Search results for "Randomized controlled trial"
showing 10 items of 2199 documents
Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disc disease.
2015
Purpose: Although several studies have established the safety and efficacy of cervical disc arthroplasty (CDA) as compared to anterior cervical discectomy and fusion (ACDF), few studies have investigated the role of hybrid surgery (HS) that incorporates ACDF and CDA techniques in multilevel cervical degenerative disc disease (MLCDDD). Methods: This prospective study enrolled patients with MLCDDD who underwent HS. Twenty consecutive patients who underwent HS were compared with patients who underwent ACDF and CDA at the same level of surgery. Patients were followed up for more than 2 years. Intraoperative parameters, clinical features and outcome scores were recorded. Radiological assessments…
Removal of annexin V–positive sperm cells for intracytoplasmic sperm injection in ovum donation cycles does not improve reproductive outcome: a contr…
2014
Objective To determine the effect of removing presumptive apoptotic sperm cells from samples from unselected males by means of magnetic activated cell sorting (MACS) on live-birth delivery rates after intracytoplasmic sperm injection (ICSI) in couples undergoing ovum donation (OD). Design Prospective, randomized, triple-blinded, and controlled study. Setting Private university-affiliated IVF center. Patient(s) A total of 237 infertile couples undergoing ICSI as part of an OD program. Intervention(s) Semen specimens from the control group were prepared by swim-up. Samples from the study group were prepared by swim-up followed by MACS and incubation with annexin V–conjugated microbeads to rem…
Alveolar bone preservation in extraction sockets using non-resorbable dPTFE membranes: a retrospective non-randomized study.
2008
Background: The aim of this study was to investigate the clinical regeneration of extraction sockets using high-density polytetrafluoroethylene (dPTFE) membranes without the use of a graft material. Methods: A total of 276 extraction sockets were evaluated in 276 subjects (151 males and 125 females; mean age, 50.2 years; age range: 24 to 73 years). After extraction, flaps were elevated and a dPTFE membrane was placed over the extraction site. The flaps were repositioned and sutured into place. Primary closure was not obtained over the membranes. The cemento-enamel junctions of the adjacent teeth were used as reference points. Measurements were taken postextraction and 12 months after surger…
Training with a computer-based simulator achieves basic manual skills required for upper endoscopy: A randomized controlled trial
2004
Changes in medical practice have constrained the time available for education and the availability of patients for training. Computer-based simulators have been devised that can be used to achieve manual skills without patient contact. This study prospectively compared, in a clinical setting, the efficacy of a computer-based simulator for training in upper endoscopy.Twenty-two fellows with no experience in endoscopy were randomly assigned to two groups: one group underwent 10 hours of preclinical training with a computer-based simulator, and the other did not. Each trainee performed upper endoscopy in 19 or 20 patients. Performance parameters evaluated included the following: esophageal int…
Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus?
2003
Psychological and physiological habituation are major goals in the treatment of patients suffering from chronic tinnitus. This study evaluates whether sound stimulation provided by use of low level white noise generators (NG) enhances the effects of cognitive-behavioral treatment (CBT). 124 outpatients with tinnitus of >6 months received manualized group treatment and were randomly assigned to the NG/no NG conditions. Those with moderate tinnitus-related distress obtained four sessions focusing on education, while severely distressed subjects were treated according to a full 10-session CBT program. Outcome was assessed at post-treatment and at 6- and 18-month follow-up. No additive effects …
Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy on the rate and severity of pancreatic fistula after pancreaticoduo…
2013
Abstract Background Anastomotic leakage of pancreaticojejunostomy (PJ) remains the single most important source of morbidity after pancreaticoduodenectomy (PD). The primary aim of this randomized clinical trial comparing PG with PJ after PD was to test the hypothesis that invaginated PG would result in a lower rate and severity of pancreatic fistula. Methods Patients undergoing PD were randomized to receive either a duct-to-duct PJ or a double-layer invaginated PG. The primary endpoint was the rate of pancreatic fistula, using the definition of the International Study Group on Pancreatic Fistula. Secondary endpoints were the evaluation of severe abdominal complications (Clavien–Dindo grade …
Low-dose aspirin desensitization in individuals with aspirin-exacerbated respiratory disease
2013
Background Nasal polyposis frequently occurs within the clinical picture of aspirin-exacerbated respiratory disease (AERD). A derailed arachidonic acid metabolism is regarded to be part of the pathophysiology of AERD, and aspirin desensitization is the only causal therapeutic option, so far. The optimal maintenance dose of aspirin desensitization to prevent nasal polyp recurrence on the one hand and to minimize aspirin-related side-effects, on the other hand, is still a matter of debate. The aim of this trial was to investigate the efficacy and safety of a low-dose aspirin desensitization protocol. Methods After sinus surgery, 70 individuals with AERD were randomly allocated to a prospectiv…
Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo…
2001
To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation. Design: Prospective, randomized, placebo-controlled, double-blind trial. Setting: University hospital, Germany. Patients: 48 patients who had radiotherapy to the head and neck. Main outcome measures: Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score). Results: 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P= 0.07). The RTOG score showed significantly fewer acute side-effects of radiation in the experime…
Shock wave therapy versus conventional surgery in the treatment of calcifying tendinitis of the shoulder.
2001
A prospective quasirandomized study was performed to compare the effects of surgical extirpation (Group I, 29 patients) with the outcome after high-energy extracorporeal shock wave therapy (Group II, 50 patients; 3,000 impulses of an energy flux density of 0.6 mJ/mm2) in patients with a chronic calcifying tendinitis in the supraspinatus tendon. Symptoms and demographic data of the two groups were comparable. According to the University of California Los Angeles Rating System, the mean score in Group I was 30 points with 75% good or excellent results after 12 months, and 32 points with 90% good or excellent results after 24 months. Radiologically, there was no calcific deposit in 85% of the …
Efficacy of the treatment with prostaglandin E-1 in venous ulcers of the lower limbs.
2005
Background. Venous ulcers represent an important medical problem due to their high prevalence and consequent sanitary costs. In this study we evaluated the effect of Prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers. Methods. We performed a randomized, placebo-controlled, single blind study, in which 87 patients, carriers of venous leg ulcers, homogeneous for dimensions and characteristics, were treated for 20 days an with infusion of Prostaglandin E-1 or placebo, in association with a topic therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months or until tota…