Search results for "controlled"
showing 10 items of 2729 documents
Ezetimibe alone or in combination with simvastatin increases small, dense low-density lipoproteins in healthy men: a randomized trial
2010
Aims The predominance of small dense low-density lipoproteins (sdLDLs) has been associated with increased cardiovascular risk. The effect of ezetimibe on LDL subfraction distribution has not been fully elucidated. This study assessed by gradient gel electrophoresis the effects of ezetimibe alone, simvastatin alone, and their combination on sdLDL subfraction distribution. Methods and results A single-centre, randomized, parallel three-group open-label study was performed in 72 healthy men with a baseline LDL-cholesterol (LDL-C) concentration of 111 ± 30 mg/dL (2.9 ± 0.8 mmol/L). They were treated with ezetimibe (10 mg/day, n = 24), simvastatin (40 mg/day, n = 24), or their combination ( n = …
Bone Marrow Concentrate and Bovine Bone Mineral for Sinus Floor Augmentation
2011
Purpose: The purpose of this work was to evaluate the potential of substituting autogenous bone (AB) by bone marrow aspirate concentrate (BMAC). Both AB and BMAC were tested in combination with a bovine bone mineral (BBM) for their ability of new bone formation (NBF) in a multicentric, randomized, controlled, clinical and histological noninferiority trial.Materials and Methods: Forty-five severely atrophied maxillary sinus from 26 patients were evaluated in a partial cross-over design. As test arm, 34 sinus of 25 patients were augmented with BBM and BMAC containing mesenchymal stem cells. Eleven control sinus from 11 patients were augmented with a mixture of 70% BBM and 30% AB. Biopsies wer…
A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma.
2015
The efficacy and safety of nab-paclitaxel versus dacarbazine in patients with metastatic melanoma was evaluated in a phase III randomized, controlled trial.Chemotherapy-naïve patients with stage IV melanoma received nab-paclitaxel 150 mg/m(2) on days 1, 8, and 15 every 4 weeks or dacarbazine 1000 mg/m(2) every 3 weeks. The primary end point was progression-free survival (PFS) by independent radiologic review; the secondary end point was overall survival (OS).A total of 529 patients were randomized to nab-paclitaxel (n = 264) or dacarbazine (n = 265). Baseline characteristics were well balanced. The majority of patients were men (66%), had an Eastern Cooperative Oncology Group status of 0 (7…
Sociodemographic, Lifestyle and Medical Factors Associated with Helicobacter Pylori Infection
2020
Background and Aims: The prevalence of Helicobacter pylori (H. pylori) infection is higher in developing countries and is often linked to lower socioeconomic status. Few studies have investigated the association between H. pylori and individual level characteristics in Europe, where several countries have a high prevalence of H. pylori infection. The study aimed to identify risk factors for H. pylori infection among adults in a large clinical trial in Latvia.
 Methods: 1,855 participants (40-64 years) of the “Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality” (GISTAR study) in Latvia tested for H. pylori IgG antibodi…
Single-Sided Deafness: Impact of Cochlear Implantation on Speech Perception in Complex Noise and on Auditory Localization Accuracy.
2017
Objective To assess auditory localization accuracy and speech reception threshold (SRT) in complex noise conditions in adult patients with acquired single-sided deafness, after intervention with a cochlear implant (CI) in the deaf ear. Study design Nonrandomized, open, prospective patient series. Setting Tertiary referral university hospital. Patients Eleven patients with late-onset single-sided deafness (SSD) and normal hearing in the unaffected ear, who received a CI. All patients were experienced CI users. Intervention Unilateral cochlear implantation. Main outcome measures Speech perception was tested in a complex multitalker equivalent noise field consisting of multiple sound sources. …
Physical loading and performance as predictors of back pain in healthy adults. A 5-year prospective study.
1996
We investigated muscle strength, aerobic power, and occupational and leisure-time physical loading as predictors of back pain in a 5-year follow-up study. A cohort of 456 adults aged 25, 35, 45 and 55 years, free of back pain, participated in measurements of anthropometric characteristics, aerobic power and muscle strength characteristics at baseline. The subjects' levels and types of physical activity and occupational physical loading were also determined. At 5 years after the baseline examinations 356 of these subjects (78.1 %) were reached by mail, and 262 of them (73.6%) properly completed and returned a questionnaire including a detailed back pain history for the 5 years following the …
Combined Strength and Endurance Training Improves Health-Related Quality of Life in Healthy Middle-Aged and Older Adults
2012
The purpose of this study was to evaluate the effects of 21 weeks of strength and/or endurance training on health related quality of life (HRQoL) in 39-77 year-old healthy subjects. 108 men and 96 women were randomized into endurance, strength, or combined training groups and controls. Strength-group performed high-intensity strength training while endurance-group performed cycle training. Combined-group completed both training protocols. Leg extension strength and maximal oxygen uptake were measured. HRQoL was assessed with a Finnish version of SF-36 questionnaire. A significant training-induced difference was observed between groups (p=0.038) in the vitality dimension of HRQoL, which was …
An Integrative Cognitive Behavioral Therapy Program for Adults With Migraine: A Feasibility Study
2019
Objective To present a novel cognitive behavioral therapy program that was developed exclusively for adults with migraine, and to assess the feasibility of this program. Background Unlike previous efforts, we combined different approaches of behavioral therapy into one program: relaxation therapy, cognitive behavioral therapy, trigger management. Methods The treatment program consists of 7 sessions (including psychoeducation, lifestyle counseling, coping with fear of attacks, trigger management, and stress management). The research was conducted in a single-group study with N = 9 completers (age: M = 41.6, SD = 17.6 years; N = 8 female, N = 1 male; N = 5 migraine without aura, N = 2 migrain…
A telemedicine platform to improve clinical parameters in paranoid schizophrenia patients: Results of a one-year randomized study
2018
Objective The study objective was to test a smartphone-based MONEO platform designed to improve the clinical condition of paranoid schizophrenia patients. Telemedicine treatment is considered to be as effective as traditional treatment in outpatient clinics. Method A total of 290 patients with paranoid schizophrenia in the symptomatic remission state were recruited to this 12-month multicenter, open-label randomized trial. A study group (n = 191) received a smartphone with the MONEO platform installed. Patients conducted cognitive training twice a week. Patients' mental state was assessed every month via teleconference. A placebo group (n = 99) received a platform with functionality limited…
Effects of a workplace physical exercise intervention on the intensity of headache and neck and shoulder symptoms and upper extremity muscular streng…
2004
The purpose of the study was to examine the effects of a workplace physical exercise intervention on the perceived intensity of headache and the intensity of symptoms in the neck and shoulders, as well as on the extension and flexion strength of the upper extremities. The study was a cluster randomized controlled trial. The cross-over design consisted of physical exercise intervention (15 weeks) and no-intervention (15 weeks). The subjects (n=53) were office workers (mean age 46.6 (SD 8.4)) who reported headache (n=41) symptoms in the neck (n=37) or shoulders (n=41), which had restricted their daily activities during the last 12 months. Pain symptoms were measured using the Borg CR10 scale …