Phase: N/A
Study type: Observational

The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.