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Inflammation clinical trials

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NCT ID: NCT03308435 Terminated - Depression Clinical Trials

Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation

Start date: November 6, 2017
Phase:
Study type: Observational

Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first catheter-based transfemoral aortic valve replacement at the University of Rouon. This historical step initiated a dramatic shift in the treatment of AS with more than 50% of patients being treated interventionally instead of the surgical approach, today. Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic valve stenosis but little is known about psychiatric comorbidities or frailty in these patients. Data from our group suggest an inflammatory trigger for depression and potentially other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are associated with considerable changes in the inflammatory state of the patients. However, no study has prospectively examined the interaction of these inflammatory markers and mood disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically, however, scientifically there is only emerging data with half of all PubMed-indexed publications being less than 18 months old and clinical use of various scores still under discussion. The " Effect of interventional aortic valve replacement on emotional status, quality of life, frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a prospective epidemiological cohort study to recruit 102 patients with symptomatic severe aortic valve stenosis within 18 months. All of these patients will undergo standardized cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory analysis focussing on the inflammatory state. The study aims to integrate these interdisciplinary findings to optimize patient treatment.

NCT ID: NCT03279718 Terminated - Clinical trials for COPD Exacerbation, Periodontal Health

Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD

Expertention
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Current data are showing a potential link between inflammatory biomarkers in chronic periodontitis and COPD. However the impact of periodontal treatment on systemic inflammation as measured by biomarkers and time to occurrence of acute exacerbations (AECOPD) remains an important but unresolved issue. This pilot study will provide information on effects of periodontal treatment on systemic inflammation and the course of COPD including acute exacerbation. 40 patients with chronic periodontitis and COPD will be included in this study. First baseline information (age, gender, lifestyle, smoking history, medical history, medication, frequency of exacerbation, dental treatments) are recorded. Then patient's health status is assessed using the COPD Assessment Test (CAT) and a comprehensive lung function testing (bodyplethysmograph) is conducted to assess lung functional severity of COPD. Blood samples are taken for analysis of various inflammatory biomarkers and saliva and sputum samples are collected for analysis of microbiome. Afterwards experienced dentists will conduct oral health examination and record the periodontal conditions of every patient. Samples of gingival crevicular fluid for determining Matrix metallopeptidase 8 (MMP8), Interleukin 1 beta (IL-1beta) and Interleukin 6 (IL-69 levels and for microbiome analysis will be taken. After randomization to one of the two study groups (intervention group: periodontal treatment / control group: no periodontal treatment) all patients get comprehensive oral hygiene instructions, irrespective of their periodontal status . Patients of the control group receive no further planned dental intervention. For patients of the experimental group, who need periodontal treatment due to the presence of periodontal pocket depth of ≥ 4 mm an appropriate care plan will be determined and supra- and subgingival scaling and root planing will be performed. During a 3, 6 and 12 months follow-up patient's current health condition will be assessed using the CAT. Additionally lung function tests (bodyplethysmograph) will be performed and clinical periodontal parameters are re-evaluated. To detect and assess COPD exacerbations in this trial, patients will complete a daily diary during the whole follow-up period which will be provided to the clinical researcher at each study visit. Furthermore the cough and sputum assessment questionnaire (CASA-Q)) will be used at each telephone call and at each visit in the pulmonary center. After 6 and 12 months blood, sputum, saliva and gingival crevicular fluid will be taken additionally. To understand the microbial ecology mechanisms linking periodontitis to COPD combined analysis of oral cavity microbiome (GCF) and lung microbiome (sputum) will be conducted. The biomarkers high sensitive C-reactive Protein (hsCRP), MMP8, IL-1beta und IL-6 will be determined in blood and in gingival crevicular fluid, respectively.

NCT ID: NCT03187886 Terminated - Clinical trials for Cerebral Amyloid Angiopathy Related Inflammation

Use Lay Language. CAA-ri : a Series of 28 Patients

Start date: January 1, 2017
Phase: N/A
Study type: Observational

INTRODUCTION: Cerebral amyloid angiopathy-related inflammation (CAA-ri) is a very rare manifestation of cerebral amyloid angiopathy, characterized by acute/subacute neurological deterioration and T2/FLAIR corticosubcortical or deep white matter hyperintensity. With the advent of new diagnostic criteria, there are more and more case reports and series reported; nevertheless, MRI findings and follow-up data need to be thoroughly described. OBJECTIVES: Our aim in this multicentrical and retrospective study was to describe the clinical and radiological features of patients with CAA-ri and assess long-term prognosis. METHODS: We reviewed the characteristics of 28 patients with CAA-ri including clinical data, systematic MRI analysis, cerebrospinal fluid results (including Alzheimer's disease biomarkers) and APOE genotype. HYPOTHESIS: We aimed at describing the clinical and radiological characteristics of a cohort of patients with CAA-ri.

NCT ID: NCT03179501 Terminated - Alzheimer Disease Clinical Trials

NP001, Alzheimer's Disease, and Blood Markers of Inflammation

Start date: September 1, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1 placebo-controlled biomarker study of NP001 in individuals with Alzheimer's Disease.

NCT ID: NCT03103490 Terminated - Cardiac Sarcoidosis Clinical Trials

18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).

NCT ID: NCT03059355 Terminated - Metabolic Syndrome Clinical Trials

Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.

CERES
Start date: April 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37 patients in two phases (Pilot and Randomized).

NCT ID: NCT03023397 Terminated - Clinical trials for Healthy Participants

Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.

Mitey Nose
Start date: March 27, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract in e-cigarette users, cigarette smokers, and non-smokers.

NCT ID: NCT03004443 Terminated - Depression Clinical Trials

Inflammation-Induced CNS Glutamate Changes in Depression

Start date: May 15, 2017
Phase: Phase 4
Study type: Interventional

Increased inflammation has been implicated in the pathophysiology of a number of neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults in the United States alone. One mechanism by which inflammation may alter behavior is through increasing brain glutamate, a neurotransmitter that in excess has been implicated in neuronal toxicity and resistance to conventional antidepressant therapy. The goal of the proposed research is to test the hypothesis that inflammation alters behavior through increasing glutamate in specific brain regions, ultimately leading to behavioral changes. The proposed research is designed to determine the cause and effect relationship between inflammation and CNS glutamate as well as the relationship between CNS glutamate and specific symptoms. To accomplish these aims, investigators will administer a single infusion of either the tumor necrosis factor (TNF) antagonist infliximab or placebo (n=30 per group) to patients with high inflammation (CRP>3mg/L). A CRP>3mg/L was chosen because it is considered high inflammation according to guidelines by the American Heart Association. Moreover, a CRP>3mg/L is associated with significantly increased basal ganglia glutamate and with a clinical response to infliximab. Inflammatory biomarkers, basal ganglia glutamate as measured by MRS, and motivation and psychomotor activity will be assessed at baseline and days 1 and 3 and weeks 1 and 2 following infliximab or placebo administration.

NCT ID: NCT02953106 Terminated - Allergy Clinical Trials

Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis

MAN06
Start date: January 20, 2017
Phase: Phase 4
Study type: Interventional

Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The primary objective is to assess the additive effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients with persistent asthma and allergic rhinitis, receiving inhaled steroid.

NCT ID: NCT02938078 Terminated - Blepharitis Clinical Trials

Ocular Comfort and Inflammation in Lid Hygiene Therapy

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

The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.