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NCT ID: NCT01949415 Completed - Rhinoconjunctivitis Clinical Trials

An Optional Investigation of Biomarkers of Efficacy

Start date: September 2013
Phase: N/A
Study type: Observational

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients. ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy. Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01949090 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older

Start date: September 25, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.

NCT ID: NCT01949051 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This study will be a randomized, double blind, placebo controlled, 3-way cross over design in allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine for 7 days in each period and the duration of the study will be about 13 weeks. An Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily (BID). Also study will be conducted to investigate the superiority of effect of 7 days treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects compared to placebo.

NCT ID: NCT01948895 Completed - Dysthymic Disorder Clinical Trials

Desvenlafaxine Monotherapy in Dysthymia

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

This multi-centred study will be conducted at two centres. The design will be an open label, flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine monotherapy for patients who meet diagnostic criteria for dysthymia.

NCT ID: NCT01948752 Completed - Calorie Consumption Clinical Trials

Clinical Trial of Menu Labeling

Start date: November 2010
Phase: N/A
Study type: Interventional

The current study sought to examine the effect of menu labeling on food ordering and food consumption, including the effect of displaying calories along with other nutrients, such as sodium, fat, and sugar, as well as in different formats, such as traffic lights. The investigators hypothesize significant differences in the calorie amount of menu selections and food consumption across experimental conditions. The investigators anticipate that calorie amounts will be significantly higher in the no calorie information) compared to each of the other 3 conditions, and significantly lower in the Traffic Light conditions compared to calories only condition. 2) Individuals in Condition 1 (no calorie information) will be significantly more likely to underestimate the calorie content of their meals compared to individuals in the intervention conditions.

NCT ID: NCT01948492 Completed - Healthy Clinical Trials

Determination of Protein Requirement in Elderly Male Subjects >75 Yrs Old

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

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements. The current dietary reference intake (DRI) requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA). Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by national health and nutrition examination survey (NHANES), the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population. The goal of this study therefore is to measure the protein requirement of male elderly subjects > 75 years using the indicator amino acid oxidation (IAAO) technique. Hypothesis: The investigators hypothesize the protein requirement in elderly male subjects will be lower (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).

NCT ID: NCT01948128 Completed - Breast Cancer Clinical Trials

Effects of Vitamin D in Patients With Breast Cancer

OTT 12-06
Start date: October 2013
Phase: Phase 2
Study type: Interventional

This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.

NCT ID: NCT01947933 Completed - Psoriasis Clinical Trials

A Safety Study of Mirikizumab (LY3074828)

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug and how the drug affects the body. The study will last about 3 months for each participant.

NCT ID: NCT01947530 Completed - Lung Cancer Clinical Trials

Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

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

The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.