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Clinical Results (clinical + result)
Kinds of Clinical Results Selected AbstractsEarly Clinical Results: SOUNDTEC Implantable Hearing Device Phase II Study,THE LARYNGOSCOPE, Issue 1 2001J. V. D. Hough MD Abstract Objective To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTECÔ Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented. Study Design The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial. Methods For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured. Results When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250,6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception. Conclusion Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures. [source] Sotrastaurin, a Novel Small Molecule Inhibiting Protein Kinase C: First Clinical Results in Renal-Transplant RecipientsAMERICAN JOURNAL OF TRANSPLANTATION, Issue 3 2010K. Budde Sotrastaurin, a novel protein-kinase-C inhibitor, blocks early T-cell activation. In this 12-month, Phase II study, de novo renal-transplant patients were randomized to sotrastaurin (200 mg b.i.d.) + standard-exposure tacrolimus (SET) or reduced-exposure tacrolimus (RET) (SET: n = 76; RET: n = 66), or control (SET + mycophenolic acid [MPA, 720 mg b.i.d.]; n = 74). In both sotrastaurin groups, patients were converted from tacrolimus to MPA after Month 3, achieving calcineurin inhibitor-free immunosuppression. The primary endpoint was composite efficacy failure (treated biopsy-proven acute rejection, graft loss, death or loss to follow-up). The key secondary endpoint was glomerular filtration rate (GFR). Composite efficacy failure rates were: 4.1%, 5.4% and 1.5% at Month 3 (preconversion) and 7.8%, 44.8% and 34.1% at study end in the control, sotrastaurin + SET and sotrastaurin + RET groups, respectively; these results led to premature study discontinuation. Median GFR at Month 6 was: 57.0, 53.0 and 60.0 mL/min/1.73 m2, respectively. Study-drug discontinuations due to adverse events occurred in 16.2%, 18.4% and 12.1%, respectively. Leukopenia and neutropenia occurred more frequently preconversion in control versus sotrastaurin groups: 13.7%, 5.6%, and 4.6%; and 11.1%, 4.3% and 3.1%, respectively. The initial sotrastaurin + tacrolimus regimen was efficacious and well tolerated but the postconversion sotrastaurin + MPA regimen showed inadequate efficacy. Longer-term evaluation of sotrastaurin + tacrolimus is warranted. [source] Early and Limited Use of Tacrolimus to Avoid Rejection in an Alemtuzumab and Sirolimus Regimen for Kidney Transplantation: Clinical Results and Immune MonitoringAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2009S. J. Knechtle Alemtuzumab induction with 60 days of tacrolimus treatment and continuous sirolimus treatment prevented acute rejection in nine of 10 consecutive renal allograft recipients. All patients are alive with a functioning kidney graft at 27,39 months of follow-up. Extensive immune monitoring was performed in all patients. Alloantibody detection, cytokine kinetics assay (CKA), and trans vivo delayed-type hypersensitivity (DTH) assay were performed every 6 months showing correlation with clinical evolution. Despite alloantibody presence in five patients, eight patients remain without the need for specific treatment and only sirolimus monotherapy in decreasing dosage. Four patients take only 1 mg sirolimus daily with levels of 3,4 ng/mL. One patient showed clinical signs of rejection at month 9 post-transplant, with slow increase in serum creatinine and histological signs of mixed cellular (endarteritis) and humoral rejection (C4d positivity in peritubular capillaries and donor-specific antibody (DSA)). In summary, the addition of tacrolimus therapy for 2 months to a steroid-free, alemtuzumab induction and sirolimus maintenance protocol limited the previously shown acute rejection development. Nevertheless, alloantibody was present in serum and/or C4d present on 1-year biopsy in half the patients. The combination of CKA and DSA monitoring or the performance of transvivo DTH correlated with immune status of the patients. [source] Low-Density Lipoprotein Apheresis: Clinical Results with Different MethodsARTIFICIAL ORGANS, Issue 2 2002Rolf Bambauer Abstract: In 40 patients (22 women, 18 men) suffering from familial hypercholesterolemia resistant to diet and lipid lowering drugs, low-density lipoprotein (LDL) apheresis was performed over 84.9 ± 43.2 months. Four different systems (Liposorber, 28 of 40, Kaneka, Osaka, Japan; Therasorb, 6 of 40, Baxter, Munich, Germany; Lipopak, 2 of 40, Pocard, Moscow, Russia; and Dali, 4 of 40, Fresenius, St. Wendel, Germany) were used. With all methods, average reductions of 50.6% for total cholesterol, 52.2% for LDL, 64.3% for lipoprotein (a) (Lp[a]), and 43.1% for triglycerides, and an average increase of 10.3% for high-density lipoprotein (HDL) were reached. Severe side effects such as shock or allergic reactions were very rare (0.5%) in all methods. In the course of treatment, an improvement in general well being and increased performance were experienced by 39 of 40 patients. Assessing the different apheresis systems used, at the end of the trial, there were no significant differences with respect to the clinical outcome experienced with the patients' total cholesterol, LDL, HDL, and triglyceride concentrations. However, to reduce high Lp(a) levels, the immunoadsorption method with special Lp(a) columns (Lipopak) seems to be most effective: ,59% versus ,25% (Kaneka) , (Baxter), and ,29% (Dali). The present data demonstrate that treatment with LDL apheresis of patients suffering from familial hypercholesterolemia resistant to maximum conservative therapy is very effective and safe even in long-term application. [source] Endovenous laser therapy , application studies and latest investigationsJOURNAL OF BIOPHOTONICS, Issue 5-6 2010Ronald Sroka Abstract Endovenous laser therapy (ELT) was introduced in clinical practice as a therapy for incompetent veins about ten years ago. One characteristic of ELT is the broad spectrum of different treatment protocols by means of a variety of laser systems as well as manifold application forms and dosimetry concepts are under investigations. Clinical results with effective, relatively pain-free occlusion of incompetent varicosis veins have been observed, as well as undesired side effects such as ecchymosis, phlebitis and recanalization. In recent years systematic experimental investigations and the analysis of clinical results have increased the understanding of the interrelation between the clinical and physical aspects, followed to a continuous optimization of ELT. The use of IR wavelengths and radial irradiation concepts, together with continuous moving of the optical fiber seem to reduce possible side effects. This way ELT treatment becomes a more standardized effective method for the treatment of varicose veins. In future controlled randomized studies are required to compare optimized ELT treatment with other endoluminal modalities as well as conventional surgery. (© 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Tumor interstitial fluid pressure may regulate angiogenic factors in osteosarcomaJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 11 2008Saminathan S. Nathan Abstract We have previously shown that osteosarcomas (OS) have states of increased interstitial fluid pressure (IFP), which correlate with increased proliferation and chemosensitivity. In this study, we hypothesized that constitutively raised IFP in OS regulates angiogenesis. Sixteen patients with the clinical diagnosis of OS underwent blood flow and IFP readings by the wick-in-needle method at the time and location of open biopsy. Vascularity was determined by capillary density in the biopsy specimens. We performed digital image analysis of immunohistochemical staining for CD31, VEGF-A, VEGF-C, and TPA on paraffin-embedded tissue blocks of the biopsy samples. Clinical results were validated in a pressurized cell culture system. Interstitial fluid pressures in the tumors (mean 33.5,±,SD 17.2 mmHg) were significantly higher (p,=,0.00001) than that in normal tissue (2.9,±,5.7 mmHg). Pressure readings were significantly higher in low vascularity tumors compared to high vascularity tumors (p,<,0.001). In the OS cell lines, growth in a pressurized environment was associated with VEGF-A downregulation, VEGF-C upregulation, and TPA upregulation. The reverse was seen in the OB cell line. Growth in the HUVEC cell line was not significantly inhibited in a pressurized environment. Immunohistochemical assessment for VEGF-A (p,=,0.01), VEGF-C (p,=,0.008), and TPA (p,=,0.0001) translation were consistent with the findings on PCR. Our data suggests that some molecules in angiogenesis are regulated by changes in IFP. © 2008 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 26:1520,1525, 2008 [source] Implementing a Smoking Cessation Program for Pregnant Women Based on Current Clinical Practice GuidelinesJOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 6 2002Lynne Buchanan APRN, PhDArticle first published online: 24 MAY 200 Purpose To describe the U.S. Department of Health and Human Services clinical practice guideline for treating tobacco use and dependence and demonstrate how the guideline was utilized in a pilot program for a small sample of pregnant women (n=20) to help them decrease smoking. Data Sources A convenience sample of 20 pregnant women was recruited from a health maintenance organization at their initial prenatal contact either by telephone or in person. A comparison group of pregnant women (n=28) was used for analysis of outcomes. Conclusions Clinical results showed better outcomes for women in the pilot program when compared to a similar group who did not participate in the program. There was a statistically significant difference between the two groups in average number of cigarettes smoked per day at delivery and two weeks after delivery with pilot program participants reporting less smoking (p<.05). Women in both groups showed a pattern of returning to smoking after delivery of the baby. Implications for Practice Although a few tobacco users achieve permanent abstinence in first or second attempts, the majority continue to use tobacco for many years and typically cycle through many lapse and relapses before permanent abstinence. Ambulatory care systems need to be developed and funded to treat tobacco use and dependence over the life span. Recognition of the chronic nature of the problem and development of long term care delivery systems are needed to assist clients to achieve goals of permanent abstinence and better personal and family health. This cycle of lapse and relapse before permanent abstinence is typical and demonstrates the chronic nature of tobacco use and dependence and the need for long term follow-up. [source] Photodynamic therapy: update 2006 Part 2: Clinical resultsJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2007PG Calzavara-Pinton Abstract In several randomized, controlled studies, the application of a standard preparation containing methyl-aminolevulinate (MAL; Metvix®, Galderma, F), followed by red light irradiation proved effective and well tolerated in the treatment of actinic keratosis and basal cell carcinoma, and has now been approved for clinical use in European countries. A brand name aminolevulinic acid (ALA) solution (Levulan Kerastick®, Dusa Pharmaceuticals Inc., Wilmington, MA) plus blue light exposure has been approved for the treatment of actinic keratosis in the USA. Randomized and controlled studies have shown that MAL as well as ALA are also effective in the treatment of Bowen's disease. In addition, a large and growing number of open studies or case reports have evaluated its use in the treatment of a broad range of other neoplastic, inflammatory and infectious skin diseases. However, efficacy and definite advantages over standard therapies remain to be clarified because the experimental design of these studies was often poor, the number of enrolled patients was generally low, and the follow-up was shorter than 12 months. However, these studies have suggested a few possible clinical applications worthy of further investigation. A growing number of laboratory and clinical findings suggest that several new synthetic sensitizers, besides ALA and MAL, may be helpful in the treatment of non-melanoma skin cancers, melanoma metastasis, and selected inflammatory and infective skin diseases. These compounds are deliverable intravenously, have short half-lives both in the blood and skin, and are highly efficient. However, they are as of yet not approved for clinical use. [source] Robotic vs. laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease: systematic review and meta-analysisTHE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY, Issue 2 2010S. R. Markar Abstract The aim of this meta-analysis was to compare clinical outcome following laparoscopic and robotic Nissen fundoplication. A systematic literature search of Medline, Embase and Cochrane Library databases was performed. Primary outcome measures were the requirement for re-operation, postoperative mortality and postoperative dysphagia. Secondary outcome measures were operative time, length of hospital stay, operative complications and cost. Six randomized trials, of 226 patients, were included in this meta-analysis. There was no significant difference in requirement for re-operation or in postoperative dysphagia. There was a significantly reduced total operative time in the laparoscopic group (weighted mean difference = 4.154; 95% CI = 1.932,6.375; p = 0.0002). There was no significant difference between robotic and laparoscopic groups for hospital stay or operative complications. Clinical results from robotic Nissen fundoplication were comparable to the standard laparoscopic approach, but there was associated increased operative time and procedure cost. Copyright © 2010 John Wiley & Sons, Ltd. [source] Clinical results with a new acoustic device to identify the epidural spaceANAESTHESIA, Issue 8 2002T. J. M. Lechner Summary Fifty patients scheduled for surgery under lumbar epidural anaesthesia were included in a study toevaluate the possibility of localising the epidural space solely by means of an acoustic signal. With an experimental set-up, the pressure generated during the epidural puncture procedure was translated into a corresponding acoustic signal. One anaesthetist held the epidural needle with both hands and detected the epidural space by means of this acoustic signal. At the same time, a second anaesthetist applied the loss of resistance technique and functioned as control. In all patients the epidural space was located with the acoustic signal. This was confirmed by conventional loss of resistance in 49 (98%) of the patients; in one patient (2%) it was not. We conclude that it is possible to locate the epidural space using an acoustic signal alone. [source] Successful Treatment of Dowling,Degos Disease with Er:YAG LaserDERMATOLOGIC SURGERY, Issue 8 2002Joerg Wenzel MD background. Dowling,Degos disease is a rare condition with a genetically determined disturbance of epidermal proliferation. The typical clinical picture is a reticulate pigmentation of the flexures, genital folds, and pectoral skin areas. Many different treatment options have been tried in recent years without a convincing therapeutic benefit. objective. To determine the effectiveness of Er:YAG laser in Dowling-Degos disease. methods. A 44-year-old woman suffering from Dowling-Degos disease was treated with the Er:YAG laser pulse energy between 1,000 and 1,200 mJ, three consecutive passes. results. The laser treatment led to a good clinical result. conclusion. Our case suggest that treatment with the Er:YAG laser might be a successful strategy in Dowling-Degos disease. [source] The Distribution of Follicular Units in the Chinese Scalp: Implications for Reconstruction of Natural-Appearing Hairlines in OrientalsDERMATOLOGIC SURGERY, Issue 6 2002Ren-Yeu Tsai MD background. Follicular transplantation using hair in its naturally occurring groups, called follicular units (FUs), has become the most popular technique in hair restoration surgery. Recently follicular transplantation was performed with a qualitative and quantitative concept to achieve the best clinical result. The characteristics and distribution of FUs are well studied in Caucasians and widely applied in hair transplantation surgery. objective. In order to understand the normal distribution of FUs in the Chinese scalp, we counted the number of hairs and FUs in normal Chinese scalp to provide general information for surgical planning and design in bald Chinese patients. methods. A total of 50 normal and 50 bald Chinese adults were enrolled to count the hairs on their scalp. One hundred bald patients receiving hairline reconstruction were also prospectively quantitatively evaluated. results. In normal Chinese scalp, an average 71.78 FUs/cm2 and 137.08 hairs/cm2 were calculated with a follicular density of 1.91 hairs/FU. Two-hair FUs are the predominate group (50.29%). In bald patients, an average of 68.07 FUs/cm2 was found, which was less than that of the occipital scalp in normal nonbald patients. In reconstruction of the frontal hairline, a total of 700,1000 FUs were implanted with an average density of 30 FUs/cm2. conclusion. We found the average number of FUs (0.72 FU/mm2) was less than that in Caucasian patients (1 FU/mm2). The average density of 30 FUs/cm2 implanted was suitable to reconstruct a natural frontal hairline in bald Chinese patients, which can achieve about 40% of normal hair density. Our results could provide the hair surgeon with general information about hair distribution on the Chinese scalp for surgical planning and design in their patients. [source] Conquering cancer through discovery researchIUBMB LIFE, Issue 9 2010William C. S. Cho Abstract Cancer is a leading cause of death worldwide. Cancer research improves our understanding of cancer biology, which leads to the discoveries of novel detection approaches and effective therapies for cancer. Translational cancer medicine changes essential science breakthroughs to the practice of medicine and uses clinical result to supply back into basic research. This article covers some studies in the field of translational cancer medicine including the identification of 319 driver genes and the 12 core cancer pathways, the use of MammaPrint in breast cancer, the development of OncoMap, the progress in genome-wide association studies, as well as the generation of microRNA networks in cancer and leukemia. Apart from cancer genome, cancer stem cells, immune and tumor microenvironment are also discussed. In addition, some innovations in translational cancer medicine are introduced. A number of targeted agents have been developed, such as the histone deacetylases inhibitors, poly(ADP-ribose) polymerase inhibitors, anti-mammalian target of rapamycin agents, and PI3K pathway inhibitors. There are also reports of the results from some important clinical trials, including the STAR P-2 trial, NeoBIG program, and BATTLE trial. This review focuses on discussions that emphasize the marriage between curiosity-driven basic research and patient care-focused clinical investigations. With highlights on the most up-to-date molecular, cellular, clinical, and therapeutic cancer research findings, this article tends to provide a wealth of insights into better understanding of the complexity of cancer. © 2010 IUBMB IUBMB Life, 62(9): 655,659, 2010 [source] Surgical Treatment of a Left Ventricular NeurofibromaJOURNAL OF CARDIAC SURGERY, Issue 3 2006Kenji Iino M.D. We describe a case of left ventricular neurofibroma in a 56-year-old woman with Von Recklinghausen disease. Resection of the tumor with concomitant mitral valve replacement yielded a satisfactory clinical result, and histological examination of the resected tissue confirmed benign neurofibroma. The anatomic distribution of the vagus nerve plexus, which penetrates the epicardium and myocardium and courses over the left ventricular subendocardial surface, provides a tissue source from which this neurogenic tumor may arise. [source] Agreement between clinical examination and quantitative tests of neurologic function among 384 subjects,AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 4 2001Kyle Steenland Abstract Background Quantitative neurological tests are often cheaper and easier than clinical examinations, and provide continuous data which may discriminate between exposed and nonexposed groups with more sensitivity than dichotomous (normal/abnormal) examination data. Methods We compare clinical examinations and analogous quantitative tests for arm tremor, postural sway, and vibrotactile sensitivity (finger and toe), for 384 subjects. Results The "abnormal" clinical outcomes studied were relatively common (range, 3,36%), and did not result in impairment of daily activity for affected subjects. All the quantitative tests were reasonably good predictors of the corresponding clinical outcome. The most predictive test was for toe vibrotactile sensitivity. The probability of an abnormal clinical result for those in the worst quartile for the toe test was 0.63, compared with 0.36 for all subjects. Conclusions Our results suggest that certain quantitative tests might be used in epidemiologic studies instead of a physical examination. Am. J. Ind. Med. 39:361,368, 2001. Published 2001 Wiley-Liss, Inc. [source] Immediate functional loading of TiOblast dental implants in full-arch edentulous mandibles: a 3-year prospective studyCLINICAL ORAL IMPLANTS RESEARCH, Issue 7 2008H. De Bruyn Abstract Introduction: Implant-prosthetic rehabilitation of the completely edentulous mandible has evolved to a simplified procedure with shorter treatment time and survival rates of 95,100% depending on the implant system used. Purpose: The aim was to evaluate the 3-year clinical success of Astra Tech TiOblast implants, functionally loaded on the day of surgery with a fixed full-arch bridge in the mandible. Materials and methods: One hundred and twenty-five implants of 3.5,4 mm width and 11,17 mm length were installed in 25 edentulous mandibles of 15 female and 10 male patients. Implants were functionally loaded on the day of surgery with a provisional, acrylic, glassfibre reinforced, 10 unit bridge. After 3,4 months, the final 12-unit bridge was constructed. Radiographical bone loss was measured on peri-apical radiographs after 3, 12, 24 and 36 months. Results: All implants were functional during the whole study period yielding a survival rate of 100%. None of the fixtures showed pain or mobility after manual torque with 20 N cm at the 3-month control. Mean radiographical bone loss after 3 months and 1, 2 and 3 years was 0.6 mm (SD 0.7), 0.8 mm (SD 0.8), 1 mm (SD 0.8) and 1.3 (SD 1) respectively, which was statistically significantly increasing up to 1 year. Conclusion: Immediate loading of full-arch mandibular bridgework on five TiOblast implants offers a long-lasting clinical result with 100% fixture survival and stable bone-to-implant contact up to 3 years. [source] Emergence of Electronic Home Monitoring in Chronic Heart Failure: Rationale, Feasibility, and Early Results With the HomMed SentryÔ-ObserverÔ SystemCONGESTIVE HEART FAILURE, Issue 3 2000Mandeep R. Mehra MD Electronic home monitoring for chronic heart failure is emerging as an available option to add to our armamentarium as a vital part of the multidisciplinary care process. This investigation describes the early clinical results of a multicenter study which suggests that important trends in medical resource utilization may be attained by the use of this modality. [source] Combination Surgical Lifting with Ablative Laser Skin Resurfacing of Facial Skin: A Retrospective AnalysisDERMATOLOGIC SURGERY, Issue 9 2004Tina S. Alster MD Background. Cutaneous aging is manifested by rhytides, dyschromias, and skin laxity. Ablative laser skin resurfacing can effectively improve many signs of skin aging; however, the photoaged patient with facial laxity often requires a surgical lifting procedure in order to obtain optimal results. Concerns with delayed or impaired wound healing has led to reluctance to perform both procedures simultaneously. Objective. To report the clinical results and side effect profiles after concomitant surgical facial lifting procedures and ablative carbon dioxide or erbium:YAG laser resurfacing in a series of patients. Methods. A retrospective analysis and chart review was performed in 34 consecutive patients who underwent combination CO2 or erbium:YAG laser skin resurfacing and surgical lifting procedures, including S-lift rhytidectomy, blepharoplasty, and brow lift. Side effects and complication rates were tabulated. Results. The side effect profile of the combined surgical-laser procedures was similar to that reported after a laser-only procedure. The most common side effect was transient hyperpigmentation which occurred in 20.6% of treated patients. None of the patients experienced delayed reepithelialization, skin necrosis, or prolonged healing times. Conclusions. Concurrent laser skin resurfacing and surgical lifting of facial skin maximizes aesthetic results without increased incidence of adverse effects. Patients benefit from the consolidation of anesthesia and convalescent times as well as enhanced global clinical outcomes. [source] Comparison of Long-Pulsed Diode and Long-Pulsed Alexandrite Lasers for Hair Removal: A Long-Term Clinical and Histologic StudyDERMATOLOGIC SURGERY, Issue 7 2001Christiane Handrick MD Background. Unwanted facial and body hair is a common problem, generating a high level of interest for treatment innovations. Advances in laser technology over the past several years has led to the development and distribution of numerous red and infrared lasers and light sources to address this issue. Despite the impressive clinical results that have been reported with the use of individual laser hair removal systems, long-term comparative studies have been scarce. Objective. To compare the clinical and histologic efficacy, side effect profile, and long-term hair reduction of long-pulsed diode and long-pulsed alexandrite laser systems. Methods. Twenty women with Fitzpatrick skin types I,IV and dark terminal hair underwent three monthly laser-assisted hair removal sessions with a long-pulsed alexandrite laser (755 nm, 2-msec pulse, 10 mm spot) and a long-pulsed diode laser (800 nm, 12.5 msec or 25 msec, 9 mm spot). Axillary areas were randomly assigned to receive treatment using each laser system at either 25 J/cm2 or 40 J/cm2. Follow-up manual hair counts and photographs of each area were obtained at each of the three treatment visits and at 1, 3, and 6 months after the final laser session. Histologic specimens were obtained at baseline, immediately after the initial laser treatment, and 1 and 6 months after the third treatment session. Results. After each laser treatment, hair counts were successively reduced and few patients found it necessary to shave the sparsely regrown hair. Optimal clinical response was achieved 1 month after the second laser treatment, regardless of the laser system or fluence used. Six months after the third and final treatment, prolonged clinical hair reduction was observed with no significant differences between the laser systems and fluences used. Histologic tissue changes supported the clinical responses observed with evidence of initial follicular injury followed by slow follicular regeneration. Side effects, including treatment pain and vesiculation, were rare after treatment with either laser system, but were observed more frequently with the long-pulsed diode system at the higher fluence of 40 J/cm2. Conclusion. Equivalent clinical and histologic responses were observed using a long-pulsed alexandrite and a long-pulsed diode laser for hair removal with minimal adverse sequelae. While long-term hair reduction can be obtained in most patients after a series of laser treatments, partial hair regrowth is typical within 6 months, suggesting the need for additional treatments to improve the rate of permanent hair removal. [source] Fractional CO2 laser: a novel therapeutic device upon photobiomodulation of tissue remodeling and cytokine pathway of tissue repairDERMATOLOGIC THERAPY, Issue 2009F. Prignano ABSTRACT Minimally ablative fractional laser devices have gained acceptance as a preferred method for skin resurfacing. Notable improvements in facial rhytides, photodamage, acne scarring, and skin laxity have been reported. The aim of the present work was to compare how different CO2 laser fluences, by modulating the secretory pathway of cytokines, are able to influence the wound-healing process, and how these fluences are associated with different clinical results. Eighteen patients, all with photodamaged skin, were treated using a fractional CO2 laser (SmartXide DOT, Deka M.E.L.A., Florence, Italy) with varying laser fluences (2.07, 2.77, and 4.15 J/cm2). An immunocytochemical study was performed at defined end points in order to obtain information about specific cytokines of the microenvironment before and after treatment. The secretory pathway of cytokines changed depending on the re-epithelization and the different laser fluences. Different but significant improvements in wrinkles, skin texture, and hyperpigmentation were definitely obtained when using 2.07, 2.77, and 4.15 J/cm2, indicating fractional CO2 laser as a valuable tool in photorejuvenation with good clinical results, rapid downtime, and an excellent safety profile. [source] Update on retinoid therapy of psoriasis in: an update on the use of retinoids in dermatologyDERMATOLOGIC THERAPY, Issue 5 2006Peter C. M. Van De Kerkhof ABSTRACT:, Both in the topical and systemic treatment of psoriasis, retinoids are mainstays. In this chapter the history and modes of actions of retinoids are presented. Tazarotene and acitretin are the only retinoids that are available in both topical and systemic formulations. A more extensive description of their pharmacology, modes of action, indications and contraindications, clinical results, and treatment strategies will be presented. Finally, retinoid X receptor ligands and retinoic acid metabolism blocking agents will be introduced as potential future retinoid mimetics in psoriasis. [source] Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved?ACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2007A systematic review, meta-analysis comparing the recent vs. the earlier rTMS studies Objective:, To investigate whether the recent repetitive transcranial magnetic stimulation (rTMS) studies on depression using new parameters of stimulation have shown improved clinical results. Method:, We performed a systematic review and a meta-analysis of the rTMS studies on depression published in the past 12 months comparing these results with an earlier meta-analysis that analyzed the results of the initial rTMS studies on depression. Results:, Using our inclusion criteria, we selected the meta-analysis of Martin [Br J Psychiatry (2003) Vol. 182, 480,491] that included 13 studies (324 patients) and five studies for the recent meta-analysis (274 patients). The pooled effect size (standardized mean difference between pretreatment vs. post-treatment) from the random effects model was ,0.76 (95% confidence interval, CI, ,1.01 to ,0.51). This result was significantly larger than that of the earlier meta-analysis (,0.35, 95% CI ,0.66 to ,0.04). Conclusion:, Our findings suggest that recent rTMS clinical trials have shown larger antidepressant effects when compared with the earlier studies. [source] EXPERIENCES OF SELF-EXPANDABLE METALLIC STENT FOR COLORECTAL OBSTRUCTIONS: 70 CASESDIGESTIVE ENDOSCOPY, Issue 2004Yoshihisa Saida ABSTRACT Clinical utilization of self-expandable metallic stent (EMS) endoprosthesis has come later for colorectal diseases than for other lesions. Recently, EMS has been used for palliative insertions for strictures caused by malignant diseases or as a ,bridge to surgery' for obstructive colorectal cancers, with good clinical results increasingly reported in many western countries. Its application for benign strictures has been reported, but we believe that the surgical indications require more careful analysis because of the absence of data concerning long-term prognosis. The advantage of this technique in the treatment of colorectal strictures is that it limits invasiveness, such as in palliative or temporary stoma creation, thereby improving patient quality-of-life. Therefore, we believe that EMS endoprosthesis will play a key role in this field. We are awaiting the introduction of the metallic stent for the colon and the associated kit, as well as the Japanese government's approval for reimbursement for this procedure. [source] Toxicity and outcome analysis of patients with recurrent head and neck cancer treated with hyperfractionated split-course reirradiation and concurrent cisplatin and paclitaxel chemotherapy from two prospective phase I and II studies,HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2005Noel M. Kramer DO Abstract Background. Patients with local recurrences or new head and neck primary tumors in previously irradiated tissues have few options for salvage treatment. One option for select patients is to undergo reirradiation with concurrent chemotherapy. The purpose of this study is to report the initial clinical results of the Fox Chase phase I and II prospective reirradiation and chemotherapy studies. Methods. Between July 1996 and January 2002, 38 patients with locally recurrent unresectable squamous cell carcinoma of the head and neck were treated with concurrent chemotherapy and reirradiation on two prospective trials. All patients had received prior radiation therapy to the head and neck region (median dose, 64.2 Gy). Patients received cisplatin and paclitaxel along with hyperfractionated external beam radiation therapy to the site of recurrence. Results. The median follow-up was 10 months. The median survival was 12.4 months, with actuarial rates of overall survival of 50% and 35% at 1 and 2 years, respectively. During follow-up, 63% of patients experienced local progression of disease, all in the irradiated field. Actuarial progression-free survival at 1 year was 33%, with a median time to progression of 7.3 months. Acute grade 3 to 4 toxicity included neutropenia, nausea, emesis, and mucositis. Conclusions. Hyperfractionated split-course reirradiation and concurrent cisplatin and paclitaxel chemotherapy demonstrates durable locoregional control in select patients, although late toxicity may occasionally be significant. Only sites of disease recurrence need to be covered in the reirradiation fields. © 2005 Wiley Periodicals, Inc. Head Neck27: XXX,XXX, 2005 [source] Fallacies of High-Speed HemodialysisHEMODIALYSIS INTERNATIONAL, Issue 2 2003Zbylut J. Twardowski Chronic hemodialysis sessions, as developed in Seattle in the 1960s, were long procedures with minimal intra- and interdialytic symptoms. Financial and logistical pressures related to the overwhelming number of patients requiring hemodialysis created an incentive to shorten dialysis time to four, three, and even two hours per session in a thrice weekly schedule. This method spread rapidly, particularly in the United States, after the National Cooperative Dialysis Study suggested that time of dialysis is of minor importance as long as urea clearance multiplied by dialysis time and scaled to total body water (Kt/Vurea) equals 0.95,1.0. This number was later increased to 1.3, but the assumption remained unchanged that hemodialysis time is of minimal importance as long as it is compensated by increased urea clearance. Patients accepted short dialysis as a godsend, believing that it would not be detrimental to their well-being and longevity. However, Kt/Vurea measures only removal of low molecular weight substances and does not consider removal of larger molecules. Besides, it does not correlate with the other important function of hemodialysis, namely ultrafiltration. Whereas patients with substantial residual renal function may tolerate short dialysis sessions, the patients with little or no urine output tolerate short dialyses poorly because the ultrafiltration rate at the same interdialytic weight gain is inversely proportional to dialysis time. Rapid ultrafiltration is associated with cramps, nausea, vomiting, headache, fatigue, hypotensive episodes during dialysis, and hangover after dialysis; patients remain fluid overloaded with subsequent poor blood pressure control, left ventricular hypertrophy, diastolic dysfunction, and high cardiovascular mortality. Short, high-efficiency dialysis requires high blood flow, which increases demands on blood access. The classic wrist arteriovenous fistula, the access with the best longevity and lowest complication rates, provides "insufficient" blood flow and is replaced with an arteriovenous graft fistula or an intravenous catheter. Moreover, to achieve high blood flows, large diameter intravenous catheters are used; these fit veins "too tightly," so predispose the patient to central-vein thrombosis. Longer hemodialysis sessions (5,8 hrs, thrice weekly), as practiced in some centers, are associated with lower complication rates and better outcomes. Frequent dialyses (four or more sessions per week) provide better clinical results, but are associated with increased cost. It is my strong belief that a wide acceptance of longer, gentler dialysis sessions, even in a thrice weekly schedule, would improve overall hemodialysis results and decrease access complications, hospitalizations, and mortality, particularly in anuric patients. [source] Intracytoplasmic sperm injection as a complement to gonadotrophin treatment in infertile men with hypogonadotrophic hypogonadismINTERNATIONAL JOURNAL OF ANDROLOGY, Issue 4 2005BRANKO ZORN Summary In this study we sought to determine whether intracytoplasmic sperm injection (ICSI) could improve the efficacy of treatment with gonadotrophins in gonadotrophin-deficient men in terms of pregnancy. A series of six adult men (aged 26,47 years) with hypogonadotrophic hypogonadism (HH) is reported: four men with prepubertal isolated idiopathic HH (IIHH) and two adult-onset HH, as part of hypopituitarism secondary to surgical treatment of a pituitary tumour. All were azoospermic. To restore spermatogenesis, all received hormonal treatment with intramuscular human menopausal gonadotrophins (HMG) and human chorionic gonadotrophin (HCG) for 2 to 23 months. High basal serum inhibin B was predictive of rapid and complete recovery of spermatogenesis. In the two adult-onset HH, a natural pregnancy was achieved within 3 months. The four men with IIHH underwent ICSI because of poor sperm quality. ICSI using fresh or frozen-thawed ejaculated spermatozoa was performed after 6,23 months of gonadotrophin treatment. ICSI provided good clinical results in terms of fertilization and embryo quality, and resulted in three pregnancies that ended in three term deliveries. In men with oligozoospermia related to prepubertal IIHH, ICSI shortens the hormonal treatment and enhances the chances of pregnancy. [source] Long-term results of three different minimally invasive therapies for lower urinary tract symptoms due to benign prostatic hyperplasia: Comparison at a single instituteINTERNATIONAL JOURNAL OF UROLOGY, Issue 4 2007Takashi Ohigashi Objective: We analyzed the efficacy and durability of three different minimally invasive therapies (MIT) for lower urinary symptoms performed at a single institution based on a 5-year prospective cohort study. Methods: The pre- and postoperative evaluation was made in 103 patients with the following three MIT options: (i) transurethral microwave thermotherapy (TUMT, n = 34); (ii) transurethral needle ablation (TUNA, n = 29); and (iii) transrectal high intensity focused ultrasound (HIFU, n = 40). Results: All three treatments significantly improved the symptom scores up to 2 years after treatment. However, no statistical difference was observed in the efficacy between MIT. The percentage of men requiring the secondary treatment also showed no statistical differences. Cox's proportional hazards multivariate regression model revealed the baseline peak flow rate (Qmax) and total International Prostate Symptom Score (IPSS) but the types of MIT are independent significant factors for determining the long-term clinical results of MIT. Conclusion: Our data showed no statistical differences in either the efficacy or in the durability between the three MIT. The baseline Qmax and total IPSS are the significant factors for determining the long-term results of MIT. [source] Essential fatty acids supplementation in different-stage atopic dogs fed on a controlled dietJOURNAL OF ANIMAL PHYSIOLOGY AND NUTRITION, Issue 3-6 2005C. Abba Summary The aim of this trial was to evaluate the effects of polyunsaturated fatty acid (PUFA) supplementation in different-stages atopic dogs fed on a controlled diet. Twenty-two non-seasonal atopic dogs of different breeds and ages were included in the 2-month trial. All the patients were given an essential fatty acid (EFA) supplementation [17 mg/kg eicosapentaenoic acid (EPA) + 5 mg/kg docosahexaenoic acid (DHA) + 35 mg/kg gammalinolenic acid (GLA)], the global (diet + supplementation) , -6 to , -3 ratio was 5.5,1. Two groups of dogs were considered: group A ,pre-immunotherapy' (15 cases) included dogs with early stages atopy, which had not been submitted to any treatment yet; group B ,post-immunotherapy' (seven cases) included dogs with chronic atopy immunotherapy non-responsive. Clinical evaluations were performed at the beginning, on day 30 and at the end of the trial. Blood serum fatty acids profile was determined at the beginning and at the end of the study. Better clinical results were obtained in group A, a great difference was found between the two groups on pruritus score. Serum arachidonic acid (AA) was significantly lower at the end of the trial in group A while GLA was significantly higher in group B. We hypothesized that different-stages atopic dogs could have different response to EFA supplementation, maybe because of a different fatty acids metabolism. Early stages cases seem to be more responsive to EFA supplementation. [source] Endovenous laser therapy , application studies and latest investigationsJOURNAL OF BIOPHOTONICS, Issue 5-6 2010Ronald Sroka Abstract Endovenous laser therapy (ELT) was introduced in clinical practice as a therapy for incompetent veins about ten years ago. One characteristic of ELT is the broad spectrum of different treatment protocols by means of a variety of laser systems as well as manifold application forms and dosimetry concepts are under investigations. Clinical results with effective, relatively pain-free occlusion of incompetent varicosis veins have been observed, as well as undesired side effects such as ecchymosis, phlebitis and recanalization. In recent years systematic experimental investigations and the analysis of clinical results have increased the understanding of the interrelation between the clinical and physical aspects, followed to a continuous optimization of ELT. The use of IR wavelengths and radial irradiation concepts, together with continuous moving of the optical fiber seem to reduce possible side effects. This way ELT treatment becomes a more standardized effective method for the treatment of varicose veins. In future controlled randomized studies are required to compare optimized ELT treatment with other endoluminal modalities as well as conventional surgery. (© 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Bilateral Axillary Artery Perfusion to Reduce Brain Damage during Cardiopulmonary BypassJOURNAL OF CARDIAC SURGERY, Issue 2 2010Kazuhiro Kurisu M.D. The aim of the present study was to examine the value of bilateral axillary artery perfusion during thoracic aortic and cardiac surgery, and to evaluate the clinical results with a particular focus on cerebral damage. Methods: From March 2002 through December 2007, 24 patients (16 male and eight female; age range, 43 to 84 years) underwent bilateral axillary artery perfusion through side grafts during cardiopulmonary bypass. Aortic surgery, including total arch replacement, hemiarch replacement, and ascending aortic replacement, was performed in 21 patients. Bilateral axillary artery perfusion was also used in three complicated valve surgeries after expanding its indication to cardiac pathology with a diseased aorta, two redo cases with severe atherosclerotic vascular disease, and one case with a porcelain aorta. Results: Bilateral axillary artery perfusion was successful in all patients. There were no complications related to this procedure except in one patient, who suffered from a local fluid retention in one wound, requiring puncture drainage. There was no hospital mortality. No strokes were identified by either clinical assessments or diagnostic imaging. Conclusions: Bilateral axillary artery perfusion is a useful method for protection of the brain during either thoracic aortic or cardiac surgery when the patients have an extensively diseased aorta.,(J Card Surg 2010;25:139-142) [source] | |||||||||||||||||||||||||||||||||||||