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NCT ID: NCT03754036 Completed - Sleep Clinical Trials

Sleep Extension and Insulin Sensitivity in Adolescents

Start date: January 5, 2019
Phase: N/A
Study type: Interventional

BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical relevance given the high prevalence of sleep deprivation in this population and the accumulating body of evidence indicating that having a good night's sleep is important for the prevention of chronic diseases including type 2 diabetes. OBJECTIVE: To determine if extending sleep duration improves insulin sensitivity in adolescents presenting with risk factors for type 2 diabetes. HYPOTHESIS: It was hypothesized that compared with decreasing sleep duration, increasing sleep duration by 1.5 hours over 1 week will improve insulin sensitivity. METHODS: Using a randomized, counterbalanced, 2-condition crossover design, 30 obese adolescents between 13 and 18 years of age who have insulin resistance will complete the study. Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of at least 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center. Participants will also be compensated for keeping the sleep schedule and daily calls to enhance adherence. The outcome measures will then be compared between both sleep conditions at the end (on day 8 of each study week). The primary outcome measure will be insulin sensitivity as measured by the Matsuda index (total body insulin sensitivity). Secondary outcomes will include the homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, food intake and physical activity. Repeated measures analysis using the mixed model will be used to assess the effect of the two sleep interventions on insulin sensitivity. RELEVANCE: The study will provide the first robust clinical evidence to determine if increasing sleep duration in youth at risk for type 2 diabetes improves insulin sensitivity. This information will be essential for clinical and public health guidelines for type 2 diabetes prevention among adolescents.

NCT ID: NCT03753945 Completed - Depression Clinical Trials

Spine MRI in Patients With Deep Brain Stimulation (DBS)

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is under strict safety guidelines. Depending on the body part being imaged, the safety may vary. Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom safety data, we designed a set of MR pulse sequences deemed as safe as possible and the protocol allows acquisition of diagnostic quality MRI images.

NCT ID: NCT03753347 Active, not recruiting - Influenza Clinical Trials

TITRE III: Influenza B Immunogenicity Investigation

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in children who were primed with two doses of trivalent inactivated influenza vaccine (TIV) containing B/Yamagata. Overall, the investigators found that 2 doses of vaccine containing B/Yamagata did not adequately prime children for response to the alternate B/Victoria antigen and that subsequent vaccine doses containing B/Victoria-lineage antigen strongly boosted antibodies to the B/Yamagata antigen that was introduced during first immunization priming, but with lower responses to B/Victoria. For the first time since 2009-10, the recommended B/Victoria component of the seasonal influenza vaccine has been changed, from B/Brisbane/60/2008 to B/Colorado/60/2007 for the coming 2018-19 season. The investigators thus have a unique opportunity to clarify lineage-specific influenza B responses in a well-characterized cohort of children originally primed to Yamagata. The investigators' main interest is to assess whether TITRE I children primed with two doses of B/Yamagata in 2008-09 have since or are now capable of achieving a sufficient antibody response to B/Victoria following a single dose of 2018-19 QIV, ten years after their initial TIV B/Yamagata priming exposure.

NCT ID: NCT03753334 Recruiting - Prostate Cancer Clinical Trials

Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

RCT-EPAII-BCR
Start date: July 10, 2017
Phase: Phase 2
Study type: Interventional

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects. Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment. This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.

NCT ID: NCT03752892 Recruiting - Clinical trials for Lung; Disease, Interstitial, With Fibrosis

Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe enough for a good workout. One way to improve the exercise training is to reduce the number of muscles being trained together. By training one leg at a time, the patient does not have to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in patients with IPF. This study will help decide whether one-legged exercise training is better at improving a patient's exercise endurance compared to the usual way of exercising with both legs at the same time.

NCT ID: NCT03752801 Completed - Oncology Clinical Trials

Improving Quality and Consistency in Family Education Prior to First Discharge Following Pediatric Cancer Diagnosis

Start date: May 1, 2018
Phase:
Study type: Observational

When a child is diagnosed with cancer the family's world is turned upside down. Parents have high levels of stress because they must learn important information about their child's diagnosis,medications and treatments. They must also learn how to care for their child once they have left the safety of the hospital. Parents have voiced that during this time they receive too much information, have paper overload, and hear and read different information causing them to feel confused. Parents have shared that small amounts of information that can be repeated when they want and as often as they want helps them to feel more confident to care for their child. This study will ask parents if they like and can easily learn information about how to care for their child with cancer from short videos that highlight key points, have visual cues, and provide case examples. If parents find short videos useful and helpful for learning, with the goal that they will feel more confident to care for their child and have lower levels of anxiety.

NCT ID: NCT03752385 Terminated - Sedentary Lifestyle Clinical Trials

The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being

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

Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact both sleep and mental health (1-3). The purpose of this study is to determine the impact of reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health in adolescents and young adults aged 13-25.

NCT ID: NCT03751748 Not yet recruiting - Clinical trials for Heart Failure With Normal Ejection Fraction

Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

FROST-HF
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

NCT ID: NCT03751657 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.

NCT ID: NCT03751423 Suspended - Clinical trials for Abortion in First Trimester

Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion

Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

A therapeutic abortion is one of the most common procedures performed in Canada, with approximately 100,000 occurring annually. 95% of induced abortions are done surgically, with just over two thirds of these procedures taking place in the first trimester. This study will be a randomized, controlled, double-blinded, single-centre superiority trial with three parallel groups; oral morphine vs intravenous fentanyl vs intravenous ketamine. The primary outcome will be immediate post-operative pain following a first trimester therapeutic abortion as assessed using the visual analogue scale. Randomization will be performed as block randomization with a 1:1:1 allocation ratio. In total, 123 participants will be recruited and randomized, with 41 being assigned to each treatment arm. This study will be conducted at the Women's Clinic at Kingston General Hospital in Kingston, Ontario, Canada. Women from Kingston and the surrounding areas are referred to this clinic and can self-refer for therapeutic abortion. The investogators hope that this research will move us towards a better form of pain control for our participants undergoing first trimester surgical abortion, without increasing length of stay, side effects, or adverse events. This, in turn, will hopefully improve access to optimal pain control to participants undergoing first trimester surgical abortion in an outpatient setting.