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Clinical Pilot Study (clinical + pilot_study)
Selected AbstractsCarbamylated erythropoietin increases frataxin independent from the erythropoietin receptorEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 6 2010Brigitte Sturm Eur J Clin Invest 2010; 40 (6): 561,565 Abstract Background, Friedreich's ataxia (FRDA) is a neurodegenerative disorder caused by decreased expression of the mitochondrial protein frataxin. Recently we showed in a clinical pilot study in Friedreich's ataxia patients that recombinant human erythropoietin (rhuEPO) significantly increases frataxin-expression. In this in vitro study, we investigated the role of the erythropoietin receptor (EPO-R) in the frataxin increasing effect of rhuEPO and if nonerythropoietic carbamylated erythropoietin (CEPO), which cannot bind to the classical EPO-R increases frataxin expression. Materials and methods, In our experiments human erythroleukaemic K562 cells (+ EPO-R), human monocytic leukemia THP-1 cells (, EPO-R) and isolated primary lymphocytes from healthy control and FRDA patients were incubated with different concentrations of rhuEPO or CEPO. Frataxin-expression was detected by an electrochemical luminescence immunoassay (based on the principle of an ELISA). Results, We show that rhuEPO increases frataxin-expression in K562 cells (expressing EPO-R) as well as in THP-1 cells (without EPO-R expression). These results were confirmed by the finding that CEPO, which cannot bind to the classical EPO-R increased frataxin expression in the same concentration range as rhuEPO. In addition, we show that both EPO derivatives significantly increase frataxin-expression in vitro in control and Friedreich's ataxia patients primary lymphocytes. Conclusion, Our results provide a scientific basis for further studies examining the effectiveness of nonerythropoietic derivatives of erythropoietin for the treatment of Friedreich's ataxia patients. [source] Improved wound healing by low-level laser irradiation after gingivectomy operations: a controlled clinical pilot studyJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 3 2008Onur Ozcelik Abstract Aim: Low-level laser therapy (LLLT) may induce morphological, molecular and cellular processes, which are involved in wound healing. The aim of this split-mouth controlled clinical trial was to assess the effects of LLLT on healing of gingiva after gingivectomy and gingivoplasty. Material and Methods: Twenty patients with inflammatory gingival hyperplasias on their symmetrical teeth were included in this study. After gingivectomy and gingivoplasty, a diode laser (588 nm) was randomly applied to one side of the operation area for 7 days. The surgical areas were disclosed by a solution (Mira-2-tones) to visualize the areas in which the epithelium is absent. Comparison of the surface areas on the LLLT-applied sites and controls were made with an image-analysing software. Results: Despite the prolonged time needed for application, patients have tolerated LLLT well. While there were no statistically significant differences between the stained surface areas of the LLLT applied and the control sites immediately after the surgery, LLLT-applied sites had significantly lower stained areas compared with the controls on the post-operative third, seventh and 15th day (p<0.001 for each). Conclusions: Within the limitations of this study, the results indicated that LLLT may enhance epithelization and improve wound healing after gingivectomy and gingivoplasty operations. [source] Decision-making models in the analysis of portal films: A clinical pilot studyJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 1 2000Andrew See SUMMARY Portal films continue to play an important role in the verification of radiotherapy treatment. There is still some discussion, however, as to what action should be taken after a port film has shown a radiation field deviation from the prescribed volume. It was the aim of the present pilot study to investigate the performance of three decision-making models (,Amsterdam', ,Quebec' and ,Newcastle') and an expert panel basing their decision on intuition rather than formal rules after portal film acquisition in a clinical setting. Portal films were acquired on every day during the first week of treatment for five head and neck and five prostate cancer patients (diagnostic phase). If required, the field position was modified according to our normal practice following the recommendation of the expert panel. In order to analyse the results of the models, however, additional port films were taken in the following 3 treatment weeks with the patient moved as required by the different models (intervention phase). The portal films were taken over 4 consecutive days, positioning the patient according to each of the different models on one day each. None of the models diagnosed a field misplacement in the head and neck patients, while the ,Amsterdam' and ,Quebec' models predicted a move in one prostate patient. The ,Newcastle' model, which is based on Hotelling's T 2 statistic, proved to be more sensitive and diagnosed a systematic displacement for three prostate patients. The intervention phase confirmed the diagnosis of the model, even if the three portal films taken with the patient position adjusted as required by the model proved to be insufficient to demonstrate an improvement. The ,Newcastle' model does not rely on assumptions about the random movement of patients and requires five portal films before a decision can be reached. This approach lends itself well to incorporation into electronic portal imaging ,packages', where repeated image acquisitions present no logistical difficulty. [source] The effect of amitriptyline on pain intensity and perception of stress in bruxersJOURNAL OF PROSTHODONTICS, Issue 2 2001Ariel J. Raigrodski DMD Purpose The purpose of this clinical pilot study was to evaluate the effect of a tricyclic antidepressant, amitriptyline, on pain-intensity level and level of stress in bruxers. Materials and Methods In a randomized, double-blind, crossover experimental design, 10 subjects received active (amitriptyline 25 mg/night) and inactive (placebo 25 mg/night) medication, over a period of 4 weeks. Results The administration of amitriptyline for 4 weeks did not significantly (p > .05) reduce pain intensity. However, it significantly (p < .05) reduced the level of stress perception. Conclusion The results of this limited study do not support the administration of small doses of amitriptyline over a period of 4 weeks for the management of pain resulting from sleep bruxism. However, the results support the administration of small doses of amitriptyline for the management of the perception of stress levels associated with sleep bruxism. [source] A novel method of comparing the healing properties of two hydrogels in chronic leg ulcersJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 2 2006M De La Brassinne Abstract Skin ulcers on the legs have a chronic, relapsing course and are often a significant management challenge. Novel methods of measuring and comparing the effects of different treatments can be of assistance in addressing this situation. A clinical pilot study using original methods was undertaken to compare the healing properties of the alginate gel Flaminal® (test) and the hydrocolloid gel Intrasite® (control) on chronic leg ulcers. The study was performed over a period of 28 days with two parallel groups of 10 patients. Both the surface (acetate tracing and planimetry) and the volume (Jeltrate® mould impression and weighting) of each wound were measured at baseline and after 7, 14 and 28 days of treatment. On both parameters results were superior with the test product compared to the control, with volume reduction being the first parameter to change. Between groups, difference in wound volume reduction was detected as early as day 7 whereas difference in surface reduction was clearly apparent only at day 28. Correlation between wound surface and volume reductions was also better in the test group (r = 0.843 vs. 0.421) than in the control. In conclusion, this pilot study suggests that combining wound surface and volume evaluations allows a more precise analysis of the healing process in venous leg ulcers and that this method is able to detect very early differences in treatments even with limited sample size. [source] Comparison of 5-aminolaevulinic acid and porphyrin photosensitization for photodynamic therapy of malignant bronchial stenosis: A clinical pilot studyLASERS IN SURGERY AND MEDICINE, Issue 1 2002Alfred Maier MD Abstract Background and Objectives Photosan®, a mixture of porphyrin oligomers as sensitizer for photodynamic therapy (PDT), carry the risk of prolonged photosensitivity of the skin. New sensitizer such as 5-aminolaevulinic acid (ALA) with low rates of skin phototoxicity appear to be promising alternatives. The aim of this study was to evaluate the efficacy of ALA compared to Photosan for PDT in malignant tracheo-bronchial stenosis. Reduction of tumor stenosis, increase in quality of life, and phototoxicity were considered as primary objectives. Improvement in clinical symptoms due to reduction of tumor stenosis, for example hemotysis, dyspnea, and poststenotic pneumonia were considered as secondary objectives. Patients and Methods After diagnostic work-up, photosensitization was done in 16 patients with ALA (60 mg/kg BW, oral, 6,8 hours prior to PDT) and in 24 patients with Phtosan (2 mg/kg BW, i.v., 48 hours before PDT). The light dose was calculated as 100 J/cm2 tumor length. Light at 630 nm was applied using a pumped dye laser. In both groups, additional hyperbaric oxygenation was applied at a level of 2 absolute atmospheric pressure. Results Stenosis diameter and Karnofsky performance status showed a significant improvement in favor of the Photosan-group, P,=,0.00073 and 0.00015, respectively. In both groups no sunburn occurred due to phototoxicity of the sensitizer. Conclusion Despite the limitations of a non-randomized study, photosensitization with Photosan seems to be more effective in PDT of malignant tracheo-bronchial stenosis compared to ALA. Lasers Surg. Med. 30:12,17, 2002. © 2002 Wiley-Liss, Inc. [source] Acotiamide (Z-338) as a possible candidate for the treatment of functional dyspepsiaNEUROGASTROENTEROLOGY & MOTILITY, Issue 6 2010H. Suzuki Abstract Acotiamide hydrochloride is a novel upper gastrointestinal (GI) motility modulator and stress regulator currently being developed for the treatment of functional dyspepsia (FD). The mechanism underlying the enhancement of GI motility by this agent has been proposed to be based on its muscarinic antagonism and inhibitory effects on acetylcholinesterase activity. Pathophysiological studies showed that acotiamide significantly improved both delayed gastric emptying and feeding inhibition in restraint stress-induced model, but did not affect both normal gastric emptying and feeding in intact animals, indicating that acotiamide exerted effects only on the impaired gastric emptying and feeding behavior. According to the clinical pilot study in Europe, acotiamide, at the dose of 100 mg t.i.d., showed to improve the symptoms and quality of life of patients with FD, indicating the need for larger scale symptomatic studies on the efficacy of acotiamide in patients with FD. The recent phase II studies conducted in Japan presented in this issue of the journal also confirmed that acotiamide, at the optimal dose of 100 mg, has potential therapeutic efficacy, especially for meal-related FD symptoms. Although a phase III study is on going, acotiamide is now expected as a novel treatment option for FD. [source] | ||||||||||