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NCT ID: NCT06193980 Recruiting - Sepsis Clinical Trials

Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

Start date: December 15, 2023
Phase:
Study type: Observational

This study aims to investigate how sepsis and shock can impair microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.

NCT ID: NCT06192771 Recruiting - Clinical trials for Head and Neck Cancer

Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

ESSI-SURG
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency. This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.

NCT ID: NCT06192277 Recruiting - Allergy Penicillin Clinical Trials

Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

DOC
Start date: October 6, 2023
Phase: N/A
Study type: Interventional

This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Following their experience with the DOC, participation in this study will be voluntary and feedback will be requested from each participant, and local primary care providers. The feedback will be used to assess the impact of the DOC clinic on participants and the medical community over the 2 - year study. Feedback will also be collected to investigate ongoing antimicrobial use for those participants who were successfully delabeled. This will be accomplished by surveying participants at six and twelve months after their DOC.

NCT ID: NCT06192251 Recruiting - Obesity Clinical Trials

Complete Lifestyle Medicine Intervention Program

CLIP
Start date: November 6, 2023
Phase:
Study type: Observational

This project will use a mixed design and will be conducted at the West Parry Sound Health Centre. Based on similar studies there is an expected 10% drop-out rate so 20 participants per group will be invited to aim to have 15 finish. Total participants invited over the two-year study will be 40. The participants will be followed over a Complete 6-month Lifestyle medicine Intervention Program (CLIP) involving a collaboration between physicians, health coach, registered dietitians, and kinesiology. The CLIP will cover the 6 pillars of lifestyle medicine in 12-14 fundamentals of lifestyle medicine group classes.

NCT ID: NCT06191315 Recruiting - Asthma Clinical Trials

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

NCT ID: NCT06190626 Recruiting - Clinical trials for Zellweger Spectrum Disorder

Longitudinal Prospective Natural History Study of Retinopathy in Zellweger Spectrum Disorder

ZSDvision
Start date: December 18, 2023
Phase:
Study type: Observational

The goal of this observational study is to define the course of the retinal degeneration in a ZSD patient cohort. The objective of this study is to gather information so the investigators can: 1. define the course of the retinal degeneration in a ZSD patient cohort with retinal degeneration 2. define what tests best monitor the progression of the retinal degeneration 3. generate prognostic information about vision loss in ZSD. At each yearly visit, the participants will answer a functional vision questionnaire, have a physical evaluation, blood test, and participate in a variety of vision tests. The investigators will also collect pertinent medical history. Participants will travel to study site. The study will provide financial support for board and travel.

NCT ID: NCT06189742 Recruiting - Clinical trials for Asthma With Allergic Rhinitis

Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

TEZARS
Start date: January 29, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about how well tezepelumab (pronounced TEZ e PEL ue mab), a Health Canada-approved drug for severe asthma, works in participants with coexisting allergic asthma and allergic rhinitis (hayfever). The main questions it aims to answer are: - How well does the study drug work to reduce nasal symptoms following exposure to an allergen after 6 doses, and after 12 doses? - Does the study drug reduce chemicals found in the nose known to be involved in the allergic rhinitis response? Both allergic and non-allergic participants will be enrolled in the study. Non-allergic participants will: - Not be receiving the study drug. - Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose. - Complete nasal symptom and quality of life questionnaires - Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure. - Visit the clinic 3 separate times: - At a screening visit to determine their eligibility to participate in the study - At the baseline Nasal Allergen Challenge visit - At the 24-hour post-Nasal Allergen Challenge follow-up visit Allergic participants will: - Receive one dose of tezepelumab every 1 month for 12 months. Tezepelumab will be administered as an injection into the fatty layer just beneath the skin on the stomach, arm, or thigh. - Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose. - Complete nasal symptom and quality of life questionnaires - Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure. - Visit the clinic 17 separate times: - At a screening visit to determine their eligibility to participate in the study - At the baseline, 6-month, and 12-month Nasal Allergen Challenge visits - At each 24-hour post-Nasal Allergen Challenge follow-up visit - For each dose of the study drug The investigator will compare changes in nasal symptoms and allergic chemicals measured from nasal fluid and blood samples between non-allergic participants and allergic participants at baseline and at 6- and 12-months following the use of the study drug.

NCT ID: NCT06189118 Recruiting - Clinical trials for Older Age; Depression

Online MBCT vs HEP for Depressive Symptoms in Older Adults: RCT

OMH-D RCT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

In Canada, depression affects more than 300,000 adults over the age of 60, which costs the healthcare system an estimated $5 billion each year. Late-life depression (LLD) is associated with more deaths, more physical and mental health problems. LLD is hard to treat, as many people will not respond to treatment and many will stop taking antidepressant medication due to negative side-effects. Unfortunately, common non-medication treatments like cognitive behavioral therapy are often inaccessible because of long (6-12 months) wait times and high costs. In a previous study, we found that an 8-week group mindfulness-based cognitive therapy (MBCT) program improved depressive symptoms more than regular LLD treatment (i.e. antidepressants and/or support counseling). Now, a larger scale study is required to compare MBCT to an active control group. Furthermore, research and clinical experience during and post-Covid pandemic has shown that older adults are nowadays far less likely to participate in in-person intervention studies but appreciate and tolerate Zoom delivery of behavioral interventions. This study will compare the effects of MBCT versus an active control group, Health Enhancement Program (HEP), both delivered by Zoom, to see if it improves symptoms of depression in older adults. The study team plans to recruit approximately 100-120 participants in across Canada, who will be randomly assigned to 8-weeks of either MBCT or HEP, delivered by Zoom. The investigators will observe if these treatments improve depression as well as cognition by conducting in-person cognitive assessments. Currently there is a lack of affordable and accessible non-medication treatments for LLD that can be scaled to reach many people. If successful, Mindfulness may be a potential solution, as it is easily given in groups and is well-tolerated by older adults with LLD.

NCT ID: NCT06188689 Recruiting - Clinical trials for Calcium Release Deficiency Syndrome (CRDS)

Evaluation of A Clinical Diagnostic Test for CRDS

DIAGNOSE CRDS
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.

NCT ID: NCT06187675 Recruiting - Pregnancy Related Clinical Trials

A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

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

Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.