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Larger Clinical Trials (larger + clinical_trials)

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Medical Sciences100%

Selected Abstracts

In vivo detection of hemorrhage in human atherosclerotic plaques with magnetic resonance imaging,

JOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 1 2004
Vincent C. Cappendijk MD
Abstract Purpose To investigate the performance of high-resolution T1-weighted (T1w) turbo field echo (TFE) magnetic resonance imaging (MRI) for the identification of the high-risk component intraplaque hemorrhage, which is described in the literature as a troublesome component to detect. Materials and Methods An MRI scan was performed preoperatively on 11 patients who underwent carotid endarterectomy because of symptomatic carotid disease with a stenosis larger than 70%. A commonly used double inversion recovery (DIR) T1w turbo spin echo (TSE) served as the T1w control for the T1w TFE pulse sequence. The MR images were matched slice by slice with histology, and the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the MR images were calculated. Additionally, two readers, who were blinded for the histological results, independently assessed the MR slices concerning the presence of intraplaque hemorrhage. Results More than 80% of the histological proven intraplaque hemorrhage could be detected using the TFE sequence with a high interobserver agreement (Kappa = 0.73). The TFE sequence proved to be superior to the TSE sequence concerning SNR and CNR, but also in the qualitative detection of intraplaque hemorrhage. The false positive TFE results contained fibrous tissue and were all located outside the main plaque area. Conclusion The present study shows that in vivo high-resolution T1w TFE MRI can identify the high-risk component intraplaque hemorrhage with a high detection rate in patients with symptomatic carotid disease. Larger clinical trials are warranted to investigate whether this technique can identify patients at risk for an ischemic attack. J. Magn. Reson. Imaging 2004;20:105,110. © 2004 Wiley-Liss, Inc. [source]

Ketoconazole in bipolar patients with depressive symptoms: a case series and literature review

BIPOLAR DISORDERS, Issue 1 2001
E Sherwood Brown
Background: Data from several studies suggest that medications, such as ketoconazole, which lower cortisol levels, may be effective for major depressive disorder (MDD). As with MDD, the manic, depressive, and mixed phases of bipolar disorder are frequently associated with elevated cortisol levels. The literature on the use of cortisol-lowering strategies in mood disorders is reviewed, and a case series illustrating the use of ketoconazole in bipolar depression is presented. Methods: For the review, the MEDLINE and PSYCHINFO databases were searched, as were the bibliographies of pertinent articles to find papers on the use of cortisol-lowering agents in patients with mood disorders. In our open-label case series (n=6), ketoconazole (up to 800 mg/day) as an add-on therapy was given to patients with treatment-resistant or intolerant bipolar I or II disorders with current symptoms of depression. Results: Several case reports and small open studies suggest that cortisol-lowering agents may be useful for patients with depression. Two recent placebo-controlled trials of ketoconazole on patients with MDD report conflicting results. In our case series, all three patients who received a dose of at least 400 mg/day had substantial reductions in depressive symptoms. None had significant increases in mania. However, cortisol levels were not lowered in any of the subjects. Conclusions: The literature suggests that cortisol-lowering medications may be effective for a subset of depressed patients. Our preliminary findings suggest that ketoconazole may be useful in some patients with bipolar depression. Larger clinical trials are needed to confirm our observations. [source]

A pilot study on systemic thrombolysis followed by low molecular weight heparin in ischemic stroke

EUROPEAN JOURNAL OF NEUROLOGY, Issue 10 2006
R. Mikulík
Low molecular weight heparin (LMWH) administered immediately after intravenous thrombolysis (IT) may reduce the risk of arterial re-occlusion. Its benefit, however, may not outweigh the risk of intracranial hemorrhage (ICH). We sought preliminary data regarding safety of this combined therapy in an open-label, non-randomized study. The patients received either a standard anticoagulation (AC) starting 24 h after IT (the standard AC group) or AC with 2850 IU of nadroparin, given every 12 h immediately after IT (the early AC group). Sixty patients received IT treatment: 25 in the standard AC group [mean age 66, median National Institutes of Health Stroke Scale (NIHSS) 13, 64% men] and 35 in the early AC group (mean age 68, median NIHSS 13, 69% men). Symptomatic ICH occurred in one patient (4%) in the standard AC group and three patients (8.6%) in the early AC group [odds ratio (OR) 1.8; 95%CI 0.2,12.8]. At 3 months, nine patients in the standard AC group (36%) and 16 patients in the early AC group (45.7%) achieved a modified Rankin scale 0 or 1 (OR 1.2; 95%CI 0.5,3.2). Our study suggests that treatment with LMWH could be associated with higher odds of ICH, although it may not necessarily lead to a worse outcome. This justifies larger clinical trials. [source]

Immune effect of hypertonic saline: fact or fiction?

ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 6 2004
J. A. Křlsen-Petersen
Hypertonicity affects many parts of the immune system. Animal studies and experiments in isolated cell cultures show that hypertonicity reversibly suppresses several neutrophil functions and at the same time up-regulates T-lymphocyte function. Infusion of hypertonic saline with or without colloids may thus, besides providing efficient plasma volume expansion, ameliorate the detrimental consequences on the immune function of trauma, shock, reperfusion, and major surgery. However, the few clinical studies conducted to date, specifically addressing the immune effect of hypertonic saline infusion, have shown little, if any, effect on markers of immune function, and larger clinical trials have not demonstrated benefit in terms of morbidity or mortality. Thus, as opposed to animal and cell-culture studies, the immune-modulating properties of hypertonic saline infusion would appear to be of limited value in clinical practice. This review presents in vitro studies, animal experiments, and clinical trials which investigated the consequences of hypertonic saline on markers of immune function. [source]

Expression of cytokeratin-18-related tissue polypeptide-specific (TPS) antigen in Wilms tumor

PEDIATRIC BLOOD & CANCER, Issue 4 2001
Winfried Rebhandl MD
Abstract Background So far, there is no approved tumour marker for diagnosis or follow-up in Wilms tumour (WT). Tissue polypeptide-specific antigen (TPS), a cytokeratin 18 proteolytic fragment, has been suggested to be of value in the clinical management of WT patients. Cytokeratin 18 fragments are an early indicator of apoptosis and cytokeratin 18 might influence tumour cell behaviour. We investigated TPS expression in specimens of WT and other paediatric renal malignancies Procedure Immunoreactivity of WT sections (n,=,9), clear cell sarcomas (CCSK, n,=,3), and a renal cell carcinoma (RCC), and two pediatric kidney tumour cell lines (WT: SK-NEP-1 and rhabdoid tumour of the kidney: G-401) were investigated using the monoclonal antibody M3. Additionally, immunoblotting and RT-PCR analysis were performed. Cell culture supernatants were evaluated for TPS release. Serum TPS was measured in five patients at diagnosis, during chemotherapy and after surgical resection. Results Moderate to strong immunoreactivity for TPS was found in tubular and blastemal components of nearly all (8/9) WT specimens. This was confirmed by Western-blotting. Cystic and epithelial-like portions of CCSKs and RCC showed distinct reactivity (3/3). The supernatant of G-401 but not of SK-NEP-1 showed a time- and cell number-dependent increase of TPS release. Interestingly, TPS synthesis was demonstrated in SK-NEP-1 cells. Median preoperative serum TPS was elevated (293 U/l) compared to healthy children and lowest after surgical resection (49.5 U/l). Conclusions This is the first study demonstrating the synthesis and release of TPS by WTs and other paediatric renal malignancies. Considering the elevated levels of TPS in serum of these patients, a further investigation of this marker by larger clinical trials seems to be justified. Med Pediatr Oncol 2001;37:357,364. © 2001 Wiley-Liss, Inc. [source]

Benefits of statin therapy in patients with special risks: Coronary bypass surgery, stable coronary disease, and acute coronary syndromes

CLINICAL CARDIOLOGY, Issue S3 2003
W. Virgil Brown M.D.
Abstract Several major clinical studies have examined the impact of lipid lowering in patients with and without coronary heart disease and have demonstrated that lowering lipid levels can successfully and significantly delay the onset of cardiovascular events. Although epidemiologic studies and small clinical trials have suggested that more aggressive and sustained lowering of low-density lipoprotein cholesterol (LDL-C) to < 100 mg/dl (2.6 mmol/l) can result in reductions in cardiovascular events in these populations, reducing LDL-C to these concentrations has only recently been shown in larger clinical trials. However, few clinical trials have been conducted in patients with certain special high risks, such as those who have had a recent revascularization procedure or have experienced an acute coronary event. Three trials examined the short- and long-term clinical benefits of aggressive lipid lowering in patients who underwent coronary artery bypass surgery (Post-CABG), were candidates for angioplasty (AVERT), or were hospitalized for acute coronary syndromes (MIRACL). [source]