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Prospective Multicenter (prospective + multicenter)

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Medical Sciences100%

Terms modified by Prospective Multicenter

  • prospective multicenter study
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    Selected Abstracts

    Enhanced Left Ventricular Endocardial Border Delineation with an Intravenous Injection of SonoVue, a New Echocardiography Contrast Agent:

    ECHOCARDIOGRAPHY, Issue 8 2000
    A European Multicenter Study
    The safety and efficacy of SonoVue (also referred to as BR1), a new contrast agent for delineating endocardial border of the left ventricle after intravenous administration, was assessed. Two hundred and eighteen patients with suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multicenter, single blind, cross-over study with random sequence allocation of four different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as O = not visible, 1 = barely visible, and 2 = well visualized before and after contrast enhancement. Analysis was performed by two pairs of off-site observers. Safety of SonoVue was also assessed. Results of our study indicated that the mean improvements in the endocardial border visualization score were as follows: 3.1 ± 7.8 (95% CI, 2.5 and 3.7) for 0.5 ml, 3.4 ± 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 ± 7.9 (95% CI, 2.8 and 4.0) for 2 ml, and 3.7 ± 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0.05) and they were dose-dependent (P < 0.001). Similar enhancements of endocardial visualization scores were observed in the apical views in patients with suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better following contrast enhancement. No significant changes in the laboratory parameters and vital signs were noted following contrast enhancement, and the side effects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal baseline images. [source]

    Efficacy of infliximab in refractory pouchitis and Crohn's disease-related complications of the pouch: A Belgian case series

    INFLAMMATORY BOWEL DISEASES, Issue 2 2010
    Marc Ferrante MD
    Abstract Background: Up to 25% of inflammatory bowel disease (IBD) patients undergoing surgery with an ileal pouch,anal anastomosis (IPAA) will develop chronic pouchitis not responding to antibiotics. In case reports, thiopurine analogs and infliximab (IFX) have been proposed as effective therapy in this setting. We analyzed the long-term efficacy of IFX in Belgian patients with refractory pouch complications. Methods: We identified 28 IPAA patients who received IFX for refractory luminal inflammation (pouchitis and/or pre-pouch ileitis, n = 25) and/or pouch fistula (n = 7). Patients with elements of Crohn's disease after review of the colectomy specimen were excluded. Clinical response was defined as complete in case of cessation of diarrhea, blood loss, and abdominal pain, and as partial in case of marked clinical improvement. Fistula response was defined as complete in case of cessation and as partial in case of reduction of fistula drainage. Results: Eighty-two percent of patients were concomitantly treated with immunomodulatory agents. At week 10 following start of IFX, 88% of patients with refractory luminal inflammation showed clinical response (14 partial, 8 complete), while 6 patients (86%) showed fistula response (3 partial, 3 complete). The mPDAI dropped significantly from 9.0 (interquartile range [IQR] 8.0,10.0) to 4.5 (3.0,7.0) points (P < 0.001). After a median follow-up of 20 (7,36) months, 56% showed sustained clinical response while 3 out of 7 fistula patients showed sustained fistula response. Five patients needed permanent ileostomy. Conclusions: In this series, IFX was effective long-term in IPAA patients with refractory luminal inflammation and pouch fistula. These results warrant a prospective multicenter randomized controlled trial. Inflamm Bowel Dis 2009 [source]

    Clinical outcomes following treatment of human intrabony defects with GTR/bone replacement material or access flap alone

    JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 9 2004
    A multicenter randomized controlled clinical trial
    Abstract Aim: This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue regeneration (GTR)/bone replacement material. Materials and Methods: One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries. All patients had at least one intrabony defect of 3 mm. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, the regenerative material was applied in the test subjects, and omitted in the controls. At baseline and 1 year following the interventions, clinical attachment levels (CALs), probing pocket depths (PPDs), recession, full-mouth plaque scores and full-mouth bleeding scores (FMBS) were assessed. Results: One year after treatment, the test defects gained 3.3±1.7 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5±1.5 mm. Pocket reduction was also significantly higher in the test group (3.7±1.8 mm) when compared with the controls (3.2±1.5 mm). A multivariate analysis indicated that the treatment, the clinical centers, baseline PPD and baseline FMBS significantly influenced CAL gains. Odds ratios (ORs) of achieving above-median CAL gains were significantly improved by the test procedure (OR=2.6, 95% CI 1.2,5.4) and by starting with deeper PPD (OR=1.7, 1.3,2.2) but were decreased by receiving treatment at the worst-performing clinical center (OR=0.9, 0.76,0.99). Conclusions: The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone. [source]

    Making Choices for Childbirth: A Randomized Controlled Trial of a Decision-aid for Informed Birth after Cesarean,

    BIRTH, Issue 4 2005
    Allison Shorten RN
    ABSTRACT:,Background:Decision-making about mode of birth after a cesarean delivery presents challenges to women and their caregivers and requires a balance of risks and benefits according to individual circumstances. The study objective was to determine whether a decision-aid for women who have experienced previous cesarean birth facilitates informed decision-making about birth options during a subsequent pregnancy. Method:A prospective multicenter randomized controlled trial of 227 pregnant women was conducted within 3 prenatal clinics and 3 private obstetric practices in New South Wales, Australia. Women with 1 previous cesarean section and medically eligible for trial of vaginal birth were recruited at 12 to 18 weeks' gestation; 115 were randomized to the intervention group and 112 to the control group. A decision-aid booklet describing risks and benefits of elective repeat cesarean section and trial of labor was given to intervention group women at 28 weeks' gestation. Main outcome measures included level of knowledge, decisional conflict score, women's preference for mode of birth, and recorded mode of birth. Results:Women who received the decision-aid demonstrated a significantly greater increase in mean knowledge scores than the control group (increasing by 2.17 vs 0.42 points on a 15-point scale)(p < 0.001, 95% CI for difference = 1.15,2.35). The intervention group demonstrated a reduction in decisional conflict score (p < 0.05). The decision-aid did not significantly affect the rate of uptake of trial of labor or elective repeat cesarean section. Preferences expressed at 36 weeks were not consistent with actual birth outcomes for many women. Conclusion:A decision-aid for women facing choices about birth after cesarean section is effective in improving knowledge and reducing decisional conflict. However, little evide nce suggested that this process led to an informed choice. Strategies are required to better equip organizations and practitioners to empower women so that they can translate informed preferences into practice. Further work needs to examine ways to enhance women's power in decision-making within the doctor-patient relationship. (BIRTH 32:4 December 2005) [source]

    Immediate and early non-occlusal loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: interim results from a prospective multicenter randomized-controlled study

    CLINICAL ORAL IMPLANTS RESEARCH, Issue 5 2008
    Axel Zöllner
    Abstract Objective: Immediate and early loading of dental implants can simplify treatment and increase overall patient satisfaction. The purpose of this 3-year prospective randomized-controlled multicenter study was to assess the differences in survival rates and bone level changes between immediately and early-loaded implants with a new chemically modified surface (SLActive). This investigation shows interim results obtained after 5 months. Material and methods: Patients ,18 years of age missing at least one tooth in the posterior maxilla or mandible were enrolled in the study. Following implant placement, patients received a temporary restoration either on the day of surgery (immediate loading) or 28,34 days after surgery (early loading); restorations consisted of single crowns or two to four unit fixed dental prostheses. Permanent restorations were placed 20,23 weeks following surgery. The primary efficacy variable was change in bone level (assessed by standardized radiographs) from baseline to 5 months; secondary variables included implant survival and success rates. Results: A total of 266 patients were enrolled (118 males and 148 females), and a total of 383 implants were placed (197 and 186 in the immediate and early loading groups, respectively). Mean patient age was 46.3±12.8 years. After 5 months, implant survival rates were 98% in the immediate group and 97% in the early group. Mean bone level change from baseline was 0.81±0.89 mm in the immediate group and 0.56±0.73 mm in the early group (P<0.05). Statistical analysis revealed a significant center effect (P<0.0001) and a significant treatment × center interaction (P=0.008). Conclusions: The results suggested that Straumann implants with an SLActive can be used predictably in time-critical (early or immediate) loading treatment protocols when appropriate patient selection criteria are observed. The mean bone level changes observed from baseline to 5 months (0.56 and 0.81 mm) corresponded to physiological observations from other studies, i.e., were not clinically significant. The presence of a significant center effect and treatment × center interaction indicated that the differences in bone level changes between the two groups were center dependent. [source]