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NCT ID: NCT02189733 Completed - Healthy Volunteers Clinical Trials

Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab. The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.

NCT ID: NCT02189577 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Trigon
Start date: June 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

NCT ID: NCT02189265 Completed - Premature Birth Clinical Trials

Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands

Start date: January 2000
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the Netherlands.

NCT ID: NCT02188992 Completed - Sepsis Clinical Trials

Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study

ExPRES
Start date: January 2014
Phase: N/A
Study type: Observational

Between 6 and 16% of patients presenting to hospital emergency departments have infections, with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue is that, at time of presentation, it can be difficult to determine who has inflammation as a result of infection and who does not. Some of the patients with infections will deteriorate to organ failure ('severe sepsis') including failure of the heart and blood vessels to maintain normal blood pressure ('septic shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with a significant mortality, which can be reduced by early intervention. However identifying those patients who are at high risk of deteriorating to septic shock can be difficult on initial presentation to hospital, and thus these patients risk being 'triaged' to an inappropriate level of care and/or missing the crucial early interventions which can modify mortality. Equally failure to identify which patients have underlying infections can lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are often unable to accurately identify those patients with infection, and those who are likely to deteriorate to severe sepsis and septic shock. Investigators in this group have recently identified several signatures of immune system activation which predict those patients who are likely to deteriorate, and which patients with suspected infection subsequently have this confirmed. Such tests would have major benefits for the management of patients with early suspected infection and sepsis if they can be translated into a test usable in everyday clinical practice. This study aims to determine the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and their predictive ability for developing established septic shock. From this investigators aim to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test. Study hypothesis is: Measurement of markers of immune activation will allow i) Risk stratification for deterioration into severe sepsis ii) Risk stratification for death amongst patients presenting with sepsis iii) Identification of patients with confirmed sepsis

NCT ID: NCT02188862 Completed - Clinical trials for Rheumatic Heart Disease

Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region

Start date: September 2012
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.

NCT ID: NCT02188342 Completed - Exercise Clinical Trials

Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients

HITCa
Start date: January 2015
Phase: N/A
Study type: Interventional

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.

NCT ID: NCT02188290 Completed - Clinical trials for Acute Myeloid Leukemia

Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

Start date: September 2014
Phase: N/A
Study type: Observational

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).

NCT ID: NCT02188238 Completed - Healthy Clinical Trials

Effect of Oral Health Ingredients on the Acquired Salivary Pellicle

Start date: July 2014
Phase:
Study type: Observational

The aim of this study is to help us understand how saliva forms a thin film inside the surfaces of the mouth which is known as the salivary pellicle, and how this film helps to protect our teeth from decay. We know that the thickness and physical properties (viscosity and mechanical strength) of the salivary pellicle influences:- - How we chew and sense the structure of food in our mouth. - How we digest the food and extract nutrients from it. - Protection against tooth decay and infection. However, studies have only recently established the different proteins within the pellicle. The effects of oral care products (e.g. toothpaste, mouthwash etc.) and ingredients they contain on pellicle formation and removal remain poorly understood. Therefore we need to understand how the formation of the salivary pellicle is controlled by ingredients it comes into contact with such as those from food and oral hygiene products (e.g. toothpaste and mouthwash). In this study, we are asking volunteers to provide samples of saliva. We will take the saliva samples back to our labs and measure how they form films under different conditions and determine the influence of ingredients from oral hygiene on the film forming properties. We will also measure the protein content of the saliva sample to see how this affects pellicle formation. Eventually, this information together with knowledge from other studies, should lead to the development of more effective oral hygiene products.

NCT ID: NCT02187861 Completed - Follicular Lymphoma Clinical Trials

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

NCT ID: NCT02187159 Completed - Clinical trials for Pain Associated With Fibromyalgia

Treatment of Pain Associated With Fibromyalgia

Start date: November 2014
Phase: Phase 3
Study type: Interventional

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.