Search results for "blind"
showing 10 items of 1063 documents
A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic ha…
2021
BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who re…
Tryptophan Fortification of Adapted Formula Increases Plasma Tryptophan Concentrations to Levels Not Different from Those Found in Breast-Fed Infants
1992
Several recent studies have demonstrated significantly lower plasma total tryptophan concentrations in formula-fed than in breast-fed infants. We have measured preprandial plasma amino acid concentrations in infants breast-fed or fed a formula with a protein concentration of 1.57 g/dl and with a whey/casein ratio of 60:40 or a formula with a protein concentration of 1.37 g/dl and a whey/casein ratio of 40:60 and fortified with 10 mg/dl (15 mg/100 kcal) of tryptophan. Healthy term infants (10 per group) were either breast-fed from birth or randomly assigned to one of the two study formulas. At 4 and 12 weeks of age, anthropometric measurements were performed and blood samples were obtained. …
The effect of hormone replacement therapy and/or exercise on skeletal muscle attenuation in postmenopausal women: a yearlong intervention
2005
Hormone replacement therapy (HRT) has been reported to exert a positive effect on preserving muscle strength following the menopause, however, the mechanism of action remains unclear. We examined whether the mechanism involved preservation of muscle composition as determined by skeletal muscle attenuation. Eighty women aged 50-57 years were randomly assigned to either: HRT, exercise (Ex), HRT + exercise (ExHRT), and control (Co) for 1 year. The study was double-blinded with subjects receiving oestradiol and norethisterone acetate (Kliogest) or placebo. Exercise included progressive high-impact training for the lower limbs. Skeletal muscle attenuation in Hounsfield units (HU) was determined …
Crataegus laevigata decreases neutrophil elastase and has hypolipidemic effect: a randomized, double-blind, placebo-controlled trial.
2011
Crataegus laevigata is a medicinal plant most commonly used for the treatment of heart failure and psychosomatic disorders. Based on previous experimental findings, this double-blind placebo-controlled study was aimed at finding beneficial effects of C. laevigata on biomarkers of coronary heart disease (CHD). The study included 49 diabetic subjects with chronic CHD who were randomly assigned to the treatment for 6 months with either a micronized flower and leaf preparation of C. laevigata (400 mg three times a day) or a matching placebo. Blood cell count, lipid profile, C-reactive protein, neutrophil elastase (NE) and malondialdehyde were analyzed in plasma at baseline, at one month and six…
Effects of hormone replacement therapy and high-impact physical exercise on skeletal muscle in post-menopausal women: a randomized placebo-controlled…
2001
An age-related decline in muscle performance is a known risk factor for falling, fracture and disability. In women, a clear deterioration is observed from early menopause. The effect of hormone replacement therapy (HRT) in preserving muscle performance is, however, unclear. This trial examined the effects of a 12-month HRT and high-impact physical exercise regimen on skeletal muscle in women in early menopause. A total of 80 women aged 50–57 years were assigned randomly to one of four groups: exercise (Ex), HRT, exercise+HRT (ExHRT) and control (Co). The exercise groups participated in a high-impact training programme. The administration of HRT (oestradiol/noretisterone acetate) or placebo …
Effectiveness of amlexanox and adcortyl for the treatment of recurrent aphthous ulcers
2015
Background Recurrent aphthous stomatitis (RAS) is a common condition that affects approximately 20% of the general population. The ulcers can interfere with speech and eating and cause significant pain and discomfort. This study aimed to evaluate the efficacy of Amlexanox and Adcortyl in the treatment of aphthous ulcers. Material and Methods In this randomized double blind clinical trial with sequential patient entry, a total of 40 patients who presented with aphthous ulcers were included. Patients were received Amlexanox or Adcortyl four times daily for 7 days. Patients were evaluated for pain, lesion size, and tingling at one day, three days, five days and seven days follow-ups. The treat…
The evaluation of psychiatric drug therapy on oral lichen planus patients with psychiatric disorders
2008
Objectives: Current treatments of oral lichen planus are palliative, not curative. Because psychiatric disorders significantly influence the development and severity of oral lichen planus, the use of psychiatric drug therapy may be an adjunct in treatment. The purpose of this study was to determine the efficacy of drug therapy of psychiatric disorders in oral lichen planus. Study design: Our controlled clinical study consisted of forty-six patients with oral lichen planus and psychiatric disorders who were randomly divided into two groups. Both groups were given topical corticosteroids and the study group received additional psychiatric drug therapy. Patients were monitored for a period of …
Sarcosinaemia in a retarded, amaurotic child.
1986
A 9-month-old Turkish girl demonstrated an abnormal qualitative amino acid excretion pattern suggestive of sarcosinaemia. She was blind and had evidence of developmental and motor retardation. No other physical abnormalities were noted. Quantitative amino acid analysis revealed elevated serum and urine sarcosine levels. An oral sarcosine loading test showed an exaggerated response with a delayed conversion to glycine. Sarcosine was undetected in other family members.
The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area…
2018
Abstract Background Liver transplantation is the best treatment for end-stage liver disease. The interruption of the blood supply to the donor liver during cold storage damages the liver, affecting how well the liver will function after transplant. The drug Simvastatin may help to protect donor livers against this damage and improve outcomes for transplant recipients. The aim of this study is to evaluate the benefits of treating the donor liver with Simvastatin compared with the standard transplant procedure. Patient and methods We propose a prospective, double-blinded, randomized phase 2 study of 2 parallel groups of eligible adult patients. We will compare 3-month, 6-month, and 12-month g…
Imaging of Ventriculoperitoneal Shunt Complications: Comparison of Whole Body Low-Dose Computed Tomography and Radiographic Shunt Series.
2016
OBJECTIVE To determine diagnostic value and radiation exposure of low-dose computed tomography (LD-CT) compared to radiographic shunt series (SS) for the detection of ventriculoperitoneal (VP) shunt complications. METHODS Fourteen VP shunts were implanted in 7 swine cadavers. Mechanical complications were induced in 50% of VP shunts. Low-dose CT (80 kVp, 10 mAs, Pitch = 1.5) and SS were acquired. Dose area product (DAP) and effective doses for SS and LD-CT were collected. Scoring of diagnostic confidence and blinded readings of SS and CT data were performed. RESULTS The sensitivity of LD-CT was high (0.97; 95% confidence interval, 0.91-1.00) with excellent interobserver agreement (κ = 0.88)…