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NCT ID: NCT01882413 Completed - Dry Eye Syndromes Clinical Trials

A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal

REVEAL
Start date: June 2013
Phase: N/A
Study type: Observational

This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.

NCT ID: NCT01882400 Completed - Cystic Fibrosis Clinical Trials

Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy

Start date: May 2001
Phase: Phase 4
Study type: Interventional

By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy. The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.

NCT ID: NCT01882192 Completed - Physical Activity Clinical Trials

Family Planning to Promote Regular Physical Activity

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

The primary research question is: 1) Does the planning condition improve adherence to regular physical activity compared to the control condition at six months? Hypothesis: Adherence will be higher for the planning condition in comparison to the more standard physical activity education condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months. Secondary Research Questions 1. Does the planning condition improve motivational, health-related quality of life, and health-related fitness outcomes compared to the control condition at six months? Hypothesis: The planning condition will not affect intentions or underlying motives (theory of planned behaviour constructs) for physical activity because its effect on behavior is to tie initial intentions better to behavioural action (i.e., behavioural regulation) and not to enhance motivation. Health-related fitness and quality of life, however, will be higher for the planning condition in comparison to the standard physical activity education intervention condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months in the planning condition compared to the standard physical activity education group. 2. Can group differences among these motivational, behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (planning, education) on use/adherence will be explained by planning and use of behavioural regulation strategies (i.e., manipulation check). In turn, the covariance between planning and behavioural regulation strategies and health-related outcomes will be explained by physical activity adherence among conditions. 3. Can motivational variables predict adherence? Do these differ by condition? Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the concept of active planning. Affective attitude and perceived behavioural control will predict intention, intention will predict planning and planning will predict adherence across conditions. 4. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Children will show greater adherence to the planning condition than their parents. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present to make any definitive statement.

NCT ID: NCT01881893 Completed - Clinical trials for Heart Defects, Congenital

Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

ACHD-CARE
Start date: June 2013
Phase: N/A
Study type: Interventional

The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.

NCT ID: NCT01881230 Completed - Breast Cancer Clinical Trials

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

tnAcity
Start date: September 26, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

NCT ID: NCT01881126 Completed - Glaucoma Clinical Trials

An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

Start date: June 2013
Phase: Phase 4
Study type: Interventional

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

NCT ID: NCT01881022 Completed - Breast Cancer Clinical Trials

An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer

IPSIC
Start date: June 2015
Phase: N/A
Study type: Interventional

Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.

NCT ID: NCT01880684 Completed - Hypovolemia Clinical Trials

Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac

Start date: March 2013
Phase: Phase 2
Study type: Observational

The aim of this study is to evaluate the correlation of capnography with non-invasive measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid challenge, a passive leg raising maneuver, using thermodilution as the gold standard. The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising maneuver.

NCT ID: NCT01880476 Completed - Clinical trials for Diabetes Mellitus, Type 2

Interprofessional Community-Based Diabetes Intervention for Older Adults

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

This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. Participants must be English speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. The 6-month intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian from DCG; participation in a monthly Diabetes Wellness Day group program offered through the Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained volunteers at the Diabetes Wellness Day group program; care coordination by the DCG Registered Nurse to help participants access necessary supports and services; and monthly team conferences between care providers at DCG and the GWSA to develop a client-centred plan of care. To evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.

NCT ID: NCT01880424 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

D5630C00001
Start date: July 2013
Phase: Phase 3
Study type: Interventional

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).