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NCT ID: NCT02961218 Completed - Sickle Cell Anemia Clinical Trials

Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia

Start date: April 5, 2017
Phase: Phase 2
Study type: Interventional

The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).

NCT ID: NCT02961036 Completed - Incentive Clinical Trials

The Role of Supplementary Material in Journal Articles QT

SupMatQT
Start date: November 15, 2016
Phase: N/A
Study type: Interventional

Questionnaires are frequently used in online research, however recruiting, and completion rates of online participants from a variety of cultures and demographic backgrounds can be challenging. The challenge is greater in an online cohort because there is no way to observe the participant beyond what is contributed online. Poor recruiting and completion can result in underpowered research that may not be representative of the sample population. This can trigger an increase in costs as the recruitment period may have to be extended until sample size is reached. When recruiting and completion rates are inadequate studies may have to be terminated and the answer to the research question can remain unknown. To mitigate these challenges, incentives may be offered in the form of gift certificate draws. There is uncertainty about whether this strategy is effective in online research and if the value of the incentive alters the outcome. A randomised trial can be used to test the intervention to establish an evidence base. This study (SupMatQT) proposes to link with a large 20,000 person international cohort study (SupMat) that will test the utility and preferences of journal supplementary materials for reviewers, authors,and readers. The research described here will examine the evidence of effect for offering a prize draw incentive on rates of recruitment, and completion for consented participants. All participants will be entered in the draw. Information about the value of the incentive of a prize draw will differ according to what group a participant is randomized to. The entry in the prize draw will not be conditional on levels of participation or group allocation. The other question researchers will address is what effect do survey reminders have on outcomes? All non-responders will be sent an initial reminder to complete the survey (Group A) and for those who have still not responded a second reminder will be sent 14 days later (Group B). Outcomes will be compared at three time points: for initial response, following reminder 1(Group A), and following reminder 2 (Group B).

NCT ID: NCT02961023 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Effect of Adding Exercise Training to Optimal Therapy in PAH

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

Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted therapy, increases EC by improving SV. Additional factors may contribute to exercise limitation: - Peripheral and respiratory muscle dysfunction - Autonomic dysfunction - An altered profile of inflammation - Mitochondrial dysfunction. The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting treatment goals, will be enrolled in a 30-week randomised exercise training program. One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other will receive standard care for 15 weeks then 15 weeks training. Aims: 1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug therapy a UK PAH population. 2. Explore mechanisms of exercise limitation and factors that improve with training, assessing: - Cardiac function - Skeletal muscle function - Autonomic function - Respiratory muscle strength - Serum and muscle profile of inflammation Primary outcomes (15 weeks) 1. 6 minute walk distance 2. QOL 3. RV ejection fraction

NCT ID: NCT02961010 Completed - Child Maltreatment Clinical Trials

Evaluating the Effectiveness of Keeping Safe - a School Based Intervention Aimed at Preventing Abuse

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

This study evaluates the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse. The intervention - Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and includes content across the following keeping safe concepts; bullying, neglect, emotional, physical, domestic and sexual abuse, in online and offline contexts. - Includes activities for the formal and informal school curricula - 63 lessons will be taught to children by their classroom teacher; 3 per term, 9 per year across 7 years from Primary 1 to primary 7 (age 4-11 years). - Each lesson is accompanied by directed homework activities to involve and engage parents and enable them reinforce learning at home. A number of whole school, key stage and year group assemblies have also been prepared. - At the beginning of each term school leaders will deliver a prepared assembly to introduce the theme for the term. Following this assembly each teacher will deliver 3 lessons tailored to the age group of their class and parents will assist with home works. The lessons use eBooks, character animations, stories, rhymes, and interactive whiteboard activities to engage children in their learning. The intervention adopts a whole-school approach and seeks to build the capacity and skills of teachers and parents as key partners. Teachers will receive a comprehensive package of training, ongoing support and resource materials to equip them with the skills they need to effectively communicate sensitive keeping safe messages. Parents will also receive a package of resources to help them feel confident about communicating sensitive messages to their children.

NCT ID: NCT02959892 Completed - Healthy Volunteers Clinical Trials

A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)

Start date: December 5, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine brain penetration of single oral doses of TAK-041 and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).

NCT ID: NCT02959814 Completed - Clinical trials for Coronary Artery Disease

Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan

FAVOR II EJ
Start date: February 22, 2017
Phase:
Study type: Observational

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as gold standard.

NCT ID: NCT02958696 Completed - Clinical trials for Bioavailability and Pharmacokinetics

Relative Bioavailability of HTL0018318 Oral Aqueous Solution Versus Capsules

Start date: October 2016
Phase: Phase 1
Study type: Interventional

HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label, randomised, crossover, single dose, trial in healthy volunteers to compare the relative bioavailability of HTL0018318 when given by oral aqueous solution and in capsule formulation.

NCT ID: NCT02958683 Completed - Surgery Clinical Trials

Chest Wall Motion Analysis in Disease

CWM
Start date: July 2011
Phase:
Study type: Observational

Breathing movements, called chest wall motion, are very complex. The investigators are studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this differs with different diseases in the chest. Breathing movements may help with diagnosis, assessment of severity or assessing the impact of treatments for chest conditions. The investigators are following people who have a chest disease, measuring their chest wall motion and comparing it to their diagnosis and and how their treatment works. Chest wall motion can be measured in different ways at rest and whilst exercising. Small stickers on the chest can be used to reflect infra red light or visible squares of light can be shone onto the chest without using stickers.

NCT ID: NCT02958449 Completed - Cancer, Breast Clinical Trials

Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy

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

Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy

NCT ID: NCT02957474 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow up phone call five days (± 1 day) after discharge.