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Anemia, Sickle Cell clinical trials

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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: NCT02850406 Active, not recruiting - Sickle Cell Disease Clinical Trials

Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease

HOPE
Start date: July 5, 2016
Phase: Phase 2
Study type: Interventional

This study consists of four parts, Parts A, B, C, and D. - Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years. - Part B is a multiple dose, safety, exploratory, efficacy, and PK study in adolescent participants with Sickle Cell Disease ages 12 to 17 years. - Part C is a multiple dose, safety, tolerability, and PK study, which includes the assessment of hematological effects and the effect on TCD flow velocity of voxelotor in pediatric participants with Sickle Cell Disease ages 4 to 17 years. - Part D is a multiple dose, safety, tolerability, and PK study, which examines the hematological effects of voxelotor in pediatric participants with Sickle Cell Disease ages 6 months to < 4 years.

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: NCT02843347 Recruiting - Anemia, Sickle Cell Clinical Trials

STRIDE Biorepository

Start date: March 13, 2017
Phase:
Study type: Observational [Patient Registry]

The STRIDE Biorepository is an optional substudy available to participants in "Bone Marrow Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)".

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: NCT02824471 Recruiting - Sickle Cell Disease Clinical Trials

Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)

Start date: October 2014
Phase:
Study type: Observational

'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes. To date, correlative studies in SCD, by us and others, have range between clinical reports, based on tests, interventions, and chart review of individuals or groups of individuals and, at the other extreme, identification of functional gene polymorphisms based on population studies. The investigators wish to augment these studies through a systematic examination of cellular membrane properties and activation status. Of hematologic disorders, SCD may be unusually susceptible to such an examination.

NCT ID: NCT02824406 Recruiting - Sickle Cell Disease Clinical Trials

Cerebrovascular Reserve Measurements in Sickle Cell Disease

CRUISE
Start date: August 2014
Phase: N/A
Study type: Observational

The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD). The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs).