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Anemia clinical trials

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NCT ID: NCT02760940 Not yet recruiting - Anemia Clinical Trials

Anemia in Inflammatory Bowel Disease

IBD
Start date: August 2016
Phase: Phase 4
Study type: Interventional

Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.

NCT ID: NCT02731378 Not yet recruiting - Clinical trials for Chemotherapy-induced Anaemia

Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia

Start date: December 2016
Phase: Phase 4
Study type: Interventional

A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority study

NCT ID: NCT02428868 Not yet recruiting - Anemia Clinical Trials

IV Iron in Association With Tranexamic Acid for Hip Fracture

Start date: April 2015
Phase: N/A
Study type: Interventional

It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.

NCT ID: NCT02037724 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Fermented Iron-rich Supplement in Reducing Anemia

FISRA
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings. A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.

NCT ID: NCT02031614 Not yet recruiting - Anemia Clinical Trials

The Immunomodulatory Effects of Phlebotomy

Start date: January 2014
Phase: N/A
Study type: Interventional

Although phlebotomy is routinely performed in blood donors, and seemingly does not have significant health risks, it is highly relevant to know what the effect of phlebotomy is on immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the suppression of the low grade inflammatory process that contributes to atherosclerosis, but in theory could also contribute to a suppressed innate immune response that could increase the risk of infection. This is not only relevant for blood donors, but also for patients suffering from blood loss and for daily clinical practice in which blood is routinely drawn of patients for laboratory determinations.

NCT ID: NCT01864395 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of MUF

MUF
Start date: July 2013
Phase: N/A
Study type: Interventional

It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass will result in improved patient outcomes over the 12-hour post-operative period as compared to control and off-line MUFF.

NCT ID: NCT01846689 Not yet recruiting - Clinical trials for Anemia of Chronic Disease

An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

NCT ID: NCT01541631 Not yet recruiting - Anemia Clinical Trials

A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

Start date: May 2012
Phase: N/A
Study type: Interventional

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

NCT ID: NCT00850317 Not yet recruiting - Fanconi Anemia Clinical Trials

Fanconi Anemia Transplant Lacking Genotypically Identical Donor

Start date: April 2009
Phase: Phase 2
Study type: Interventional

A research study for patients with Fanconi Anemia whose bone marrow has changed and now failed, giving rise to a pre-leukemia or leukemia. This study is a Phase II clinical trial in which patients will undergo allogenic transplant of stem cells, meaning they will receive bone marrow cells from a healthy donor. The purpose of this study is to see if transplant course of treatment will lower the risk of graft vs. host disease.

NCT ID: NCT00498511 Not yet recruiting - Clinical trials for Anemia, Iron-Deficiency

Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

Start date: August 2007
Phase: N/A
Study type: Observational

Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.