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NCT ID: NCT02141828 Completed - Leukemia Clinical Trials

A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene

Start date: May 2014
Phase: Phase 1
Study type: Interventional

A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of patients with MLL-rearranged leukemias.

NCT ID: NCT02141399 Completed - Clinical trials for Major Depressive Disorder

A Long-Term Safety Study of ALKS 5461

Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

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Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

NCT ID: NCT02141035 Completed - Clinical trials for Carpal Tunnel Syndrome

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome

Start date: September 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe carpal tunnel syndrome. Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In severe cases, nerve regeneration and functional recovery are incomplete even with surgery. The goal of this pilot project is to test a potentially promising medication, acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled study design. Along with surgery, those in the treatment group will also receive ALCAR while the other half in the control group will be given placebo. To gauge the effects of ALCAR, we will compare motor and sensory nerve growth as well as functional outcomes. The data from this study will provide crucial information when designing a full scale clinical trial. If successful, this will represent an important first step in finding a novel treatment to improve functional outcomes in patients with severe CTS.

NCT ID: NCT02140957 Completed - Clinical trials for Educational Intervention and Toddler Bottle Use

Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial

Start date: January 2007
Phase: N/A
Study type: Interventional

Observational studies support an association between bottle feeding beyond 15 to 18 months of age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency, behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic households, choose to feed their children by bottle much beyond this age. Recognizing the need for further educational interventions for bottle feeding, the TARGet Kids! Research Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9 month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational intervention for parents of 9-month-old children could reduce bottle use and iron depletion at 2 years of age.

NCT ID: NCT02140099 Completed - Clinical trials for Mental Health Wellness 1

Evaluation of the Healthy Relationships Plus Program for Youth

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

Adolescent risk behaviours, such as violence and substance use, are prevalent public health concerns in Canada. Further, these behaviours often co-occur, and are associated with poor mental health. However, the majority of prevention programs focus on preventing single issues and do not consider mental health, and also neglect the importance of relationships when promoting positive youth development. To address this gap, the Centre for Addiction and Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy Relationships Plus Program, a small group program focused on the promotion of positive mental health and the reduction of violence and substance use, via the development of improved communication, interpersonal and help-seeking skills. The purpose of this study is to evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and process evaluation tools. The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus program will be associated with positive growth in treatment participants' psychological well-being from pre-test to 12-month follow-up, as compared to control participants. In secondary analyses, the study will explore if treatment participants report less substance use, peer violence, bullying and dating violence at 12-month follow-up than control participants. Since certain person-level (e.g., sex, personality, executive functioning) and program-level (e.g., implementation quality) variables may moderate treatment-outcome relationships, these associations will also be explored. The final hypothesis is that treatment participants will report better attitudes, knowledge and assertive communication at post-test compared to control participants, and that these improvements will mediate the association between program participation and 12-month outcomes.

NCT ID: NCT02139969 Completed - Clinical trials for Benign Prostatic Hyperplasia

GreenLight XPS Laser System Retrospective Chart Review

Start date: May 2014
Phase:
Study type: Observational

The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.

NCT ID: NCT02139943 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

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

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

NCT ID: NCT02139865 Completed - Muscle Weakness Clinical Trials

The Effects of Lifting Light or Heavy Weights on Muscle Growth and Strength in Trained Young Men

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

When practicing weightlifting regularly the body makes new proteins within the muscle. These new proteins can increase the size of the cells within the muscle to make them larger, a process called hypertrophy. The common convention surrounding gains in skeletal muscle size and strength is that heavy weights are needed. In contrast, lifting lighter weights are thought to be required to induce muscular endurance and not to promote growth. However, it has previously been shown in untrained men that lifting lighter weights results in similar gains in muscle mass and strength as lifting heavier weights. The purpose of this study is to examine how performing resistance training of different intensities (light or heavy weights) affects the degree of muscle growth and strength gain in individuals who are already resistance training. This information will be valuable when designing exercise protocols for increasing muscle size and strength at all ages, or in individuals returning from injury, as a way to stimulate muscle growth and promote strength gains without the need to lift heavy weights.

NCT ID: NCT02139839 Completed - Clinical trials for Vaginosis, Bacterial

Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14

Start date: September 2012
Phase: Phase 0
Study type: Interventional

The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis of microbial ecology, human microarrays and multiplex immunological assessments are included to characterize potential effects.