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NCT ID: NCT03045861 Completed - HIV Infections Clinical Trials

Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults

Start date: March 17, 2017
Phase: Phase 2
Study type: Interventional

GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study. This study will be conducted in two Parts (Part A and Part B) consisting single daily doses of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of an interim analysis of part A data, further cohorts of 8 subjects will then be studied in Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the study. Subjects in both parts will have a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation will be approximately 6 Weeks.

NCT ID: NCT03045354 Completed - Childhood Obesity Clinical Trials

Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite

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

The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.

NCT ID: NCT03043859 Completed - Type2 Diabetes Clinical Trials

A Trial to Evaluate the Effectiveness of the Pure Prairie Living Program

Start date: May 9, 2017
Phase: N/A
Study type: Interventional

In Canada, there is a growing burden of type 2 diabetes (T2D). Approaches to implement nutrition recommendations and promote sustainable eating behaviours are required. The investigating research team developed an educational curriculum that includes practical information about Eating Well with Canada's Food Guide, portion control and food label reading. The research team also developed a cookbook, "Pure Prairie Eating Plan" which translates the Canadian Diabetes Association Clinical Practice Guidelines into a practical menu plan with recipes, grocery lists and cooking tips. These resources promote behaviour change and skill development to independently manage diabetes. These resources have been successfully employed in a clinical study trial conducted at the University of Alberta and in a pilot project at the community (Pure Prairie Living Program -PPLP), and showed beneficial effects in management of diabetes among participants. The objective of this study is to implement and evaluate the PPLP in a community level, to promote healthy lifestyle among people with T2D in the general community. To meet the study objective, 60 adult participants with diagnosed T2D will be recruited from three different primary care networks (total of 180 participants) and at each site 30 participants will be randomized into the education intervention (PPLP) and 30 will be the wait-listed controls (CON) receiving usual care. PPLP participants will attend 5, biweekly education sessions and a grocery store tour scheduled over a period of 3 months.The benefits of the lifestyle intervention on physiological indicators (BMI, Haemoglobin A1C, blood lipids, blood pressure) and lifestyle choices (adherence to dietary recommendations, self-efficacy and participation in physical activity) will be examined.

NCT ID: NCT03043833 Completed - Anxiety Disorders Clinical Trials

Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians

Start date: January 18, 2017
Phase: N/A
Study type: Interventional

This study represents Phase II of a research program involving an international collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive behavior therapy for the treatment of anxiety and depression in French-speaking Canadians from the Atlantic Provinces. The primary objective is to establish the clinical efficacy of a French-Canadian self-guided format version of the Wellbeing Course by conducting a randomized-control trial where an experimental group will be compared to a waitlist control group. A secondary objective is to demonstrate the course's acceptability through participants' satisfaction with the course.

NCT ID: NCT03043443 Completed - Clinical trials for Alcohol-Related Disorders

Melatonin Use for Sleep Problems in Alcohol Dependent Patients

Start date: January 25, 2017
Phase: Phase 2
Study type: Interventional

A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for demographics. Sleeping problems will be the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality index (PSQI) scale.

NCT ID: NCT03042819 Completed - Soft Tissue Sarcoma Clinical Trials

Study of Selinexor and Doxorubicin in Advanced Soft Tissue Sarcomas

Start date: May 16, 2017
Phase: Phase 1
Study type: Interventional

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population. Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing.

NCT ID: NCT03042494 Completed - Healthy Clinical Trials

Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Start date: May 15, 2016
Phase: N/A
Study type: Interventional

In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.

NCT ID: NCT03042416 Completed - Parkinson Disease Clinical Trials

18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

Start date: June 29, 2017
Phase: Phase 3
Study type: Interventional

Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Adult patients with a clinical suspicion of Parkinson's disease 5. Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.

NCT ID: NCT03041935 Completed - Pain, Postoperative Clinical Trials

Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

Surgical intervention to treat undescended testis is a very common pediatric surgical procedure, often performed using an inguinal incision or subscrotal incision approach. Children who undergo orchiopexy can suffer from a significant degree of discomfort postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative analgesia following a orchiopexy repair. It is hypothesized that US guided IIG/IHG nerve block leads to more effective pain control post-operatively while in hospital relative to an US guided CE block for orchiopexy surgery.

NCT ID: NCT03041454 Completed - Clinical trials for Uptake of Systematic Review Evidence

Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers

Start date: May 16, 2017
Phase: N/A
Study type: Interventional

The purpose of this project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and British Columbia to participate in a randomized-control trial. Participants will receive a link to an online consent survey, and then be randomly allocated to receive access to a novel SR or its traditional presentation. There is no time limit to completing the task, and participants are able to save their responses and finish later. Participants are able to withdraw from the study by not completing the task.