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NCT ID: NCT03604809 Completed - Delirium Clinical Trials

Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients

GOTCI
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients Short Title: GOTCI Methodology: Randomized Control Trial Study Duration: 12-15 months Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive interventions on delirium in adult critically ill patients. Number of Subjects: 112 Primary Outcome: Delirium Prevalence and Duration Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of stay, hospital length of stay and days of mechanical ventilation. Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU, Calgary, Alberta Type of Intervention: OT guided cognitive intervention based on RASS score Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between 0800-1600. There will be twice daily sessions for 20 minutes each. Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the duration of participant ICU admission. Reference therapy: Standard of care within the Department of Critical Care Medicine in Calgary is delirium prevention strategies using the ABCDEF bundled approach. Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed to describe the study population. The primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be performed.

NCT ID: NCT03604263 Completed - Atrial Fibrillation Clinical Trials

ArcticLine Feasibility Study

Start date: October 18, 2018
Phase: N/A
Study type: Interventional

The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.

NCT ID: NCT03603522 Completed - Atopic Asthma Clinical Trials

Probiotics and Capsaicin Evoked Coughs

PCEC
Start date: July 16, 2019
Phase: N/A
Study type: Interventional

Cough in asthma is a very common and troublesome symptom in asthma, which predicts severity and poor prognosis. Previous studies have shown that asthmatics have an exaggerated cough response to capsaicin. Currently available asthma treatment is not designed to target the cough reflex directly, so this presents an unmet need for patients. The treatment being tested in this study is the commercially available over the counter oral probiotic BioGaia® DSM17938. Based on clinical and pre-clinical evidence, it is hypothesized that TRPV1 antagonism with BioGaia® DSM17938 will result in a reduction in capsaicin evoked coughs in patients with asthma.

NCT ID: NCT03603314 Completed - Clinical trials for Severe Sudden Sensorineural Hearing Loss

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

AUDIBLE-S
Start date: February 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

NCT ID: NCT03602768 Completed - Aging Clinical Trials

Evaluation of the Online Memory & Aging Program and Online Goal Management Training

Start date: June 18, 2018
Phase: N/A
Study type: Interventional

The current study is designed to test the effectiveness of online programs for memory and executive functions in healthy aging. The investigators are testing online adaptations of two cognitive interventions that have been extensively studied, validated, and implemented in clinical settings: The Memory & Aging Program (MAP) targets normal memory change in healthy aging, and Goal Management Training (GMT) targets executive functioning deficits in a variety of cognitive and neurological conditions including healthy aging. Both programs combine psycho-education, targeted skills training and clinical support to empower participants with knowledge and strategies to harness their cognitive faculties. These programs are being tested against a waitlist control as well as against a commercial/research brain training platform (Cambridge Brain Sciences) in a design comparing performance on memory and executive functioning measures before and after the interventions/controls. The main hypothesis is that MAP will lead to memory-specific improvements above control conditions, whereas GMT will lead to greater improvements in measures of executive functions relative to controls.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03601845 Completed - Clinical trials for Diffuse and Focal Liver Diseases, Cerebral Function

MRE-IA in Liver Disease and Neurovascular Imaging

MRE-IA
Start date: January 31, 2019
Phase: N/A
Study type: Interventional

The objective of this research project is to develop Magnetic Resonance Elastography by Intrinsic Activation (MRE-IA) imaging methods at two imaging centers (CRCHUS and CRCHUM) for use in ongoing studies in liver disease and neurovascular imaging. MRE is a developing MR imaging modality that provides detailed maps of tissue's mechanical properties, based on displacement measurements made during the propagation of low amplitude vibrations through the region of interest. MRE-IA uses the pressure pulses of the cardiac cycle to induce the vibrations needed for MRE image reconstruction. MRE-IA has already been demonstrated based on the use of existing, clinically approved MR imaging sequences, and once this capability has been established at the two centers, initial trials will be done to demonstrate the method's potential in liver and neurovascular imaging. In the case of the liver, this pilot project funding will be used to perform MRE-IA imaging in patients with chronic liver disease and focal liver lesions. Results will be analyzed to establish the relationship between the mechanical properties mentioned above and disease stage. In the neurovascular case, imaging will be conducted under basic visual and motor stimulus conditions in healthy subjects, and results compared non-stimulus control images to determine changes in the above properties based on brain function. In addition, MRE-IA images will be compared with BOLD imaging to investigate the role of fluid conductivity in fMRI results.

NCT ID: NCT03601793 Completed - Alcohol Problem Clinical Trials

An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.

NCT ID: NCT03601663 Completed - Physical Activity Clinical Trials

Exploring the Effect of an Intervention on Women's Physical Activity Behaviour

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Physical activity has been shown to reduce the risk of chronic diseases and promote physical and mental health and wellbeing, yet few women are active enough to see these benefits. Wearable activity trackers show promise for helping people increase their physical activity levels by supporting self-monitoring. However, few researchers have examined how providing people with these devices impacts physical activity levels, or motivation for physical activity which is a significant and robust predictor of physical activity. Based on previous research, it is possible that women's physical activity levels would be more likely to increase if they received an autonomy-supportive intervention to enhance motivation in addition to a wearable activity tracker. A pilot, three-armed randomized controlled trial was developed to test this hypothesis and to assess if changes in perceived autonomy-support, basic psychological need satisfaction/thwarting, motivational regulations, wellbeing indicators are associated with changes in physical activity over time.

NCT ID: NCT03601637 Completed - Cystic Fibrosis Clinical Trials

Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

Start date: September 7, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).