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NCT ID: NCT01241903 Completed - Clinical trials for Acute Coronary Syndrome

Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.

NCT ID: NCT01241500 Completed - Clinical trials for Myelodysplastic Syndromes

Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts

ONTIME
Start date: November 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.

NCT ID: NCT01240564 Recruiting - Kidney Disease Clinical Trials

The Nephrotic Syndrome Study Network (NEPTUNE)

Start date: October 2010
Phase: N/A
Study type: Observational

Background: - The Nephrotic Syndrome Study Network (NEPTUNE) is a network of multidisciplinary researchers who are investigating why kidney disease happens. NEPTUNE researchers will collect kidney tissue and other samples (for example, blood and urine) from individuals who are scheduled to have kidney biopsies to determine the cause of protein in the urine (only one kidney biopsy is necessary). Objectives: - To collect kidney tissue, other samples, and data /information for continuing research into kidney diseases. Eligibility: - Individuals at least 18 years of age who need to have a kidney biopsy to determine the cause of protein in the urine, do not have a systemic disease that is the cause of the their kidney disease, and have not received specific treatment for kidney disease. Design: - This study involves a screening and baseline visit and additional followup visits after the kidney biopsy. - Participants will be screened with a medical history and physical examination, as well as blood and urine samples and collection of fingernail clippings. Participants will also complete questionnaires about their history of kidney problems. - During the kidney biopsy, performed at the NIH Clinical Center, researchers will take an additional tissue sample for research. - Participants will return for followup visits at NIH every 4 months in the first year, and every 6 months in the second through fifth years after the biopsy. Additional blood and urine samples will be collected at each visit, and fingernail clippings will also be collected annually by the study researchers. - Treatment for kidney disease will not be provided as part of this protocol and instead will generally be provided by the patient s own physician. Compensation: Subjects received compensation for each visit to the NIH Clinical Center.

NCT ID: NCT01239966 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

PARSA
Start date: November 2010
Phase: Phase 3
Study type: Interventional

In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension. Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome. The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased. For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.

NCT ID: NCT01238250 Recruiting - Clinical trials for STXBP1 Encephalopathy With Epilepsy

Online Study of People Who Have Genetic Changes and Features of Autism: Simons Searchlight

Start date: October 2010
Phase:
Study type: Observational

Simons Searchlight is an observational, online, international research program for families with rare genetic variants that cause neurodevelopmental disorders and may be associated with autism. Simons Searchlight collects medical, behavioral, learning, and developmental information from people who have these rare genetic changes. The goal of this study is to improve the clinical care and treatment for these people. Simons Searchlight partners with families to collect data and distribute it to qualified researchers.

NCT ID: NCT01237769 Unknown status - Metabolic Syndrome Clinical Trials

Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome

Start date: October 2010
Phase: Phase 4
Study type: Interventional

In recent years emphasis has been given to investigate the role of vitamin D in areas beyond bone metabolism and maintenance of calcium homeostasis. Thus, vitamin D deficiency has been associated with risk factors for the occurrence of cardiovascular disease as well as with overall mortality.In addition, there are indications that a large proportion of the population (up to 50%) is vitamin D deficient. The measurement of vitamin 25 (OH) D3 levels is the best way to estimate the vitamin D actual reserves. It is worth mentioning that elevated levels of parathyroid hormone (PTH) [5] and reduced levels of 1,25 (OH)2 vitamin D3 (calcitriol have also been associated with cardiovascular disease. The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in approximately 25% of the Greek population.There are a lot of data linking low vitamin D levels with the metabolic syndrome as a whole as well as with its individual characteristics. Specifically, vitamin D deficiency has been associated with increased incidence of hypertension, dyslipidemia, obesity, inflammation and dysglycemia. Many studies have explored the effect of giving vitamin D supplements on the risk factors associated with the metabolic syndrome and the cardiovascular disease. The results of these studies are conflicting and this may partially be due to different doses of vitamin D used. The form of vitamin D most commonly used in these studies is cholecalciferol (vitamin D3. Aim of the study: Determination of the effect of cholecalciferol (VitD3) (2200 IU/day) on metabolic parameters in patients with metabolic syndrome. Endpoints: The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting treatment: - Waist circumference - Blood pressure - Levels of fasting serum triglycerides - Levels of high-density lipoprotein cholesterol (HDL-C) - Levels of fasting serum glucose. The secondary endpoints will include changes in: - The levels of low-density lipoprotein cholesterol (LDL-C) and non-HDL-C - Subfractions of LDL-C [average particle size of LDL-C, levels of small dense (sd) LDL-C] - Subfractions of HDL-C (levels of small and large particle HDL-C) - The activity and levels of Lp-PLA2 (lipoprotein-associated phospholipase A2) - The levels of serum apolipoprotein AI, A-II, AV, B, E, C-II, C-III and lipoprotein (Lp) (a) - The activity of paraoxonase-1 (PON1) - The concentration of pre-beta1-HDL - The levels of hs-CRP (high sensitivity C-reactive protein) - Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and oxidized LDL (oxLDL) - Adipokine levels (leptin, adiponectin, visfatin) - Glucose homeostasis (index HOMA: fasting insulin X fasting glucose/405) - The levels of glycosylated hemoglobin (HbA1c) - The levels of 25 (OH) vitamin D3, of 1,25 (OH)2 vitamin D3 and PTH - The levels of serum electrolytes (Ca, PO4) and the activity of alkaline phosphatase (ALP) in serum. Study population: The investigators will study patients with metabolic syndrome (n = 50 adults) attending the Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina. Diagnosis of the Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III). All patients will be instructed to exercise and lose weight according to the NCEP-ATP III diet. The participants will be randomized in an open manner into one of the following 2 treatment groups: a) cholecalciferol (VitD3) (2200 IU/day) plus lifestyle measures or b) only lifestyle measures. Recruitment will be completed within one year. The reassessment of the patients will be done 3 months after starting of treatment.

NCT ID: NCT01237418 Active, not recruiting - Clinical trials for Myocardial Infarction

French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

FAST-MI 2010
Start date: October 2010
Phase:
Study type: Observational

The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months. Patients will be followed up at 1 month and then followed annually for 10 years. Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

NCT ID: NCT01237106 Completed - Clinical trials for Polycystic Ovarian Syndrome

In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)

Start date: November 2010
Phase: N/A
Study type: Interventional

This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment. In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).

NCT ID: NCT01236144 Completed - Clinical trials for Acute Myeloid Leukaemia

A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.

AML18 Pilot
Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to 60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients/investigators will be able to choose which intervention to enter. Depending on recruitment requirements, only one intervention might be available at any one time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

NCT ID: NCT01235572 Completed - Clinical trials for Recurrent Adult Acute Myeloid Leukemia

Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.