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NCT ID: NCT05694884 Recruiting - Atopic Dermatitis Clinical Trials

Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Start date: December 21, 2022
Phase: Phase 2
Study type: Interventional

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up period up to Week 24. Eligible participants will be randomized into one of the 2 treatment arms.

NCT ID: NCT05694260 Recruiting - Clinical trials for Hypercholesterolemia

A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing

CLEAR Path 1
Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.

NCT ID: NCT05694247 Recruiting - Corneal Disease Clinical Trials

Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

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

A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

NCT ID: NCT05694156 Recruiting - Clinical trials for Major Depressive Disorder

Musical Attention Control and Executive Function Training for Adults With MDD

Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes of depression. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with major depressive disorder.

NCT ID: NCT05693272 Active, not recruiting - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2 Infection

A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults

Start date: January 31, 2023
Phase: Phase 1
Study type: Interventional

VIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0. The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years. Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.

NCT ID: NCT05693194 Recruiting - Anemia Clinical Trials

Pathophysiology of Anemia in PICU Survivors

Start date: October 3, 2019
Phase:
Study type: Observational

In 2007, the TRIPICU trial which demonstrated the safety of tolerating anemia in critically ill children through avoidance of unnecessary red cell transfusions. This landmark study led to practice changes and a reduction in the use of red cell transfusion during PICU stay. However, although this restrictive approach appears safe in the acute setting of PICU, there is a paucity of data regarding its long-term impact on the burden of anemia at discharge. Although 98% of patients now survive their PICU stay, we and other groups have documented that around 50% of PICU admissions will be anemic at discharge. A major contributing factor may be the increasing adoption of restrictive red cell transfusion policies during the phase of ICU admission. Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children are discharged with anemia. The causes of anemia are multifactorial, including inflammation, co-morbidities and nutritional, including iron depletion. Anemia, in particular iron deficiency anemia, is well recognized to be associated with abnormal neurocognitive development in infants and young children. Anemia can also contribute to lower exercise tolerance levels impeding children's development and quality of life. This protocol describes a prospective observational cohort study of PICU survivors, to better understand the epidemiology of anemia at and after PICU discharge. The primary aim will be to determine the prevalence of anemia at 2 months after PICU discharge (primary aim) as well as at 6 and 12 months follow-up (secondary aim). We will evaluate the association of anemia with neurocognitive dysfunction, and quality of life (secondary aim). We will also investigate the pathophysiology of anemia after PICU discharge. We will perform blood tests on anemic patients to measure inflammatory markers as well as markers of iron deficiency (including the new biomarker hepcidin) (tertiary aim).All patients included will be followed while hospitalized in the PICU, as well as at dedicated clinics at 2, 6, and 12 months after PICU discharge. Anemia affects a large proportion of PICU survivors. This study will allow us to better understand the long-term prevalence and causes of anemia in this population as well as potential association with long-term outcome. Anemia (specifically iron responsive anemia) could be a potentially readily modifiable risk factor, to improve the long-term well-being of these children.

NCT ID: NCT05692921 Recruiting - Clinical trials for Myocardial Infarction

Tailoring Post Discharge (The TPD Study)

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

This randomized control trial seeks to better understand the educational needs of Acute Coronary Symptom (ACS) patients including the optimal timing and method of delivery as well as linkages with appropriate community resources and supports are important for cardiac patients to self-manage post hospital discharge to improve outcomes. While there is some literature of the learning needs of ACS patients, there is a paucity of research related to the timing and preferred methods of delivery. This study aims to better understand how best to tailor care for ACS patients from hospital to community. Specifically, the investigators propose a 2 phased approach to understand the needs of patients, and then to develop and deliver a tailored approach to assess, educate and support patients both in-hospital and within the community. The intervention compares 1) a virtual remote home monitoring (RHM) platform and 2) Rapid Response Nursing (RRN) staff to follow, educate and support ACS patients post hospital discharge for a period of no more than 30 days. The Primary Objective of this study is to safely transition low risk ACS patients, from hospital to home, with appropriate supports to safely self-manage in the community and to provide educational and community supports to improve post discharge outcomes of low risk ACS patients

NCT ID: NCT05692713 Recruiting - Leukemia Clinical Trials

Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

Chronic graft-versus-host disease (cGvHD) is one of the most serious complications following BMT (Bone Marrow Transplantation). cGvHD occurs when donor immune cells "attack" the tissues and organs of the person receiving the BMT. cGvHD can be difficult to treat once it is established leading to poor quality of life for recipients of a BMT. The goal of this study is to determine if, by using biomarkers, the investigators can predict which patients are at the highest risk of developing cGvHD after BMT, before cGvHD develops. The ABLE3.0 / CTTC 2201 study will validate and potentially refine the initial predictive biomarker algorithm developed from the original ABLE/PBTMC 1202 study (ABLE1.0), allowing clinicians the ability to pre-emptively predict their patient's future risk of developing both late-acute and chronic GvHD. This will provide the foundation for the later development of clinical trials aimed at reducing immune suppression quicker after transplant for low-risk patients (<10% risk) and justifying more intensive approaches such as pre-emptive treatments before the onset of chronic GvHD in high-risk patients (>45% risk).

NCT ID: NCT05692271 Recruiting - Clinical trials for Alcohol Use Disorder

Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder

Start date: July 15, 2023
Phase: Phase 2
Study type: Interventional

This study evaluates the therapeutic tolerability of the use of Cognitive Processing Therapy (CPT) with propranolol in participants with Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). The investigators are planning to perform an initial proof -of- concept randomized, placebo- controlled trial evaluating propranolol in participants with PTSD and AUD starting CPT for 12 weeks with three post-treatment follow ups at week-16, week-20, and week-24. Participants with current diagnosis of PTSD and AUD seeking treatment will be randomized to either a propranolol group (n=24) or placebo group (n=24) after enrollment. All participants will receive CPT for 12 weeks after randomization. Primary outcomes will be measured in both groups at the end of the study (week 12).

NCT ID: NCT05692180 Recruiting - Asthma Clinical Trials

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

DOMINICA
Start date: April 5, 2023
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.