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Pathologic Processes clinical trials

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NCT ID: NCT02927119 Completed - Clinical trials for Thyroid; Functional Disturbance

Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

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

The purpose of the investigation is to assess iodine status of pregnant women at week 16 of gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The investigators aim to assess whether pre-gestational initiation of iodine supplementation is more advantageous in comparison to supplementation start at the time of pregnancy detection.

NCT ID: NCT02852902 Completed - Sepsis Clinical Trials

Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.

INCREMENT-SOT
Start date: January 1, 2016
Phase:
Study type: Observational

Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT. Secondary objectives: 1. To evaluate the efficacy and safety of different antibiotics used for the treatment of infections caused by ESBL- and carbapenemase-producing Enterobacterales in the SOT population. 2. To compare the efficacy of different antimicrobials between SOT and non-SOT patients (using matched controls from the "non-transplant" INCREMENT cohort). 3. To create a microbiological collection of ESBL- and carbapenemase-producing Enterobacterales isolated from the SOT population. 4. To provide data on specific MICs for each antimicrobial evaluated. 5. To provide data on the prevalence of specific mechanisms of resistance and their clinical impact in the particular setting of SOT. 6. To organise an international consortium capable of developing high quality prospective cohort studies and randomised clinical trials in the area of MDR and XDR Enterobacterales in SOT.

NCT ID: NCT02690454 Completed - Clinical trials for Cardiovascular Diseases

Which Platelet Function Test Best Reflects the In Vivo Plasma Concentrations of Ticagrelor and Its Active Metabolite?

HARMONIC
Start date: November 2015
Phase: N/A
Study type: Observational

Ticagrelor is a direct-acting, reversible platelet P2Y12 receptor inhibitor recommended by the recent European Society of Cardiology guidelines in patients with acute coronary syndromes (ACS) (class of recommendation I, level of evidence B). Ticagrelor inhibits platelet function stronger, faster and more consistently than clopidogrel, the former standard of antiplatelet therapy. In the landmark PLATO trial (Study of PLATelet inhibition and patient Outcomes), ticagrelor therapy as compared with clopidogrel treatment was associated with the reduced occurrence of major adverse cardiovascular events and all-cause mortality, but also resulted in a small, but statistically significant, increase in the rate of major bleeding. The optimum choice of antiplatelet treatment, aimed to provide each patient with maximum protection against ischemic events, while minimizing the risk of bleeding complications, is the challenge of contemporary ACS therapy. The tool which may help physicians and facilitate clinical decision making is platelet function testing. According to the guidance of both European and American groups of experts, there are three currently recommended platelet function tests, namely the VerifyNow device, the Multiplate analyzer and the Vasodilator Stimulated Phosphoprotein Phosphorylation (VASP) assay. It needs to be emphasized that none of these three methods is preferred over others. So far there are no studies linking pharmacokinetic analysis of ticagrelor and its active metabolite with comparative evaluation of platelet reactivity. The aim of this trial is to assess the relationship between concentrations of ticagrelor and its active metabolite (AR-C124910XX) and results of all three recommended platelet function tests in patients with myocardial infarction. Patients who receive GP IIb/IIIa receptor inhibitor will be excluded from the primary analysis. Statistical analysis: The correlation will be assessed using correlation coefficients and intraclass correlation coefficients. while the agreement between the results of the compared platelet function tests will be measured using the Kappa statistic and Bland-Altman analysis.

NCT ID: NCT02529137 Completed - Clinical trials for Pathologic Processes

Pivotal Study for Validation of Philips Dx (PDx)

Start date: July 2015
Phase:
Study type: Observational

The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.

NCT ID: NCT02445365 Completed - Clinical trials for Inflammatory Bowel Diseases

Remote Ischemic Conditioning in Patients With Ulcerative Colitis

Start date: May 2015
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic tools. This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is likely to involve suppressed inflammation and cell death. Our study is a randomized clinical controlled study including 38 patients. Patients will receive RIC or sham for 10 consecutive days. The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy findings, and various markers in the blood, faeces and the intestinal wall.

NCT ID: NCT02390336 Completed - Clinical trials for Musculoskeletal Diseases

Mobilization With Movement in Patients With Osteoarthritis of the Hip

MWM
Start date: March 2015
Phase: N/A
Study type: Interventional

The concept of mobilization with movement, also referred to as a Mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. The aim of this randomized controlled study is to compare the immediate effects of Mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.

NCT ID: NCT02296593 Completed - Clinical trials for Other Functional Disturbances Following Cardiac Surgery

Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device

MONILAG
Start date: November 2014
Phase: N/A
Study type: Observational

Continuous lactate and glucose blood levels

NCT ID: NCT02287142 Completed - Pain Clinical Trials

Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery

Start date: October 2014
Phase: N/A
Study type: Interventional

The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.

NCT ID: NCT02258698 Completed - Insulin Resistance Clinical Trials

Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery

Start date: May 2013
Phase: N/A
Study type: Observational

BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response. Insulin resistance plays an intriguing role in these metabolic alterations and depends on the intensity of injury. Metabolic derangements resulting from peripheral insulin resistance are unambiguously related to adverse outcomes and higher perioperative complication rates. Therefore, insulin resistance offers to act as a marker for stress and is potentially relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an established indicator for blood glucose control and has a prognostic value regarding outcomes after major surgical interventions. Adipose tissue holds a key function in endocrine metabolism by releasing multiple substances, so-called adipose-derived secreted factors or adipokines. Recent studies have linked several adipokines to overall insulin sensitivity in metabolic syndrome-related conditions as well as in critical illness. Irisin, a recently identified myokine acts on white adipose tissue and plays a role in the prevention of insulin resistance. AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on previous studies suggesting glucose homeostasis and insulin resistance are associated with severity of illness and outcome in critically ill patients,it is proposed that patients with marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin resistance and explores for correlation with adverse clinical outcomes after 30 days. MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine blood samples will be assessed the day before surgery. Study blood samples will be drawn preoperatively in the induction bay of anesthesia to measure the insulin resistance indices HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin, adipokines, and routine biochemical tests will be assessed upon admission to the intensive care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.

NCT ID: NCT01976403 Completed - Pain Clinical Trials

Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

Start date: January 2012
Phase: N/A
Study type: Interventional

The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery. The primary objectives are to: 1. Develop and implement a pain booklet to improve pain management after cardiac surgery 2. Evaluate the effect of the pain booklet compared to a group of patients given usual care