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Anemia, Sickle Cell clinical trials

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NCT ID: NCT03235011 Completed - Sickle Cell Disease Clinical Trials

Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.

SEXODREP
Start date: March 10, 2017
Phase:
Study type: Observational

Evaluation of knowledge about contraception in sickle cell adolescents.

NCT ID: NCT03233269 Completed - Sickle Cell Disease Clinical Trials

BEATS 2: Music Therapy in Sickle Cell

Start date: June 26, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of the BEATS music therapy program on the self-efficacy, trust, knowledge, and adherence of young adult patients with SCD. Primary Hypotheses: Compared to baseline, young adult patients with SCD who receive the music therapy interventions will report: Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES), Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge Quiz. Secondary Hypotheses Compared to the one year prior to the study period, young adults with SCD who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period. Additional Questions Do music therapy interventions influence the rate of hospital utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during the study period compared to the previous year? Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period? Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period? Does the schedule of music therapy interventions in this study improve outcomes more significantly than the schedule of music therapy interventions from [IRB# 03-15-30]?

NCT ID: NCT03226691 Completed - Sickle Cell Disease Clinical Trials

Peripheral Blood Stem Cell Collection for Sickle Cell Disease (SCD) Patients

Start date: July 25, 2017
Phase: Phase 1
Study type: Interventional

The constitution of blood relies upon hematopoietic stem cells (HSCs), which stay in the bone marrow and differentiate to all lineages of peripheral blood cells. HSC transplantation is the only curative option currently available for sickle cell disease (SCD) patients either via allogeneic HSC transplantation or HSC-targeted gene therapy. Granulocyte-colony stimulating factor (G-CSF)- mobilized HSCs are frequently utilized in the adult setting of HSC transplantation because of the faster hematologic recovery as compared to bone marrow. As an autologous HSC source for gene therapy, bone marrow harvest has been generally employed since G-CSF has been prohibitive in SCD patients due to granulocyte stimulation and the associated reports of vaso-occlusive crises, multi-organ failure, and death. However, when bone marrow harvest is used, the amounts of collected cells are limited and anesthesia is required. In order to obtain HSCs in large numbers without anesthesia, patients will undergo mobilization followed by large volume apheresis. Plerixafor is an alternative treatment for mobilization without direct stimulation to granulocytes, and it is theoretically applicable for SCD patients. The primary endpoint of this study is to obtain sufficient amounts of HSCs collected from the peripheral blood in SCD patients after plerixafor mobilization with an acceptable safety profile. The harvested products will be stored as backup for patients undergoing gene therapy as well as allogeneic HSC transplantation.

NCT ID: NCT03224429 Completed - Sickle Cell Disease Clinical Trials

Sickle Cell Disease (SCD) Decision Aid

Start date: May 15, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to gather decision making needs information from caregivers and patients with sickle cell disease (SCD) in order to develop a web-based decision aid tool. Study subjects will participate in interviews defining treatment decision making needs during which investigators will ask information about their SCD. Notes taken from these interviews will allow the research team to better understand current practice related to clinical practice and allow for better refinement of the decision aid tool. An additional group of participants will be asked to review the web-based Sickle Cell Decision Aid. Participants will be asked to describe thoughts about the site, including but not limited to ease of navigation, content and construction. This study will provide information for the conduct of a randomized controlled trial for the use of a web based decision aid to give patients with sickle cell disease and parent/legal guardian of children with sickle cell disease accurate information about risks and benefits of therapies and enable them to make decisions based on their individual values and preferences.

NCT ID: NCT03214354 Recruiting - Sickle Cell Disease Clinical Trials

Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor

Sickle-AID
Start date: July 5, 2017
Phase: Phase 2
Study type: Interventional

The aim of this study to evaluate the safety and efficacy of a nonmyeloablative conditioning regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients with sickle cell disease (SCD) who have a matched related major ABO-incompatible donor. The nonmyeloablative regimen will use alemtuzumab, total body irradiation (TBI) and sirolimus for immune suppression. This study will expand the access of HSCT for patients with SCD who are currently not eligible because of donor restrictions.

NCT ID: NCT03201874 Completed - Sickle Cell Disease Clinical Trials

iCanCope With Sickle Cell Pain

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.

NCT ID: NCT03178643 Completed - Malaria,Falciparum Clinical Trials

Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)

EPiTOMISE
Start date: January 23, 2018
Phase: Phase 4
Study type: Interventional

This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.

NCT ID: NCT03176849 Completed - Clinical trials for Myelodysplastic Syndromes

A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT

Start date: November 1, 2017
Phase: Phase 4
Study type: Interventional

Research has suggested that children with sufficient vitamin D levels undergoing hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences of infection and graft-versus-host disease (GVHD), as well as overall improved survival. However, supplementation in children undergoing HSCT has shown to be a challenge using standard or aggressive supplementation strategies. The primary objective of this study is to determine the safety and efficacy of a single, high dose oral vitamin D (Stoss Therapy) at the start of transplant followed by maintenance supplementation in children undergoing HSCT.

NCT ID: NCT03167450 Completed - Sickle Cell Disease Clinical Trials

Examining the Knowledge, Attitudes, and Beliefs of Sickle Cell Disease Patients, Parents of Patients With Sickle Cell Disease, and Providers Towards the Integration of CRISPR in Clinical Care

Start date: April 28, 2017
Phase:
Study type: Observational

Background: Sickle cell disease (SCD) is caused by a genetic defect that affects how hemoglobin is made. Due to this, people with SCD have abnormally-shaped red blood cells, which can result in poor oxygen transport in the body and increase risk of blood clots. CRISPR Cas9 is a new tool which allows scientists to snip and edit genes in a way that is faster, cheaper, and more precise than other gene-editing tools. Recently, research has been done using CRISPR Cas9 to correct the sickle cell gene in animal models and human cells. Researchers want to understand the views of those with SCD, parents of people with SCD, and the providers of these patients regarding use of CRISPR Cas9 in clinical trials and treatment. Objectives: To study the attitudes, beliefs, and opinions of those with SCD, parents of those with SCD, and providers on the use of CRISPR Cas9 gene-editing. An additional purpose of this study is to assess the utility of an educational tool for improving understanding of CRISPR Cas9. Eligibility: People ages 18 and older who speak English and either have SCD, are a parent of someone with SCD, or are a physician for people with SCD. Design: Participants will be screened via phone. Those with SCD will be screened with data from their SCD genotype. Participation lasts about 2 hours. Participants will fill out three surveys. Participants will watch a video about CRISPR Cas9. Participants will engage in a focus group session. This will be audiotaped and analyzed. The data from the survey questions and focus groups may be used for future research. However, all personally identifiable information will be removed before data is shared. Participants data will be identified with a code number instead of their name. Participants may be invited to join future studies of SCD.

NCT ID: NCT03150433 Completed - Pain Clinical Trials

Sleep and Pain in Sickle Cell Disease

Start date: November 5, 2017
Phase: N/A
Study type: Interventional

This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.