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NCT ID: NCT02891785 Completed - Clinical trials for Cancer Pain Self-management

Praxis Evaluation of a Pain Self-management Support Intervention for Oncology Patients: A Stepped Wedge Design Study

EvANtiPain
Start date: January 5, 2017
Phase: N/A
Study type: Interventional

Background: Significant barriers to cancer pain management are patient-related. So far, cancer pain self-management support interventions have only been tested in strictly controlled settings of randomized controlled trials (RCT) and thus evidence for comparative effectiveness is lacking. Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in clinical practice. The primary patient-related aim is to improve pain interference with daily activities. Secondary patient-related aims are pain intensity, barriers to pain management, self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency and satisfaction with cancer pain self-management support, participation rates, and implementation fidelity. Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular pain medication, able to understand German, discharged with pain self-management, and give informed consent. Patients with signs of disorientation that may severely limit pain self-management will be excluded. Interventions: Pre-implementation, patients receive standard care. Post-implementation, patients receive ANtiPain which is based on 3 key strategies: information, skills building and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone calls after discharge. The implementation process will include training of the designated staff nurses, case discussions, as well as measures to ensure sustainability of the implementation (e.g., training of clinical nurse specialists). Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be collected before implementation and 1 and 3 months after implementation. Data on ward and hospital level will be collected at the beginning of the study. Statistical analysis: The statistical analysis will be conducted based on mixed models, with a random intercept for the respective ward and time as a covariate. Qualitative substudy: The qualitative substudy will comprise interviews with head and intervention nurses about their views of the implementation.

NCT ID: NCT02890147 Completed - Healthy Subjects Clinical Trials

Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control

PRECISESADST
Start date: December 2014
Phase:
Study type: Observational

Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

NCT ID: NCT02890121 Completed - Clinical trials for Systemic Autoimmune Diseases

Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases:

PRECISESADS
Start date: December 2014
Phase:
Study type: Observational

Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

NCT ID: NCT02882217 Completed - Asthma Clinical Trials

Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8

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

The study focusses on the evaluation of safety and tolerability of the XC8. The design of the study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of the product after receiving conclusion and recommendation for further continuation of the study from the Dose Escalation Committee.

NCT ID: NCT02880436 Completed - Clinical trials for Acute Myocardial Infarction

Association of Air Quality and Myocardial Infarction

Start date: January 2007
Phase: N/A
Study type: Observational

Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol levels and diabetes there are also acute factors potentially triggering acute coronary events. The impact of various substances and air pollution are described. Particulate matter, especially with small particle size (<2.5µm) has been shown to have a positive correlation with myocardial infarctions. However, other studies failed to show this correlation. With respect to nitric oxydes the majority of published studies detected a significant correlation with myocardial infarction, too, although a highly ranked publication failed to show the same result. In addition data on the impact of sulfur dioxide and carbon monoxide concentration on cardiac events is very heterogeneous. Published data indicates additive effects of age and other epidemiological variables suggesting the need of a multivariate analysis. The rationale of the study is to test if the above mentioned air pollution factors have a significant and independent impact on the incidence of myocardial infarctions

NCT ID: NCT02879305 Completed - Anaemia Clinical Trials

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

Start date: September 28, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.

NCT ID: NCT02878603 Completed - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

Start date: October 6, 2016
Phase: Phase 3
Study type: Interventional

The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).

NCT ID: NCT02877459 Completed - Emphysema Clinical Trials

Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System

STAGE
Start date: November 2016
Phase: N/A
Study type: Interventional

A multicenter, prospective, single-arm clinical investigation to evaluate the short term and long term safety of a modified staged treatment algorithm using the AeriSeal System.

NCT ID: NCT02876601 Completed - Healthy Volunteers Clinical Trials

Defibrotide in the Human Endotoxemia Model --‐ an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

LPS_DF
Start date: April 18, 2017
Phase: Phase 4
Study type: Interventional

Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be investigated in the human endotoxemia model in order to gather further information on its actions.

NCT ID: NCT02875899 Completed - Clinical trials for Chronic Venous Thrombosis

Surfacer System to Facilitate Access in Venous Occlusions

SAVE
Start date: February 7, 2017
Phase:
Study type: Observational [Patient Registry]

Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.