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NCT ID: NCT02223260 Completed - Clinical trials for Venous Thromboembolism

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

NCT ID: NCT02223234 Completed - Obesity Clinical Trials

Guelph Family Health Study: Pilot Study

Start date: September 2014
Phase: N/A
Study type: Interventional

The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile. To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk. We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve: 1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period. 2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes) 3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period. We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.

NCT ID: NCT02223182 Completed - Food Allergy Clinical Trials

Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

MILES
Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.

NCT ID: NCT02222571 Completed - Obesity Clinical Trials

Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context

Start date: July 2013
Phase: N/A
Study type: Interventional

This formative research shows that parents of preschool-aged children are enthusiastic about learning general parenting skills, such as discipline strategies, but that they are less interested in information on child nutrition and physical activity needs. To capitalize on this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that embeds strategies to improve children's nutrition and activity behaviours within an existing general skills parenting program. Results from the investigators feasibility trial with 16 Boston-area parents show that PTT is feasible for implementation and is extremely well-received by parents. Results are also encouraging with respect to changing parent feeding behaviours and children's nutrition and activity behaviours. What is not known is whether this program is feasible and contextually appropriate for Canadian families. Thus, the next step in this research program, and the overall goal of this study, is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children 3 to 5 years of age, within the Canadian context. To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60 families recruited through Ontario Early Years Centres (OEYC). The investigators will randomize 30 families to the 3-month PTT intervention and 30 to a control condition. The investigators primary objective is to implement and test the feasibility and acceptability of PTT among families with preschool children so appropriate revisions can be made to adapt it to a Canadian context. The investigators secondary objective is to compare the following outcomes among intervention versus control participants: 1. Parent weight-related behaviours (i.e., parent physical activity, intake of sugar-sweetened beverages, and television/video viewing, as well as responsiveness to child satiety cues). 2. General parenting behaviours (i.e., use of positive discipline strategies). 3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing). 4. Nutritional risk score based on a screening tool for preschoolers. 5. Child change in body mass index (BMI), standardized to age and gender.

NCT ID: NCT02222506 Completed - Clinical trials for Diabetic Foot Ulcers

Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers

Start date: April 2013
Phase: N/A
Study type: Interventional

The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with diabetic foot ulcers.

NCT ID: NCT02222493 Completed - Clinical trials for Rheumatoid Arthritis

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Start date: August 26, 2014
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

NCT ID: NCT02222467 Completed - Venous Leg Ulcers Clinical Trials

Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers

Start date: November 2012
Phase: N/A
Study type: Interventional

The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with venous leg ulcers.

NCT ID: NCT02222454 Completed - Clinical trials for Pressure Ulcers Stage III

Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers

Start date: November 2012
Phase: N/A
Study type: Interventional

The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III pressure ulcers.

NCT ID: NCT02222259 Completed - Breast Cancer Clinical Trials

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy. Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

NCT ID: NCT02222207 Completed - Clinical trials for Macular Degeneration

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

DREAM
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: - how often the regorafenib eye drops need to be given per day - whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.