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Anemia, Sickle Cell clinical trials

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NCT ID: NCT01911871 Completed - Sickle Cell Disease Clinical Trials

Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

SUFEMYO
Start date: March 2012
Phase: N/A
Study type: Observational

The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

NCT ID: NCT01895998 Completed - Sickle Cell Disease Clinical Trials

Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The proposed research study is a cross-sectional study enrolling young children with sickle cell disease between 5 and 12 years of age. They will be screened as outpatients for consent to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of bronchodilator response will be assessed at each session. To estimate presence of pulmonary hypertension, echocardiography will be performed at the time of PFT measures. Study Design: 1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established patients within the Duke Pediatric Sickle Cell Clinic. 2. Perform a chart review of all enrolled subjects to obtain specific details regarding birth history, nutritional status (weight, height), family history, sickle cell genotype, parental smoking history, recent laboratory parameters, parental smoking history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle cell complications and prescribed medications. 3. Perform spirometry and plethysmography with the administration of albuterol. 4. Before or after completion the PFT session, the patient will have echocardiography in the PFT lab area 5. Using medical record information, determine number of hospitalizations for any pulmonary symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing, hypoxia, cough, chest pain). In addition, we will track any respiratory or cardiac symptoms or therapies for each subject 6 years after enrollment up to age 18 years using the registry. 6. As standard of care, refer any child identified as having lung disease or pulmonary hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment and ongoing care.

NCT ID: NCT01895361 Completed - Sickle Cell Disease Clinical Trials

Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

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

The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream. Funding Source - FDA Office of Orphan Products Development (OOPD)

NCT ID: NCT01879592 Completed - Asthma Clinical Trials

Molecular Phenotyping of Asthma in Sickle Cell Disease

MoP-ASC
Start date: June 2011
Phase: N/A
Study type: Observational

Asthma and sickle cell disease each are serious medical problems. People with asthma have difficulty breathing, wheeze (a whistling noise when breathing), cough, produce sputum or phlegm, and have inflammation (swelling, irritation, redness) and narrowing of the bronchial tubes. When a person has both asthma and sickle cell disease together, more serious medical problems can occur such as having acute chest syndrome and pain episodes more often. It is sometimes hard to diagnose asthma in a person with sickle cell disease because sickle cell disease can also cause lung problems. The purpose of this study is to see if the investigators can better understand asthma when it occurs in a person who has sickle cell disease. The investigators will do this by taking a blood, urine, and saliva sample. The blood and urine samples will be analyzed for chemicals and DNA (genes). Certain genes can cause patients to have sickle cell disease or asthma. The investigators will use the saliva sample for future studies to compare the results from the blood testing with saliva. The investigator's long-term goal is to make sure people who have asthma and sickle cell disease are getting the best asthma treatments. The investigator's hypothesis is that the analysis of the blood, urine and saliva using a method called, metabolomics, may identify a unique asthma signature in children with sickle cell disease which may lead to targeted treatments.

NCT ID: NCT01877837 Completed - Sickle Cell Disease Clinical Trials

Stem Cell Transplantation for Sickle Cell Anemia

Start date: June 2011
Phase: Phase 3
Study type: Interventional

This protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to vaso-occlusion, which causes irreversible damage in almost all systems in the body, including the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.

NCT ID: NCT01849016 Completed - Sickle Cell Disease Clinical Trials

N-Acetylcysteine in Patients With Sickle Cell Disease

NAC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the frequency of pain in daily life in patients with Sickle Cell Disease (SCD). Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality of Life of patients and the medical health care system. Oxidative stress is hypothesized to play a central role in its pathophysiology. In pilot studies the administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a small pilot study in patients with SCD. This study will be performed as a multicenter, randomized, controlled trial where patients will be treated with either NAC or placebo for a period of 6 months. The investigators expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving their quality of life and participation in society.

NCT ID: NCT01848925 Completed - Sickle Cell Disease Clinical Trials

Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.

NCT ID: NCT01848691 Completed - Sickle Cell Anemia Clinical Trials

Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis

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

People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans. These red blood cells breakdown faster, and this is called hemolysis. When red blood cells breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated in exhaled breath. This research study will use a device called CoSense™, which will measure Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device measures the CO levels that an individual breathes out.

NCT ID: NCT01835496 Completed - Sickle Cell Disease Clinical Trials

Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the pharmacokinetics of deferiprone and its 3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in patients with sickle cell disease.

NCT ID: NCT01833702 Completed - Chronic Pain Clinical Trials

Use of a Mobile-based App for SCD Patients

SMART
Start date: June 2012
Phase:
Study type: Observational

The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system.