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Biomarkers clinical trials

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NCT ID: NCT03582631 Completed - Inflammation Clinical Trials

Biomarkers in Acute High-risk AbdoMinAl Surgery

BAHAMAS
Start date: June 1, 2013
Phase:
Study type: Observational

Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but it carries a high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programs have been suggested, but the quality of care and mortality varies between hospitals (5)(6). The use of postoperative intensive care seem to be inadequate for this high risk population (1)(7)(8). It is of paramount importance to identify the frailest and acutely deranged patients, who are in risk of poor outcome, to allocate resources for optimization postoperatively. Failure to escalate care intensity after having developed postoperative complications affect outcome. Organization, teamwork and culture is important postoperatively to be able to escalate care especially in standard care wards (9)(10). However, it is difficult to predict which patients will develop complications. Different risk assessment tools have been proposed for patients undergoing AHA (11)(12). The APACHE-II score, even though developed for critical care, seems to give the best prediction of outcome. Objective risk assessment tools support clinical decision making as subjective clinical assessment often underestimates the risk for the patients in highest risk of complications and death (13). Good clinical decision-making is likely to improve the clinical outcome by allocating appropriate resources. Prognostic tools are also useful to inform patients about what to expect in the postoperative phase and of long-term outcome. Especially in the elder population with increased risk of loss of function or independency, this can be useful to give informed consent to treatment. Furthermore, good risk assessment is important to optimize palliative care after end-of-life decisions, which is often ignored in research, but highly relevant in clinical work. Prognostic biomarkers in other high mortality populations have received much attention for risk stratification (14). An ideal biomarker should be readily available upon decision-making, easy to measure, and reliable. Furthermore, it should accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment. It should also be linked to the clinical outcomes. The investigators aim to identify AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalization.

NCT ID: NCT03581955 Completed - Biomarkers Clinical Trials

Identification of New Biomarkers of Banana and Tomato Intake

BioBanaTom
Start date: March 26, 2016
Phase: N/A
Study type: Interventional

The intake of fruits and vegetables has been associated to a lower risk of developing metabolic diseases and cancer. The intake of tomato has been proposed to decrease the risk of prostate cancer while the high content of pro-vitamine A carotenes in banana have shown to alleviate Vitamin A deficiency in different countries. Interestingly in spite of their popularity, there are no biomarkers of banana intake reported in the literature while lycopene is the most frequently used metabolite to indicate tomato consumption however, its limited specificity and between-subjects variation sets doubt of its accuracy. Therefore, the identification of novel biomarkers for both banana and tomato is of great value. Untargeted metabolomics, allows a holistic analysis of the food metabolome allowing a deeper inquiry in the metabolism of different compounds and the recognition of patterns and individual differences that may lead to new hypothesis and further research. Therefore, the aim of the present study is to identify biomarkers of acute intake of banana and tomato using an untargeted approach on urine serum of 12 volunteers that participated in a crossover, randomized, controlled study. Volunteers consumed three different test foods: 1) 240g of banana, 2) 300g of tomato and 3) Fresubin 2kcal as control. Serum and urine samples were collected in kinetics over 24h and processed to be analyzed using LC-QTof analysis. The metabolomics profiles are compared using univariate (ANOVA) and multivariate statistical methods (PCA, PLSDA). The identification of discriminant compounds was performed by tandem mass fragmentation with a high-resolution LTQ-Orbitrab Mass spectrometer and by an extensive inquiry of different online databases.

NCT ID: NCT03531008 Completed - Epilepsy Clinical Trials

Human Epilepsy Project 2: Resistant Focal Seizures Study

HEP2
Start date: May 7, 2018
Phase:
Study type: Observational [Patient Registry]

The HEP2 study is designed to better understand the challenges of living with focal seizures that do not respond to medication, by following 205 people with medication-resistant focal epilepsy over two years to measure changes in health status, healthcare costs, quality of life, and biomarkers of epilepsy severity and treatment response.

NCT ID: NCT03345992 Completed - Sepsis Clinical Trials

Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System

INCLASS
Start date: December 15, 2017
Phase: Phase 3
Study type: Interventional

High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls for alternative, individualized therapies in selected patients that might benefit form specific interventions. Role of macrolides as potential immunomodulatory treatment in sepsis is promising, but unclear. Subgroup analysis of previous large-scale clinical trials on patients with ventilator-associated pneumonia or gram-negative sepsis, showed that addition of clarithromycin to standard antibiotic therapy conferred a significant survival benefit in the subgroup of patients with respiratory dysfunction and MODS. The INCLASS study is aiming to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day mortality among patients suffering from these entities.

NCT ID: NCT03282383 Completed - Biomarkers Clinical Trials

Identification of Biomarkers for Severe Pneumonia

Start date: January 1, 2014
Phase: N/A
Study type: Observational

To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.

NCT ID: NCT03269019 Not yet recruiting - Thrombosis Clinical Trials

Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

Start date: November 20, 2017
Phase: N/A
Study type: Observational

Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important. This study is planned to assess the use of thrombotic biomarkers in patients with HIT, including thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and clinical outcomes, including new thrombus and death, were recorded during follow-up.

NCT ID: NCT03268668 Recruiting - Stroke, Acute Clinical Trials

Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

COMPO-CLOT
Start date: July 13, 2017
Phase:
Study type: Observational

The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology. The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.

NCT ID: NCT03263039 Active, not recruiting - Biomarkers Clinical Trials

Biomarkers in Urothelial Cancer Patients Treated With Pembrolizumab

RESPONDER
Start date: August 21, 2017
Phase: Phase 2
Study type: Interventional

In the RESPONDER study, the role of the immune evasive mechanisms combined with genomic characterization will be explored in urothelial cancer patients treated with second-line treatment with pembrolizumab. Combined profiling of immune and molecular status is novel and may contribute to improved patient stratification and provide rationale for future treatment strategies containing pembrolizumab.

NCT ID: NCT03250312 Terminated - Low Back Pain Clinical Trials

The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers

Start date: September 13, 2017
Phase: N/A
Study type: Interventional

This study intends to understand the effects of osteopathic manipulative treatment (OMT) on the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear cells (PBMC) of each participant, before and after intervention - OMT or seated control. This study will utilize participants with a history of low back pain (LBP), and will identify and validate those immune cell biomarkers that change in most participants after OMT, by using the novel protein subcellular localization (PSL) microarray technology. This study intends to uncover the important immune cells affected by OMT techniques, therefore to uncover the molecular mechanisms of OMT.

NCT ID: NCT03197350 Recruiting - Clinical trials for Magnetic Resonance Imaging

Characterization of Heart Failure With Preserved Ejection Fraction

Start date: December 4, 2014
Phase: N/A
Study type: Interventional

The goals of this research will be to define some of the mechanisms underlying the progression and complications of heart failure (HF) with preserved left ventricular ejection fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and fibrosis markers through the spectrum of HF stages in order to deepen the understanding of the pathophysiology driving HF progression. Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes, obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF. Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or biomarkers) with incident cardiovascular events and determine whether these measures provide incremental prognostic information beyond clinical characteristics.