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NCT ID: NCT03575104 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Start date: May 29, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT ID: NCT03574597 Completed - Obesity Clinical Trials

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

SELECT
Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

NCT ID: NCT03573830 Completed - Wounds and Injuries Clinical Trials

Randomized Control Trial of Booster Seat Education Material to Increase Perceived Benefit Among Parents

Start date: December 10, 2018
Phase: N/A
Study type: Interventional

Seat belts protect people from injuries by diverting crash forces to stronger anatomical structures: the rib cage and the pelvis. Children between the ages of 4 and 8 years are typically not tall enough to wear the seat belt correctly across the chest and hips, and instead wear it on their abdomen and neck. When worn in this way, seat belts direct crash forces to these parts of the body, potentially causing serious damage to internal organs and the spine. For this reason, children of these ages need to use a booster seat; a safety device that prevents seat belt related injuries by raising the child and ensuring the straps are correctly worn across the thorax and hips. In Canada, half of the children who should be using booster seats are prematurely restrained using only the seat belt. The present research project seeks to develop and test a novel intervention to encourage booster seat use. Many Canadian provinces have enacted laws mandating use, and have developed and implemented evidence-based education programs. Despite these efforts, new approaches to encourage booster seat use are required. In 2010, more than 10 years after booster seats became mandatory, the rate of utilization in the Canadian provinces of Ontario and Quebec was still low (25%). Furthermore, recent research indicates that parents' perception of the safety benefit of booster seats is the strongest predictor of use, yet no study to date has tested an education intervention that increases perceived benefit; instead, these interventions focus on teaching guidelines (i.e., minimum and maximum age, height, and weight to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt). The present approach to encouraging booster seat use is novel, because it increases perceived benefit by teaching two principles: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (internal organs and spine). Once parents grasp these two principles, they are expected to better appreciate the safety benefit of booster seats and, thus, be more likely to use them.

NCT ID: NCT03573479 Completed - Critical Illness Clinical Trials

Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study

PICULiber8
Start date: January 3, 2019
Phase:
Study type: Observational

This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. Advancements in the care provided in Pediatric Intensive Care Units (PICUs) have led to fewer deaths in children. These improvements are unfortunately countered by the emergence of side effects of critical illness, known as PICU-acquired complications (PACs). Delirium, muscle weakness, drug dependency and withdrawal are increasingly common. PACs occur because children are often over-sedated and experience long periods of immobilization. PACs delay recovery, increase disability and worsen long-term function and quality-of-life. Although they are preventable, PACs are very common and frequently overlooked by clinicians. This study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (PICU Liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.

NCT ID: NCT03573323 Completed - Plaque Psoriasis Clinical Trials

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

IXORA-R
Start date: November 9, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT03572439 Completed - Labor Pain Clinical Trials

Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing

Start date: July 17, 2018
Phase: N/A
Study type: Interventional

Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. A variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. In addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. Not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. Another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. This lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. Considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. The objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).

NCT ID: NCT03572101 Completed - Colorectal Cancer Clinical Trials

Living With Colorectal Cancer: Patient and Caregiver Experience

Start date: January 11, 2018
Phase:
Study type: Observational

This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway becomes the new standard of care in Calgary, Alberta, Canada).

NCT ID: NCT03571893 Completed - Obesity Clinical Trials

Study of an International Commercial Program on Weight Loss and Health Outcomes

Start date: June 19, 2018
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) of the Weight Watchers (WW) Freestyle ® (Flex® in UK) weight loss program compared to a control group following a do-it-yourself (DIY) approach for 12 months. Participants in the United States, Canada and the UK (n=360 total) will be randomly assigned to either participate in the commercially available WW program in their local community or to follow their own approach for weight loss. This study will examine the impact of the WW program on weight, fitness levels, quality of life, health behaviors and other health outcomes in overweight and obese adults after 3 and 12 months.

NCT ID: NCT03571165 Completed - Dementia Clinical Trials

Feasibility Study of "My Tools 4 Care-In Care" for Family Caregivers of Residential-Living Older Persons With Dementia

Start date: June 2016
Phase: N/A
Study type: Interventional

Following institutionalization of a relative with Alzheimer's disease and related dementia (ADRD), family carers continue to provide care and must learn to negotiate with staff, and navigate the system, all of which can affect their mental health. A web-based intervention, My Tools 4 Care - In Care (MT4C-In Care) will be developed to aid carers through the transitions experienced when their frail older relative/friend with ADRD resides a in Long-Term Care Facility (LTC). A mixed method pre-post-test longitudinal feasibility study will be used to evaluate MT4C-In Care for feasibility, acceptability, ease of use, and satisfaction. In addition, the investigators expect that MT4C-In Care will improve carers hope, general self-efficacy, quality of life, and reduce their feelings of loss and grief. Following baseline data collection 40 carers of persons with ADRD will be given access to MT4C-In Care over a 2 month period. Measures will be collected at baseline, 1, and 2 months.

NCT ID: NCT03570216 Completed - Clinical trials for Stroke, Cardiovascular

Cardiovascular Effects of Acute Exercise Post-Stroke

ACES
Start date: March 27, 2019
Phase: N/A
Study type: Interventional

There is an urgent need to reduce the impact of stroke by promoting optimal rehabilitation strategies that decrease the risk of stroke. Improving cardiovascular health following a stroke is a key rehabilitation strategy that has the potential to reduce the risk of a recurrent event. Adverse cardiovascular events, including stroke, are often due to chronic atherosclerosis, which shows as increased arterial stiffness. Elevated arterial stiffness is prevalent in individuals with cardiovascular disease, is associated with markers of silent cerebrovascular disease and is a new marker for predicting cardiovascular risk. Cardiopulmonary exercise tests (CPETs) are used to assess cardiorespiratory fitness. Novel CPET protocols have emerged for stroke, enabling safe and valid measurements of cardiorespiratory fitness. Cardiovascular exercise, typically performed through moderate-intensity continuous exercise (MICE), can improve function and fitness in individuals living with stroke and lower the risk of recurrent stroke. Recently, high-intensity interval exercise (HIIE) has emerged as a potentially potent stimulus that may also lead to improvements in function and fitness. While HIIE has shown benefits in clinical and non-clinical populations, only a few small, preliminary studies have examined the effects of HIIE in individuals living with stroke, and most have primarily focused on examining the effects of HIIE on function and gait. No study has examined and compared the acute effects of a CPET, MICE and HIIE on arterial stiffness in stroke. This study will (1) examine the acute effects of a single session of this HIIE protocol compared to a CPET and a single session of MICE on arterial stiffness among individuals with chronic stroke, and (2) the feasibility of a high-intensity interval training exercise protocol previously found to be tolerable and effective in attaining high levels of exercise intensity in in these individuals.