Search results for "Randomized controlled"
showing 10 items of 2220 documents
A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Rando…
2018
Background: The reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking. Objective: We aimed to evaluate the impact of remote monitoring using a Web system—Telemonitorizacion de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis (TECCU)—as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD. Methods: We performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospita…
Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local …
2005
Background: It remains unclear whether application of local anesthesia (LA) interferes with clinical e!cacy of extracorporeal shock wave therapy (ESWT) for chronic plantar fasciitis. Aims: To evaluate the e"ect of local anesthesia on the clinical outcome after repetitive low-energy ESWT for chronic plantar fasciitis. Methods: Eighty-six patients with chronic plantar fasciitis were randomly assigned to receive either low-energy ESWT without LA, given weekly for three weeks (Group I, n = 45; 3 · 2000 pulses, total energy flux density per shock 0.09 mJ/mm 2 ) or identical ESWT with LA (Group II, n = 41). Primary outcome measure was: Reduction of pain from baseline to month 3 post-treatment in …
Expectations modulate long-term heat pain habituation.
2011
Habituation to pain was shown to be a complex mechanism involving the pain encoding regions and the antinociceptive system in the brain. Pain perception can be modulated by cognitive factors; however it is unclear whether cognitive factors also influence habituation to pain. We used an established experimental design with repetitive moderate painful heat stimulation over eight consecutive days. Thirty-seven healthy subjects were recruited and assigned to four different groups: The first group (n=10) was instructed that pain perception over time will habituate; the second group (n=9) that pain will increase; the third group (n=8) was instructed that pain will remain stable over the 8 days of…
Enhancing the efficacy of treatment for temporomandibular patients with muscular diagnosis through cognitive-behavioral intervention, including hypno…
2011
Objective This study evaluated the efficacy of a cognitive-behavioral therapy (CBT), including hypnosis, in patients with temporomandibular disorders (TMDs) with muscular diagnosis. Study Design Seventy-two patients (65 women and 7 men with an average age of 39 years) were selected according to the Research Diagnostic Criteria for TMD, and assigned to the experimental group (n = 41), receiving the 6-session CBT program, and the control group (n = 31). All patients received conservative standard treatment for TMD. The assessment included pain variables and psychologic distress. Results There were significant differences between the groups, the experimental group showing a higher improvement …
Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis:A Randomized, Placebo-Controlled, Phase II Study
2017
Objective To determine the effect of selexipag, an oral, selective IP prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (RP) in patients with systemic sclerosis (SSc). Methods Patients with SSc-related RP were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 μg twice daily) during a 3-week titration period. The primary end point was the weekly average number of RP attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of RP attacks. Other outcome measures included Raynaud's Condition Score (RCS), RP attack duration, and treat…
Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial.
2011
Objective To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex. Methods The device was tested on a sample of patients with xerostomia due to Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage d…
Kinetics of plasma biomarkers of inflammation and lung injury in surgical patients with or without postoperative pulmonary complications
2017
Background Postoperative pulmonary complications (PPCs) are common after major abdominal surgery. The kinetics of plasma biomarkers could improve identification of patients developing PPCs, but the kinetics may depend on intraoperative ventilator settings. Objective To test whether the kinetics of plasma biomarkers are capable of identifying patients who will develop PPCs, and whether the kinetics depend on the intraoperative level of positive end-expiratory pressure (PEEP). Design A preplanned substudy of a randomised controlled trial. Setting Operation room of five centres. Patients Two hundred and forty-two adult patients scheduled for abdominal surgery at risk of developing PPCs. Interv…
Deferiprone versus Deferoxamine in Sickle Cell Disease: Results from a 5-year long-term Italian multi-center randomized clinical trial
2014
Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-y…
Long-term treatment with deferiprone enhances left ventricular ejection function when compared to deferoxamine in patients with thalassemia major
2013
Transfusion and iron chelation treatment have significantly reduced morbidity and improved survival of patients with thalassemia major. However, cardiac disease continues to be the most common cause of death. We report the left-ventricular ejection fraction, determined by echocardiography, in one hundred sixtyeight patients with thalassemia major followed for at least 5 years who received continuous monotherapy with deferoxamine (N = 108) or deferiprone (N = 60). The statistical analysis, using the generalized estimating equations model, indicated that the group treated with deferiprone had a significantly better left-ventricular ejection fraction than did those treated with deferoxamine (c…
Therapeutic synergism between hyaluronic acid and dexamethasone in the intra-articular treatment of osteoarthritis of the knee: a preliminary open st…
1992
In vitro studies on the effects of dexamethasone on human synovial cells have shown that with high concentrations of the steroid in the culture medium cellular activity was completely blocked whereas with low concentrations (10(-6)M), cellular density decreased but there was an increase in the synthesis of RNA, DNA, protein and hyaluronic acid. These data, coupled with clinical experience of using intra-articular hyaluronic acid to treat patients with osteoarthritis of the knee, prompted the investigators to carry out an open, randomized study of the use of very small doses of dexamethasone in association with hyaluronic acid in 40 osteoarthritic patients. Twenty patients received a weekly …