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Anemia clinical trials

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NCT ID: NCT01788631 Completed - Sickle Cell Anemia Clinical Trials

A Phase II Trial of Regadenoson in Sickle Cell Anemia

Start date: July 2013
Phase: Phase 2
Study type: Interventional

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works in treating a specific disease, in this case Sickle Cell Disease (SCD). "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved the drug for your type of disease. SCD is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) than people without SCD. This different type of hemoglobin makes the red blood cells change into crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in the blood vessels blocking the flow of blood, and cause inflammation and injury to important areas in the body. Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making the heart beat faster. Regadenoson has been studied as a long infusion at this dose in adults, and no safety issues have been identified (ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient benefit with the long infusion of the drug. This drug has been used in laboratory experiments and information from those other research studies suggests that this drug may help to protect the body from damage caused by sickle-shaped cells in this research study. In this research study, the investigators are specifically looking to see if Regadenoson is an effective treatment for pain crises and acute chest syndrome in SCD.

NCT ID: NCT01786408 Withdrawn - Diabetes Clinical Trials

A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

Start date: March 2013
Phase: N/A
Study type: Interventional

This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.

NCT ID: NCT01785407 Completed - Anemia Clinical Trials

Using Stable Iron Isotopic Techniques and Serum Hepcidin Profiles to Optimize Iron Supplementation

Start date: February 2013
Phase: N/A
Study type: Interventional

Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: it may be in the range of 24 to 96 hr. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens. Objectives: 1) Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2) Compare the bioavailability of a single dose to iron supplements consumed one after the other (two dosages).

NCT ID: NCT01783093 Completed - Clinical trials for Pulmonary Hypertension

Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

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

The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension. It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.

NCT ID: NCT01772420 Completed - Anemia Clinical Trials

Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well lenalidomide (LEN) and eltrombopag olamine (ELT) work in treating patients with symptomatic anemia in low or intermediate myelodysplastic syndrome (MDS). Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Eltrombopag olamine may increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving lenalidomide and eltrombopag olamine may be an effective treatment for myelodysplastic syndrome.

NCT ID: NCT01768351 Completed - Anemia Clinical Trials

Paricalcitol Effect on Anemia in CKD

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

Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.

NCT ID: NCT01763502 Completed - Anemia Clinical Trials

The Impact of Cash and Food Transfers Linked to Preschool Enrollment on Child Nutrition and Cognitive Outcomes

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

Recent evidence shows that early childhood is a critical period for investments in human capital and that micronutrient deficiency and inadequate stimulation are major causes of impaired child development in poor countries. These findings have increased interest in promoting nutrition interventions and preschool participation during early childhood. Transfers to households linked to preschool participation have the potential to improve nutrition and cognitive outcomes in young children. Receipt of transfers may induce improvements in diet quality and greater preschool participation, enhancing both nutrition and stimulation. However, there is limited evidence on the impacts of such programs, all of it from Latin America. There is also no evidence on the relative impact of different transfer modalities linked to preschool participation. This study is a cluster-randomized controlled evaluation of a transfer program linked to preschool participation. The transfer program, administered by the World Food Programme, provides food or cash transfers to children aged 3-5 years enrolled in preschools at baseline. The preschools, operating in the Karamoja sub-region of Uganda, are supported by UNICEF and managed by District representatives of the Government of Uganda. The food transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar, totaling approximately 1200 calories per day per child and including 99% of iron requirements. Cash transfers equal the estimated value of the food basket if purchased in the market. Randomization into the food treatment, cash treatment or control was done across 98 preschools, referred to as Early Childhood Development (ECD) centers. The intervention period was from February 2011 to May 2012 and included distribution of transfers on a six-to-eight-week cycle. A longitudinal (panel) survey of households with children aged 3-5 years at baseline was conducted before exposure to the transfers and 18 months later. The randomized design of this effectiveness study and the panel nature of the data allow for a rigorous field trial in which impacts on nutrition and cognitive outcomes can be assessed and compared across modalities. We examine the impacts of the two transfer modalities, cash transfers or multiple-micronutrient-fortified food transfers, linked to preschool enrollment, on child nutrition and cognitive development. In addition, we explore potential mechanisms through intermediate impacts on food intake and participation in preschools. The key research objectives are to assess the following: 1. Impacts on targeted groups: Assess the effects of cash or food transfers on nutrition and cognitive outcomes in children aged 3-5 years at baseline and explore pathways for these effects. 2. Optimal program design: Assess the differential impacts of a program in which children are provided multiple-micronutrient-fortified food transfers linked to preschool enrollment compared with one in which they are given the equivalent value of cash transfers linked to preschool enrollment.

NCT ID: NCT01763242 Completed - Anemia Clinical Trials

Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease

EMAN-Anaemia
Start date: December 2011
Phase: Phase 4
Study type: Interventional

Aims: 1. To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA). 2. To compare this electronic process with "present anaemia management" in the traditional outpatient setting. 3. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

NCT ID: NCT01760096 Active, not recruiting - Thrombosis Clinical Trials

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

NCT ID: NCT01759732 Recruiting - Clinical trials for Acquired Aplastic Anemia

Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic Anemia

Start date: September 2012
Phase: Phase 2
Study type: Interventional

Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion of CD3 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation. Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for children with acquired severe aplastic anemia