Search results for "SINGLE-BLIND"
showing 10 items of 165 documents
Semaglutide reduces fat accumulation in the tongue: A randomized single-blind, pilot study
2021
Abstract Aim We evaluated the effect of the latest GLP-1 RA semaglutide on tongue fat storage in obese women. Design. We conducted a randomized single-blind, pilot study. Methods Twenty-five obese women with polycystic ovary syndrome (PCOS) (33.7 ± 5.3 years, body mass index (BMI) 36.1 ± 3.9 kg/m2, mean ± SD) were randomized to semaglutide 1.0 mg or placebo for 16 weeks. We quantified tongue volume and its fat tissue and fat proportion by magnetic resonance imaging. Results Tongue fat tissue and fat proportion significantly reduced after semaglutide vs placebo (-1.94 ± 5.51 vs. + 3.12 ± 4.87 cm3, p = 0.022, and −0.02 ± 0.07 vs. 0.04 ± 0.06, p = 0.010, respectively). Correlation analysis rev…
A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma
2014
Purpose To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). Design Prospective, multicenter, randomized, single-masked, controlled clinical trial. Participants One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. Methods On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Wa…
Clinical and Microbiologic Effects of Subgingival Controlled-Release Delivery of Chlorhexidine Chip in the Treatment of Periodontitis: A Multicenter …
2008
Background: The main therapeutic approach for periodontal diseases is mechanical treatment of root surfaces via scaling and root planing (SRP). Multicenter clinical trials have demonstrated that the adjunctive use of a chlorhexidine (CHX) chip is effective in improving clinical results compared to SRP alone. However, some recent studies failed to confirm these clinical results, and conflicting results were reported regarding the effects of the CHX chip on subgingival microflora. The aim of this study was to provide further data on the clinical and microbiologic effects of CHX chips when used as an adjunct to SRP. Methods: A total of 116 systemically healthy individuals with moderate to adva…
Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent.
2014
Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms.OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery…
Autologous whole blood injections to patients with chronic urticaria and a positive autologous serum skin test: a placebo-controlled trial.
2005
<i>Background:</i> Patients with chronic urticaria (CU) frequently exhibit positive skin test reactions to autologous serum (ASST). Therapies aimed at inducing tolerance to circulating histamine-releasing factors in ASST+ CU patients, e.g. by treatment with autologous whole blood (AWB), have not yet been tested. <i>Objective:</i> To test whether ASST+ CU patients can benefit from repeated low-dose intramuscular injections of AWB. <i>Methods:</i> We characterized CU severity and duration, anti-Fc<sub>&#917;</sub>RI and anti-IgE expression, use of antihistamines, and quality of life in 56 CU patients (ASST+: 35, ASST–: 21) and assessed the t…
A randomized clinical trial to evaluate the plaque removal efficacy of an oscillating-rotating toothbrush versus a sonic toothbrush in orthodontic pa…
2018
ABSTRACT Objective: To compare the plaque removal efficacy of an oscillating-rotating electric toothbrush with an orthodontic brush head versus a sonic toothbrush in adolescent patients with fixed orthodontic appliances. Materials and Methods: This was a randomized, examiner-blind, replicate single-use, two-treatment, four-period, crossover study with a washout period between visits of approximately 24 hours. Forty-four adolescent patients with fixed orthodontic appliances in both arches were randomized based on a computer-generated randomization schedule to one of four toothbrush treatment sequences. The primary outcome was plaque score change from baseline, measured using digital plaque i…
Closed-Loop Automatic Oxygen Control (CLAC) in Preterm Infants: A Randomized Controlled Trial
2014
BACKGROUND AND OBJECTIVE: In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FIO2) is often difficult and time consuming. We developed a system for closed-loop automatic control (CLAC) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study. The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels. METHODS: We performed a multicenter, randomized controlled, crossover clinical trial in 34 preterm infa…
Response of periodontium to mineral trioxide aggregate and Biodentine: a pilot histological study on humans.
2018
Background The aim of this study was to investigate for the first time the histological response of human periodontium to mineral trioxide aggregate (MTA) and Biodentine. Methods Six patients scheduled for implant full-arch rehabilitation were randomly assigned to one of the two test groups: MTA or Biodentine treatment. For each patient, two teeth scheduled for strategic extraction were randomly assigned either to the test or to the control treatment. A lateral perforation was drilled on the root and either repaired with MTA/Biodentine or filled with gutta-percha(control). Three months later, the teeth were extracted along with the coronal third of the alveolar bone and a portion of gingiva…
Chronic lateral epicondylitis of the elbow: A prospective study of low-energy shockwave therapy and low-energy shockwave therapy plus manual therapy …
2001
Abstract Rompe JD, Riedel C, Betz U, Fink C. Chronic lateral epicondylitis of the elbow: a prospective study of low-energy shockwave therapy and low-energy shockwave therapy plus manual therapy of the cervical spine. Arch Phys Med Rehabil 2001;82:578-82. Objective: To compare the effects of extracorporeal shockwave therapy (ESWT) alone with a combination of ESWT and manual therapy of the cervical spine in treating chronic tennis elbow. Design: Prospective, matched single-blind control trial. Setting: University hospital clinic. Patients: Thirty patients with unilateral chronic tennis elbow, an unsuccessful conservative therapy during the 6 months before referral, and clinical signs of cervi…
Effects of a low-frequency sound wave therapy programme on functional capacity, blood circulation and bone metabolism in frail old men and women
2009
Objective: To evaluate the effects of a low-frequency sound wave therapy programme on functional capacity, blood circulation and bone metabolism of the frail elderly. Design: Single-blind, randomized, controlled trial. Setting: Two senior service centres. Subjects: Forty-nine volunteers (14 males and 35 females) aged 62—93 years with up to 12 diagnosed diseases were allocated in either the intervention group (n = 30) or control group (n = 19). Intervention: The intervention group underwent sound wave therapy, 3—5 times a week for 30 minutes per session over a period of 6 months. The control group received no intervention. Main measurements: Blood pressure, functional capacity, mobility, bo…