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NCT ID: NCT05696626 Recruiting - Clinical trials for Metastatic Breast Cancer

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

ELAINEIII
Start date: October 31, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

NCT ID: NCT05696613 Recruiting - Clinical trials for Primary Membranous Nephropathy

A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy

Start date: March 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24.

NCT ID: NCT05695248 Recruiting - Clinical trials for Hereditary Angioedema

A Study of STAR-0215 in Participants With Hereditary Angioedema

Start date: February 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

NCT ID: NCT05695131 Recruiting - Speech Disorders Clinical Trials

Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Factors related to successful rehabilitation are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Furthermore, surrounding salience, patients may lose interest or find an intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for the patient but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes. One avenue to increase patient adherence is through the gamification of rehabilitation therapies using virtual reality (VR). Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the immersive experience achieved through VR can further promote salience and be customizable to individual patient requirements. As VR systems are now highly portable and relatively simple to utilize, they can provide an excellent opportunity to continue rehabilitation practice on the home front. Overall, the VR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose VR-delivered speech-language therapies (Cognitive Projections Lab, University of Alberta) have been developed and piloted in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with vocal therapy. The proposed studies are to investigate the feasibility of implementing this technology in routine clinical care (specific to voice disorders), obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose VR speech-language therapies on patient adherence and clinical outcomes, compared to traditional clinical care.

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: 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