Kusajili – Centralise les essais cliniques mondiaux

Effect of bleaching on microhardness of esthetic restorative materials. This study evaluated the effect of a high-concentration carbamide peroxide–containing home bleaching system (Opalescence PF) and a hydrogen peroxide–containing over-the-counter bleaching system (Treswhite Supreme) on the microhardness of two nanocomposites (Filtek Supreme XT and Premise) and leucite-reinforced glass ceramic (Empress Esthetic), glass ceramic (Empress 2 layering), and feldspathic porcelain (Matchmaker MC). A total of 100 specimens, 20 of each kind of the restorative materials, 2 mm in thickness and 10 mm in diameter, were fabricated. Then the specimens were polished with SiC paper and 1 μm alumina polishing paste. After polishing, porcelain specimens were glazed in accordance with the manufacturer's instructions. Each type of restorative material was then randomly divided into two groups (n=10), and the specimens were treated with either Opalescence PF or Treswhite Supreme. The microhardness of the specimens before bleaching (baseline) and after bleaching was determined using a digital microhardness tester. Data were analyzed using the Mann-Whitney U-test and the Wilcoxon test. Opalescence PF significantly influenced the hardness of all the restorative materials. Statistically significant decreases with respect to before bleaching were found for Premise (p=0.005), Empress Esthetic (p=0.003), Empress 2 layering (p=0.005), and Matchmaker-MC (p=0.003), whereas a statistically significant increase was observed in Filtek Supreme XT (p=0.028). The difference in the microhardness values between before and after bleaching using Treswhite Supreme was statistically significant only for Premise (p=0.022). High-concentration carbamide peroxide–containing home bleaching may affect the microhardness of restorative materials.

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The evaluation of psychiatric drug therapy on oral lichen planus patients with psychiatric disorders. Current treatments of oral lichen planus are palliative, not curative. Because psychiatric disorders significantly influence the development and severity of oral lichen planus, the use of psychiatric drug therapy may be an adjunct in treatment. The purpose of this study was to determine the efficacy of drug therapy of psychiatric disorders in oral lichen planus. Our controlled clinical study consisted of forty-six patients with oral lichen planus and psychiatric disorders who were randomly divided into two groups. Both groups were given topical corticosteroids and the study group received additional psychiatric drug therapy. Patients were monitored for a period of 6 months. Response to treatment was evaluated in each group and was compared with the other group using Mann-Whitney tests. We evaluated the correlation between psychiatric disorders and the recovery of oral lesions using Spearman's correlation coefficient analysis. Decrease in the size of the lesions was significantly greater in the study group after six months, but this difference was not significant in relationship to the pain experienced and the kind of lesion. Spearman's correlation coefficient analysis demonstrated that, in the sixth month, there was a significant and direct relationship between recovery from the psychiatric disorders and response to treatment of OLP lesions, particularly as it pertained to the kind of lesion. The present study indicates that the combination of psychiatric drug therapy and routine treatment methods were effective in reducing the size of the lesions, but did not have any significant effect on the symptoms.

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A bolus dose of esmolol attenuates tachycardia and hypertension after tracheal intubation. Forty-five patients of ASA physical status I and II undergoing a variety of non-cardiac surgical procedures were studied to determine the effect of bolus administration of esmolol, a new short-acting beta blocking drug, on heart rate and blood pressure responses to induction of anaesthesia and tracheal intubation. Subjects were allocated randomly to receive placebo, 100 mg or 200 mg of esmolol IV as part of an anaesthetic induction technique. The differences in heart rate between the placebo group and both the 100 mg and 200 mg groups were significant prior to intubation (95 +/- 7.9, 82 +/- 9.7, 80 +/- 7.3 beats per min respectively), and also at 0.5 min and 1.5 min following intubation for the 200 mg group. In the 200 mg group there was a significant decrease, compared with placebo, in systolic blood pressure at 0.5 min (144 +/- 32.1 vs 165 +/- 18.7 mmHg) and 1.5 min (154 +/- 25.0 vs 170 +/- 19.5 mmHg) after intubation. In this study, adequate haemodynamic control was obtained following administration of 200 mg of esmolol.

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[Low molecular-weight dextran in patients with peptic ulcer].

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ACTRN12612607000628448

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Phase II randomized trial comparing vinorelbine versus vinorelbine plus cisplatin in patients with recurrent salivary gland malignancies. Some previous studies have shown that vinorelbine (VNB) is active in recurrent salivary gland tumors. Between April 1993 and April 1997, 36 patients in a Phase II randomized trial received either cisplatin, 80 mg/m(2), on Day 1 plus VNB, 25 mg/m(2), on Days 1 and 8 (every 3 weeks) (for a minimum of 3 cycles (Arm A [16 patients]), or VNB, 30 mg/m(2)/week, (for a minimum of 9 wks) (Arm B [20 patients]). There were 23 males and 13 females with a median age of 59 years (range, 20-74 years) and a median Eastern Cooperative Oncology Group performance status of 1 (range, 0-2). Four patients had been treated with prior surgery (S) or radiotherapy (RT), 27 patients had been treated with S plus RT, and 5 patients had been treated with S plus RT plus mitoxantrone. Eighteen patients had major salivary gland tumors, and 18 patients had minor salivary gland tumors; 9 patients had adenocarcinoma, 22 patients had adenoid cystic carcinoma, 1 patient had a malignant mixed carcinoma, 3 patients had undifferentiated carcinoma, and 1 patient had a mucoepidermoid carcinoma. The site of recurrence was local in 16 patients, local plus metastatic in 5 patients, and metastatic only in 15 patients. These characteristics were well balanced between the 2 arms. In Arms A and B a complete response (CR) was noted in 3 patients (19%) and no patients, respectively; a partial response (PR) was noted in 4 patients (25%) and 4 patients (20%), respectively; no change was noted in 6 patients (37.5%) and 9 patients (45%), respectively; and progressive disease was noted in 3 patients (19%) and 7 patients (35%), respectively. The median duration of the CR was 15+ months (range, 6-27+ months) and for PR the median duration was 7.5 months (range, 3-11+ months) and 6 months (range, 3-9 months) in Arms A and B, respectively. Number of patients surviving > 12 months was 6 versus 1 in Arms A and B, respectively (P < 0.05). Grade 2-3 nausea and emesis was statistically higher (P < 0.001) in Arm A; there was no significant difference with regard to other side-effects between the two treatment arms. VNB is a drug with moderate activity in salivary gland malignancies. The combination of cisplatin plus VNB was found to be more active than VNB alone, with a good number of CRs and long-term survivors reported in the current study.

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Quality of life assessment in advanced pancreatic adenocarcinoma: results from a phase III randomized trial. A phase III trial suggested that a PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) regimen might improve the outcome compared to gemcitabine in advanced pancreatic adenocarcinoma. The analysis of treatment impact on quality of life (QOL) is reported. Patients completed the European Organization for Research and Treatment of Cancer QLQ-C30 and PAN-26 questionnaires at baseline and every second month of treatment until disease progression. The largest differences between arms favored PEFG. Expressed as improvement > or =10 points from baseline (PEFG/gemcitabine), these were: emotional function (43/18%), fatigue (41/17%), QOL (55/29%), pain (64/41%), and flatulence (50/26%). Only change in sexual function favored gemcitabine (19/42%). Physical function, fatigue, appetite, and satisfaction with healthcare improved in 40-46% of partial responders compared with 0-12% of patients with stable disease. Clinically relevant improvement in QOL from baseline was observed more often after PEFG than after gemcitabine, suggesting that the PEFG regimen did not impair QOL, Partial response was associated with improved QOL suggesting that effective treatment of pancreatic adenocarcinoma may have an important role in these patients.

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Survey finds that most meta-analysts do not attempt to collect individual patient data. To characterize current efforts and outcomes of individual patient data (IPD) collection among meta-analysts of randomized controlled clinical trials. Corresponding authors of meta-analyses of randomized controlled trials in general medicine with a binary endpoint were sent an e-mail survey inquiring about their efforts to obtain IPD. Descriptive statistics of each meta-analysis were extracted to evaluate their association with data seeking. Only 22 (4.2%) of the sampled meta-analyses included IPD. Of the 360 authors surveyed, 256 (71%) reported not seeking IPD: 48% thought that the undertaking would be too difficult, 30% thought that it was not necessary for their main analysis, 25% did not have sufficient time or resources, and 22% never considered it. Seeking IPD was not significantly associated with any trial characteristic examined, including whether subgroup analyses were performed. Authors who sought IPD obtained a median of two data sets (interquartile range=0-5). Unsuccessful contact (43%), refusal without explanation (21%), and lost or inaccessible data (20%) were the most common reasons why trial data could not be obtained. The infrequency of attempts made by meta-analysts to obtain participant data is an important contributor to the rarity of IPD meta-analyses.

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Air vs perfluoropropane gas in pneumatic retinopexy: a randomized noninferiority trial. To evaluate whether air is as effective as perfluoropropane gas in treating rhegmatogenous retinal detachment by pneumatic retinopexy. In a double-blind, randomized, clinically controlled noninferiority trial, eligible patients were randomized into 2 treatment groups by using block randomization and treated by pneumatic retinopexy using filtered air or perfluoropropane gas. Retinal reattachment rate and final visual recovery. One hundred twenty-six patients were recruited. Half (63 patients) were assigned to receive filtered air during pneumatic retinopexy and half received perfluoropropane gas. The single-procedure reattachment rate was higher for the perfluoropropane gas group (73.0%[46 patients]) than for the air group (60.3% [38]), but the difference was not statistically significant (risk difference, -12.7%; 95% confidence interval, -29.0% to 3.6%). The final reattachment rate after additional pneumatic retinopexy and/or surgical procedures was 92.1% (58) in the air group and 96.8% (61) in the perfluoropropane gas group. This result showed an equivalent effect on the final reattachment rate (risk difference, -4.7%; 95% confidence interval, -12.7% to 3.2%). Final visual acuity did not differ significantly between groups. Pneumatic retinopexy using filtered air is associated with a nonsignificantly lower initial reattachment rate than using perfluoropropane gas but results in an equivalent final reattachment rate and final visual recovery. Air is an acceptable alternative to perfluoropropane gas when treating rhegmatogenous retinal detachment by pneumatic retinopexy. clinicaltrials.gov Identifier: NCT00120445.

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Reduction in proliferation with six months of letrozole in women on hormone replacement therapy. The objective of this study was to determine if 6 months of the aromatase inhibitor letrozole, administered to postmenopausal women taking a stable dose of hormone replacement remedy, would be safe and would modulate biomarkers of breast cancer risk. The intent was to reduce the proliferation marker Ki-67 while maintaining adequate systemic levels of estradiol so as to avoid perimenopausal symptoms. Postmenopausal women at high risk for development of breast cancer and taking a stable dose of estrogen or estrogen plus progestin were screened by random periareolar fine needle aspiration (RPFNA). To be eligible, the acquired breast epithelial cells had to be characterized as cytologic atypia or borderline atypia with > or =1,000 epithelial cells on the cytomorphology slide; plus > or =500 epithelial cells on a slide processed for Ki-67 immunocytochemistry. Forty-two women were enrolled in the one arm study and received 2.5 mg letrozole per day for 6 months, followed by repeat assessment of biomarkers. Ki-67 was reduced by a median relative value of 66%. There was no significant change in breast cell cytomorphology; ER weighted index score; serum estradiol, testosterone, or IGF-1:IGFBP-3 ratio; mammographic breast density, or frequency or severity of perimenopausal symptoms. Given the dramatic reduction in proliferation, the effect of letrozole on risk and response biomarkers should be explored further in a randomized, placebo-controlled Phase IIB breast cancer chemoprevention trial.

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