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Anemia clinical trials

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NCT ID: NCT00395993 Completed - Anemia Clinical Trials

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Start date: May 2005
Phase: Phase 3
Study type: Interventional

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

NCT ID: NCT00394953 Completed - Anemia Clinical Trials

A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients.

Start date: January 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis. Eligible patients receiving once-weekly intravenous darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00392418 Completed - Anemia Clinical Trials

Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.

Start date: May 2004
Phase: N/A
Study type: Interventional

Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a widespread serious public health problem, especially for infants in developing countries mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by supplementation to targeted populations. Although iron drops have been used, they have been largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as a sustainable alternative to current iron supplementation approaches, an optimal model of use and distribution for Sprinkles® needs to be established. By comparing daily versus flexible use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged 6-24 months, the primary objectives are to study the effect of the three administration models of Sprinkles® on changes in: 1. hemoglobin concentration; and 2. compliance or adherence to the intervention. ii. The secondary objective of this study is to determine the acceptability of each of the three intervention models. We hypothesize that adherence will be greater and hemoglobin concentration response will be higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a specific period of time compared to those given strict instructions for daily use.

NCT ID: NCT00388336 Completed - Neoplasms Clinical Trials

PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy

Start date: February 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.

NCT ID: NCT00382044 Completed - Anemia Clinical Trials

Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients

Start date: September 2006
Phase: N/A
Study type: Observational

The purpose of this study is to audit the effects of changing all hemodialysis patients from intravenous to subcutaneous administration of ESA's, to ensure that a cost-saving is achieved and that this does not occur at the expense of anemia control. The dose changes will occur according to usual clinical care of patients and not along a protocol.

NCT ID: NCT00377481 Completed - Anemia Clinical Trials

COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

Start date: September 2006
Phase: Phase 4
Study type: Interventional

This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

NCT ID: NCT00369005 Completed - Anemia Clinical Trials

Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

Start date: December 1992
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.

NCT ID: NCT00367588 Completed - Cytopenia Clinical Trials

Low Bacterial Diet in Patients With Cytopenia

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.

NCT ID: NCT00367380 Completed - ANEMIA Clinical Trials

Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Start date: December 2006
Phase: Phase 2
Study type: Interventional

The study is a randomized open label clinical trial to verify the reproducibility of a sporozoite challenge model for Plasmodium vivax in humans. The verification of the reproducibility of such a model will make it possible to evaluate the efficacy of candidate P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps: Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of patients who present with active P. vivax infection and accept to donate infected blood. Samples of P. vivax infected blood will be collected and will be screened for infectious diseases, according to standard blood bank procedures. Colonized Anopheles albimanus mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16) days after, selected positive mosquito batches will be used for step B. Step B Challenge: After informed consent signature, a total of 18 healthy volunteers will be randomly allocated to Groups 1, 2 and 3, of 6 volunteers each and will be challenged with the bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated parasite. Volunteers will be closely monitored post infection, and will be treated as soon as blood infection becomes patent as ascertained by microscopic examination of thick blood smears (TBS). Comparison of data obtained in the three different groups will be used to determine reproducibility of challenge model. Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands. Secondary objective: To determine the influence of the type of parasite isolated on reproducibility and safety of the challenge model with P. vivax in human volunteers Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human volunteers using P. vivax experimentally infected An. albimanus mosquitoes.

NCT ID: NCT00364832 Completed - Anemia Clinical Trials

A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

Start date: October 2001
Phase: Phase 2
Study type: Interventional

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.