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NCT ID: NCT02576067 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study

CIRT
Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

Vascular inflammation, a central feature of atherosclerosis, participates in the initiation, perpetuation and instability of plaques. Multiple clinical trials of cholesterol lowering therapy with statins have demonstrated that reductions in atherosclerotic cardiovascular disease (CVD) events are associated with reductions in both LDL cholesterol (LDL-C) and the systemic inflammatory mediator C-reactive protein (CRP). The Cardiovascular Inflammation Reduction Trial (CIRT) investigates if an anti-inflammatory agent commonly used in rheumatoid arthritis (low dose methotrexate (LDM)) can reduce CV morbidity and mortality among patients with a prior myocardial infarction or angiographically demonstrated multivessel coronary artery disease (GCO#13-1467). In this ancillary CIRT imaging study, the investigators propose to use this well validated approach by non-invasive serial FDG-PET/CT imaging in a subset of patients enrolled in the main CIRT trial to directly visualize vascular inflammation. Once the subjects are enrolled in the main CIRT trial, baseline imaging will be done and follow up imaging will be done approximately 8 months after the baseline imaging. 18FDG-PET imaging data will be acquired, analyzed centrally and results incorporated into the main CIRT database. The investigators hypothesize that LDM treatment will result in a significant decrease in plaque inflammation as measured by 18-FDG-PET/CT after 8 months as compared to placebo.

NCT ID: NCT02575430 Completed - Clinical trials for Retinitis Pigmentosa (RP)

Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT

Start date: December 2015
Phase: N/A
Study type: Observational

To evaluate the natural history of visual function in subjects with IRD phenotypically diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutations.

NCT ID: NCT02574481 Completed - Clinical trials for Atherosclerosis of Native Arteries of the Extremities

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

IMPERIAL
Start date: December 2015
Phase: N/A
Study type: Interventional

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

NCT ID: NCT02574455 Completed - Breast Cancer Clinical Trials

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

ASCENT
Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

NCT ID: NCT02574429 Completed - Clinical trials for Posttraumatic Stress Disorder

CPT Group for DBT Clients With Co-Occurring Borderline Personality Disorder and PTSD

CPTDBT
Start date: April 2016
Phase: N/A
Study type: Interventional

Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.

NCT ID: NCT02573454 Completed - Sedentary Lifestyle Clinical Trials

Prosocial Exercise: Does Exercising for Charity Result in Greater Well-Being and Physical Activity?

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether prosocial exercise (exercising for the benefit of others) results in greater well-being and physical activity when compared to personal exercise (exercising without attempting to benefit others). Participants will be randomly assigned to utilize one of two exercise apps for a two week period: Charity Miles, which allows users to donate money to charities based on exercise participation, or Nike+ Running, which is a standard GPS exercise app. Participants will be provided with questionnaires at pre- and post-test, at a 4 week-follow-up, and immediately before and after each use of the app.

NCT ID: NCT02573441 Completed - Clinical trials for Childhood Brain Tumor

KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer

Start date: October 2015
Phase: N/A
Study type: Interventional

The study will examine whether school liaison services and home-based parental tutoring can help with academic difficulties of paediatric brain tumour survivors who received cranial spinal radiation and have returned to school. Forty-five patients will participate in the project. All patients will receive psychology liaison services to link resources at the hospital with those in the community. Patients will participate in one of two tutoring programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone calls will be used to support parents using the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities.

NCT ID: NCT02573324 Completed - Glioblastoma Clinical Trials

A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Intellance1
Start date: January 4, 2015
Phase: Phase 3
Study type: Interventional

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

NCT ID: NCT02573233 Completed - Asthma Clinical Trials

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

EXPEDITION
Start date: January 27, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

NCT ID: NCT02573168 Completed - Schizophrenia Clinical Trials

Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment With Antipsychotics

Start date: January 2016
Phase: N/A
Study type: Interventional

Antipsychotics are approved to treat several conditions, including Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, and Major Depressive Disorder among others. The typical and atypical antipsychotics, derive their therapeutic benefit predominantly from the antagonism of dopamine D2 and 5-HT2A receptors. Many of these compounds are associated with common and significant adverse effects (e.g. weight gain, extrapyramidal symptoms, hyperprolactinemia, sexual dysfunction, and cardiac effects) which negatively impact on adherence. Today, antipsychotic induced weight gain (AIWG) is a leading cause for antipsychotic discontinuation. Importantly as well, approximately 20-30% of all patients with schizophrenia do not respond adequately to an initial antipsychotic trial, and strikingly, 83% of those who go on to a second antipsychotic trial do not meet criteria for response. To-date, no RCT has been conducted to evaluate the outcomes in patients taking antipsychotics following the use of pharmacogenomic guidance of treatment selections. Therefore, the rationale for this trial is to utilize a double-blinded RCT design to evaluate and compare the clinical outcomes in participants treated with the benefit of GEN and E-GEN testing. Furthermore, this trial also intends to develop an evidence- based case for the value of GEN and E-GEN to Canadian health-care payers.