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Larger Trials (larger + trials)
Selected AbstractsThe management of dyslipidaemias in antiretroviral-treated HIV infection: a systematic reviewHIV MEDICINE, Issue 6 2007C McGoldrick Objectives The aim of the study was to assess the currently available evidence concerning the management of dyslipidaemias in HIV-infected individuals treated with antiretroviral therapy. Methods Randomized trials, published within the 5 years preceding 5 October 2005, were identified in PubMed Medline, Embase, and The Cochrane Central Register of Controlled Trials. Studies were then included or excluded, dependent on their meeting inclusion/exclusion criteria. The evidence obtained in the studies that were included was assessed using methods employed by the Scottish Intercollegiate Guidelines Network (SIGN). Results Thirteen relevant trials were identified, concerning the use of statins, fibrates, antiretroviral drug switches and insulin-sensitizing drugs. Most contained small numbers of trial participants. Conclusions Most studies suggested beneficial effects and satisfactory safety profiles for the interventions studied. However, the insulin-sensitizing drug rosiglitazone appeared to have some detrimental effects on lipid profiles. With the small numbers of participants in the majority of studies, these studies were likely to have been inadequately powered to assess the effects of the interventions examined. Larger trials are therefore necessary. [source] The use of light-emitting diode therapy in the treatment of photoaged skinJOURNAL OF COSMETIC DERMATOLOGY, Issue 3 2007FACCS, FRACGP, Fabien Baez MBBS, MAACS, MCPSA Summary Background, Light-emitting diode (LED) therapy is an increasingly popular methodology for the treatment of sun damage. Combination use of light wavelengths reported to stimulate collagen synthesis and accelerate fibroblast,myofibroblast transformation may display a composite rejuvenative effect. Objective, To clinically assess reduction in sun damage signs following a 5-week course of LED therapy and to assess subject's perception of the treatment. Methods, Thirteen subjects with wrinkles or fine lines in the periorbital and nasolabial region and those presenting Glogau scale photodamage grade II,III received nine 20-min duration light treatments using the OmniluxÔ LED system. The treatments combined wavelengths of 633 and 830 nm at fluences of 126 and 66 J/cm2, respectively. Sun-damage reduction was assessed at 6, 9, and 12 weeks by clinical photography and patient satisfaction scores. Results, The majority of subjects displayed "moderate" (50%) or "slight" (25%) response to treatment at investigator assessment. Treatment of the periorbital region was reported more effective than the nasolabial region. At 12-week follow-up, 91% of subjects reported improved skin tone, and 82% reported enhanced smoothness of skin in the treatment area. Conclusion, Good response to LED therapy has been shown in this modest sample. Larger trials are needed to assess optimum frequency of light treatments and overall treatment time. [source] Rapamycin versus methotrexate in early diffuse systemic sclerosis: Results from a randomized, single-blind pilot studyARTHRITIS & RHEUMATISM, Issue 12 2009Tien-I Karleen Su Objective To assess the safety and efficacy of rapamycin in the treatment of diffuse systemic sclerosis (SSc; scleroderma). Methods Eighteen patients with diffuse SSc of ,5 years duration were randomized to receive rapamycin or methotrexate (MTX) in a single-blind, 48-week study. Abnormalities in clinical and laboratory parameters were compared between the 2 treatment groups. The potential efficacy of the study drugs was evaluated by comparing results of the baseline and 48-week assessments, including the modified Rodnan skin thickness score (MRSS) and the Health Assessment Questionnaire disability index. Results The baseline characteristics of the patients were similar in both groups (n = 9 in each). One patient in the rapamycin group who never received the study drug was excluded from the analysis. Three patients in each group withdrew from the study; 2 of the withdrawals were treatment-related (severe hypertriglyceridemia associated with rapamycin, and pancytopenia associated with MTX), and 4 were SSc-related. Hypertriglyceridemia was the most notable side effect associated with rapamycin, but it was generally well tolerated and treatable. The incidence and severity of other adverse drug reactions were comparable between the 2 groups. Within each group, the MRSS improved significantly from baseline. In the rapamycin group, the patient's global assessment showed a significant improvement from baseline, while forced vital capacity values declined from baseline. The disease activity scores at 48 weeks and the changes in these scores from baseline were not significantly different between the 2 groups. Conclusion Rapamycin has a reasonable safety profile in a select group of patients with scleroderma. Larger trials are needed to assess the efficacy of rapamycin in patients with early diffuse SSc. [source] Preschool outcome in children born very prematurely and cared for according to the Newborn Individualized Developmental Care and Assessment Program (NIDCAP)ACTA PAEDIATRICA, Issue 4 2004B Westrup Aim: Care based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been reported to exert a positive impact on the development of prematurely born infants. The aim of the present investigation was to determine the effect of such care on the development at preschool age of children born with a gestational age of less than 32 wk. Methods: All surviving infants in a randomised controlled trial with infants born at a postmenstrual age less than 32 wk (11 in the NIDCAP group and 15 in the control group) were examined at 66.3 (6.0) mo corrected for prematurity [mean (SD)]. In the assessment we employed the Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R) for cognition, Movement Assessment Battery for Children (Movement ABC) for motor function, subtests of the NEPSY test battery for attention and distractibility, and the WHO definitions of impairment, disability and handicap. Exact binary logistic regression was employed. Results: There were no significant differences between the intervention group in Full-Scale IQ 93.4 (14.2) [mean (SD)] versus the control group 89.6 (27.2), Verbal IQ 93.6 (16.4) versus 93.7 (26.8) or Performance IQ 94.3 (14.7) versus 86.3 (24.8). In the NIDCAP group 8/13 (62%) survived without disability and for the children with conventional care this ratio was 7/19 (37%). The corresponding ratios for surviving without mental retardation were 10/13 (77%) and 11/19 (58%), and for surviving without attention deficits 10/13 (77%) and 10/19 (53%). Overall, the differences were not statistically significant, although the odds ratio for surviving with normal behaviour was statistical significant after correcting for group imbalances in gestational age, gender, growth retardation and educational level of the parents. Conclusion: Our trial suggests a positive impact by NIDCAP on behaviour at preschool age in a sample of infants born very prematurely. However, due to problems of recruitment less than half of the anticipated subjects were included in the study, which implies a low power and calls for caution in interpreting our findings. Larger trials in different cultural contexts are warranted. [source] Diagnosis of Nonmelanoma Skin Cancer/Keratinocyte Carcinoma: A Review of Diagnostic Accuracy of Nonmelanoma Skin Cancer Diagnostic Tests and TechnologiesDERMATOLOGIC SURGERY, Issue 10 2007METTE MOGENSEN MD BACKGROUND Nonmelanoma skin cancer (NMSC) is the most prevalent cancer in the light-skinned population. Noninvasive treatment is increasingly used for NMSC patients with superficial lesions, making the development of noninvasive diagnostic technologies highly relevant. OBJECTIVE The scope of this review is to present data on the current state-of-the-art diagnostic methods for keratinocyte carcinoma: basal cell carcinoma, squamous cell carcinoma, and actinic keratosis. METHODS AND MATERIALS MEDLINE, BIOSIS, and EMBASE searches on NMSC and physical and clinical examination, biopsy, molecular marker, ultrasonography, Doppler, optical coherence tomography, dermoscopy, spectroscopy, fluorescence imaging, confocal microscopy, positron emission tomography, computed tomography, magnetic resonance imaging, terahertz imaging, electrical impedance and sensitivity, specificity, and diagnostic accuracy. RESULTS State-of-the-art diagnostic research has been limited in this field, but encouraging results from the reviewed diagnostic trials have suggested a high diagnostic accuracy for many of the technologies. Most of the studies, however, were pilot or small studies and the results would need to be validated in larger trials. CONCLUSIONS Some of these new imaging technologies have the capability of providing new, three-dimensional in vivo, in situ understanding of NMSC development over time. Some of the new technologies described here have the potential to make it from the bench to the clinic. [source] Tretinoin Peels versus Glycolic Acid Peels in the Treatment of Melasma in Dark-Skinned PatientsDERMATOLOGIC SURGERY, Issue 5 2004Niti Khunger MD Background. Chemical peels have become a popular method for treating melasma. Although daily topical 0.05 and 0.1% tretinoin have been used for melasma, the therapy takes at least 4 to 6 months to produce clinically significant lightening. In a recent trial, 1% tretinoin peel has shown good clinical and histologic results after biweekly applications in 2.5 weeks only in the treatment of melasma. Objective. Because there is a paucity of studies evaluating the efficacy and safety of 1% tretinoin peel in the treatment of melasma in dark-skinned Asian population, we conducted a pilot study to evaluate the efficacy and side effects of this potentially new peeling agent versus a standard peeling agent, 70% glycolic acid, in the treatment of melasma in Indian women. Methods. Ten female patients of melasma, after written consent, were taken up for an open left,right comparison pilot study of 12 weeks. One percent tretinoin peel was applied on one-half of the face, whereas 70% glycolic acid was applied on the other at weekly intervals. The results were evaluated by a clinical investigator by using the modified Melasma Area and Severity Index and with photographs at baseline and 6 and 12 weeks. Results. A significant decrease in the modified Melasma Area and Severity Index from baseline to 6 weeks and then from 6 to 12 weeks was observed on both facial sides (p<0.001). Nevertheless, there was no statistically significant difference between the right and the left sides. Side effects were minimal and 1% tretinoin peel appeared to be well tolerated by the patients. Conclusions. It was concluded from the present trial that serial 1% tretinoin peel is a well tolerated and as effective a therapy for melasma in dark-skinned individuals as a standard and well-tried chemical peel, 70% glycolic acid, although larger trials over longer periods may be necessary to substantiate such findings. [source] Augmentation of clozapine with a second antipsychotic , a meta-analysis of randomized, placebo-controlled studiesACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2009D. M. Taylor Objective:, Inadequate response to clozapine treatment is frequently encountered in practice and augmentation strategies have been developed in an attempt to improve response. Aims of the study were to evaluate the therapeutic effect of adding an antipsychotic drug to clozapine treatment. Method:, Meta-analysis of randomized, placebo-controlled studies of antipsychotic augmentation of clozapine treatment. Results:, Ten studies (including 522 subjects) met inclusion criteria. Antipsychotic augmentation showed significant benefit over the addition of placebo on only one outcome measure examined [mean effect size for rating scale score (BPRS/PANSS) ,0.180, 95% CI ,0.356 to ,0.004]. Antipsychotic augmentation showed no advantage on withdrawals from trials (risk ratio 1.261, 95% CI 0.679,2.345) or on CGI scores (effect size ,0.661, 95% CI ,1.475 to 0.151). Duration of study was not associated with outcome (P = 0.95). There was no evidence of publication bias. Conclusion:, In studies lasting up to 16 weeks, the addition of an antipsychotic to clozapine treatment has marginal therapeutic benefit. Longer and larger trials are necessary to demonstrate the precise therapeutic utility of antipsychotic co-therapy with clozapine. [source] The application of transcranial magnetic stimulation in psychiatry and neurosciences researchACTA PSYCHIATRICA SCANDINAVICA, Issue 5 2002P. B. Fitzgerald Objective:,Over recent years transcranial magnetic stimulation (TMS) has become widely applied in the study of neuropsychiatric disorders. The aim of this article is to review the application of TMS as an investigative tool and as a potential therapeutic modality in psychiatric disorders. Method:,A comprehensive literature review. Results:,When applied as an investigative tool, TMS provides innovative ways to directly study the excitability of the cortex, cortical regional connectivity, the plasticity of brain responses and cognitive functioning in illness and disease states. A number of studies suggest the potential of treatment with TMS in disease states, especially in patients with depression, although difficulties exist with the interpretation of the published literature. Conclusion:,TMS has a considerable role in neuropsychiatric research. It appears to have considerable potential as a therapeutic tool in depression, and perhaps a role in several other disorders, although widespread application requires larger trials and establishment of sustained response. [source] Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gumADDICTION, Issue 9 2009Ned L. Cooney ABSTRACT Aims The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes. Design Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment. Setting Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions. Participants Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day. Intervention All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions. Findings Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions. Conclusions Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation. [source] Cocaine Rapid Efficacy Screening Trials (CREST): lessons learnedADDICTION, Issue 2005Kyle M. Kampman ABSTRACT Aims The Cocaine Rapid Efficacy Screening Trials (CREST) were designed by the National Institute on Drug Abuse Division of Treatment Research and Development (NIDA, DT R&D) to rapidly screen a number of medications potentially useful for the treatment of cocaine dependence. Design Each CREST trial was designed to compare several medications in a single trial against an unmatched placebo. The placebo group was included in each trial to avoid the nearly universal positive response to medications seen in open-label trials. In addition, a common set of procedures and outcome measures were employed throughout to increase comparability of results obtained from different trials and from different times. Participants In all, 18 medications were screened in seven different trials, conducted in four different sites throughout the United States involving 398 cocaine-dependent patients. Findings Three medications were found to be promising enough to include in subsequent larger trials. Common statistical procedures for evaluating medications were developed to facilitate comparisons across sites and across time. A portion of the data were pooled and analyzed, which yielded some useful insights into cocaine dependence and its treatment. Finally, a review of individual trials together with the pooled analysis revealed several potential improvements for future screening trials. Conclusions Overall, the CREST trials proved to be useful for rapidly screening medications for treatment of cocaine dependence, but several modifications in design should be made before this framework is applied further. [source] A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcersINTERNATIONAL WOUND JOURNAL, Issue 2 2008Georgia Noble-Bell Abstract Foot ulcers are a common complication in patients with diabetes. Negative pressure wound therapy (NPWT) is a wound care therapy that is being increasingly used in the management of foot ulcers. This article presents a systematic review examining the effectiveness of this therapy. The review question is how effective is NPWT in achieving wound healing in diabetes foot ulcers? The primary outcome for this study was the number of patients achieving complete wound healing (secondary outcomes, other markers of wound healing, adverse events and patient satisfaction). A systematic literature review and tabulative synthesis of randomised controlled trials (RCTs). The review identified four RCTs of weak to moderate quality. Only one study examining NPWT in postamputation wound healing reported data on the primary outcome. These data show a 20% improvement in wound healing [odds ratios = 2·0%, confidence interval (CI) ,1·0 to 4·0] and number needed to treat = 6 (CI 4,64). No serious treatment-related complications were reported by any of the studies. One study suggested a reduction in the risk of secondary amputation (absolute risk reduction = 7·9%, CI 0·5,15·43). Studies also reported an increase in granulation and wound-healing rates in patients treated with NPWT therapy. No data on patient satisfaction or experience were reported. While all the studies included in the review indicated that the NPWT therapy is more effective than conventional dressings, the quality of the studies were weak and the nature of the inquiries in terms of outcome and patient selection divergent. There is a strong need for larger trials to assess NPWT therapy in diabetes care with different groups of patients and in relation to different clinical objectives and parameters. [source] A pilot study of recombinant interferon beta-1a for the treatment of chronic hepatitis CLIVER INTERNATIONAL, Issue 6 2000François Habersetzer Abstract:Aims: Interferon alpha monotherapy induces a sustained response in less than 20% of patients treated for chronic hepatitis C. Interferon beta represents a potential therapeutic alternative for the treatment of chronic hepatitis C. The aim of this pilot study was to evaluate the efficacy and tolerance of recombinant interferon beta-1a administered subcutaneously. Methods: Twenty-one drug-naive patients with chronic hepatitis C were treated with recombinant interferon beta-1a administered, subcutaneously, for 24 weeks using two different regimens: 9 MU, three times per week (n=11) and 12 MU, three times per week (n=10). Results: At the end of the treatment period, nine (43%) patients had a biochemical and virological response (i.e. normal ALT and absence of hepatitis C virus RNA by PCR). Four of these patients were in the 9 MU group and five in the 12 MU group. A biochemical and virological sustained response occurred in four (19%) patients, all in the 9 MU dose group. The 4 patients with a sustained response maintained their response during a follow-up period of 33 to 58 months. Side effects were mild and 19 (90%) patients completed the treatment period. Conclusions: The results of this pilot study indicate that interferon beta-1a administered subcutaneously is an effective therapy for some patients with chronic hepatitis C, and suggest that interferon beta-1a deserves further evaluations in larger trials especially in combination with ribavirin. [source] Targeted Pharmacotherapy of Evoked Phenomena in Neuropathic Pain: A Review of the Current EvidencePAIN MEDICINE, Issue 1 2007BSc(Med), Ron Granot MB BS ABSTRACT Objective., Evoked phenomena in clinical neuropathic pain are viewed as a window into the underlying pathophysiology. They are also potential therapeutic targets. This study sought evidence for the effect on such evoked phenomena of currently used agents. Design., We reviewed MEDLINE (1966,2006) and EMBASE (1980,2006) to locate all randomized, double-blind, placebo-controlled trials examining therapeutic responses of evoked neuropathic pain phenomena, including dynamic mechanical allodynia, pin prick hyperalgesia, and thermal allodynia. We also noted the methods of elicitation of these evoked pain phenomena. Results., We found 40 articles meeting our inclusion criteria. A wide variety of methods was used to evoke neuropathic pain phenomena. For dynamic mechanical allodynia, there is some evidence for the efficacy of ketamine, alfentanil, and morphine, but only when administered intravenously. For other agents and other evoked pain phenomena, there is insufficient evidence to draw firm conclusions. Conclusions., There is minimal evidence to guide clinicians in treating evoked pain phenomena in clinical neuropathic pain states. There is little clinical evidence to either support or refute theoretical arguments for efficacy of specific agents in evoked neuropathic pain phenomena. More and larger trials are needed to examine these phenomena. Consensus is required with respect to methods used to elicit these evoked phenomena. [source] De novo Therapy with Everolimus, Low-Dose Ciclosporine A, Basiliximab and Steroid Elimination in Pediatric Kidney TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2010L. Pape The number of acute rejections and infections after pediatric kidney transplantation (KTX) could not be reduced in the last years. To reduce these events, we investigated a new immunosuppressive protocol in a prospective trial. After KTX, 20 children (median age 12 years, range 1,17) were initially treated with Basiliximab, ciclosporine A (CsA) (trough-level = C0 200,250 ng/mL) and prednisolone. After 2 weeks, CsA dose was reduced to 50% (C0 75,100 ng/mL, after 6 months: 50,75 ng/mL) and everolimus (1.6 mg/m2/day) was started (C0 3,6 ng/mL). Six months after KTX prednisolone was set to alternate dose and stopped 3 months later. All 20 protocol biopsies 6 months after KTX showed no acute rejection or borderline findings. Indication biopsies resulted in no acute rejections and two borderline findings. Mean glomerular filtration rate (GFR) 1 year after KTX was 71 ± 25 mL/min/1.73 m2. Without cytomegalovirus (CMV)-prophylaxis, only two primary CMV infections were seen despite a donor/recipient-CMV-constellation pos./neg. in 10/20 children. In pediatric KTX, de novo immunosuppression with low-dose CsA, everolimus and steroid withdrawal after 9 months led to promising results according to numbers of acute rejections and infections. Further follow up is needed. Future larger trials will have to confirm our findings. [source] Combined treatment with pegylated interferon,,-2a and dacarbazine in patients with advanced metastatic melanomaCANCER, Issue 6 2008A phase 2 study Abstract BACKGROUND. Dacarbazine (DTIC) and pegylated interferon (IFN),,-2a have both demonstrated some efficacy as single agents in metastatic melanoma. To the authors' knowledge, the current study is the first to test a combination of these 2 agents in a phase 2 trial. METHODS. Twenty,eight patients with stage IV melanoma without brain metastases were treated with DTIC (at a dose of 850 mg/m2 every 3 weeks) combined with weekly pegylated IFN,,-2a at a dose of 180 ,g. The study was initiated to evaluate the efficacy and tolerability of the combination. The primary study endpoint was objective response. RESULTS. Twenty,five patients were evaluable for response. Two patients (8.0%) achieved a complete response that continued for >480 days and 746 days, respectively. Four patients (16.0%) demonstrated a partial response, and another patient experienced stable disease. Six of 7 nonprogressive patients had either not received treatment or had not developed disease progression during adjuvant IFN treatment for stage II/III disease. The median duration of response was 236 days, the median progression-free survival was 56 days, and the overall survival time was 403 days. Few grade 3 toxicities and only 1 grade 4 toxicity were observed (according to National Cancer Institute Common Toxicity Criteria). CONCLUSIONS. The combination of DTIC and pegylated IFN,,-2a was found to be well tolerated in patients with metastatic melanoma. The response rate of 24%, including 2 long-lasting complete responses, is encouraging, but must be confirmed in larger trials. Cancer 2008. © 2008 American Cancer Society. [source] | ||||||||||