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NCT ID: NCT03068351 Completed - Multiple Myeloma Clinical Trials

Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma

Start date: June 26, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels.

NCT ID: NCT03068117 Completed - Clinical trials for Mesothelioma, Malignant

Malignant Mesothelioma - Can we Improve Quality of Life

RESPECT-Meso
Start date: April 3, 2014
Phase: N/A
Study type: Interventional

Patients with malignant pleural mesothelioma (MPM) frequently have significant physical symptoms, with up to 92% of patients complaining of three or more symptoms at presentation. Such symptom scores are similar to those reported in advanced non small cell lung cancer (NSCLC) and have been demonstrated to correlate with interference with activity and worse quality of life (QOL). Several studies have reported that baseline Quality of Life (QOL) is a significant prognostic factor for survival in NSCLC patients. In 2010, a non-blinded randomised controlled trial of 151 patients in the United States (US) demonstrated an improved QOL, fewer depressive symptoms and improved survival with early, regular specialist palliative care team (SPCT) involvement in addition to their routine care. The RESPECT-Meso study will examine the effect on quality of life following early Specialist Palliative Care (SPC) involvement for Regular Early Symptom Control Treatment (RESSCT) in addition to routine care in patients with newly diagnosed MPM in the United Kingdom (UK).

NCT ID: NCT03068039 Completed - Healthy Clinical Trials

Millets and Oats MRI

MOM
Start date: October 25, 2016
Phase: N/A
Study type: Interventional

Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the nutritional value of different grains and their potential effects on the body may vary dramatically: for example the effect on blood sugar, on how fast the stomach empties after eating and how full people may feel. RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories. The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel. Blood glucose levels will be measured using a finger prick test (the same as used by diabetics) and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones.

NCT ID: NCT03068026 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Influence of the VitaBreath on Exercise Tolerance in COPD

Start date: June 6, 2017
Phase: N/A
Study type: Interventional

People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation". Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements. Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.

NCT ID: NCT03067714 Completed - Immunity Clinical Trials

A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy

TEMPO
Start date: March 30, 2017
Phase: Phase 3
Study type: Interventional

With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Infant formulas based on hydrolysed proteins have been developed to be used by infants at increased risk of developing allergy in case a mother is unable or chooses not to breastfeed her infant. It has recently been demonstrated that the gut microbiota composition and microbiota activity of infants receiving an infant formula based on partially hydrolysed proteins, supplemented with oligosaccharides, is more similar to breastfed infants than to infants receiving standard cow's milk formula, demonstrated by increased levels of bifidobacteria. However the interaction between microbial changes impacted by an hypoallergenic concept and its influence on early life immune development should be further explored. The aim of the present study is therefore to investigate the bifidogenic effect of a hypoallergenic formula supplemented with prebiotics and probiotics compared to standard infant formula in infants at increased risk of developing allergic disease. This study will secondary assess the effects of this concept on the development of allergic manifestations up to the age of 12 months, which will be verified in a separate clinical study MAESTRO as primary outcome. Furthermore, the effects on growth and safety will be studied.

NCT ID: NCT03067545 Completed - Clinical trials for Patellofemoral Pain Syndrome

Do Simple Running Technique Changes Reduce Pain and Change Injury Causing Mechanics

Start date: March 22, 2017
Phase: N/A
Study type: Interventional

This project aims to investigate whether an increase in step rate can be used to reduce pain and injury causing movement patterns in runners who are currently experiencing achilles tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress syndrome. Many injuries have been reported to share similar injury causing movement patterns. For example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be caused by increased side to side drop of the pelvis and inward movement of the hip. Gait retraining is a method of changing the way people run in order to change movement patterns.Increasing step rate may present a gait retraining method that does not pose further injury risks and can be used across multiple different injury populations. Studies have shown increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the changes in movement patterns increasing step rate has been recommended as an intervention for the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an increase in step rate can reduce pain and change injury causing mechanics in runners currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendinopathy. The aim of the project is to use a simple gait intervention, increasing step rate to investigate if this technique change can reduce pain immediately, at short term follow up and long term follow up. The project will also look at whether an increased step rate can be maintained at follow up and whether this changes movement patterns proposed to be the cause of injury. Runners will be recruited from local running clubs and competitions using poster advertisement at running clubs and emailed to running clubs

NCT ID: NCT03067506 Completed - Clinical trials for Major Depressive Disorder

Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology

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

The purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).

NCT ID: NCT03067376 Completed - Healthy Clinical Trials

A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

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

The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

NCT ID: NCT03067246 Completed - Airway Management Clinical Trials

A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel

Start date: January 2017
Phase: N/A
Study type: Interventional

A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.

NCT ID: NCT03067129 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

DORA
Start date: March 20, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years.