
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome...
Metabolic SyndromeInflammation1 moreMetabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004). Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.

A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
Alport SyndromeKidney DiseaseThe goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Large amounts of protein in the urine is often an early sign of kidney disease. Information needs to be collected in boys who are not taking medications known as angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain accurate data about the length of time between the onset of microalbuminuria and the start of overt proteinuria. This new information will give physicians a better understanding of how to treat patients with Alport syndrome. The information we gather by conducting this study will aid in planning future clinical trials because the identification of time points in disease progression, such as microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical benefit of a new treatment option. The study has been approved by the University of Minnesota's Institutional Review Board.

Sex Differences in Early Brain Development; Brain Development in Turner Syndrome
Turner SyndromeRelative risk for many psychiatric disorders differs dramatically in males and females. Early-onset disorders, such as autism, occur more often in males; other conditions, such as schizophrenia, occur at similar rates in males and females, but the sexes differ in expression. It has been hypothesized that the prevalence and expression of these disorders is related to sex differences in brain development. X-chromosome effects and early exposure to gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to characterize sex differences in brain development from birth to age 2; (2) to test whether brain development is altered in infants with Turner syndrome, a well-defined genetic disorder resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1, high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize sex differences in brain development from birth to age 2 in a longitudinal cohort of 250 children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1. The investigators hypothesize that sex differences in gray and white matter development and in white matter maturation as assessed by DTI will be present during the first 2 years of life and that children with TS will exhibit abnormal gray and white matter development in the neonatal period.

S9910, Collecting and Storing Blood and Bone Marrow Samples From Patients With Hematologic Cancer...
LeukemiaMyelodysplastic Syndromes1 moreRATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and how well patients will respond to treatment. PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with hematologic cancer to be tested in the laboratory.

Phenotypic and Genotypic Identification and Characterization of MYH9-related Constitutional Thrombocytopenia...
May-HemalinFechtner Syndrome (Disorder)2 moreThe research involves the establishment of a cohort including as much as possible cases of macrothrombocytopenia related to a "MYH9 syndrome" and the study of mutations and polymorphisms of MYH9 gene in all these patients. As MYH9 syndrome is an autosomal dominant disorder, patients should be heterozygous for a MYH9 gene mutation. The main goal of our project is looking for correlations between genotype and phenotype. It is planned to characterize the phenotype and genotype of a cohort of patients, including family members that will be addressed during the study in order to better understand the platelet disorder and improve the epidemiological knowledge of MYH9 syndrome. The data will be recorded in a database.

Metabolic Syndrome in Childhood Cancer Survivors
Brain and Central Nervous System TumorsLeukemia3 moreRATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.

Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations...
Acute Coronary SyndromeTo collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).

The Utility of Ischemia Modified Albumin (IMA) in Sepsis
SepsisSevere Sepsis2 moreThe purpose of this study is to determine if levels of ischemia modified albumin (IMA) in blood are elevated in patients with suspected infection and are predictive of severity of illness in patients with sepsis. In order to compare subjects with infection to those without infection who are representative of the ED population at each site, a group of non-infected control patients will be enrolled. Each hospital will enroll subjects with age (by decade) and sex matched controls to reflect the population of subjects suspected of infection.

PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome, Phase 2...
Polycystic Ovary SyndromePolycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, many of whom do not know they have the syndrome. Women with PCOS produce abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries' ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation. PCOS is the number one cause of hormonally related infertility and also increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS. The proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1) establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource for future studies. In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening. This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels. Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will be invited to undergo...

A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome...
Myelodysplastic SyndromesThrombocytopeniaThis is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.