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Anemia, Sickle Cell clinical trials

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NCT ID: NCT05348915 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Start date: March 29, 2022
Phase: Phase 3
Study type: Interventional

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

NCT ID: NCT05347043 Not yet recruiting - Sickle Cell Anemia Clinical Trials

The Montreal Cognitive Assessment.Test in Adults With Sickle Cell Disease

EvaCAD
Start date: May 2022
Phase: N/A
Study type: Interventional

This study will assess the performances of the Montreal Cognitive Assessment (MoCA) to screen for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.

NCT ID: NCT05336201 Recruiting - Clinical trials for Cognitive Impairment

Cognitive Remediation Intervention to Prepare for Transition of Care

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

NCT ID: NCT05334576 Recruiting - Sickle Cell Disease Clinical Trials

Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA

CRIZ
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

In this prospective, single-arm, open-label, imaging and treatment study, the investigator will test the hypothesis that crizanlizumab will prevent the progression of silent cerebral infarcts in patients with sickle cell disease. Study participants will undergo brain MRI before initiation of crizanlizumab and at 6 and 30 months after starting crizanlizumab infusions. The crizanlizumab cohort will be compared to a matched, observational cohort of patients not receiving crizanlizumab.

NCT ID: NCT05329649 Recruiting - Sickle Cell Disease Clinical Trials

Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD)

Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

This is a single-dose, open-label study in pediatric participants with severe SCD and hydroxyurea (HU) failure or intolerance. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).

NCT ID: NCT05315908 Terminated - Obesity Clinical Trials

COVID-19 Testing in Underserved and Vulnerable Populations

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County, California. In collaboration with CHC partners, their consortium organization, Health Quality Partners (HQP), investigators are pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text messaging for uptake of COVID-19 testing among asymptomatic adult patients with select medical conditions and those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination.

NCT ID: NCT05292781 Recruiting - Sickle Cell Disease Clinical Trials

CHOICES3: Sickle Cell Disease Parenting CHOICES

CHOICES3
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.

NCT ID: NCT05289700 Recruiting - Sickle Cell Disease Clinical Trials

Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)

HBOT-SCD
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC.

NCT ID: NCT05285917 Recruiting - Sickle Cell Disease Clinical Trials

Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa

PUSHUP
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

Sickle cell anemia (SCA) is among the world's most common and devastating blood disorders, affecting more than 300,000 newborns per year. Most infants with SCA are born in the low-resource settings of sub- Saharan Africa, where an estimated 50-90% will die before 5 years of age due to lack of early diagnosis and appropriate care. Hydroxyurea is a safe and effective once-daily oral medication that has become the standard of care for the treatment of children with SCA in high-resource settings. There is now a growing body of evidence to support the safety and clinical benefits of hydroxyurea for the treatment of SCA in sub-Saharan Africa. The requirement for frequent laboratory monitoring, uncertainties about appropriate, most effective dosing, and the concern for hematologic laboratory toxicities, however, will continue to limit widespread hydroxyurea utilization and real-world effectiveness. The investigators have recently developed and prospectively evaluated an individualized, pharmacokinetics-guided hydroxyurea dosing strategy for children with SCA that has demonstrated optimal clinical and laboratory benefits with minimal toxicity. In this research study, the investigators aim to extend this precision medicine approach to Africa.

NCT ID: NCT05283148 Active, not recruiting - Osteoporosis Clinical Trials

Sickle Cell Disease (SCD) Bone Pain Study

Start date: November 3, 2022
Phase: N/A
Study type: Interventional

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease