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Anemia, Sickle Cell clinical trials

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NCT ID: NCT02909283 Completed - Sickle Cell Disease Clinical Trials

Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

DREAM²
Start date: March 2, 2015
Phase:
Study type: Observational

The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological properties.

NCT ID: NCT02868138 Completed - Sickle Cell Disease Clinical Trials

Study of Hydroxyurea to Treat Sickle Cell Disease

Start date: May 2016
Phase: N/A
Study type: Observational

The aim of this single-center observational study was to evaluate quality of life, clinical effectiveness, and satisfaction in pediatric and young adult patients with sickle cell disease receiving hydroxyurea.

NCT ID: NCT02867800 Completed - Sickle Cell Disease Clinical Trials

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

Start date: July 2016
Phase: Phase 1
Study type: Interventional

To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine, thiotepa, melphalan, and alemtuzumab for conditioning.

NCT ID: NCT02863068 Completed - Sickle Cell Disease Clinical Trials

Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

Start date: April 6, 2018
Phase: Phase 2
Study type: Interventional

The investigators are conducting a Phase II prospective and placebo controlled study of a topical cream containing sodium nitrite compared to the current standard of care. Sodium nitrite is a local donor of nitric oxide, which is known to improve blood flow and decrease bacterial load in the ulcer bed. The primary objectives are to evaluate the safety of topical sodium nitrite cream treatment in patients with sickle cell disease and chronic leg ulcers and to determine its effectiveness in accelerating the healing process and decreasing the pain associated with ulceration. Potential benefit will be a durable resolution or improvement of the leg ulcer and its associated pain. Possible side effects include decreased blood pressure and methemoglobinemia, secondary to sodium nitrite absorption through the ulcerated skin. Funding source FDA OOPD.

NCT ID: NCT02857023 Completed - Anemia, Sickle Cell Clinical Trials

Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

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

Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.

NCT ID: NCT02851615 Completed - Sickle Cell Disease Clinical Trials

Improving Self-Management in Adolescents With Sickle Cell Disease

SCThrive
Start date: March 31, 2016
Phase: N/A
Study type: Interventional

The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.

NCT ID: NCT02844673 Completed - Sickle Cell Anaemia Clinical Trials

Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

mDOT
Start date: April 28, 2017
Phase: Phase 2
Study type: Interventional

To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.

NCT ID: NCT02829580 Completed - Sickle Cell Disease Clinical Trials

Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

Start date: September 2008
Phase: N/A
Study type: Interventional

Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide. The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

NCT ID: NCT02813850 Completed - Sickle Cell Disease Clinical Trials

Oxygen Therapy and Pregnancy in Sickle Cell Disease

DRO2G
Start date: October 5, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficiency of the preventive oxygen therapy on the occurrence of vaso-occlusive complications, which last more than 24 hours and require hospitalisation, in women with sickle cell disease.

NCT ID: NCT02770534 Completed - Sickle Cell Disease Clinical Trials

Evaluating Thromboelastography (TEG) and ETP in Sickle Adults

Start date: April 2016
Phase: N/A
Study type: Observational

The primary aim of this study is to investigate the reported enhanced coagulation status (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests; thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results to healthy race matched controls to ascertain if there is a significant difference. Race matching of the control participants is being carried out due to the well reported racial differences in coagulation parameters that exist in healthy individuals. The investigators are aiming to study the clotting state in sickle patients on regular transfusion therapy and those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the condition. The study will assess the reported prothrombotic state using TEG and ETP.