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NCT ID: NCT04817670 Completed - Sickle Cell Disease Clinical Trials

Study to Assess Efficacy and Safety of VIT-2763 (Vamifeport) in Subjects With Sickle Cell Disease

ViSionSerenity
Start date: June 18, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.

NCT ID: NCT04817644 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets

Start date: September 10, 2021
Phase: Phase 1
Study type: Interventional

Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.

NCT ID: NCT04817410 Completed - Clinical trials for Alcohol Use Disorder

ED Initiated Oral Naltrexone for AUD

Start date: September 28, 2021
Phase: Phase 1
Study type: Interventional

This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.

NCT ID: NCT04817228 Completed - Diabetic Foot Ulcer Clinical Trials

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

NCT ID: NCT04817176 Completed - Clinical trials for Mild Cognitive Impairment

MI-CBT Adherence Program for Lifestyle Interventions in Older Adults

MI-CBT KNAP
Start date: September 24, 2021
Phase: Early Phase 1
Study type: Interventional

Objective 1: Assess feasibility and acceptability of all protocol components of a pilot trial testing a 6-week telehealth Mediterranean ketogenic nutrition adherence (KNA) program using motivational interviewing and cognitive behavioral strategies (MI-CBT) compared to a KN information only group for older adults with mild cognitive impairment (MCI) to prepare for a full-scale trial. Specifically, the investigators will examine the feasibility of the recruitment, retention, assessment, and intervention delivery methods. The investigators hypothesize that: 1. The study protocol will result in high patient retention (90%) and patient attendance of intervention sessions (80%), and 2. A centralized MI-CBT telehealth delivery approach will be associated with high intervention acceptability ratings from patients. Objective 2: Assess signal of initial effect of the KNA program on important clinical outcomes and adherence relative to a KN information-only condition. The investigators hypothesize that patients in the KNA condition, relative to the KN-only condition, will show: 1. higher rates of clinically significant improvements on the RBANS total scale scores, improvements in daily functioning (FSQ), and decreases in patient CAIDE risk score( (Cardiovascular Risk Factors, Aging, and Incidence of Dementia), and 2. improved adherence to KN, as evidenced by higher levels of measurable urine ketones in the KNA condition compared to the KN-only condition.

NCT ID: NCT04817111 Completed - Friedreich Ataxia Clinical Trials

NAD+ Precursor Supplementation in Friedreich's Ataxia

Start date: May 17, 2021
Phase: Phase 2
Study type: Interventional

The primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle bioenergetics.

NCT ID: NCT04817085 Completed - Dry Eye Clinical Trials

An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug

Start date: October 6, 2020
Phase: N/A
Study type: Interventional

This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.

NCT ID: NCT04817059 Completed - Adhd Clinical Trials

Reducing Head Motion With Customized Head Mold in Young Children

Start date: June 19, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of a customized head mold for reducing head motion during MRI scanning in young children.

NCT ID: NCT04816708 Completed - Anxiety Clinical Trials

A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers

LIFT-HCW
Start date: May 19, 2021
Phase: N/A
Study type: Interventional

This is a pilot randomized waitlist control trial assessing if the feasibility of using a mobile mindfulness app to treat emotional distress and burnout amongst nurses taking care of COVID-19 patients. This trial will help inform the study team if dissemination the intervention to a large number of nurses in a short time period is feasible, and if the intervention has evidence of a clinical impact.

NCT ID: NCT04816669 Completed - COVID-19 Clinical Trials

A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. - 2-dose schedule (separated by 21 days) - At a dose of 30µg (as studied in the Phase 2/3 study C4591001) - In healthy adults 18 through 55 years of age - The duration of the study for each participant will be approximately 2 months (3 visits in total) - The study will be conducted in the United States