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NCT ID: NCT05958602 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Improving Recruitment and Retention for Diabetes Self-Management Education and Support

Start date: April 2024
Phase: N/A
Study type: Interventional

This randomized clinical trial aims to examine the effectiveness of utilizing CHWs (community health workers) and supplemental diabetes education technology to improve DSMES (diabetes self-management education and support) participation, retention, engagement, and clinical outcomes in adults in Jefferson County, AL living with diabetes. The main questions this study aims to answer are as follows: 1) Is the utilization of a multi-directional recruitment model via partnerships with community health workers and local primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) effective in increasing recruitment and retention of people living with diabetes into a pharmacist-led DSMES program? 2) Is the utilization of the HICO Health Mobile application and provider dashboard as a supplementary tool alongside a standard DSMES curriculum effective at improving patient participation, retention, engagement, and clinical outcomes in a pharmacist-led DSMES program versus standard DSMES alone in Jefferson County, AL? After eligibility screenings and enrollment, participants will be randomized into two groups: one group will receive standard DSMES programming based on the 7 Self Care Behaviors and one group will receive standard DSMES programming and access to HICO Health, a diabetes-related mobile health application. The study team plans to evaluate whether a CHW- recruitment strategy will lead to an increase in referral and enrollment and whether incorporating the HICO Health application will lead to better retention, engagement, and clinical outcomes in terms of HbA1C levels. This novel project will utilize continued stakeholder engagement, community health workers, and diabetes-related technology which we hope will increase the uptake and retention of participants in DSMES in Jefferson County, AL.

NCT ID: NCT05973240 Not yet recruiting - Clinical trials for Adults Undergoing Oral Anticoagulation Therapy

Developing Anticoagulation Self-Report Measure in Adults

PERSONAE
Start date: April 2024
Phase:
Study type: Observational

The use of oral anticoagulants has been increasing globally to prevent strokes associated with atrial fibrillation and heart valve replacements. Patients on long-term anticoagulation have the option to self-test their blood clotting time using point-of-care testing equipment (POCT). They can choose to self-manage their medication dosage or self-monitor and seek dose adjustments from a clinic. Studies have shown that self-testing approaches are effective and cost-effective. However, future research should focus on understanding the factors that influence people's preparedness for self-testing, such as health literacy, self-efficacy, and perceived support. Assessing preparedness is crucial for tailoring healthcare delivery and supporting patient education. Highlighting preparedness can also encourage the adoption of self-testing approaches in countries facing barriers to implementation.

NCT ID: NCT05974293 Not yet recruiting - Spasticity, Muscle Clinical Trials

A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders

SENS-NMO
Start date: April 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.

NCT ID: NCT05977400 Not yet recruiting - Premature Birth Clinical Trials

NICU Antibiotics and Outcomes (NANO) Follow-up Study

NANO-FU
Start date: April 2024
Phase: Phase 3
Study type: Interventional

The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.

NCT ID: NCT05977686 Not yet recruiting - Clinical trials for Post Partum Hemorrhage

Hemoglobin Testing in Pregnant Patients

Prosp Anemia
Start date: April 2024
Phase:
Study type: Observational

The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.

NCT ID: NCT05981625 Not yet recruiting - Clinical trials for Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

Start date: April 2024
Phase: N/A
Study type: Interventional

This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive glass air polishing system in patients with non-cervical lesions.

NCT ID: NCT05994157 Not yet recruiting - Clinical trials for Non-hodgkin Lymphoma

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Start date: April 2024
Phase: Phase 1
Study type: Interventional

Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.

NCT ID: NCT06002243 Not yet recruiting - Clinical trials for Rheumatic Heart Disease

Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics

NEARER SCAN
Start date: April 2024
Phase: N/A
Study type: Interventional

The Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics (NEARER SCAN) study is a co-designed, implementation research project that will improve equitable access to culturally safe, best quality care for Rheumatic Heart Disease (RHD) in high-burden Aboriginal and Torres Strait Islander communities in Australia, and in Timor-Leste. The research addresses an area of unmet need, using novel technologies and embedding them in health practice, to enhance and accelerate diagnosis of RHD outside acute health settings and improve outcomes. The study will be conducted in partnership with community leaders and local partners.

NCT ID: NCT06003127 Not yet recruiting - Healthy Clinical Trials

REcovery From DEXmedetomidine-induced Unconsciousness

REDEX
Start date: April 2024
Phase: N/A
Study type: Interventional

This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.

NCT ID: NCT06003166 Not yet recruiting - Clinical trials for Peripheral Nerve Injury

4-AP Peripheral Nerve Crossover Trial

Start date: April 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the role of single dose 4-aminopyridine (4-AP) on the diagnosis of severing vs non-severing nerve injury after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after peripheral nerve traction and/or crush injuries allowing the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment. Participants will be randomized to one of two groups to determine the order of treatment they receive (drug and placebo vs placebo and drug). Participants will undergo baseline testing for nerve assessment, receive either drug or placebo based on randomization and undergo hourly sensory and motor evaluation, EDX testing and serum 4AP levels for three hours after dosing. Participants will then repeat this with the crossover arm.