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Study Completion (study + completion)
Selected AbstractsA randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post,liver transplantation hepatitis B prophylaxis,HEPATOLOGY, Issue 5 2008Peter W. Angus Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)-related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to <5% at 5 years; however, HBIG administration is costly and inconvenient. We conducted a multicenter randomized study of adefovir dipivoxil substitution for low-dose intramuscular (IM) HBIG in patients without HBV recurrence at least 12 months posttransplantation for HBV-related disease. Thirty-four patients were randomized, 16 to adefovir (1 patient withdrew consent at 3 months and is not considered in the results) and 18 to continue HBIG. All continued lamivudine. Groups were well matched by age, sex, and time since transplantation (median, 4.5 years), and background virological risk for HBV recurrence (30% of patients in the adefovir group, 24% in the HBIG group having detectable HBV DNA at transplantation). All patients were alive at study completion without recurrence. One patient in the adefovir group became hepatitis B surface antigen,positive at 5 months but was persistently HBV DNA undetectable via polymerase chain reaction (sensitivity 14 IU/mL) over the following 20 months. Median creatinine was not significantly changed over the course of the study in either group. One patient in the adefovir group with a background of diabetic and hypertensive nephropathy (baseline creatinine 150 ,mol/L) developed increased creatinine leading to dose reduction and ultimately cessation of adefovir at 15 months. Yearly cost of combination adefovir/lamivudine prophylaxis was $8,290 versus $13,718 IM HBIG/lamivudine. Conclusion: Compared with combination HBIG plus lamivudine prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost. (HEPATOLOGY 2008.) [source] Stopping antipsychotic drug therapy in demented nursing home patients: a randomized, placebo-controlled study,,The Bergen District Nursing Home Study (BEDNURS)INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 9 2008Sabine Ruths Abstract Background Despite modest efficacy, unpredictable individual utility, and a high rate of adverse effects, behavioural and psychological symptoms of dementia (BPSD) are common determinants for antipsychotic drug therapy in nursing home patients. Aims To explore the impact on BPSD of stopping long-term antipsychotic treatment in nursing home patients with dementia. Methods Fifty-five patients (43 women; mean age 84.1) taking haloperidol, risperidone, or olanzapine for BPSD were randomly assigned to cessation (intervention group, n,=,27) or continued treatment with antipsychotic drugs (reference group, n,=,28) for 4 consecutive weeks. The Neuropsychiatric Inventory (NPI) Questionnaire was used to examine changes in behavioural and psychological symptoms. Results By study completion, 23 of the 27 intervention group patients were still off antipsychotics. Symptom scores (NPI) remained stable or even improved in 42 patients (intervention group, 18 out of 27; reference group, 24 out of 28; p,=,0.18). As compared to patients with stable or improved symptom scores, patients with behavioural deterioration after antipsychotic cessation used higher daily drug doses at baseline (p,=,0.42). Conclusion A large share of elderly nursing home patients on long-term treatment with antipsychotics for BPSD, do well without this treatment. Standardized symptom evaluations and drug cessation attempts should therefore be undertaken at regular intervals. Copyright © 2008 John Wiley & Sons, Ltd. [source] Low level laser therapy for healing acute and chronic wounds , the extendicare experienceINTERNATIONAL WOUND JOURNAL, Issue 2 2008Anita E Saltmarche Abstract The purpose of the study is to assess the effectiveness of low level laser therapy for wound healing when combined with the Extendicare Wound Prevention and Management Program. Sixteen residents at a Canadian Extendicare nursing home had a total of 27 sites treated consisting of 23 open wounds and 4 ,at risk' areas. Of the 23 open wounds, two wounds in between toes were not able to be ,traced' and deemed ,immeasurable' wounds, resulting in 21 open, measured wounds. The four ,at risk' (closed) areas were treated preventatively. Pressure, venous insufficiency and diabetic wounds were included. The majority (12/21) or 57·1%, of the wounds were chronic (,3 months duration) and 42·9% were acute (<3 months duration). The primary outcome measures included the PUSH Tool score, EZ GraphTM tracings and photographs. Secondary outcome measures were employed to better understand potential barriers to successful integration into clinical practice. Feedback on the effectiveness of low level laser therapy, the education program and determinations of hands-on relevance was sought from staff. At the end of the 9-week trial, the majority (61·9%) of the 21 wounds achieved significant improvement (,50% wound closure). Nine (42·8%) had 100% closure. Some improvement was seen in 14·3% and 23·8% of wounds demonstrated no change. Chronic and acute wounds had similar improvement. None of the wounds in this debilitated, frail population deteriorated during the study and no negative consequences of treatment were encountered. Without staff support, even if new technology has positive clinical outcomes, success would be limited. Staff rated low level laser, easy to learn and use, effective for the majority of their residents worth the additional time. Staff requested a continuation of low level laser even after study completion. [source] Utilities of the P -value Distribution Associated with Effect Size in Clinical Trials,BIOMETRICAL JOURNAL, Issue 6 2003H.M. James Hung Abstract The P -value, which is widely used for assessing statistical evidence in randomized comparative clinical trials, is a function of the observed effect size of the experimental treatment relative to the control treatment. The relationship of the P -value with the observed effect size at study completion and the effect size anticipated at the design stage has potential usefulness in providing guidance for planning and interpretation of a clinical trial. The post-trial power associated with a statistically significant P -value from a completed study is also a random variable and its use may assist in planning a follow-up trial to confirm the statistically significant findings in an initial study. A measure of robustness is explored to quantify the degree of sensitivity of the observed P -value to potential bias that may be contained in the observed effect size. [source] Comparative efficacy of two ,1 -adrenoreceptor antagonists, doxazosin and alfuzosin, in patients with lower urinary tract symptoms from benign prostatic enlargementBJU INTERNATIONAL, Issue 6 2004T.M. De Reijke OBJECTIVES To compare doxazosin and alfuzosin in patients with moderate to severe lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction. PATIENTS AND METHODS In all, 210 men with LUTS were randomized to receive doxazosin 1,8 mg once daily or alfuzosin 5,10 mg divided in two or three daily doses in a 14-week, multicentre, double-blind, baseline-controlled, dose-titration study. The International Prostate Symptom Score (IPSS) and maximum urinary flow rate were used to assess the efficacy of the treatment. RESULTS At study completion, the mean dose of doxazosin was 6.1 mg/day and alfuzosin 8.8 mg/day. The least squares mean (se) change from baseline in total IPSS was ,9.23 (0.6) for doxazosin and ,7.45 (0.6) (both P < 0.001) for alfuzosin. The respective mean change from baseline in irritative symptoms was ,3.5 (0.2) and ,2.8 (0.3) (both P < 0.001). The differences between the treatment groups were statistically significant in favour of doxazosin (total IPSS, P = 0.036; irritative symptoms, P = 0.049). The improvement between groups was also significantly different for postvoid residual urine volume, at ,29.19 (8.6) and +,9.59 (8.9) mL for doxazosin and alfuzosin, respectively (P = 0.002). Improvements in mean and maximum urinary flow rates were similar for both treatments, at +,1.5 and +,1.2, and +,2.8 and +,2.5 mL/s, respectively. Doxazosin and alfuzosin were both well tolerated, with most all-cause adverse events reported as mild or moderate. CONCLUSIONS The mean doses of doxazosin and alfuzosin used in this study were not equipotent. Doxazosin 6.1 mg/day produced significantly greater improvements than alfuzosin 8.8 mg/day in total and irritative urinary symptom scores and postvoid residual urine volume in men with moderate to severe LUTS. Changes in maximum and mean flow rates were comparable. Doxazosin and alfuzosin were both well tolerated. [source] Randomized cross-over clinical trial of injectable vs. implantable depot testosterone for maintenance of testosterone replacement therapy in androgen deficient menCLINICAL ENDOCRINOLOGY, Issue 1 2010Carolyn Fennell Summary Background, Life-long testosterone replacement therapy (TRT) for younger men with organic androgen deficiency is best provided by depot testosterone (T) products. This study compared directly the two long-acting depot T products, subdermal T implants (TI) and injectable T undecanoate (TU) for maintenance of TRT. Design, setting and participants, Men with organic androgen deficiency (n = 38) undergoing regular TRT at an academic Andrology centre were recruited for a two period, randomized sequence, cross-over clinical trial without intervening wash-out period of TRT maintenance. Outcomes, For both depot T products, their pharmacokinetics and pharmacodynamics were evaluated using a range of androgen sensitive clinical, laboratory and quality of life measures as well as preference for ongoing treatment after experience of both products. Results, The two depot T products had distinct pharmacokinetics and were not bioequivalent. However, there were no consistent clinical differences in a comprehensive range of pharmacodynamic measures reflecting androgen effects on biochemistry and haematology, muscle mass and strength, and quality of life, mood and sexual function. The majority (91%) of participants chose TU over TI at study completion. Conclusion, Despite significant pharmacokinetic differences, the two depot T products are clinically interchangeable allowing for choice dependent on patient and physician delivery preference in practice but most patients preferred the injectable over the implantable form. [source] | ||||||||||