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NCT ID: NCT05319795 Enrolling by invitation - Parkinson Disease Clinical Trials

Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties. Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD? Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.

NCT ID: NCT05318781 Enrolling by invitation - Weight Loss Clinical Trials

Impacts of Bariatric Surgery on the Microbiome and Brain Function

EMBRACE
Start date: August 1, 2022
Phase:
Study type: Observational

Emerging evidence suggests that dietary and metabolic interventions could potentially target prevention and supportive therapies as well as treatments that may slow the clinical deterioration of neurodegenerative disorders. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, there is still no consensus on the optimal diet to maintain brain health. Studies have also shown an association between the gut microbiome and neurocognition, as the microbiota can affect neuronal function through neurotransmitters and neuroactive microbial metabolites. Furthermore, studies indicate that diet may strongly influence the gut microbiota. However, the mechanisms for these complex relationships are still poorly understood. Bariatric procedures [i.e., weight loss surgeries] create a unique environment, in which a fast change in gut microbiota composition and dietary patterns occurs through surgery-induced intestinal and metabolic modifications, leading to changes in gut-brain communication. Interestingly, improvements in neurocognitive domains including memory and executive function have been reported post-bariatric surgery. However, there is large variability in these outcomes, indicating that the benefits are not universal. The goal of the current study is to explore the associations between dietary patterns and gut microbiota with cognition and brain structure, using bariatric surgery as an efficient naturalistic experimental design. This project will also explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure. A total of 120 adult patients (> 30y yrs.) scheduled to undergo a first bariatric surgery along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal. These individuals will undergo assessments 3 months before surgery, as well as 6- and 12-months post-surgery, or an equivalent time for those on the waitlist. This study will also include 60 age-and sex-matched individuals who are not eligible for bariatric surgery as an additional healthy Canadian comparison group (only one assessment time point). Assessments taken during the data collection period will include: self-report information [e.g., sociodemographic and background information, health and diet behaviours]; information from medical records [e.g., medications usage, peri- and post-surgical complications, etc.]; physiological measures [i.e., blood, urine and fecal samples collection]; cognitive assessment [i.e., neuropsychological tests battery]; and brain imaging [i.e., structural MRI]. Collectively, this study is designed to provide critical information about potential individually targeted diet-based preventative strategies to reduce the development and progression of neurodegenerative disorders. Moreover, this project will explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure, and as such, it will provide essential information on key mechanisms, stimulating further research and the creation of parallel non-dietary therapeutic options.

NCT ID: NCT05307666 Enrolling by invitation - Aging Clinical Trials

MinMed: Do Older Adults do Better With Less Medication

Start date: July 28, 2022
Phase: Phase 4
Study type: Interventional

Many health care providers believe "less-is-more" for older adults, and evidence suggests minimizing certain medications might improve health outcomes. While this evidence focuses on specific medications believed potentially problematic for seniors, it is really adverse reactions to COMMON medications (e.g. medications lowering blood sugar or treating pain) that bring older adults to emergency departments. Knowing recommended drug doses are lower in seniors, and knowing most adverse drug reactions are dose-related, the investigators are organizing primary care providers (family physicians and nurse practitioners) to invite their patients 80 years and older on 6 or more medications to review with them whether some medications could be safely reduced. For drugs treating a symptom (e.g. heartburn), patients and providers will work together to find the lowest dose that provides the same benefit. For drugs that lower blood pressure or blood sugar, doses will be adjusted to keep blood pressure and blood sugar in the upper end of the target range, a range many providers feel to be safer for older adults. Each provider will invite half their eligible patients to a minimization visit at the start of the study, and invite the other half later - after the health effects of minimizing the early group's medications is assessed. To do this, investigators will compare early minimizers to those whose medicines have not yet changed using electronic health data routinely collected on all Albertans. We hypothesize that minimizing medications will prolong independence, reduce mortality and hospitalization, and improve quality of life. It is important to recognize that the intervention (reviewing all medications and determining the lowest effective doses) is already widely recommended as best practice when prescribing for older adults. Despite this however, such medication reviews only infrequently take place. In this study investigators hope to demonstrate that family physicians can minimize their own prescribing, and that organizing providers in a way that permits such reviews to take place can provide health benefits to patients.

NCT ID: NCT05303532 Enrolling by invitation - Cancer Clinical Trials

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

ROSY-D
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

NCT ID: NCT05275049 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Neuromodulation in MS Using Translingual Stimulation

NeuroMSTraLS
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).

NCT ID: NCT05270356 Enrolling by invitation - Clinical trials for Adult Congenital Heart Disease

MINDS Imaging Ancillary Study

MINDS
Start date: May 27, 2021
Phase:
Study type: Observational

This study is an ancillary study to the NHLBI-funded Pediatric Heart Network (PHN) "Multi-Institutional Neurocognitive Discovery Study" (MINDS) in Adult Congenital Heart Disease (ACHD). The MINDS-ACHD" study will recruit 500 complex CHD patients between18-30 years old. The investigators propose to quantitate multi-modal neuroimaging biomarkers (brain injury, structure and physiology) which are not only important components of brain and cognitive reserve but can be predictive of neurocognitive decline and early onset of dementia in the aging non-CHD population.

NCT ID: NCT05258422 Enrolling by invitation - Clinical trials for Ventricular Tachycardia

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)

StAR-VT
Start date: July 1, 2023
Phase: Phase 2
Study type: Interventional

In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by noninvasive cardiac mapping. More recently, Robinson et al. reported on the results of their Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia (ENCORE-VT) trial, also using a similar SBRT technique in a series of 17 patients with refractory VT. Both studies report a marked reduction in VT burden, a decrease in antiarrhythmic drug use, and an improvement in quality of life. Since then, numerous other centres have detailed their initial experience with this technique. These initial results suggest that this new treatment paradigm has the potential to improve morbidity and mortality for patients suffering from treatment-refractory VT by means of a minimally invasive technique, but requires further validation for widespread use. The appropriate dose for therapeutic effect of this new treatment is not well established as only a single dose prescription of 25 Gy in 1 fraction has been described with benefit. In this phase 2 trial, the investigators plan on expanding the experience with this technique but also by contributing to understanding the relationship between dose-effect relationship through a dose de-escalation stratification, to 20 Gy in 1 fraction, with the goal of minimizing possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.

NCT ID: NCT05243537 Enrolling by invitation - Preterm Birth Clinical Trials

QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal

Start date: January 1, 2023
Phase:
Study type: Observational

Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, <1000 g) infants or preterms. Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data. Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable [EMA guideline, FDA guidance].

NCT ID: NCT05231200 Enrolling by invitation - Length of Stay Clinical Trials

Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)

ABC-QI
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.

NCT ID: NCT05220761 Enrolling by invitation - Delirium Clinical Trials

Family Assessment of Pediatric Delirium

FAM-CAPD
Start date: August 9, 2021
Phase:
Study type: Observational

In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).