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Pilot Clinical Study (pilot + clinical_study)
Selected AbstractsQuiescent-interval single-shot unenhanced magnetic resonance angiography of peripheral vascular disease: Technical considerations and clinical feasibilityMAGNETIC RESONANCE IN MEDICINE, Issue 4 2010Robert R. Edelman Abstract We performed technical optimization followed by a pilot clinical study of quiescent-interval single-shot MR angiography for peripheral vascular disease. Quiescent-interval single-shot MR angiography acquires data using a modified electrocardiographic (ECG)-triggered, fat suppressed, two-dimensional, balanced steady-state, free precession pulse sequence incorporating slice-selective saturation and a quiescent interval for maximal enhancement of inflowing blood. Following optimization at 1.5 T, a pilot study was performed in patients with peripheral vascular disease, using contrast-enhanced MR angiography as the reference standard. The optimized sequence used a quiescent interval of 228 ms, ,/2 catalyzation of the steady-state magnetization, and center-to-out partial Fourier acquisition with parallel acceleration factor of 2. Spatial resolution was 2-3mm along the slice direction and 0.7-1mm in-plane before interpolation. Excluding stented arterial segments, the sensitivity, specificity, and positive and negative predictive values of quiescent-interval single-shot MR angiography for arterial narrowing greater than 50% or occlusion were 92.2%, 94.9%, 83.9%, and 97.7%, respectively. Quiescent-interval single-shot MR angiography provided robust depiction of normal peripheral arterial anatomy and peripheral vascular disease in less than 10 min, without the need to tailor the technique for individual patients. Moreover, the technique provides consistent image quality in the pelvic region despite the presence of respiratory and bowel motion. Magn Reson Med 63:951,958, 2010. © 2010 Wiley-Liss, Inc. [source] Different amounts of isoflavones in various commercially available soy extracts in the light of gene expression-targeted isoflavone therapyPHYTOTHERAPY RESEARCH, Issue S1 2010Ewa Piotrowska Abstract Isoflavones are plant-derived, biologically active compounds that are commonly used as natural drugs or diet supplements in the treatment of menopausal symptoms and as antioxidants. Recently, it was proposed that genistein (4,,5,7-trihydroxyisoflavone) may be used in the treatment of patients suffering from Sanfilippo disease (mucopolysaccharidosis type III), a severe genetic disorder for which no therapy is available. A pilot clinical study with this novel therapy, called ,gene expression-targeted isoflavone therapy' (GET IT), indicated that a standardized, genistin-rich soy isoflavone extract is effective in the treatment of such patients. Since various isoflavone-containing products are commercially available, the content of the main isoflavones were measured in such products. Extremely different amounts of isoflavones were determined in various products, from 0.13 to 39 mg per tablet. Only some of these products were found to be effective in inhibition of the synthesis of glycosaminoglycans (compounds whose degradation is severely impaired in mucopolysaccharidoses, including Sanfilippo disease) in cultured fibroblasts. Since in GET IT the dose of genistein is calculated per patient's body weight, the amount of this isoflavone in a tablet is crucial for this therapy. Therefore, the results presented in this report indicate that a careful choice of a proper isoflavone extract is necessary for GET IT. Copyright © 2009 John Wiley & Sons, Ltd. [source] Bipolar Radiofrequency-Induced Thermotherapy of Turbinate Hypertrophy: Pilot Study and 20 Months' Follow-upTHE LARYNGOSCOPE, Issue 1 2003Jan Seeger MD Abstract Objectives/Hypothesis The present report is a pilot clinical study about a new bipolar ablation technique for the treatment of turbinate hypertrophy, which offers an alternative to conventional methods. Study Design Prospective, clinical. Methods From August 1999 to March 2000, a new bipolar radiofrequency system with acoustic feedback control was submucosally applied for the treatment of 38 patients with nasal airway obstruction of vasomotor (n = 31) or allergic (n = 7) genesis. The therapy was made ambulatory with surface anesthesia. Data were collected by questionnaire and rhinomanometry preoperatively and 2 and 20 months postoperatively. Results Nearly all patients reported an improvement of their nasal breathing, with 68% of them reporting a full and 29% a partial recovery. No significant differences were reported with regard to the response of the allergic versus the vasomotor rhinitis. On average, a definite benefit was observed after 2 weeks. Side effects, such as bleeding, synechia, or atrophic changes of the mucosa, which would have to be treated, were not observed. Conclusion The new bipolar radiofrequency thermotherapy presents an efficient option for the treatment of turbinate hypertrophy, which meets the requirements for an outpatient treatment. [source] Vaccination with selected synovial T cells in rheumatoid arthritisARTHRITIS & RHEUMATISM, Issue 2 2007Guangjie Chen Objective This pilot clinical study was undertaken to investigate the role of T cell vaccination in the induction of regulatory immune responses in patients with rheumatoid arthritis (RA). Methods Autologous synovial T cells were selected for pathologic relevance, rendered inactive by irradiation, and used for vaccination. Fifteen patients received T cell vaccination via 6 subcutaneous inoculations over a period of 12 months. Results T cell vaccination led to induction of CD4+ Tregs and CD8+ cytotoxic T cells specific for T cell vaccine. There was selective expansion of CD4+,V,2+ Tregs that produced interleukin-10 (IL-10) and expressed a high level of transcription factor Foxp3, which coincided with depletion of overexpressed BV14+ T cells in treated patients. CD4+ IL-10,secreting Tregs induced by T cell vaccination were found to react specifically with peptides derived from IL-2 receptor ,-chain. The expression level of Foxp3 in CD4+ T cells and increased inhibitory activity of CD4+,CD25+ Tregs were significantly elevated following T cell vaccination. The observed regulatory immune responses collectively correlated with clinical improvement in treated patients. In an intent-to-treat analysis, a substantial response, defined as meeting the American College of Rheumatology 50% improvement criteria, was shown in 10 of the 15 patients (66.7%) and was accompanied by a marked improvement in RA-related laboratory parameters. Conclusion These findings suggest that T cell vaccination induces regulatory immune responses that are associated with improved clinical and laboratory variables in RA patients. [source] Use of Quantitative Broad-based Polymerase Chain Reaction for Detection and Identification of Common Bacterial Pathogens in Cerebrospinal FluidACADEMIC EMERGENCY MEDICINE, Issue 7 2010Richard Rothman MD ACADEMIC EMERGENCY MEDICINE 2010; 17:741,747 © 2010 by the Society for Academic Emergency Medicine Abstract Background:, Conventional laboratory diagnosis of bacterial meningitis based on microscopy followed by culture is time-consuming and has only moderate sensitivity. Objectives:, The objective was to define the limit of detection (LOD), analytic specificity, and performance characteristics of a broad-based quantitative multiprobe polymerase chain reaction (PCR) assay for rapid bacterial detection and simultaneous pathogen-specific identification in patients with suspected meningitis. Methods:, A PCR algorithm consisting of initial broad-based detection of Eubacteriales by a universal probe, followed by pathogen identification using either pathogen-specific probes or Gram-typing probes, was employed to detect pathogens. The 16S rRNA gene, which contains both conserved and variable regions, was chosen as the target. Pathogen-specific probes were designed for Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, and Listeria monocytogenes. Gram-positive and -negative typing probes were designed based on conserved regions across all eubacteria. The LOD and time to detection were assessed by dilutional mocked-up samples. A total of 108 convenience cerebrospinal fluid (CSF) clinical samples obtained from the Johns Hopkins Hospital (JHH) microbiology laboratory were tested, and results were compared with hospital microbiologic culture reports. Results:, The LOD of the assay ranged from 101 to 102 colony-forming units (CFU)/mL. Pathogen-specific probes showed no cross-reactivity with other organisms. Time to detection was 3 hours. In clinical specimens, the universal probe correctly detected 16 of 22 culture-positive clinical specimens (sensitivity = 72.7%; 95% confidence interval [CI] = 49.8% to 89.3%), which were all correctly characterized by either pathogen-specific or Gram-typing probes. Adjusted sensitivity after removing probable microbiologic laboratory contaminants was 88.9% (95% CI = 65.3% to 98.6%). The universal probe was negative for 86 of 86 culture-negative specimens. Conclusions:, A broad-based multiprobe PCR assay demonstrated strong analytic performance characteristics. Findings from a pilot clinical study showed promise in translation to human subjects, supporting potential utility of the assay as an adjunct to traditional diagnostics for early identification of bacterial meningitis. [source] | ||||||||||