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NCT ID: NCT02776735 Completed - Clinical trials for Juvenile Idiopathic Arthritis

An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

SKYPP
Start date: September 6, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population Secondary Objective: To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.

NCT ID: NCT02776579 Completed - Physical Inactivity Clinical Trials

Effect of a Female Strength & Conditioning Specialist on High School Girls' Health

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

The majority of today's youth do not engage in enough physical activity (PA) to maintain good health. Low PA levels are associated with poor health (e.g. diabetes, high blood pressure) and early mortality. Girls are less likely than boys to be active, and their rates of participation drop off more steeply during adolescence. Girls report many barriers to exercise, including transportation issues and feeling self-conscious about their appearance and abilities. School-based PA programs that try to improve health, mainly through aerobic exercise and education, have had a small effect to date. However, the few programs that included resistance training as the focus showed strong improvements in health related measures. In this project, we will examine the effect of a female strength and conditioning specialist on decreasing barriers and increasing the overall health of high school girls, with the delivery of in-school, girls-only resistance training programs. We will see if physical and mental health changes with the training, and how the presence of the S & C specialist affects the girls' social interactions within the school. The results will help individuals in the education sector plan programs and services to improve overall youth and school health.

NCT ID: NCT02776072 Completed - Multiple Sclerosis Clinical Trials

Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

EFFECT
Start date: May 2016
Phase: N/A
Study type: Observational

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

NCT ID: NCT02776033 Completed - Psoriasis Clinical Trials

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in Subjects With Psoriasis

Start date: August 30, 2016
Phase: Phase 2
Study type: Interventional

This is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase inhibitor, in subjects with active plaque-type psoriasis (PsO). The primary objective will be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 milligram (mg) twice daily (BID) for 84 days in Cohort 1 and 60 mg thrice daily (TID) for 84 days in Cohort 2. In addition, a number of experimental and clinical endpoints will be employed to obtain information on the pharmacokinetics, pharmacodynamics, and efficacy in subjects with active PsO. There will be two Cohorts of subjects. In Cohort 1 after a screening period of up to 30 days, approximately 30 subjects will be randomized to receive either GSK2982772 60 mg BID or placebo for 84 days (12 Weeks), followed by a follow-up period (28 days). In Cohort 2 after a screening period of up to 30 days, approximately 24 subjects will be randomized to receive either GSK2982772 60 mg TID or placebo for 84 days (12 Weeks), followed by a follow-up period (28 days). The total duration of participation is approximately 20 Weeks from screening to the last study visit.

NCT ID: NCT02775903 Completed - Clinical trials for Myelodysplastic Syndromes

An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

Start date: June 3, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

NCT ID: NCT02775604 Completed - Clinical trials for Identification of Home Fall Hazards

Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in Detection of Fall Hazards at Home

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility and potential impact of video analysis of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold standard home assessment as a means of detecting home fall hazards. Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera will be better than a homeowner paper checklist in hazard identification.

NCT ID: NCT02774876 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes

Start date: June 2016
Phase: Phase 2
Study type: Interventional

Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. The objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.

NCT ID: NCT02774824 Completed - Clinical trials for Coronary Artery Disease

9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution

Start date: October 1, 2015
Phase: N/A
Study type: Observational

This is a 9-months extension to the following study, protocol number: 003-03: "A study to evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients undergoing coronary artery bypass grafting (GABG)". Participation is allowed exclusively to participants enrolled in the main protocol SOMVC001 (GALA).

NCT ID: NCT02774720 Completed - Dementia Clinical Trials

Centre- Versus Home-based Exercise for MCI and Early Dementia

CHIME
Start date: September 2016
Phase: N/A
Study type: Interventional

The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.

NCT ID: NCT02774499 Completed - Pain Clinical Trials

Preoperative Oral Methadone for Patients Undergoing Cardiac Surgery: Reduction of Postoperative Pain

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Oral medications like gabapentin and acetaminophen are commonly given to patients prior to surgery to provide balanced anaesthesia. Intravenous methadone has been shown to decrease postoperative pain as well as postoperative nausea and vomiting, which are known barriers to discharge. Oral methadone would be a convenient alternative to give as a preoperative medication with its bioavailability approaching 80%. No clinical trials to date have explored the utility of oral methadone as a preoperative analgesic to improve postoperative outcomes. Current literature shows preoperative IV methadone reduces opioid consumption in the perioperative period for cardiac surgeries; therefore, investigators hypothesize that preoperative oral methadone will also reduce postoperative pain and opioid consumption in patients undergoing sternotomy for cardiac surgery.