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NCT ID: NCT03522623 Recruiting - IBD Clinical Trials

Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study

Start date: November 1, 2017
Phase:
Study type: Observational

inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American study demonstrated the direct costs of caring for children with IBD was double those for adults. Indirect health care costs in children with IBD have not been well-described. The Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new and established IBD clinician-researchers and methodologists from 6 provinces experienced in the use of health administrative data. CanGIEC is evaluating variation in care of children with IBD, and will expand this research stream to assess direct and indirect cost of care. This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12 pediatric IBD centres across Canada. Hypothesis: Direct health costs are dominated by medication expenses (particularly biologics), with resulting variation within and across provinces in costs and out-of-pocket expenses to the families due to coverage disparity. Indirect costs include school and parental absenteeism, and productivity losses. Aims: 1. Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include: a Indirect costs - costs to the patient or family related to having the disease but not to direct health care. b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not covered by the public health or private insurance systems. 2. Determine the sociodemographic and disease characteristics associated with higher costs Methods: Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300). Indirect and OOP disease-related costs will be determined with surveys conducted one year following diagnosis and every 6mo for 2y. These will be conducted querying families on the preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance travelled to appointments, medications expenses incurred, and disability benefits collected. Indirect costs will be calculated using the Human Capital Approach (gross income not earned due to disease).

NCT ID: NCT03522467 Recruiting - Cancer Clinical Trials

Cannabis Oil for Pain Effectiveness

COPE
Start date: July 25, 2018
Phase: Phase 2
Study type: Interventional

This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.

NCT ID: NCT03522454 Recruiting - Exercise Clinical Trials

The PERFORM-TAVR Trial

PERFORM-TAVR
Start date: March 15, 2019
Phase: N/A
Study type: Interventional

The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR Men and women undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial with a parallel-group design. The investigators will screen consecutive patients ≥70 years of age before TAVR and enrol those that have evidence of physical frailty defined by an SPPB score ≤8 or an SF36-PF score ≤55. The investigators will randomly allocate 200 patients to receive a multi-faceted intervention consisting of a home-based exercise program and a protein-rich oral nutritional supplement or usual lifestyle counselling. The primary endpoint will be the change in SF36-PF score at 12 weeks.

NCT ID: NCT03522246 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

ATHENA
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

NCT ID: NCT03522207 Terminated - Chronic Pain Clinical Trials

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

Start date: October 15, 2018
Phase: Phase 4
Study type: Interventional

The objective is to evaluate the accuracy and efficacity of 1 dose of trazodone in TMD patient (with chronic orofacial pain and poor sleep quality). Subject will have 3 polysomnography (PSG) over 3 weeks. The first one being the baseline. Half of the patient will receive trazodone on their 2nd PSG and placebo on their 3rd PSG, and the other half will receive placebo bedofe their 2nd PSG and trazodone for the 3rd PSG. Pain quality and sleep quality will be assessed before and after PSG. polysomnograms from baseline, placebo night and trazodone night will also be compared.

NCT ID: NCT03521934 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)

NCT ID: NCT03521804 Terminated - Clinical trials for Chronic Total Occlusion of Coronary Artery

Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.

ACTIVE
Start date: June 21, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).

NCT ID: NCT03520959 Terminated - Cancer Clinical Trials

A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

NCT ID: NCT03520556 Completed - Obesity Clinical Trials

Systematic Review and Meta-analysis of the Differential Effects of DHA and EPA on Inflammation

Start date: April 16, 2018
Phase:
Study type: Observational

According to the World Health Organization, cardiovascular diseases (CVDs) are the number 1 cause of death globally. Systemic and local tissue inflammation is now recognized as a key etiological process leading to CVD. Hence, elevated blood levels of inflammation markers are classified among the well-established risk factors for the development of CVD. Among nutritional strategies to prevent and/or reduce chronic inflammation, long-chain omega 3 PUFA (LCn-3PUFA), notably eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have raised tremendous interest for their purported anti-inflammatory effects. Previous meta-analysis of randomized controlled trials (RCTs) substantiated the anti-inflammatory effect of LCn-3PUFA supplementation as evidenced by significant reductions in plasma concentrations of specific inflammation markers such as C-reactive protein (CRP) and tumor necrosis factor alpha (TNF-alpha). However, it is stressed that almost all of the reported RCTs have used a mix of EPA and DHA in various ratios, as EPA and DHA occur concomitantly and naturally in food (fish oils) and in most dietary supplements. Yet, several recent RCTs have recently been undertaken to test the hypothesis that not all LCn-3PUFAs are equal, at least when it comes to their anti-inflammatory effects. Accordingly, there is increasing interest and evidence for potential distinctive effects of DHA compared to EPA on systemic inflammation, raising the question: Is DHA a more potent anti-inflammatory nutrient than EPA? To formally answer this question, we will conduct a systematic review and meta-analysis of RCTs to assess and compare the individual anti-inflammatory effects of DHA and of EPA. The present work will be a pairwise and network meta-analysis focusing on RCTs comparing the effects of EPA and DHA on surrogate markers of systemic inflammation. The findings generated by these analyses will provide invaluable and timely comparative information on the specific efficacy of DHA and EPA as one of the key nutritional modalities for the treatment of chronic inflammation in high-risk men and women. This is important considering that LCn-3PUFA supplements are increasingly being used by the population and an ever growing market in the dietary supplements' industry.

NCT ID: NCT03520244 Completed - Celiac Disease Clinical Trials

A 12-week Exercise Program for Adults With Celiac Disease

MOVE-C
Start date: November 15, 2016
Phase: N/A
Study type: Interventional

Engagement in regular physical activity (PA) is associated with a range of physical and psychological benefits among chronic disease populations. Celiac disease is a chronic autoimmune condition that requires strict adherence to a gluten-free diet (GFD) for the best medical outcomes, as well as to prevent detrimental health outcomes including bloating, diarrhea, constipation, and increased risk of intestinal cancers and osteoporosis. Despite following a GFD, individuals with celiac disease often report dissatisfaction with the diet, are less likely to engage in social activities, can have an imbalance in gut bacteria and up to 30% still report negative symptoms (e.g., gastro-intestinal upset). Furthermore, preliminary research revealed that rates of PA among those with celiac disease are dismal, with the majority of participants failing to engage in regular PA. The purpose of this pilot research project is to examine the effects of a 12-week structured exercise program on inactive adults with celiac disease. It is anticipated that compared to those in a wait-list control condition, participants who engage in the 12-week exercise program will report greater improvements in quality of life and experience improved balance of gut bacteria. The findings from this project may reveal an additional strategy to optimize health while living with celiac disease. In addition, results from this study will provide essential pilot data that will inform a grant application for a larger clinical trial to further investigate the role of exercise in the promotion of health and well-being among those with celiac disease.