Search results for "Randomized controlled"
showing 10 items of 2220 documents
Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered sep…
2003
The safety and reactogenicity of a booster dose of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (N=4725) was compared with the separate administration of GSK Biologicals' DTPa-IPV/Hib and HBV vaccines (N=4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N=1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N=8050), where fever was the only solicited sympt…
Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: st…
2015
Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this stu…
Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Respons…
2015
UNLABELLED Although sofosbuvir has been approved for patients with genotypes 2/3 (G2/3), many parts of the world still consider pegylated Interferon alpha (P) and ribavirin (R) as standard of care for G2/3. Patients with rapid virological response (RVR) show response rates >80%. However, SVR (sustained virological response) in non-RVR patients is not satisfactory. Longer treatment duration may be required but evidence from prospective trials are lacking. A total of 1006 chronic HCV genotype 2/3 patients treated with P/R were recruited into a German HepNet multicenter screening registry. Of those, only 226 patients were still HCV RNA positive at week 4 (non-RVR). Non-RVR patients with ongoin…
Construction of Group Exercise Sessions in Geriatric Inpatient Rehabilitation
2008
There is little knowledge about the ways geriatric physiotherapy is being carried out in practice and about the situational construction of formal policies for promoting physical activity. This article examines how professional physiotherapists and frail community-dwelling older adults as their clients use talk and action to construct a group exercise session in an inpatient rehabilitation setting in Finland. The analysis of 7 group exercise sessions with a total of 52 clients and 9 professional physiotherapists revealed 3 different practitioner approaches, which served different functions in older adults' empowerment and lifestyle activity change. The highly structured approach favored tac…
Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon-[alpha]2b: A Randomized Trial
2009
BACKGROUND Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. OBJECTIVE To evaluate use of peginterferon-alpha2a plus ribavirin to re-treat nonresponders to peginterferon-alpha2b plus ribavirin. DESIGN Randomized, parallel-group trial conducted between September 2003 and February 2007. Patients and researchers were not blinded to intervention assignment. Random assignment was centralized, computer-generated, and stratified by geographic region, hepatitis C virus (HCV) genotype, and histologic diagnosis. SETTING 106 international centers. PATIENTS 950 nonresponders to 12 or more weeks of therapy with peginterferon-alpha2b plus ribav…
Laparoscopic versus open mesh repair for recurrent inguinal hernia: a meta-analysis of outcomes
2009
Abstract Background The objective of this study was to examine the outcomes of comparisons between laparoscopic and open mesh repairs in the setting of recurrent inguinal hernia. Methods The electronic databases MEDLINE, Embase, Pubmed, and the Cochrane Library were used to search for articles from 1990 to 2008. The present meta-analysis pooled the effects of outcomes of a total of 1,542 patients enrolled into 5 randomized controlled trials and 7 comparative studies, using classic and modern meta-analytic methods. Results Significantly fewer cases of hematoma/seroma formation were observed in the laparoscopic group in comparison with the Lichtenstein group (odds ratio, .38; .15–.96; P = .04…
Improved outcome in multisystem Langerhans cell histiocytosis is associated with therapy intensification
2007
Multisystem Langerhans cell histiocytosis (MS-LCH) is associated with high mortality when patients have risk organ involvement (RO+) or are younger than 2 years. In an international randomized trial, LCH-II, we intensified their treatment: arm A consisted of 6 weeks of daily prednisone and weekly vinblastine followed by 18 weeks of daily 6-mercaptopurine with vinblastine/prednisone pulses; etoposide was added in arm B. Considering all 193 randomized risk patients, there were similar outcomes: rapid (6 weeks) response (arm A vs arm B: 63%/71%), 5-year survival probability (74%/79%), disease reactivation frequency (46%/46%), and permanent consequences (43%/37%). However, (1) patients younger …
Influenza Vaccination After Myocardial Infarction:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
2021
Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. Results: Because of the COV…
New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-come…
2019
Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear.We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke a…
Deep sclerectomy versus punch trabeculectomy with or without phacoemulsification: a randomized clinical trial.
2004
Purpose: To compare the efficacy of non-penetrating deep sclerectomy without implant with Crozafon-De Laage punch trabeculectomy, and to evaluate the effect of simultaneous temporal approach phacoemulsification on both techniques. Patients and Methods: Setting: Department of Ophthalmology of the University of Palermo. Design: Prospective randomized clinical trial. Patients and intervention procedures: Sixty-five patients (65 eyes) with primary open angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEXG): 32 eyes underwent non-penetrating deep sclerectomy (NPDS), 17 as single procedure and 15 combined with phacoemulsification (phaco- NPDS), and 33 eyes underwent punch trabeculectomy (PT),…