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NCT ID: NCT05903651 Completed - Healthy Clinical Trials

Retinal Deep PhenotypingTM

Start date: April 3, 2023
Phase:
Study type: Observational

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. A sub-set of the images will also be analyzed by eye specialists to determine if visual inspection of the images could provide useful information in their practice. As an exploratory study, there are no endpoints per se, however the following sub-objective will be evaluated for determining the success of this study: - Collection and characterization of MHRC retinal images from at least 2000 participants that score at least 80 on the real-time Quality Index (included in the MHRC software). - Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting. - At least 5% of participants shall have an MHRC retinal image reviewed by an eye specialist (Optometrist or Ophthalmologist) to assess the image quality and potential clinical usefulness.

NCT ID: NCT05903638 Active, not recruiting - Quality of Life Clinical Trials

A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.

NCT ID: NCT05902364 Recruiting - Dry Eye Clinical Trials

Systane® Ultra Preservative Free Lubricant Eye Drops

Start date: October 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.

NCT ID: NCT05902325 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Identifying Predictors Of Response To Mepolizumab In CRSwNP

ISS-RESMEPO
Start date: October 3, 2023
Phase: Phase 4
Study type: Interventional

The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline. However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated. The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects: i) Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.

NCT ID: NCT05902312 Recruiting - Clinical trials for Major Depressive Disorder

Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

ReDeeMD
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are: type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).

NCT ID: NCT05901831 Recruiting - Clinical trials for Chronic Kidney Disease

A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes

FINE-ONE
Start date: February 26, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: - medical problems (also called treatment-emergent adverse events (TEAEs)) - serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important - higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: - collect blood and urine samples - check the participants' vital signs such as blood pressure and heart rate - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - do pregnancy tests in women of childbearing potential

NCT ID: NCT05901597 Recruiting - Cataract Clinical Trials

Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

Start date: May 9, 2023
Phase:
Study type: Observational

The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.

NCT ID: NCT05900505 Recruiting - Type 1 Diabetes Clinical Trials

Social Navigator to Address Social Determinants of Health in Pediatrics

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified. Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support. The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.

NCT ID: NCT05899881 Active, not recruiting - Healthy Clinical Trials

A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults

Start date: May 29, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot study is to examine how to design a large-scale randomized control trial examining yoga as a way to improve positive body image in men and women across the lifespan. The main questions it will answer are: - Is the study acceptable to participants? - Is recruitment, adherence, and retention adequate? - Are study procedures appropriate? - What is the preliminary effect of yoga on embodiment (sense of connection with the body), self-objectification (evaluating oneself based on outer appearance rather than internal functions) and body appreciation? Participants will either take part in a 10-week yoga program or a control condition (where they will be asked to not change their lifestyle). They will complete online questionnaires at the start, middle and end of the 10-weeks.

NCT ID: NCT05899829 Completed - Healthy Clinical Trials

Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant

Start date: June 21, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.