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Randomized Comparative Study (randomized + comparative_study)
Selected AbstractsDoes defense style or psychological mindedness predict treatement response in major depression?DEPRESSION AND ANXIETY, Issue 7 2009Kim Kronström M.D. Abstract Background: The aim of this study was to define the impact of defense style and psychological mindedness (PM) on the prognosis of major depressive disorder (MDD) in patients treated with either fluoxetine (FLX) or short-term psychodynamic psychotherapy (STPP) in a randomized comparative study. Method: 50 patients with MDD received either STPP or FLX treatment for 16 weeks. The Hamilton Depression Rating Scale (HDRS) was the outcome measure completed at baseline and in the follow-ups at 4- and 12-months. Patients completed the Psychological Mindedness Scale (PMS) and the Defense Style Questionnaire at the baseline. Results: In the FLX group recovery measured by the decrease in the HDRS during the 4-month follow-up associated with baseline mature defense style (r=,.59, P=.015). There were no correlations between the PMS-scores and the outcome measures in either treatment groups nor defense status and the outcome in the STPP group. Conclusion: Mature defense style predicts good response to FLX therapy in major depression. This association was not found in the psychotherapy group. The results may imply that patients with immature defenses benefit relatively more from brief psychotherapy than medication. PM measured by the PMS was not useful in predicting recovery in MDD. Depression and Anxiety, 2009. © 2009 Wiley-Liss, Inc. [source] Multidrug intravenous anesthesia for children undergoing MRI: a comparison with general anesthesiaPEDIATRIC ANESTHESIA, Issue 12 2007AHMED A. SHORRAB MD Summary Background:, We used a multidrug intravenous anesthesia regimen with midazolam, ketamine, and propofol to provide anesthesia for children during magnetic resonance imaging (MRI). This regimen was compared with general anesthesia in a randomized comparative study. Outcome measures were safety, side effects and recovery variables in addition to adverse events in relation to age strata. Methods:, The children received either general anesthesia with propofol, vecuronium and isoflurane [general endotracheal anesthesia (GET) group; n = 313] or intravenous anesthesia with midazolam, ketamine, and propofol [intravenous anesthesia (MKP) group; n = 342]. Treatment assignment was randomized based on the date of the MRI. Physiological parameters were monitored during anesthesia and recovery. Desaturation (SpO2 < 93%), airway problems, and the need to repeat the scan were recorded. The discharge criteria were stable vital signs, return to baseline consciousness, absence of any side effects, and ability to ambulate. Results:, With the exception of two children (0.6%) in the MKP group, all enrolled children completed the scan. A significantly greater number (2.3%) required a repeat scan in the MKP group (P < 0.05) and were sedated with a bolus dose of propofol. The total incidence of side effects was comparable between the MKP (7.7%) and GET groups (7.0%). Infants below the age of 1 year showed a significantly higher incidence of adverse events compared with the other age strata within each group. Within the MKP group, risk ratio was 0.40 and 0.26 when comparing infants aged below 1 year with the two older age strata, respectively. Recovery characteristics were comparable between both groups. Conclusions:, Intravenous midazolam, ketamine and propofol provides safe and adequate anesthesia, comparable with that obtained from general endotracheal anesthesia, for most children during MRI. [source] Effects of bathing immediately after birth on early neonatal adaptation and morbidity: A prospective randomized comparative studyPEDIATRICS INTERNATIONAL, Issue 5 2000Yasushi Nako Abstract Objective: Because the risks and benefits of early bathing of newborn infants are not well established, we investigated the effects of bathing immediately after birth on rectal temperature, respiratory rate, heart rate, blood pressure, percutaneous arterial blood oxygen saturation (SpO2) and early neonatal morbidity. Methods: The study was designed as a randomized prospective comparative study in the neonatal care unit of a university hospital. A total of 187 healthy term and near-term newborn infants, who were delivered vaginally without asphyxia, between January and December 1997 were the study subjects. We compared findings in newborns who were bathed 2,5 min after birth (n=95) with those of a control group (n=92) who received dry care instead. Groups were comparable with respect to gestational age, birthweight, male : female ratio, Apgar score and umbilical blood pH. Rectal temperature was measured with an electronic thermometer immediately before the intervention bathing or dry care and at 30 min and 1, 2, 3, 8 and 12 h after birth. Heart rate, respiratory rate, systolic and diastolic blood pressure and SpO2 were measured at 1, 2, 8 and 12 h after birth. The incidence of early neonatal morbidity, including hyperbilirubinemia and gastrointestinal and respiratory problems, was also compared. Results: Rectal temperature changed over time postnatally in both groups (P<0.0001, ANOVA) and there was a significant difference in rectal temperature between groups (P<0.0001, ANOVA). Mean (± SEM) rectal temperature at 30 min after birth (i.e. approximately within 20 min after intervention) was significantly higher in the bathed group than in the control (dry care) group (37.30~0.06 vs 37.00~0.05°C, respectively; P=0.000022). Respiratory rate, heart rate, blood pressure and the ratio of the number of infants with SpO2 90,94% and 95,100% did not differ significantly between the two groups. The incidence of early neonatal morbidity, including vomiting, acute gastric mucosal lesion, polycythemia, need for tube feeding, phototherapy and oxygen therapy, also did not differ between the two groups. Conclusions: Early bathing, minutes after birth, did not appear to adversely affect the adaptation of healthy full-term and near-term newborn infants. [source] Pharmacokinetics for Once- Versus Twice-Daily Tacrolimus Formulations in De Novo Kidney Transplantation: A Randomized, Open-Label TrialAMERICAN JOURNAL OF TRANSPLANTATION, Issue 11 2009Z. Wlodarczyk Tacrolimus, a cornerstone immunosuppressant, is widely available as a twice-daily formulation (Tacrolimus BID). A once-daily prolonged-release formulation (Tacrolimus QD) has been developed that may improve adherence and impart long-lasting graft protection. This study compared the pharmacokinetics (PK) of tacrolimus in de novo kidney transplant patients treated with Tacrolimus QD or Tacrolimus BID. A 6-week, open-label, randomized comparative study was conducted in centers in Europe and Australia. Eligible patients received Tacrolimus QD or Tacrolimus BID. PK profiles were obtained following the first tacrolimus dose (day 1), and twice under steady-state conditions. As secondary objectives, efficacy and safety parameters were also evaluated. Sixty-six patients completed all PK profiles (34 Tacrolimus QD, 32 Tacrolimus BID). Mean AUC0,24 of tacrolimus on day 1 was approximately 30% lower for Tacrolimus QD than Tacrolimus BID (232 and 361 ng.h/mL, respectively), but was comparable by day 4. There was a good correlation and a similar relationship between AUC0,24 and Cmin for both formulations. Efficacy and safety data were also comparable over the 6-week period. Tacrolimus QD can be administered once daily in the morning on the basis of the same systemic exposure and therapeutic drug monitoring concept as Tacrolimus BID. [source] Prospective randomized comparative study of macular thickness following phacoemulsification and manual small incision cataract surgeryACTA OPHTHALMOLOGICA, Issue 4 2010Sambuddha Ghosh Abstract. Purpose:, To compare macular thickness following uncomplicated phacoemulsification with foldable acrylic lens and manual small incision cataract surgery (MSICS) with non-foldable polymethyl methacrylate (PMMA) lens implantation. Methods:, Prospective study was carried out with one eye each of 224 patients with senile cataract randomized into two groups, phacoemulsification and MSICS, by simple 1:1 randomization. Following surgery by either of the two methods, macular thickness was measured by optical coherence tomography (OCT) on the 1st, 7th, 42nd and 180th postoperative day. Main outcome measure was postoperative macular thickness. Results:, On the first postoperative day, central subfield mean thickness (CSMT) in MSICS group was 192.8 ± 17.9 ,m and that in phacoemulsification group was 192.1 ± 27.4 ,m, with no significant difference (p = 0.12). On the 7th day, CSMT in MSICS group (198.9 ± 21.4 ,m) was significantly (p = 0.04) more than that in phacoemulsification group (193.1 ± 19.3 ,m). On the 42nd day, CSMT in MSICS group was 207.8 ± 26.3 ,m and that in phacoemulsification group was 198.3 ± 23 ,m, the difference being significant (p = 0.007). Clinically macular oedema was not diagnosed in any of the patients at any visit. The increase in macular thickness was sub-clinical and did not affect final visual outcome in any patient. Conclusion:, In spite of the greater theoretical risk of increased postoperative inflammation following MSICS, there was no evidence of cystoid macular oedema, either clinically or on OCT. However, chance of sub-clinical increase in CSMT was more following MSICS compared to phacoemulsification. [source] A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infectionsCLINICAL MICROBIOLOGY AND INFECTION, Issue 8 2010S. Towfigh Clin Microbiol Infect 2010; 16: 1274,1281 Abstract Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI). The present study comprised a multicentre, open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or CTX (2 g once daily) plus MET (1,2 g daily), for 4,14 days. The primary endpoint was the clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with CTX/MET (95% CI ,13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores ,10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The microbiologic response was similar between the two treatment arms, with microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated subjects and 71.5% (98/137) of CTX/MET-treated subjects. ( The most frequently reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and comparator-treated subjects, respectively. The results obtaned in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI. [source] | ||||||||||