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NCT ID: NCT01656889 Completed - Venous Leg Ulcers Clinical Trials

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

NCT ID: NCT01656538 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer

Start date: February 20, 2013
Phase: Phase 2
Study type: Interventional

Researchers doing this study want to evaluate the side effects of Reolysin when given together with paclitaxel. As these drugs have not been given together before, 6-9 patients will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.

NCT ID: NCT01656473 Completed - Clinical trials for Concurrent Disorders

Evaluating the Effectiveness of Motivational Interviewing and a Dialectical Therapy Skills- Based Intervention for Youth

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

The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an integrated treatment approach for youth with concurrent disorders. The combined intervention will include individual sessions of Motivational Interviewing, followed by inclusion in a Dialectical Behaviour Therapy skills-based group. The following main hypotheses will be examined: 1. Youth with CD who receive an MI intervention will show increased motivation and readiness to change from pre to post MI intervention. 2. Youth with CD who participate in a DBT intervention (orientation session followed by 12-week DBT skills training group)will show reductions in substance use and improvements in mental health, coping and affect regulation between pre to post treatment. The investigators expect that these treatment gains will be maintained at three-month follow-up.

NCT ID: NCT01655901 Completed - Clinical trials for Active Video Games and Appetite Control

Active Video Games and Appetite Control in Adolescents

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

STATEMENT OF THE PROBLEM: Video games have enormous mass appeal, are omnipresent in the daily schedule of most children and youth and have been linked to the obesity epidemic. The investigators research group recently reported that sedentary video game playing increases food intake in adolescents. Interestingly, the overconsumption of food associated with seated video game play was observed without increased sensations of hunger and appetite, as previously observed with television viewing. Active video games offer an appealing opportunity for increasing energy expenditure and promoting healthy body weight among children and youth who might otherwise be spending time in sedentary screen-based activities. However, significant increases in energy expenditure as a result of active video game play might be of little importance to energy balance if one compensates by increasing energy intake and/or decreasing physical activity. Studies to date have failed to measure energy intake so it is currently unknown the effects of active video games on daily energy balance. OBJECTIVE: The main aim of this study is to examine the acute effects of playing active video games on energy intake and expenditure. HYPOTHESIS: The investigators hypothesize that the increase in energy expenditure promoted by active video games will be offset by compensatory adjustments in food intake and spontaneous physical activity subsequent to the intervention. RESEARCH PLAN: With the use of a randomized crossover design, 30 normal-weight and 30 obese adolescents between 13 and 17 years of age will complete three 1-hour experimental conditions, namely (1) resting in a sitting position (control condition), (2) playing Xbox 360 (sedentary video game condition) and (3) playing Kinect (active video game condition), followed by an ad libitum lunch. The primary outcomes will be acute (24-h) and short-term (3-day) energy intake and expenditure. Food intake will be measured using an ad libitum test meal immediately following the intervention, a food menu for the remainder of the day and a dietary record for the subsequent 3-day period. Energy expenditure will be measured using indirect calorimetry during the intervention and an Actical accelerometer for the subsequent 3-day period. Secondary outcomes will include appetite sensations (visual analogue scales), stress markers (heart rate variability, blood pressure, and mental workload), and levels of appetite-related hormones and substrates (glucose, insulin, cortisol, leptin, and ghrelin). RELEVANCE: The present study is innovative and likely to result in a number of new and important findings that can inform future recommendations. If the investigators confirm our hypothesis, the clinical implication will be to rethink the strategy of promoting active video games as an intervention tool for the prevention of overweight and obesity in youth.

NCT ID: NCT01655862 Completed - Torticollis Clinical Trials

A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

Start date: July 2012
Phase: N/A
Study type: Observational

This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.

NCT ID: NCT01655706 Completed - Clinical trials for Major Depressive Disorder

Canadian Biomarker Integration Network for Depression Study

CAN-BIND-1
Start date: April 23, 2012
Phase: Phase 3
Study type: Interventional

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

NCT ID: NCT01655563 Completed - Clinical trials for Kidney Transplantation

Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation

Start date: September 2011
Phase: Phase 2
Study type: Interventional

Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.

NCT ID: NCT01655095 Completed - Clinical trials for Colon Capsule Polyp Detection

Improving Bowel Preparation for the Colon Capsule

Start date: July 2012
Phase: Phase 3
Study type: Interventional

Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America. The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit. Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon. The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.

NCT ID: NCT01655069 Completed - Clinical trials for Urinary Bladder, Overactive

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076

LEOPARD
Start date: October 4, 2012
Phase: Phase 3
Study type: Interventional

This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

NCT ID: NCT01654458 Completed - Ovarian Neoplasms Clinical Trials

A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer

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

There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment. The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.