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Filter by:In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in the number or in the function of Treg lymphocytes in the peripheral blood of patients. This observation suggests the central role of Tregs in homeostasis of the immune response during RA. In the literature the Tregs frequency and phenotype in the peripheral blood are well documented, however the analyses done on the Tregs in inflamed environment are still fragmentary or disparate. In this project Tregs phenotype as well as expression of several transcripts will be analysed in order to better characterize the Treg cell subsets within the synovial fluid. Moreover, the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will allow us to better understand the cause of functional loss. Outcomes: Primary outcome: Identification and characterization of the Tregs subpopulation present in the synovial fluid for RA patients suffering an episode of acute arthritis. Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.
The purpose of this study is the examine the feasibility of and estimate the efficacy of a preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e. age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the possible effect of this intervention. Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery. Study participants will undergo four types of assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke electronic medical record system. The risks of the exercise intervention are generally mild, since moderate exercise in this patient population generally results in improved health outcomes. Data from these patients will be analyzed in comparison to propensity matched patients from the Duke Markers of Alzheimer's Disease and neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this prehabilitation exercise intervention. Taken together, the results of this study will allow the investigators to estimate the possible effect of prehabilitation exercise on multiple domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity, etc) and will provide important preliminary data.
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.
The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation. Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses . Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression. Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear. It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes. Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.
The purpose of this study is to evaluate the safety and tolerability of ATA188 as a monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188 as monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical disability, as assessed by confirmed Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).
Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.
Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disorders characterized by lipid accumulation in hepatocytes. Evidence shows that thyroid hormone might be beneficial for this condition. Objective: To determine whether low dose levothyroxine (LT4) therapy may be a potential treatment for diabetic patients with NAFLD in a single arm study. Primary: To ascertain whether administration of LT4 for 16 weeks by titrating the serum thyroid stimulating hormone (TSH) to 0.34 mIU/L - 1.7 mIU /L reduces liver fat content by at least 3% among patients with type II diabetes as measured by functional MRI. Secondary: To ascertain whether administration of LT4 for 16 weeks by titrating the serum TSH to 0.34 mIU/L - 1.7 mIU /L can improve glycemic control as measured by reduction in glycosylated hemoglobin (HbA1c), improve serum lipid profile in Type II diabetic patients with NAFLD as measured by total serum cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and total triglycerides (TG) and reduce the proportion of liver fat over body fat, which is reflected by fat in abdominal subcutaneous and visceral tissues, as measured by functional MRI on abdomen. Subjects and Centres: A total of 50 eligible adult diabetic men with NAFLD will be recruited from 6 centres in Singapore - Changi General Hospital (CGH), Singapore General Hospital (SGH), Tan Tock Seng Hospital (TTSH), National University Health System (NUHS), Khoo Teck Puat Hospital (KTPH), Jurong Health (JH) Eligible patients: Males between 21 to 60 years of age diagnosed with stable Type II diabetes mellitus (DM) with a baseline alanine aminotransferase (ALT) < 3 times upper limit of normal as per the institution's specified reference range, with a liver ultrasound (US) showing presence of fatty liver and baseline Thyroid stimulating hormone (TSH) levels between 1 - 10 mIU/L. Treatment: Low dose levothyroxine (LT4) for 16 weeks, not including the 12 weeks of pre-study titration of LT4 in order to attain target TSH level of 0.34-1.70 mIU/L. Statistical Analysis: The absolute change in liver fat content from baseline (primary endpoint) will be analyzed using one-sample two-sided t-test at a 5% significance level. The same test will be applied to secondary endpoints. Mean, standard deviation and 95% confidence interval will be calculated for primary endpoint and secondary endpoints.
This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph nodes and may work better in imaging patients with rectal cancer when given with MRI.
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.